LitCovid-sentences  

PubMed:32513289 JSONTXT 16 Projects

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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.