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LitCovid-OGER-BB

Id Subject Object Predicate Lexical cue
T1 4-14 SP_7 denotes SARS-CoV-2
T2 107-115 SP_7 denotes COVID-19
T3 153-161 SP_7 denotes COVID-19
T4 377-387 CHEBI:6078 denotes ivermectin
T5 377-387 CHEBI:6078 denotes ivermectin
T6 426-434 SP_7 denotes COVID-19
T7 539-549 SP_7 denotes SARS-CoV-2
T8 599-613 UBERON:0001728 denotes nasopharyngeal
T9 702-712 CHEBI:31705 denotes ivermectin
T10 702-712 CHEBI:31705 denotes ivermectin
T11 727-737 SP_7 denotes SARS-CoV-2
T12 738-743 NCBITaxon:10239 denotes viral
T13 756-770 UBERON:0001728 denotes nasopharyngeal
T14 992-1002 CHEBI:31705 denotes ivermectin
T15 992-1002 CHEBI:31705 denotes ivermectin
T16 1056-1062 UBERON:0002405 denotes immune
T17 1056-1071 GO:0006955 denotes immune response
T18 1080-1090 SP_7 denotes SARS-CoV-2
T19 1142-1152 SP_7 denotes SARS-CoV-2
T20 1352-1362 CHEBI:31705 denotes ivermectin
T21 1352-1362 CHEBI:31705 denotes ivermectin
T22 1544-1558 UBERON:0001728 denotes nasopharyngeal
T23 1577-1587 SP_7 denotes SARS-CoV-2
T24 1605-1613 SP_7 denotes COVID-19
T25 1703-1711 GO:0007565 denotes pregnant
T26 1856-1864 SP_7 denotes COVID-19
T27 1947-1957 SP_7 denotes SARS-CoV-2
T28 2101-2110 GO:0007565 denotes pregnancy
T29 2516-2524 SP_7 denotes COVID-19
T30 2589-2594 UBERON:0001443 denotes chest
T31 2664-2667 GO:0071735 denotes IgG
T32 2676-2686 SP_7 denotes SARS-CoV-2
T33 2844-2848 UBERON:0000970 denotes eyes
T34 2899-2908 UBERON:0002048 denotes Pulmonary
T35 2964-2969 UBERON:0002113 denotes renal
T36 2989-2997 UBERON:0001621 denotes coronary
T37 3017-3032 UBERON:0002037 denotes cerebrovascular
T38 3118-3125 NCBITaxon:7209 denotes Loa loa
T39 3301-3308 PR:000006130 denotes CYP 3A4
T40 3317-3326 CHEBI:35222 denotes inhibitor
T41 3317-3326 CHEBI:35222 denotes inhibitor
T42 3327-3332 CHEBI:23888 denotes drugs
T43 3327-3332 CHEBI:23888 denotes drugs
T44 3341-3350 CHEBI:28593 denotes quinidine
T45 3341-3350 CHEBI:28593 denotes quinidine
T46 3352-3362 CHEBI:2663 denotes amiodarone
T47 3352-3362 CHEBI:2663 denotes amiodarone
T48 3364-3373 CHEBI:101278 denotes diltiazem
T49 3364-3373 CHEBI:101278 denotes diltiazem
T50 3375-3389 CHEBI:9241 denotes spironolactone
T51 3375-3389 CHEBI:9241 denotes spironolactone
T52 3391-3400 CHEBI:9948 denotes verapamil
T53 3391-3400 CHEBI:9948 denotes verapamil
T54 3402-3416 CHEBI:3732 denotes clarithromycin
T55 3402-3416 CHEBI:3732 denotes clarithromycin
T56 3402-3416 DG_11 denotes clarithromycin
T57 3418-3430 CHEBI:23953 denotes erythromycin
T58 3418-3430 CHEBI:23953 denotes erythromycin
T59 3418-3430 DG_16 denotes erythromycin
T60 3432-3444 CHEBI:6076 denotes itraconazole
T61 3432-3444 CHEBI:6076 denotes itraconazole
T62 3446-3458 CHEBI:47519 denotes ketoconazole
T63 3446-3458 CHEBI:47519 denotes ketoconazole
T64 3460-3472 CHEBI:27641 denotes cyclosporine
T65 3460-3472 CHEBI:27641 denotes cyclosporine
T66 3474-3484 CHEBI:15891 denotes tacrolimus
T67 3474-3484 CHEBI:15891 denotes tacrolimus
T68 3486-3495 CHEBI:44032 denotes indinavir
T69 3486-3495 CHEBI:44032 denotes indinavir
T70 3486-3495 DG_21 denotes indinavir
T71 3497-3506 CHEBI:45409 denotes ritonavir
T72 3497-3506 CHEBI:45409 denotes ritonavir
T73 3497-3506 DG_30 denotes ritonavir
T74 3510-3520 DG_40 denotes cobicistat
T75 3538-3544 PR:000006130 denotes CYP3A4
T76 3555-3560 CHEBI:23888 denotes drugs
T77 3555-3560 CHEBI:23888 denotes drugs
T78 3569-3577 CHEBI:10033 denotes warfarin
T79 3569-3577 CHEBI:10033 denotes warfarin
T80 3804-3814 GO:0042697 denotes menopausal
T81 3843-3855 GO:0042703 denotes menstruation
T82 4243-4251 SP_7 denotes COVID-19
T83 4937-4942 NCBITaxon:10239 denotes virus
T84 5088-5098 SP_7 denotes SARS-CoV-2
T85 5110-5124 UBERON:0001728 denotes nasopharyngeal
T86 5172-5177 NCBITaxon:10239 denotes viral
T87 5404-5409 GO:0016265 denotes death
T88 5498-5502 CHEBI:23888 denotes drug
T89 5498-5502 CHEBI:23888 denotes drug
T90 5562-5565 GO:0071735 denotes IgG
T91 5567-5570 GO:0071735 denotes IgM
T92 5572-5575 GO:0071735 denotes IgA
T93 5623-5633 SP_7 denotes SARS-CoV-2
T94 5643-5650 CL:0000084 denotes T cells
T95 5793-5796 GO:0071735 denotes IgG
T96 5798-5801 GO:0071735 denotes IgM
T97 5803-5806 GO:0071735 denotes IgA
T98 6422-6428 NCBITaxon:9606 denotes person
T99 6447-6451 CHEBI:23888 denotes drug
T100 6447-6451 CHEBI:23888 denotes drug

Inflammaging

Id Subject Object Predicate Lexical cue
T1 0-214 Sentence denotes The SARS-CoV-2 Ivermectin Navarra-ISGlobal Trial (SAINT) to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission in low risk, non-severe COVID-19 patients in the first 48 hours after symptoms onset:
T2 215-293 Sentence denotes A structured summary of a study protocol for a randomized control pilot trial.
T3 294-305 Sentence denotes OBJECTIVES:
T4 306-643 Sentence denotes The primary objective is to determine the efficacy of a single dose of ivermectin, administered to low risk, non-severe COVID-19 patients in the first 48 hours after symptom onset to reduce the proportion of patients with detectable SARS-CoV-2 RNA by Polymerase Chain Reaction (PCR) test from nasopharyngeal swab at day 7 post-treatment.
T5 644-673 Sentence denotes The secondary objectives are:
T6 674-1153 Sentence denotes 1.To assess the efficacy of ivermectin to reduce the SARS-CoV-2 viral load in the nasopharyngeal swab at day 7 post treatment.2.To assess the efficacy of ivermectin to improve symptom progression in treated patients.3.To assess the proportion of seroconversions in treated patients at day 21.4.To assess the safety of ivermectin at the proposed dose.5.To determine the magnitude of immune response against SARS-CoV-2.6.To assess the early kinetics of immunity against SARS-CoV-2.
T7 1154-1281 Sentence denotes TRIAL DESIGN: SAINT is a single centre, double-blind, randomized, placebo-controlled, superiority trial with two parallel arms.
T8 1282-1467 Sentence denotes Participants will be randomized to receive a single dose of 400 μg/kg ivermectin or placebo, and the number of patients in the treatment and placebo groups will be the same (1:1 ratio).
T9 1468-1481 Sentence denotes PARTICIPANTS:
T10 1482-1671 Sentence denotes The population for the study will be patients with a positive nasopharyngeal swab PCR test for SARS-CoV-2, with non-severe COVID-19 disease, and no risk factors for progression to severity.
T11 1672-1809 Sentence denotes Vulnerable populations such as pregnant women, minors (i.e.; under 18 years old), and seniors (i.e.; over 60 years old) will be excluded.
T12 1810-1831 Sentence denotes Inclusion criteria 1.
T13 1832-1962 Sentence denotes Patients diagnosed with COVID-19 in the emergency room of the Clínica Universidad de Navarra (CUN) with a positive SARS-CoV-2 PCR.
T14 1963-1965 Sentence denotes 2.
T15 1966-2021 Sentence denotes Residents of the Pamplona basin ("Cuenca de Pamplona").
T16 2022-2024 Sentence denotes 3.
T17 2025-2088 Sentence denotes The patient must be between the ages of 18 and 60 years of age.
T18 2089-2091 Sentence denotes 4.
T19 2092-2148 Sentence denotes Negative pregnancy test for women of child bearing age*.
T20 2149-2151 Sentence denotes 5.
T21 2152-2246 Sentence denotes The patient or his/her representative, has given informed consent to participate in the study.
T22 2247-2249 Sentence denotes 6.
T23 2250-2401 Sentence denotes The patient should, in the PI's opinion, be able to comply with all the requirements of the clinical trial (including home follow up during isolation).
T24 2402-2423 Sentence denotes Exclusion criteria 1.
T25 2424-2460 Sentence denotes Known history of ivermectin allergy.
T26 2461-2463 Sentence denotes 2.
T27 2464-2512 Sentence denotes Hypersensitivity to any component of ivermectin.
T28 2513-2515 Sentence denotes 3.
T29 2516-2535 Sentence denotes COVID-19 pneumonia.
T30 2536-2601 Sentence denotes Diagnosed by the attending physician.Identified in a chest X-ray.
T31 2602-2604 Sentence denotes 4.
T32 2605-2651 Sentence denotes Fever or cough present for more than 48 hours.
T33 2652-2654 Sentence denotes 5.
T34 2655-2712 Sentence denotes Positive IgG against SARS-CoV-2 by rapid diagnostic test.
T35 2713-2715 Sentence denotes 6.
T36 2716-2746 Sentence denotes Age under 18 or over 60 years.
T37 2747-2749 Sentence denotes 7.
T38 2750-2860 Sentence denotes The following co-morbidities (or any other disease that might interfere with the study in the eyes of the PI):
T39 2861-3058 Sentence denotes Immunosuppression.Chronic Obstructive Pulmonary Disease.Diabetes.Hypertension.Obesity.Acute or chronic renal failure.History of coronary disease.History of cerebrovascular disease.Current neoplasm.
T40 3059-3061 Sentence denotes 8.
T41 3062-3282 Sentence denotes Recent travel history to countries that are endemic for Loa loa (Angola, Cameroon, Central African Republic, Chad, Democratic Republic of Congo, Ethiopia, Equatorial, Guinea, Gabon, Republic of Congo, Nigeria and Sudan).
T42 3283-3285 Sentence denotes 9.
T43 3286-3521 Sentence denotes Current use of CYP 3A4 or P-gp inhibitor drugs such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat.
T44 3522-3732 Sentence denotes Use of critical CYP3A4 substrate drugs such as warfarin. *Women of child bearing age may participate if they use a safe contraceptive method for the entire period of the study and at least one month afterwards.
T45 3733-3935 Sentence denotes A woman is considered to not have childbearing capacity if she is post-menopausal (minimum of 2 years without menstruation) or has undergone surgical sterilization (at least one month before the study).
T46 3936-4161 Sentence denotes The trial is currently planned at a single center, Clínica Universidad de Navarra, in Navarra (Spain), and the immunology samples will be analyzed at the Barcelona Institute for Global Health (ISGlobal), in Barcelona (Spain).
T47 4162-4268 Sentence denotes Participants will be recruited by the investigators at the emergency room and/or COVID-19 area of the CUN.
T48 4269-4384 Sentence denotes They will remain in the trial for a period of 28 days at their homes since they will be patients with mild disease.
T49 4385-4585 Sentence denotes In the interest of public health and to contain transmission of infection, follow-up visits will be conducted in the participant's home by a clinical trial team comprising nursing and medical members.
T50 4586-4661 Sentence denotes Home visits will assess clinical and laboratory parameters of the patients.
T51 4662-4690 Sentence denotes INTERVENTION AND COMPARATOR:
T52 4691-4829 Sentence denotes Ivermectin will be administered to the treatment group at a 400μg/Kg dose (included in the EU approved label of Stromectol and Scabioral).
T53 4830-4869 Sentence denotes The control group will receive placebo.
T54 4870-5025 Sentence denotes There is no current data on the efficacy of ivermectin against the virus in vivo, therefore the use of placebo in the control group is ethically justified.
T55 5026-5040 Sentence denotes MAIN OUTCOMES:
T56 5041-5154 Sentence denotes Primary Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab at day 7 post-treatment.
T57 5155-5845 Sentence denotes Secondary 1.Mean viral load as determined by PCR cycle threshold (Ct) at baseline and on days 4, 7, 14, and 21.2.Proportion of patients with fever and cough at days 4, 7, 14, and 21 as well as proportion of patients progressing to severe disease or death during the trial.3.Proportion of patients with seroconversion at day 21.4.Proportion of drug-related adverse events during the trial.5.Median levels of IgG, IgM, IgA measured by Luminex, frequencies of innate and SARS-CoV-2-specific T cells assessed by flow cytometry, median levels of inflammatory and activation markers measured by Luminex and transcriptomics.6.Median kinetics of IgG, IgM, IgA levels during the trial, until day 28.
T58 5846-5860 Sentence denotes RANDOMISATION:
T59 5861-6033 Sentence denotes Eligible patients will be allocated in a 1:1 ratio using a randomization list generated by the trial statistician using blocks of four to ensure balance between the groups.
T60 6034-6233 Sentence denotes A study identification code with the format "SAINT-##" (##: from 01 to 24) will be generated using a sequence of random numbers so that the randomization number does not match the subject identifier.
T61 6234-6337 Sentence denotes The sequence and code used will be kept in an encrypted file accessible only to the trial statistician.
T62 6338-6497 Sentence denotes A physical copy will be kept in a locked cabinet at the CUN, accessible only to the person administering the drug who will not enrol or attend to patient care.
T63 6498-6585 Sentence denotes A separate set of 24 envelopes for emergency unblinding will be kept in the study file.
T64 6586-6605 Sentence denotes BLINDING (MASKING):
T65 6606-6663 Sentence denotes The clinical trial team and the patients will be blinded.
T66 6664-6803 Sentence denotes The placebo will not be visibly identical, but it will be administered by staff not involved in the clinical care or participant follow up.
T67 6804-6843 Sentence denotes NUMBERS TO BE RANDOMISED (SAMPLE SIZE):
T68 6844-6875 Sentence denotes The sample size is 24 patients:
T69 6876-6975 Sentence denotes 12 participants will be randomised to the treatment group and 12 participants to the control group.
T70 6976-6989 Sentence denotes TRIAL STATUS:
T71 6990-7015 Sentence denotes Current protocol version:
T72 7016-7043 Sentence denotes 1.0 dated 16 of April 2020.
T73 7044-7112 Sentence denotes Recruitment is envisioned to begin by May 14th and end by June 14th.
T74 7113-7132 Sentence denotes TRIAL REGISTRATION:
T75 7133-7148 Sentence denotes EudraCT number:
T76 7149-7186 Sentence denotes 2020-001474-29, registered April 1st.
T77 7187-7247 Sentence denotes Clinicaltrials.gov: submitted, pending number FULL PROTOCOL:
T78 7248-7356 Sentence denotes The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1).
T79 7357-7537 Sentence denotes In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
T1 0-214 Sentence denotes The SARS-CoV-2 Ivermectin Navarra-ISGlobal Trial (SAINT) to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission in low risk, non-severe COVID-19 patients in the first 48 hours after symptoms onset:
T2 215-293 Sentence denotes A structured summary of a study protocol for a randomized control pilot trial.
T3 294-305 Sentence denotes OBJECTIVES:
T4 306-643 Sentence denotes The primary objective is to determine the efficacy of a single dose of ivermectin, administered to low risk, non-severe COVID-19 patients in the first 48 hours after symptom onset to reduce the proportion of patients with detectable SARS-CoV-2 RNA by Polymerase Chain Reaction (PCR) test from nasopharyngeal swab at day 7 post-treatment.
T5 644-673 Sentence denotes The secondary objectives are:
T6 674-1153 Sentence denotes 1.To assess the efficacy of ivermectin to reduce the SARS-CoV-2 viral load in the nasopharyngeal swab at day 7 post treatment.2.To assess the efficacy of ivermectin to improve symptom progression in treated patients.3.To assess the proportion of seroconversions in treated patients at day 21.4.To assess the safety of ivermectin at the proposed dose.5.To determine the magnitude of immune response against SARS-CoV-2.6.To assess the early kinetics of immunity against SARS-CoV-2.
T7 1154-1281 Sentence denotes TRIAL DESIGN: SAINT is a single centre, double-blind, randomized, placebo-controlled, superiority trial with two parallel arms.
T8 1282-1467 Sentence denotes Participants will be randomized to receive a single dose of 400 μg/kg ivermectin or placebo, and the number of patients in the treatment and placebo groups will be the same (1:1 ratio).
T9 1468-1481 Sentence denotes PARTICIPANTS:
T10 1482-1671 Sentence denotes The population for the study will be patients with a positive nasopharyngeal swab PCR test for SARS-CoV-2, with non-severe COVID-19 disease, and no risk factors for progression to severity.
T11 1672-1809 Sentence denotes Vulnerable populations such as pregnant women, minors (i.e.; under 18 years old), and seniors (i.e.; over 60 years old) will be excluded.
T12 1810-1831 Sentence denotes Inclusion criteria 1.
T13 1832-1962 Sentence denotes Patients diagnosed with COVID-19 in the emergency room of the Clínica Universidad de Navarra (CUN) with a positive SARS-CoV-2 PCR.
T14 1963-1965 Sentence denotes 2.
T15 1966-2021 Sentence denotes Residents of the Pamplona basin ("Cuenca de Pamplona").
T16 2022-2024 Sentence denotes 3.
T17 2025-2088 Sentence denotes The patient must be between the ages of 18 and 60 years of age.
T18 2089-2091 Sentence denotes 4.
T19 2092-2148 Sentence denotes Negative pregnancy test for women of child bearing age*.
T20 2149-2151 Sentence denotes 5.
T21 2152-2246 Sentence denotes The patient or his/her representative, has given informed consent to participate in the study.
T22 2247-2249 Sentence denotes 6.
T23 2250-2401 Sentence denotes The patient should, in the PI's opinion, be able to comply with all the requirements of the clinical trial (including home follow up during isolation).
T24 2402-2423 Sentence denotes Exclusion criteria 1.
T25 2424-2460 Sentence denotes Known history of ivermectin allergy.
T26 2461-2463 Sentence denotes 2.
T27 2464-2512 Sentence denotes Hypersensitivity to any component of ivermectin.
T28 2513-2515 Sentence denotes 3.
T29 2516-2535 Sentence denotes COVID-19 pneumonia.
T30 2536-2601 Sentence denotes Diagnosed by the attending physician.Identified in a chest X-ray.
T31 2602-2604 Sentence denotes 4.
T32 2605-2651 Sentence denotes Fever or cough present for more than 48 hours.
T33 2652-2654 Sentence denotes 5.
T34 2655-2712 Sentence denotes Positive IgG against SARS-CoV-2 by rapid diagnostic test.
T35 2713-2715 Sentence denotes 6.
T36 2716-2746 Sentence denotes Age under 18 or over 60 years.
T37 2747-2749 Sentence denotes 7.
T38 2750-2860 Sentence denotes The following co-morbidities (or any other disease that might interfere with the study in the eyes of the PI):
T39 2861-3058 Sentence denotes Immunosuppression.Chronic Obstructive Pulmonary Disease.Diabetes.Hypertension.Obesity.Acute or chronic renal failure.History of coronary disease.History of cerebrovascular disease.Current neoplasm.
T40 3059-3061 Sentence denotes 8.
T41 3062-3282 Sentence denotes Recent travel history to countries that are endemic for Loa loa (Angola, Cameroon, Central African Republic, Chad, Democratic Republic of Congo, Ethiopia, Equatorial, Guinea, Gabon, Republic of Congo, Nigeria and Sudan).
T42 3283-3285 Sentence denotes 9.
T43 3286-3521 Sentence denotes Current use of CYP 3A4 or P-gp inhibitor drugs such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat.
T44 3522-3732 Sentence denotes Use of critical CYP3A4 substrate drugs such as warfarin. *Women of child bearing age may participate if they use a safe contraceptive method for the entire period of the study and at least one month afterwards.
T45 3733-3935 Sentence denotes A woman is considered to not have childbearing capacity if she is post-menopausal (minimum of 2 years without menstruation) or has undergone surgical sterilization (at least one month before the study).
T46 3936-4161 Sentence denotes The trial is currently planned at a single center, Clínica Universidad de Navarra, in Navarra (Spain), and the immunology samples will be analyzed at the Barcelona Institute for Global Health (ISGlobal), in Barcelona (Spain).
T47 4162-4268 Sentence denotes Participants will be recruited by the investigators at the emergency room and/or COVID-19 area of the CUN.
T48 4269-4384 Sentence denotes They will remain in the trial for a period of 28 days at their homes since they will be patients with mild disease.
T49 4385-4585 Sentence denotes In the interest of public health and to contain transmission of infection, follow-up visits will be conducted in the participant's home by a clinical trial team comprising nursing and medical members.
T50 4586-4661 Sentence denotes Home visits will assess clinical and laboratory parameters of the patients.
T51 4662-4690 Sentence denotes INTERVENTION AND COMPARATOR:
T52 4691-4829 Sentence denotes Ivermectin will be administered to the treatment group at a 400μg/Kg dose (included in the EU approved label of Stromectol and Scabioral).
T53 4830-4869 Sentence denotes The control group will receive placebo.
T54 4870-5025 Sentence denotes There is no current data on the efficacy of ivermectin against the virus in vivo, therefore the use of placebo in the control group is ethically justified.
T55 5026-5040 Sentence denotes MAIN OUTCOMES:
T56 5041-5154 Sentence denotes Primary Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab at day 7 post-treatment.
T57 5155-5845 Sentence denotes Secondary 1.Mean viral load as determined by PCR cycle threshold (Ct) at baseline and on days 4, 7, 14, and 21.2.Proportion of patients with fever and cough at days 4, 7, 14, and 21 as well as proportion of patients progressing to severe disease or death during the trial.3.Proportion of patients with seroconversion at day 21.4.Proportion of drug-related adverse events during the trial.5.Median levels of IgG, IgM, IgA measured by Luminex, frequencies of innate and SARS-CoV-2-specific T cells assessed by flow cytometry, median levels of inflammatory and activation markers measured by Luminex and transcriptomics.6.Median kinetics of IgG, IgM, IgA levels during the trial, until day 28.
T58 5846-5860 Sentence denotes RANDOMISATION:
T59 5861-6033 Sentence denotes Eligible patients will be allocated in a 1:1 ratio using a randomization list generated by the trial statistician using blocks of four to ensure balance between the groups.
T60 6034-6233 Sentence denotes A study identification code with the format "SAINT-##" (##: from 01 to 24) will be generated using a sequence of random numbers so that the randomization number does not match the subject identifier.
T61 6234-6337 Sentence denotes The sequence and code used will be kept in an encrypted file accessible only to the trial statistician.
T62 6338-6497 Sentence denotes A physical copy will be kept in a locked cabinet at the CUN, accessible only to the person administering the drug who will not enrol or attend to patient care.
T63 6498-6585 Sentence denotes A separate set of 24 envelopes for emergency unblinding will be kept in the study file.
T64 6586-6605 Sentence denotes BLINDING (MASKING):
T65 6606-6663 Sentence denotes The clinical trial team and the patients will be blinded.
T66 6664-6803 Sentence denotes The placebo will not be visibly identical, but it will be administered by staff not involved in the clinical care or participant follow up.
T67 6804-6843 Sentence denotes NUMBERS TO BE RANDOMISED (SAMPLE SIZE):
T68 6844-6875 Sentence denotes The sample size is 24 patients:
T69 6876-6975 Sentence denotes 12 participants will be randomised to the treatment group and 12 participants to the control group.
T70 6976-6989 Sentence denotes TRIAL STATUS:
T71 6990-7015 Sentence denotes Current protocol version:
T72 7016-7043 Sentence denotes 1.0 dated 16 of April 2020.
T73 7044-7112 Sentence denotes Recruitment is envisioned to begin by May 14th and end by June 14th.
T74 7113-7132 Sentence denotes TRIAL REGISTRATION:
T75 7133-7148 Sentence denotes EudraCT number:
T76 7149-7186 Sentence denotes 2020-001474-29, registered April 1st.
T77 7187-7247 Sentence denotes Clinicaltrials.gov: submitted, pending number FULL PROTOCOL:
T78 7248-7356 Sentence denotes The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1).
T79 7357-7537 Sentence denotes In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

LitCovid-PD-FMA-UBERON

Id Subject Object Predicate Lexical cue fma_id
T1 550-553 Body_part denotes RNA http://purl.org/sig/ont/fma/fma67095
T2 2589-2594 Body_part denotes chest http://purl.org/sig/ont/fma/fma9576
T3 2664-2667 Body_part denotes IgG http://purl.org/sig/ont/fma/fma62872
T4 2844-2848 Body_part denotes eyes http://purl.org/sig/ont/fma/fma54448
T5 5562-5565 Body_part denotes IgG http://purl.org/sig/ont/fma/fma62872
T6 5567-5570 Body_part denotes IgM http://purl.org/sig/ont/fma/fma62873
T7 5572-5575 Body_part denotes IgA http://purl.org/sig/ont/fma/fma62874
T8 5645-5650 Body_part denotes cells http://purl.org/sig/ont/fma/fma68646
T9 5793-5796 Body_part denotes IgG http://purl.org/sig/ont/fma/fma62872
T10 5798-5801 Body_part denotes IgM http://purl.org/sig/ont/fma/fma62873
T11 5803-5806 Body_part denotes IgA http://purl.org/sig/ont/fma/fma62874

LitCovid-PD-UBERON

Id Subject Object Predicate Lexical cue uberon_id
T1 2589-2594 Body_part denotes chest http://purl.obolibrary.org/obo/UBERON_0001443

LitCovid-PD-MONDO

Id Subject Object Predicate Lexical cue mondo_id
T1 4-12 Disease denotes SARS-CoV http://purl.obolibrary.org/obo/MONDO_0005091
T2 107-115 Disease denotes COVID-19 http://purl.obolibrary.org/obo/MONDO_0100096
T3 153-161 Disease denotes COVID-19 http://purl.obolibrary.org/obo/MONDO_0100096
T4 426-434 Disease denotes COVID-19 http://purl.obolibrary.org/obo/MONDO_0100096
T5 539-547 Disease denotes SARS-CoV http://purl.obolibrary.org/obo/MONDO_0005091
T6 727-735 Disease denotes SARS-CoV http://purl.obolibrary.org/obo/MONDO_0005091
T7 1080-1088 Disease denotes SARS-CoV http://purl.obolibrary.org/obo/MONDO_0005091
T8 1142-1150 Disease denotes SARS-CoV http://purl.obolibrary.org/obo/MONDO_0005091
T9 1577-1585 Disease denotes SARS-CoV http://purl.obolibrary.org/obo/MONDO_0005091
T10 1605-1613 Disease denotes COVID-19 http://purl.obolibrary.org/obo/MONDO_0100096
T11 1856-1864 Disease denotes COVID-19 http://purl.obolibrary.org/obo/MONDO_0100096
T12 1947-1955 Disease denotes SARS-CoV http://purl.obolibrary.org/obo/MONDO_0005091
T13 2452-2459 Disease denotes allergy http://purl.obolibrary.org/obo/MONDO_0005271
T14 2464-2480 Disease denotes Hypersensitivity http://purl.obolibrary.org/obo/MONDO_0000605|http://purl.obolibrary.org/obo/MONDO_0005271
T16 2516-2524 Disease denotes COVID-19 http://purl.obolibrary.org/obo/MONDO_0100096
T17 2525-2534 Disease denotes pneumonia http://purl.obolibrary.org/obo/MONDO_0005249
T18 2676-2684 Disease denotes SARS-CoV http://purl.obolibrary.org/obo/MONDO_0005091
T19 3049-3057 Disease denotes neoplasm http://purl.obolibrary.org/obo/MONDO_0005070|http://purl.obolibrary.org/obo/MONDO_0021079
T21 4243-4251 Disease denotes COVID-19 http://purl.obolibrary.org/obo/MONDO_0100096
T22 4449-4458 Disease denotes infection http://purl.obolibrary.org/obo/MONDO_0005550
T23 5088-5096 Disease denotes SARS-CoV http://purl.obolibrary.org/obo/MONDO_0005091
T24 5623-5631 Disease denotes SARS-CoV http://purl.obolibrary.org/obo/MONDO_0005091

LitCovid-PD-CLO

Id Subject Object Predicate Lexical cue
T1 184-186 http://purl.obolibrary.org/obo/CLO_0001382 denotes 48
T2 215-216 http://purl.obolibrary.org/obo/CLO_0001020 denotes A
T3 239-240 http://purl.obolibrary.org/obo/CLO_0001020 denotes a
T4 260-261 http://purl.obolibrary.org/obo/CLO_0001020 denotes a
T5 294-304 http://purl.obolibrary.org/obo/BFO_0000030 denotes OBJECTIVES
T6 318-327 http://purl.obolibrary.org/obo/BFO_0000030 denotes objective
T7 360-361 http://purl.obolibrary.org/obo/CLO_0001020 denotes a
T8 457-459 http://purl.obolibrary.org/obo/CLO_0001382 denotes 48
T9 589-593 http://purl.obolibrary.org/obo/UBERON_0000473 denotes test
T10 658-668 http://purl.obolibrary.org/obo/BFO_0000030 denotes objectives
T11 1177-1178 http://purl.obolibrary.org/obo/CLO_0001020 denotes a
T12 1276-1280 http://www.ebi.ac.uk/efo/EFO_0001410 denotes arms
T13 1325-1326 http://purl.obolibrary.org/obo/CLO_0001020 denotes a
T14 1456-1459 http://purl.obolibrary.org/obo/CLO_0053733 denotes 1:1
T15 1533-1534 http://purl.obolibrary.org/obo/CLO_0001020 denotes a
T16 1568-1572 http://purl.obolibrary.org/obo/UBERON_0000473 denotes test
T17 1739-1741 http://purl.obolibrary.org/obo/CLO_0050510 denotes 18
T18 1936-1937 http://purl.obolibrary.org/obo/CLO_0001020 denotes a
T19 2065-2067 http://purl.obolibrary.org/obo/CLO_0050510 denotes 18
T20 2111-2115 http://purl.obolibrary.org/obo/UBERON_0000473 denotes test
T21 2191-2194 http://purl.obolibrary.org/obo/CLO_0051582 denotes has
T22 2587-2588 http://purl.obolibrary.org/obo/CLO_0001020 denotes a
T23 2589-2594 http://www.ebi.ac.uk/efo/EFO_0000965 denotes chest
T24 2642-2644 http://purl.obolibrary.org/obo/CLO_0001382 denotes 48
T25 2707-2711 http://purl.obolibrary.org/obo/UBERON_0000473 denotes test
T26 2726-2728 http://purl.obolibrary.org/obo/CLO_0050510 denotes 18
T27 2844-2848 http://www.ebi.ac.uk/efo/EFO_0000827 denotes eyes
T28 3635-3636 http://purl.obolibrary.org/obo/CLO_0001020 denotes a
T29 3733-3734 http://purl.obolibrary.org/obo/CLO_0001020 denotes A
T30 3860-3863 http://purl.obolibrary.org/obo/CLO_0051582 denotes has
T31 3970-3971 http://purl.obolibrary.org/obo/CLO_0001020 denotes a
T32 4303-4304 http://purl.obolibrary.org/obo/CLO_0001020 denotes a
T33 4524-4525 http://purl.obolibrary.org/obo/CLO_0001020 denotes a
T34 4749-4750 http://purl.obolibrary.org/obo/CLO_0001020 denotes a
T35 4794-4799 http://purl.obolibrary.org/obo/CLO_0007225 denotes label
T36 4937-4942 http://purl.obolibrary.org/obo/NCBITaxon_10239 denotes virus
T37 5077-5078 http://purl.obolibrary.org/obo/CLO_0001020 denotes a
T38 5108-5109 http://purl.obolibrary.org/obo/CLO_0001020 denotes a
T39 5643-5650 http://purl.obolibrary.org/obo/CL_0000084 denotes T cells
T40 5713-5723 http://purl.obolibrary.org/obo/CLO_0001658 denotes activation
T41 5900-5901 http://purl.obolibrary.org/obo/CLO_0001020 denotes a
T42 5902-5905 http://purl.obolibrary.org/obo/CLO_0053733 denotes 1:1
T43 5918-5919 http://purl.obolibrary.org/obo/CLO_0001020 denotes a
T44 6034-6035 http://purl.obolibrary.org/obo/CLO_0001020 denotes A
T45 6133-6134 http://purl.obolibrary.org/obo/CLO_0001020 denotes a
T46 6338-6339 http://purl.obolibrary.org/obo/CLO_0001020 denotes A
T47 6370-6371 http://purl.obolibrary.org/obo/CLO_0001020 denotes a
T48 6498-6499 http://purl.obolibrary.org/obo/CLO_0001020 denotes A
T49 7443-7446 http://purl.obolibrary.org/obo/CLO_0051582 denotes has
T50 7486-7487 http://purl.obolibrary.org/obo/CLO_0001020 denotes a

LitCovid-PD-CHEBI

Id Subject Object Predicate Lexical cue chebi_id
T1 377-387 Chemical denotes ivermectin http://purl.obolibrary.org/obo/CHEBI_6078
T2 702-712 Chemical denotes ivermectin http://purl.obolibrary.org/obo/CHEBI_6078
T3 828-838 Chemical denotes ivermectin http://purl.obolibrary.org/obo/CHEBI_6078
T4 992-1002 Chemical denotes ivermectin http://purl.obolibrary.org/obo/CHEBI_6078
T5 1352-1362 Chemical denotes ivermectin http://purl.obolibrary.org/obo/CHEBI_6078
T6 2441-2451 Chemical denotes ivermectin http://purl.obolibrary.org/obo/CHEBI_6078
T7 2501-2511 Chemical denotes ivermectin http://purl.obolibrary.org/obo/CHEBI_6078
T8 2856-2858 Chemical denotes PI http://purl.obolibrary.org/obo/CHEBI_28874|http://purl.obolibrary.org/obo/CHEBI_53806|http://purl.obolibrary.org/obo/CHEBI_61484|http://purl.obolibrary.org/obo/CHEBI_74790
T12 3301-3304 Chemical denotes CYP http://purl.obolibrary.org/obo/CHEBI_38559
T13 3317-3326 Chemical denotes inhibitor http://purl.obolibrary.org/obo/CHEBI_35222
T14 3327-3332 Chemical denotes drugs http://purl.obolibrary.org/obo/CHEBI_23888
T15 3341-3350 Chemical denotes quinidine http://purl.obolibrary.org/obo/CHEBI_28593
T16 3352-3362 Chemical denotes amiodarone http://purl.obolibrary.org/obo/CHEBI_2663
T17 3364-3373 Chemical denotes diltiazem http://purl.obolibrary.org/obo/CHEBI_101278
T18 3375-3389 Chemical denotes spironolactone http://purl.obolibrary.org/obo/CHEBI_9241
T19 3391-3400 Chemical denotes verapamil http://purl.obolibrary.org/obo/CHEBI_9948
T20 3402-3416 Chemical denotes clarithromycin http://purl.obolibrary.org/obo/CHEBI_3732
T21 3418-3430 Chemical denotes erythromycin http://purl.obolibrary.org/obo/CHEBI_42355|http://purl.obolibrary.org/obo/CHEBI_48923
T23 3432-3444 Chemical denotes itraconazole http://purl.obolibrary.org/obo/CHEBI_6076
T24 3446-3458 Chemical denotes ketoconazole http://purl.obolibrary.org/obo/CHEBI_47519
T25 3474-3484 Chemical denotes tacrolimus http://purl.obolibrary.org/obo/CHEBI_61049|http://purl.obolibrary.org/obo/CHEBI_61057
T27 3486-3495 Chemical denotes indinavir http://purl.obolibrary.org/obo/CHEBI_44032
T28 3497-3506 Chemical denotes ritonavir http://purl.obolibrary.org/obo/CHEBI_45409
T29 3510-3520 Chemical denotes cobicistat http://purl.obolibrary.org/obo/CHEBI_72291
T30 3555-3560 Chemical denotes drugs http://purl.obolibrary.org/obo/CHEBI_23888
T31 3569-3577 Chemical denotes warfarin http://purl.obolibrary.org/obo/CHEBI_10033
T32 4740-4745 Chemical denotes group http://purl.obolibrary.org/obo/CHEBI_24433
T33 4794-4799 Chemical denotes label http://purl.obolibrary.org/obo/CHEBI_35209
T34 4803-4813 Chemical denotes Stromectol http://purl.obolibrary.org/obo/CHEBI_6078
T35 4842-4847 Chemical denotes group http://purl.obolibrary.org/obo/CHEBI_24433
T36 4914-4924 Chemical denotes ivermectin http://purl.obolibrary.org/obo/CHEBI_6078
T37 4996-5001 Chemical denotes group http://purl.obolibrary.org/obo/CHEBI_24433
T38 5498-5502 Chemical denotes drug http://purl.obolibrary.org/obo/CHEBI_23888
T39 6447-6451 Chemical denotes drug http://purl.obolibrary.org/obo/CHEBI_23888
T40 6928-6933 Chemical denotes group http://purl.obolibrary.org/obo/CHEBI_24433
T41 6969-6974 Chemical denotes group http://purl.obolibrary.org/obo/CHEBI_24433
T42 7469-7475 Chemical denotes Letter http://purl.obolibrary.org/obo/CHEBI_6446

LitCovid-PD-HP

Id Subject Object Predicate Lexical cue hp_id
T1 2452-2459 Phenotype denotes allergy http://purl.obolibrary.org/obo/HP_0012393
T2 2464-2480 Phenotype denotes Hypersensitivity http://purl.obolibrary.org/obo/HP_0041092
T3 2525-2534 Phenotype denotes pneumonia http://purl.obolibrary.org/obo/HP_0002090
T4 2605-2610 Phenotype denotes Fever http://purl.obolibrary.org/obo/HP_0001945
T5 2614-2619 Phenotype denotes cough http://purl.obolibrary.org/obo/HP_0012735
T6 3049-3057 Phenotype denotes neoplasm http://purl.obolibrary.org/obo/HP_0002664
T7 5296-5301 Phenotype denotes fever http://purl.obolibrary.org/obo/HP_0001945
T8 5306-5311 Phenotype denotes cough http://purl.obolibrary.org/obo/HP_0012735

LitCovid-PD-GO-BP

Id Subject Object Predicate Lexical cue
T1 1056-1071 http://purl.obolibrary.org/obo/GO_0006955 denotes immune response
T2 2464-2480 http://purl.obolibrary.org/obo/GO_0002524 denotes Hypersensitivity
T3 3843-3855 http://purl.obolibrary.org/obo/GO_0042703 denotes menstruation

LitCovid-sentences

Id Subject Object Predicate Lexical cue
T1 0-214 Sentence denotes The SARS-CoV-2 Ivermectin Navarra-ISGlobal Trial (SAINT) to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission in low risk, non-severe COVID-19 patients in the first 48 hours after symptoms onset:
T2 215-293 Sentence denotes A structured summary of a study protocol for a randomized control pilot trial.
T3 294-305 Sentence denotes OBJECTIVES:
T4 306-643 Sentence denotes The primary objective is to determine the efficacy of a single dose of ivermectin, administered to low risk, non-severe COVID-19 patients in the first 48 hours after symptom onset to reduce the proportion of patients with detectable SARS-CoV-2 RNA by Polymerase Chain Reaction (PCR) test from nasopharyngeal swab at day 7 post-treatment.
T5 644-673 Sentence denotes The secondary objectives are:
T6 674-1153 Sentence denotes 1.To assess the efficacy of ivermectin to reduce the SARS-CoV-2 viral load in the nasopharyngeal swab at day 7 post treatment.2.To assess the efficacy of ivermectin to improve symptom progression in treated patients.3.To assess the proportion of seroconversions in treated patients at day 21.4.To assess the safety of ivermectin at the proposed dose.5.To determine the magnitude of immune response against SARS-CoV-2.6.To assess the early kinetics of immunity against SARS-CoV-2.
T7 1154-1281 Sentence denotes TRIAL DESIGN: SAINT is a single centre, double-blind, randomized, placebo-controlled, superiority trial with two parallel arms.
T8 1282-1467 Sentence denotes Participants will be randomized to receive a single dose of 400 μg/kg ivermectin or placebo, and the number of patients in the treatment and placebo groups will be the same (1:1 ratio).
T9 1468-1481 Sentence denotes PARTICIPANTS:
T10 1482-1671 Sentence denotes The population for the study will be patients with a positive nasopharyngeal swab PCR test for SARS-CoV-2, with non-severe COVID-19 disease, and no risk factors for progression to severity.
T11 1672-1809 Sentence denotes Vulnerable populations such as pregnant women, minors (i.e.; under 18 years old), and seniors (i.e.; over 60 years old) will be excluded.
T12 1810-1831 Sentence denotes Inclusion criteria 1.
T13 1832-1962 Sentence denotes Patients diagnosed with COVID-19 in the emergency room of the Clínica Universidad de Navarra (CUN) with a positive SARS-CoV-2 PCR.
T14 1963-1965 Sentence denotes 2.
T15 1966-2021 Sentence denotes Residents of the Pamplona basin ("Cuenca de Pamplona").
T16 2022-2024 Sentence denotes 3.
T17 2025-2088 Sentence denotes The patient must be between the ages of 18 and 60 years of age.
T18 2089-2091 Sentence denotes 4.
T19 2092-2148 Sentence denotes Negative pregnancy test for women of child bearing age*.
T20 2149-2151 Sentence denotes 5.
T21 2152-2246 Sentence denotes The patient or his/her representative, has given informed consent to participate in the study.
T22 2247-2249 Sentence denotes 6.
T23 2250-2401 Sentence denotes The patient should, in the PI's opinion, be able to comply with all the requirements of the clinical trial (including home follow up during isolation).
T24 2402-2423 Sentence denotes Exclusion criteria 1.
T25 2424-2460 Sentence denotes Known history of ivermectin allergy.
T26 2461-2463 Sentence denotes 2.
T27 2464-2512 Sentence denotes Hypersensitivity to any component of ivermectin.
T28 2513-2515 Sentence denotes 3.
T29 2516-2535 Sentence denotes COVID-19 pneumonia.
T30 2536-2601 Sentence denotes Diagnosed by the attending physician.Identified in a chest X-ray.
T31 2602-2604 Sentence denotes 4.
T32 2605-2651 Sentence denotes Fever or cough present for more than 48 hours.
T33 2652-2654 Sentence denotes 5.
T34 2655-2712 Sentence denotes Positive IgG against SARS-CoV-2 by rapid diagnostic test.
T35 2713-2715 Sentence denotes 6.
T36 2716-2746 Sentence denotes Age under 18 or over 60 years.
T37 2747-2749 Sentence denotes 7.
T38 2750-2860 Sentence denotes The following co-morbidities (or any other disease that might interfere with the study in the eyes of the PI):
T39 2861-3058 Sentence denotes Immunosuppression.Chronic Obstructive Pulmonary Disease.Diabetes.Hypertension.Obesity.Acute or chronic renal failure.History of coronary disease.History of cerebrovascular disease.Current neoplasm.
T40 3059-3061 Sentence denotes 8.
T41 3062-3282 Sentence denotes Recent travel history to countries that are endemic for Loa loa (Angola, Cameroon, Central African Republic, Chad, Democratic Republic of Congo, Ethiopia, Equatorial, Guinea, Gabon, Republic of Congo, Nigeria and Sudan).
T42 3283-3285 Sentence denotes 9.
T43 3286-3521 Sentence denotes Current use of CYP 3A4 or P-gp inhibitor drugs such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat.
T44 3522-3732 Sentence denotes Use of critical CYP3A4 substrate drugs such as warfarin. *Women of child bearing age may participate if they use a safe contraceptive method for the entire period of the study and at least one month afterwards.
T45 3733-3935 Sentence denotes A woman is considered to not have childbearing capacity if she is post-menopausal (minimum of 2 years without menstruation) or has undergone surgical sterilization (at least one month before the study).
T46 3936-4161 Sentence denotes The trial is currently planned at a single center, Clínica Universidad de Navarra, in Navarra (Spain), and the immunology samples will be analyzed at the Barcelona Institute for Global Health (ISGlobal), in Barcelona (Spain).
T47 4162-4268 Sentence denotes Participants will be recruited by the investigators at the emergency room and/or COVID-19 area of the CUN.
T48 4269-4384 Sentence denotes They will remain in the trial for a period of 28 days at their homes since they will be patients with mild disease.
T49 4385-4585 Sentence denotes In the interest of public health and to contain transmission of infection, follow-up visits will be conducted in the participant's home by a clinical trial team comprising nursing and medical members.
T50 4586-4661 Sentence denotes Home visits will assess clinical and laboratory parameters of the patients.
T51 4662-4690 Sentence denotes INTERVENTION AND COMPARATOR:
T52 4691-4829 Sentence denotes Ivermectin will be administered to the treatment group at a 400μg/Kg dose (included in the EU approved label of Stromectol and Scabioral).
T53 4830-4869 Sentence denotes The control group will receive placebo.
T54 4870-5025 Sentence denotes There is no current data on the efficacy of ivermectin against the virus in vivo, therefore the use of placebo in the control group is ethically justified.
T55 5026-5040 Sentence denotes MAIN OUTCOMES:
T56 5041-5154 Sentence denotes Primary Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab at day 7 post-treatment.
T57 5155-5845 Sentence denotes Secondary 1.Mean viral load as determined by PCR cycle threshold (Ct) at baseline and on days 4, 7, 14, and 21.2.Proportion of patients with fever and cough at days 4, 7, 14, and 21 as well as proportion of patients progressing to severe disease or death during the trial.3.Proportion of patients with seroconversion at day 21.4.Proportion of drug-related adverse events during the trial.5.Median levels of IgG, IgM, IgA measured by Luminex, frequencies of innate and SARS-CoV-2-specific T cells assessed by flow cytometry, median levels of inflammatory and activation markers measured by Luminex and transcriptomics.6.Median kinetics of IgG, IgM, IgA levels during the trial, until day 28.
T58 5846-5860 Sentence denotes RANDOMISATION:
T59 5861-6033 Sentence denotes Eligible patients will be allocated in a 1:1 ratio using a randomization list generated by the trial statistician using blocks of four to ensure balance between the groups.
T60 6034-6233 Sentence denotes A study identification code with the format "SAINT-##" (##: from 01 to 24) will be generated using a sequence of random numbers so that the randomization number does not match the subject identifier.
T61 6234-6337 Sentence denotes The sequence and code used will be kept in an encrypted file accessible only to the trial statistician.
T62 6338-6497 Sentence denotes A physical copy will be kept in a locked cabinet at the CUN, accessible only to the person administering the drug who will not enrol or attend to patient care.
T63 6498-6585 Sentence denotes A separate set of 24 envelopes for emergency unblinding will be kept in the study file.
T64 6586-6605 Sentence denotes BLINDING (MASKING):
T65 6606-6663 Sentence denotes The clinical trial team and the patients will be blinded.
T66 6664-6803 Sentence denotes The placebo will not be visibly identical, but it will be administered by staff not involved in the clinical care or participant follow up.
T67 6804-6843 Sentence denotes NUMBERS TO BE RANDOMISED (SAMPLE SIZE):
T68 6844-6875 Sentence denotes The sample size is 24 patients:
T69 6876-6975 Sentence denotes 12 participants will be randomised to the treatment group and 12 participants to the control group.
T70 6976-6989 Sentence denotes TRIAL STATUS:
T71 6990-7015 Sentence denotes Current protocol version:
T72 7016-7043 Sentence denotes 1.0 dated 16 of April 2020.
T73 7044-7112 Sentence denotes Recruitment is envisioned to begin by May 14th and end by June 14th.
T74 7113-7132 Sentence denotes TRIAL REGISTRATION:
T75 7133-7148 Sentence denotes EudraCT number:
T76 7149-7186 Sentence denotes 2020-001474-29, registered April 1st.
T77 7187-7247 Sentence denotes Clinicaltrials.gov: submitted, pending number FULL PROTOCOL:
T78 7248-7356 Sentence denotes The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1).
T79 7357-7537 Sentence denotes In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.