Trial CTRI/2020/06/026001
Publication Mohan A, 2021 (preprint)
Dates: 7/28/2020 to 9/29/2020
Funding: Mixed (Department of Science and Technology, Government of India; WindLas BioTech Ltd. Haryana (drug contribution))
Conflict of interest: No
Methods | |
RCT Blinding: quadruple blinding | |
Location :
Single center / India Follow-up duration (days): 28 | |
Inclusion criteria | - Aged 18 years or above;
- Diagnosed (based on a positive result on either SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) or the rapid antigen test) - Non-severe COVID-19 (i.e. room air saturation (SpO2) >90%, no hypote |
Exclusion criteria | - If they did not give informed consent
- Pregnancy or lactation - Known hypersensitivity to ivermectin - Chronic kidney disease with creatinine clearance <30 mL/min - Elevated transaminase levels (>5 x upper limit of normal) |
Interventions | |
Treatment 1 Ivermectin 12 mg ( / ) Co-Intervention: Standard care Duration : | |
Control Placebo | |
Treatment 3 Ivermectin 24 mg ( / ) Co-Intervention: Standard care Duration : | |
Participants | |
Randomized 152 participants n1=49/ n2=52/ n3=51 | |
Characteristics of participants N=152 Mean age : 35.3 111 males Severity : Mild: n=115 / Moderate: n=10/ Severe: n=0 Critical: n=0 | |
Primary outcome | |
In the register Frequency of RT-PCR negativity at day 5 after drug administration; Change in viral load (as determined by RTPCR cycle threshold) at day 5 as compared to baseline | |
In the report Reduction of viral load and conversion to negativity of nasopharyngeal/oropharyngeal RT-PCR on day 5 after intervention | |
Documents available |
Protocol NR Statistical plan NA Data-sharing stated NR |
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 |
Some concerns |
General comment | In addition to the pre-print article, the study registry and supplementary materials were used in data extraction and risk of bias assessment. It is not clear what the target sample size was and if it was achieved. Outcomes were not reported in the study registry, so it is unclear if there were reported at the correct follow-up point. There is no change from the study registration in the intervention and control treatments |