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LitCovid-PubTator

Id Subject Object Predicate Lexical cue tao:has_database_id
3 42-50 Species denotes patients Tax:9606
4 56-64 Disease denotes COVID-19 MESH:C000657245
5 74-81 Disease denotes COVID19 MESH:C000657245
74 316-324 Disease denotes COVID-19 MESH:C000657245
75 325-332 Species denotes patient Tax:9606
76 367-374 Disease denotes COVID19 MESH:C000657245
77 493-505 Species denotes PARTICIPANTS Tax:9606
78 507-515 Species denotes Patients Tax:9606
79 719-727 Disease denotes COVID-19 MESH:C000657245
80 785-794 Species denotes SARS-CoV2 Tax:2697049
81 832-837 Species denotes women Tax:9606
82 1164-1169 Species denotes woman Tax:9606
83 1601-1606 Species denotes women Tax:9606
84 1618-1625 Disease denotes allergy MESH:D004342
85 1767-1775 Disease denotes COVID-19 MESH:C000657245
86 1835-1843 Disease denotes COVID-19 MESH:C000657245
87 1861-1884 Disease denotes mal-absorptive syndrome MESH:C564600
88 1930-1948 Disease denotes infectious disease MESH:D003141
89 1978-1991 Disease denotes liver disease MESH:D008107
90 2005-2020 Disease denotes liver cirrhosis MESH:D008103
91 2121-2129 Disease denotes COVID-19 MESH:C000657245
92 2250-2258 Species denotes patients Tax:9606
93 2536-2543 Species denotes patient Tax:9606
94 2551-2558 Species denotes Patient Tax:9606
95 3273-3281 Species denotes patients Tax:9606
96 3304-3314 Chemical denotes ivermectin MESH:D007559
97 3364-3372 Species denotes patients Tax:9606
98 3416-3426 Chemical denotes ivermectin MESH:D007559
99 3428-3436 Species denotes patients Tax:9606
100 3509-3519 Chemical denotes ivermectin MESH:D007559
101 3521-3529 Species denotes patients Tax:9606
102 3587-3597 Chemical denotes ivermectin MESH:D007559
103 3688-3696 Species denotes patients Tax:9606
104 3776-3784 Species denotes patients Tax:9606
105 3837-3845 Species denotes patients Tax:9606
106 3927-3935 Species denotes patients Tax:9606
107 4287-4292 Species denotes women Tax:9606
108 4318-4326 Disease denotes COVID-19 MESH:C000657245
109 4378-4387 Species denotes SARS-CoV2 Tax:2697049
110 4414-4421 Disease denotes allergy MESH:D004342
111 4515-4520 Species denotes women Tax:9606
112 4848-4853 Species denotes woman Tax:9606
113 5129-5135 Chemical denotes oxygen MESH:D010100
114 5241-5249 Disease denotes COVID-19 MESH:C000657245
115 5309-5317 Disease denotes COVID-19 MESH:C000657245
116 5403-5426 Disease denotes mal-absorptive syndrome MESH:C564600
117 5470-5488 Disease denotes infectious disease MESH:D003141
118 5516-5529 Disease denotes liver disease MESH:D008107
119 5543-5558 Disease denotes liver cirrhosis MESH:D008103
120 5657-5665 Disease denotes COVID-19 MESH:C000657245
121 5684-5702 Chemical denotes hydroxychloroquine MESH:D006886
122 5706-5717 Chemical denotes chloroquine MESH:D002738
123 5780-5788 Species denotes Patients Tax:9606
124 6081-6089 Species denotes patients Tax:9606
125 6095-6103 Disease denotes COVID-19 MESH:C000657245
126 6310-6317 Species denotes patient Tax:9606
127 6405-6412 Species denotes patient Tax:9606
128 6715-6722 Species denotes patient Tax:9606
129 6738-6746 Species denotes patients Tax:9606
130 6797-6805 Species denotes patients Tax:9606
131 6961-6970 Disease denotes mortality MESH:D003643
132 7020-7025 Disease denotes death MESH:D003643
133 7033-7040 Species denotes patient Tax:9606
134 7216-7224 Species denotes patients Tax:9606
135 7323-7330 Species denotes patient Tax:9606
136 7348-7353 Disease denotes death MESH:D003643
137 7791-7799 Species denotes patients Tax:9606
138 8387-8393 Chemical denotes oxygen MESH:D010100
139 8482-8494 Species denotes participants Tax:9606
140 8637-8645 Species denotes patients Tax:9606
141 8651-8659 Species denotes patients Tax:9606

LitCovid-PD-HP

Id Subject Object Predicate Lexical cue hp_id
T1 1618-1625 Phenotype denotes allergy http://purl.obolibrary.org/obo/HP_0012393
T2 1978-1991 Phenotype denotes liver disease http://purl.obolibrary.org/obo/HP_0001392
T3 2005-2020 Phenotype denotes liver cirrhosis http://purl.obolibrary.org/obo/HP_0001394
T4 4414-4421 Phenotype denotes allergy http://purl.obolibrary.org/obo/HP_0012393
T5 5516-5529 Phenotype denotes liver disease http://purl.obolibrary.org/obo/HP_0001392
T6 5543-5558 Phenotype denotes liver cirrhosis http://purl.obolibrary.org/obo/HP_0001394

hydroxychloroquine

Id Subject Object Predicate Lexical cue hp_id
T1 1618-1625 Phenotype denotes allergy http://purl.obolibrary.org/obo/HP_0012393
T2 1978-1991 Phenotype denotes liver disease http://purl.obolibrary.org/obo/HP_0001392
T3 2005-2020 Phenotype denotes liver cirrhosis http://purl.obolibrary.org/obo/HP_0001394
T4 4414-4421 Phenotype denotes allergy http://purl.obolibrary.org/obo/HP_0012393
T5 5516-5529 Phenotype denotes liver disease http://purl.obolibrary.org/obo/HP_0001392
T6 5543-5558 Phenotype denotes liver cirrhosis http://purl.obolibrary.org/obo/HP_0001394

LitCovid-sentences

Id Subject Object Predicate Lexical cue
T1 0-159 Sentence denotes Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19): a structured summary of a study protocol for a randomized controlled trial.
T2 160-171 Sentence denotes OBJECTIVES:
T3 172-344 Sentence denotes To assess the efficacy of ivermectin in addition to standard treatment compared to standard treatment alone in reducing hospitalizations in the COVID-19 patient population.
T4 345-492 Sentence denotes TRIAL DESIGN: IVERCOR-COVID19 will be a single-center, prospective, randomized, double-blind, parallel group (1:1 ratio), placebo-controlled study.
T5 493-506 Sentence denotes PARTICIPANTS:
T6 507-579 Sentence denotes Patients who meet the following criteria will be invited to participate:
T7 580-1161 Sentence denotes Inclusion criteria: (1) Over 18 years of age who reside in the province of Corrientes at the time of diagnosis. (2) Confirmed diagnosis of COVID-19 by polymerase chain reaction (PCR) test for detection of SARS-CoV2 in the last 48 h. (3) In the case of women of childbearing age, they must be using a contraceptive method of proven efficacy and safety (barrier, hormonal, or permanent contraceptives) for at least 3 months prior to inclusion in the present study and for the entire period of time for the duration of the study and until at least 30 days after the end of this study.
T8 1162-1550 Sentence denotes A woman will be considered to have no reproductive capacity if she is postmenopausal (at least 2 years without her menstrual cycles) or if she has undergone surgical sterilization (at least 1 month before the time of inviting her to participate in this study). (4) Weight at the time of inclusion greater than 48 kg. (5) That they sign the informed consent for participation in the study.
T9 1551-2490 Sentence denotes EXCLUSION CRITERIA: (1) pregnant or breastfeeding women; (2) known allergy to ivermectin or some of the components of ivermectin tablets or placebo; (3) current use of home oxygen; (4) require hospitalization due to COVID-19 at the time of diagnosis or history of hospitalization for COVID-19; (5) presence of mal-absorptive syndrome; (6) presence of any other concomitant acute infectious disease; (7) known history of severe liver disease, for example liver cirrhosis; (8) need or use of antiviral drugs at the time of admission for another viral pathology other than COVID-19; (9) need or use of hydroxychloroquine or chloroquine; (10) use of ivermectin up to 7 days prior to randomization; (11) patients on dialysis or who have required it in the last 2 months or who plan to do it in the next 2 months; and (12) current participation or in the last 30 days in a research study that has included the administration of a drug (Table 1).
T10 2491-3223 Sentence denotes Table 1 Ivermectin/placebo dose according to patient weight Patient weight Ivermectin/placebo dose Total dose (mg) Equal to or greater than 48 kg and less than 80 kg 2 tablets of 6 mg each at the time of inclusion and 2 tablets 24 h after the first intake 24 Equal or greater than 80 kg and less than 110 kg 3 tablets of 6 mg each at the time of inclusion and 3 tablets 24 h after the first intake 36 Equal or greater than 110 kg 4 tablets of 6 mg each at the time of inclusion and 4 tablets 24 h after the first intake 48 The study will be carried out by the Ministry of Public Health of the Province of Corrientes (Argentina) in coordination with the Institute of Cardiology of Corrientes in the Province of Corrientes, Argentina.
T11 3224-3252 Sentence denotes INTERVENTION AND COMPARATOR:
T12 3253-3672 Sentence denotes Intervention group: patients who are randomized to ivermectin will receive the dose according to their weight (patients up to 80 kg will receive 2 tablets of 6 mg ivermectin; patients with more than 80 kg and up to 110 kg will receive 3 tablets of 6 mg of ivermectin; patients weighing more than 110 kg will receive 4 tablets of 6 mg ivermectin) the day they enter the study and the same dose 24 h after the first dose.
T13 3673-4088 Sentence denotes CONTROL GROUP: patients who are randomized to placebo will receive the dose according to their weight (patients up to 80 kg will receive 2 tablets of 6 mg placebo; patients with more than 80 kg and up to 110 kg will receive 3 tablets of 6 mg of placebo; patients weighing more than 110 kg will receive 4 tablets of 6 mg placebo) on the day they enter the study and the same dose 24 h after the first dose (Table 2).
T14 4089-4170 Sentence denotes Table 2 Inclusion and exclusion criteria Inclusion criteria Exclusion criteria 1.
T15 4171-4260 Sentence denotes Over 18 years of age who reside in the province of Corrientes at the time of diagnosis 1.
T16 4261-4407 Sentence denotes Pregnant or breastfeeding women 2.Confirmed diagnosis of COVID-19 by polymerase chain reaction test for detection of SARS-CoV2 in the last 48 h 2.
T17 4408-4497 Sentence denotes Known allergy to ivermectin or some of the components of ivermectin tablets or placebo 3.
T18 4498-4845 Sentence denotes In case of being women of childbearing age, they must be using a contraceptive method of proven efficacy and safety (barrier, hormonal, or permanent contraceptives) for at least 3 months prior to inclusion in the present study, during the entire period of time for the duration of the study, and until at least 30 days after the end of this study.
T19 4846-5108 Sentence denotes A woman will be considered to have no reproductive capacity if she is postmenopausal (at least 2 years without her menstrual cycles) or if she has undergone surgical sterilization (at least 1 month before the time of inviting her to participate in this study) 3.
T20 5109-5138 Sentence denotes Current use of home oxygen 4.
T21 5139-5204 Sentence denotes Weight at the time of inclusion equal to or greater than 48 kg 4.
T22 5205-5320 Sentence denotes That require hospitalization due to COVID-19 at the time of diagnosis or history of hospitalization for COVID-19 5.
T23 5321-5390 Sentence denotes That they sign the informed consent for participation in the study 5.
T24 5391-5429 Sentence denotes Presence of mal-absorptive syndrome 6.
T25 5430-5491 Sentence denotes Presence of any other concomitant acute infectious disease 7.
T26 5492-5561 Sentence denotes Known history of severe liver disease, for example liver cirrhosis 8.
T27 5562-5668 Sentence denotes Need or use of antiviral drugs at the time of admission for another viral pathology other than COVID-19 9.
T28 5669-5721 Sentence denotes Need or use of hydroxychloroquine or chloroquine 10.
T29 5722-5779 Sentence denotes Use of ivermectin up to 7 days prior to randomization 11.
T30 5780-5891 Sentence denotes Patients on dialysis or who have required it in the last 2 months or who plan to do it in the next 2 months 12.
T31 5892-6018 Sentence denotes Current participation or in the last 30 days in a research study that has included the administration of a drug MAIN OUTCOMES:
T32 6019-6143 Sentence denotes Primary outcome will be the percentage of hospitalizations in patients with COVID-19 in the intervention and control groups.
T33 6144-7057 Sentence denotes SECONDARY OUTCOMES: time to hospitalization in each of the arms of the study: number of days elapsed from the inclusion in the study until the hospitalization of the patient; percentage of use of invasive mechanical ventilation in each of the study arms: every patient who is connected to invasive mechanical ventilation after signing the informed consent and before the final study visit; time to invasive mechanical ventilation in each of the arms of the study: number of days elapsed from inclusion in the study to connection to invasive mechanical ventilation of the patient; percentage of patients requiring dialysis in each of the study arms: all patients who require renal replacement therapy of any kind, temporary or permanent, and which begins after signing the informed consent and before the final visit; mortality from all causes in each of the two trial groups: death of the patient, from any cause.
T34 7058-7126 Sentence denotes Negative PCR swab at 3 ± 1 and 12 ± 2 days after entering the study.
T35 7127-7272 Sentence denotes Ivermectin safety: it will be analyzed according to the incidence of adverse events that patients present in the intervention and control groups.
T36 7273-7354 Sentence denotes The end of study (EOS) is recorded as the day the patient is discharged or death.
T37 7355-7485 Sentence denotes Discharge will be granted according to the current recommendations of the Ministry of Public Health of the Province of Corrientes.
T38 7486-7589 Sentence denotes A follow-up visit (EOF) will be made by phone 30 days after the EOS when vital status will be verified.
T39 7590-7604 Sentence denotes RANDOMIZATION:
T40 7605-7683 Sentence denotes Randomization will be done through a web system with randomly permuted blocks.
T41 7684-7843 Sentence denotes Randomization will be carried out by one of the investigators who will not participate in the inclusion of patients or in the delivery of medication (Table 3).
T42 7844-8477 Sentence denotes Table 3 EOS end of study, EOF end of follow-up Visit Basal and randomization, day 0 Day 3 ± 1 Day 12 ± 2 V#1 V#2 V#3 EOS EOF Informed consent X - - - - Inclusion/exclusion criteria X - - - - Demographic data and medical history X - - - - Concomitant medication X - - - - Vital signs* X X - - - Anthropometric data^ X - - - - Basal laboratory X - - - - PCR swab - X X - - Assessment of adverse events - X X X - Final objective evaluation - X X X X Randomization X - - - - Adherence to treatment X X - - - *Includes heart rate, temperature, and oxygen saturation by a digital saturometer ^Includes weight and height BLINDING (MASKING):
T43 8478-8565 Sentence denotes The participants, investigators, care providers, and outcome assessors will be blinded.
T44 8566-8605 Sentence denotes NUMBERS TO BE RANDOMIZED (SAMPLE SIZE):
T45 8606-8675 Sentence denotes We will include a total of 500 patients (250 patients in each group).
T46 8676-8689 Sentence denotes TRIAL STATUS:
T47 8690-8726 Sentence denotes This is version 1.0, 17 August 2020.
T48 8727-8842 Sentence denotes The recruitment started on 19 August 2020, and we anticipate the trial will finish recruitment on 31 December 2020.
T49 8843-8862 Sentence denotes TRIAL REGISTRATION:
T50 8863-8895 Sentence denotes ClinicalTrials.gov NCT04529525 .
T51 8896-8939 Sentence denotes Registered on 26 August 2020 FULL PROTOCOL:
T52 8940-9048 Sentence denotes The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1).
T53 9049-9233 Sentence denotes In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.