SLCTR/2021/020.

Study name	A randomized control trial to assess the efficacy and safety of ivermectin in the treatment of mild to moderate COVID 19 patients
Methods	Trial design: double‐blinded RCT with 2 parallel arms Type of record: trial register entry Sample size: 236 Setting: inpatient Country: Sri Lanka Language: English Number of centres: NR Study purpose (treatment, prevention): treatment Trial registration number: SLCTR/2021/020 Date of registration: 19 July 2021
Participants	Inclusion criteria > 18 years old Both gender Positive for SARS‐CoV‐2 by RT‐PCR tests or antigen testing using nasopharyngeal swab/aspirate within 48 hours prior to randomization and is admitted for treatment to National Institute of Infectious Diseases Cycle threshold (Ct) value < 38 at the time of recruitment Mild to moderate COVID‐19 infection Negative antibody test Within 4 days of onset of symptoms and RT‐PCR positivity within 48 hours in asymptomatic patient Exclusion criteria Pregnancy Breastfeeding mothers HIV co‐infection Patients who are known to have allergy to ivermectin or anthelminths Patients with severe disease as indicated by SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300, respiratory rate ≥ 30/min, heart rate ≥ 125/min Patients with critical disease, i.e. those who require mechanical ventilation or anticipated impending need for mechanical ventilation Received the vaccine Recruited in any other trials simultaneously
Interventions	Details of intervention of relevant arms Type and dose: ivermectin 24 mg, once daily for 5 days Route of administration: oral Treatment details of control group Placebo Concomitant therapy: standard of care (no details provided) administered in both study arms
Outcomes	Primary study outcome Reduction of viral burden (by 50%) based on the natural log Cycle threshold (Ct) value of the RT‐PCR for SARS‐COV‐2 Clinical progression of the patient using WHO Clinical Progression Scale Percentage of participants who experience side effects recorded by the patient on data sheet for assessment of symptoms and side effects. Relevant review outcomes planned Clinical progression of the patient using WHO Clinical Progression Scale Percentage of participants who experience side effects recorded by the patient on data sheet for assessment of symptoms and side effects Additional study outcomes Improvement of symptoms by 50% by day 6 and by 100% by day 10 of intervention 50% reduction of development of hypoxia (SPO2 < 94%) 50% improvement of lymphopaenia by day 6
Starting date	26 July 2021
Contact information	Dr Ananda Wijewickrama Consultant Physician National Institute of Infectious Diseases Mandawila road, Angoda, Sri Lanka
Notes	Recruitment status: recruiting Prospective completion date: NR Planned completion date more than 6 months ago: unclear Date last update posted: 18 October 2021 Sponsor/funding: National Institute of Infectious Diseases

ALT: alanine aminotransferase; AST: aspartate aminotransferase; BMI: body mass index; COPD: chronic obstructive pulmonary disease; COVID‐19: coronavirus disease 2019; CRP: C‐reactive protein; CT: computer tomography; ESR: erythrocyte sedimentation rate;GFR: glomerular filtration rate; ICU: intensive care unit; IgA: immunoglobulin A; IgG: immunoglobulin G; IgM: immunoglobulin M; NA: not available; NAAT: nucleic acid amplification test; NR: not reported; PaO₂/FIO₂: partial pressure of oxygen/fraction of inspired oxygen; PCR: polymerase chain reaction; RAT: rapid antigen test; RCT: randomized controlled trial; RNA: ribonucleic acid; RT‐PCR: reverse transcription polymerase chain reaction; RT‐qPCR: reverse transcription quantitative polymerase chain reaction; SaO₂: oxygen saturation; SARS‐CoV‐2: severe acute respiratory syndrome coronavirus 2; SD: standard deviation; ULN: upper limit of normal; WHO: World Health Organization.