I‐TECH 2022.

Study characteristics
Methods	Trial design: open‐label RCT with 2 parallel arms Type of publication: journal publication Setting: outpatient Recruitment dates: May to October 2021 Country: Malaysia Language: English Number of centres: 21 Study purpose (treatment, prevention): treatment Trial registration number: NCT04920942 Date of registration: 10 June 2021
Participants	Number of participants (randomized/analysed): 500/490 Age (mean): overall 63 years Males, n: overall 264 (58%) Severity of condition according to study definition: the study author stated, that the majority of participants were ambulatory and well during admission, hospitalization mostly for isolation and close monitoring only in case of high risk of disease progression (based on public health policy at the time of study). Severity of condition according to WHO scale: 2 to 4, but accounting for an outpatient population (WHO 2 to 3) based on the study author's statement. Time from symptom onset to enrolment (mean): overall 5 (SD 1.3) days Comorbidities: at least one pre‐existing condition, obesity, diabetes, hypertension, respiratory disease Virus detection performed at baseline (test‐positive at baseline): RT‐PCR or RAT (100%) Vaccination status: overall 159 (32%) participants without any vaccination Inclusion criteria: ≥ 1 comorbidity; aged ≥ 50 years; confirmed SARS‐CoV‐2 by RT‐PCR or antigen detection; beginning of symptoms in the past 7 days; mild to moderate disease; informed consent Exclusion criteria: asymptomatic SARS‐CoV‐2 infection; need for supplemental oxygen or pulse oximetry oxygen saturation (SpO2) level < 95% at rest; severe hepatic impairment (ALT level > 10 times of upper normal limit); acute medical or surgical emergency; concomitant viral infection; pregnancy or breastfeeding; warfarin therapy; history of taking ivermectin or any antiviral drugs with reported activity against COVID‐19 (favipiravir, hydroxychloroquine, lopinavir, and remdesivir) in the past 7 days before enrolment.
Interventions	Details of intervention Type and dose: ivermectin 0.4 mg/kg (rounded to the nearest 6 mg or 12 mg whole tablets), once daily for 5 days Route of administration: oral Treatment details of control group No treatment except standard of care Concomitant therapy: standard of care (only symptomatic therapy) administered in both study arms Duration of follow‐up: 28 days Treatment cross‐overs: none
Outcomes	Primary study outcome Proportion of patients with progression to severe COVID‐19 disease, defined as hypoxic stage requiring supplemental oxygen to maintain SpO2 ≥ 95% Relevant review outcomes reported All‐cause mortality at 28 days Clinical worsening ‐ ICU admission or death at 28 days Adverse events at 28 days (outcome provided by study author via personal communication upon request) Serious adverse events at 28 days (outcome provided by study author via personal communication upon request) Additional study outcomes reported Time of progression to severe disease Length of hospital stay after study enrolment Clinical worsening ‐ rate of mechanical ventilation at 28 days Symptom resolution at 5 days
Notes	Date of publication: 18 February 2022 Sponsor/funding: Ministry of Health Malaysia Correspondence with the author team: initially author provided unpublished study data without request, in the meantime results are already published as journal article; author request sent regarding further review relevant outcome data as indicated above; 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