Trial NCT04784481
Publication Chahla R, Research Square, 2021 (preprint)
Funding: Public/non profit (Ministry of Public Health, Tucumán, Argentina)
Conflict of interest: No
Methods | |
RCT Blinding: Unblinded | |
Location :
Multicenter / Argentina Follow-up duration (days): 28 | |
Inclusion criteria | Over 18 years of age of any sex; Outpatients infected by SARS-CoV-2 conrmed by positive RT-PCR test; Women of childbearing age with a negative pregnancy test; Mild disease-patients with two or more of the following symptoms: fever less than 38·5°C and higher than 37.5°C according to Ministry of Health, Argentina(16), isolated diarrheal episodes, hyposmia or hypogeusia, mild desaturation (between 96 and 93%), dyspnea, polyarthralgia, persistent headache, abdominal pain, erythema of the kidney, nonspecic rash |
Exclusion criteria | Hypersensitivity or allergy to ivermectin; Pregnant or lactating; Children or adolescents under 18 years of age; Patients with neurological pathology, renal insuciency, hepatic insuciency; Weight less than 40kg; Patients with concomitant use of drugs that act on GABA, barbiturate and benzodiazepine receptors; Patients who have not completed / signed the informed consent |
Interventions | |
Treatment
Standard care * |
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Control
Ivermectin ( / ) | |
Participants | |
Randomized 254 participants (n1=144 / n2= 110) | |
Characteristics of participants N=254 Mean age : NR 121 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
Primary outcome | |
In the register Proportion of patients with symptoms (fever, diarrhea, taste and/or smell disturbance, SpO2, polyarthralgia, headache, body pain, abdominal pain, ALRI symptoms and signs) [ Time Frame: from 5th to 9th day ]; [ Time Frame: from 10th to 14th day ] | |
In the report Increase discharge from outpatient care with COVID-19 mild disease | |
Documents available |
Protocol NR Statistical plan NR Data-sharing stated
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Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
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General comment |