Kirti 2021.

Study characteristics
Methods	Trial design: double‐blind RCT with 2 parallel arms Type of publication: journal publication Setting: inpatient Recruitment dates: August to October 2020 Country: India Language: English Number of centres: 1 Study purpose (treatment, prevention): treatment Trial registration number: CTRI/2020/08/027225 Date of registration: 18 August 2020
Participants	Number of participants (randomized/analysed): 115/112 Age (mean): overall 53 (SD 14.7) years Males, n: overall 81 (72%) Severity of condition according to study definition: hospitalized, with mild‐to‐moderate symptoms, and without admission to ICU Severity of condition according to WHO scale: 4 to 5 Time from symptom onset to enrolment (mean): overall 6.9 (SD 6.6) days Comorbidities: diabetes, hypertension, respiratory disease Vaccination status: NR, study period before vaccination was available Virus detection performed at baseline (test‐positive at baseline): RT‐PCR or RAT (100%) Inclusion criteria: RT‐PCR positive or RAT positive; mild‐to‐moderate COVID‐19; aged > 18 years Exclusion criteria: known allergy to or adverse drug reaction with ivermectin; unwillingness or inability to provide consent to participation; prior use of ivermectin during the course of this illness; pregnancy, lactation
Interventions	Details of intervention Type and dose: ivermectin 12 mg, once daily for 2 days Route of administration: oral Treatment details of control group Placebo Concomitant therapy: standard of care including hydroxychloroquine, chloroquine, steroids, enoxaparin, antibiotics, remdesivir, convalescent plasma, tocilizumab administered to both study arms Duration of follow‐up: 28 days Treatment cross‐overs: none
Outcomes	Primary study outcome RT‐PCR negativity at 6 days Relevant review outcomes reported RT‐PCR negativity at 6 days Mortality at 28 days (details on time point provided by study author via personal communication) Additional study outcomes reported Discharged at 10 days Worsening of clinical status – need for invasive mechanical ventilation/need for ICU admission at 28 days (outcome combined with mortality not provided by study author upon request via personal communication) ICU admission within 28 days (outcome combined with mortality not provided by study author upon request via personal communication) Symptom resolution at 6 days
Notes	Date of publication: 15 July 2021 Sponsor/funding: Sun Pharma Pvt Ldt and AIIMS, Patna administration Correspondence with the author team: author request sent (ethics approval number, publication status, review relevant outcome data); only partial response received from author Information on ethics votum: ethics committee approval by a nationally‐recognized ethics committee, as defined in the country's clinical trial regulations: approval number not reported, but provided by study author via personal communication