Mohan 2021.

Study characteristics
Methods	Trial design: double‐blind RCT with 3 parallel arms, the 2 intervention arms were pooled for this review Type of publication: journal publication Setting: inpatient Recruitment dates: July to September 2020 Country: India Language: English Number of centres: 1 Study purpose (treatment, prevention): treatment Trial registration number: CTRI/2020/06/026001 Date of registration: 21 June 2020
Participants	Number of participants (randomized/analysed): 157/152 (test‐positive population 157/125 Age (mean): overall 35 (10.4%) Males, n: overall 111 (89%) Severity of condition according to study definition: hospitalized, non‐severe symptoms Severity of condition according to WHO scale: 4 to 5 including people who were asymptomatic Time from symptom onset to enrolment (median): overall 5 (IQR 3 to 7) days Comorbidities: diabetes, hypertension Virus detection performed at baseline (test‐positive at baseline): RT‐PCR (relevant population 100% test‐positive) Vaccination status: NR, study period before vaccination was available Inclusion criteria: aged ≥ 18 years; diagnosed with non‐severe COVID‐19, i.e. SpO2 > 90% in room air and with no hypotension or requirement of mechanical ventilation; diagnosis of COVID‐19 was based on a positive result on either SARS‐CoV‐2 RT‐PCR or RAT Exclusion criteria: no informed consent; pregnancy or lactation; known hypersensitivity to ivermectin, chronic kidney disease with creatinine clearance < 30 mL/minutes; elevated transaminase levels (> 5 × upper limit of normal); myocardial infarction or heart failure within 90 days prior to enrolment; prolonged corrected QT interval (> 450 ms) on ECG; any other severe comorbidity as per investigator's assessment; enrolment in a concomitant clinical trial
Interventions	Details of intervention Type and dose: ivermectin 12 mg and 24 mg (pooled), single dose Route of administration: oral Treatment details of control group Placebo Concomitant therapy: standard of care including hydroxychloroquine, favipiravir, remdesivir, dexamethasone, dalteparin, azithromycin, amoxycillin/clavulanate, doxycycline, or ceftriaxone administered in both study arms Duration of follow‐up: 14 days or until hospital discharge Treatment cross‐overs: none
Outcomes	Primary study outcome Reduction of viral load and conversion to negativity of nasopharyngeal/oropharyngeal RT‐PCR at 3, 5, and 7 days Relevant review outcomes reported Viral clearance (RT‐PCR) at 3 and 5 days (detailed data provided by study author via personal communication) Adverse events within 14 days Serious adverse events within 14 days Additional study outcomes reported Mortality at 14 days Need for invasive mechanical ventilation at 14 days Change in WHO Ordinal Scale score between day 0 to 14 Any clinical worsening during treatment Duration of symptom resolution Discharge at 14 days Hospital‐free days at day 28 Viral clearance (RT‐PCR) at 7 days (not reported for complete intention‐to‐treat population)
Notes	Date of publication: 24 August 2021 Sponsor/funding: Department of Science and Technology, Government of India and WindLas BioTech Ltd Haryana Correspondence with the author team: author request sent (publication status, clarification of healthcare setting, proportion of only symptomatic participants reaching symptom resolution in modified intention‐to‐treat, clarification of viral clearance outcome); only partial response received from author Information on ethics votum: ethics committee approval number reported by a nationally‐recognized ethics committee, as defined in the country's clinical trial regulations