Ashraf 2021.

Study name	Efficacy of subcutaneous ivermectin with or without zinc in COVID‐19 patients (SIZI‐COVID‐PK)
Methods	Trial design: RCT with 6 parallel arms, unclear blinding description Type of record: trial register entry and published protocol Sample size: 180 Setting: NR Country: Pakistan Language: English Number of centres: 2 Study purpose (treatment, prevention): treatment Trial registration number: NCT04472585 Date of registration: 15 July 2020
Participants	Inclusion criteria People with positive nasopharyngeal RT‐PCR SARS‐CoV‐2 test with mild‐to‐moderate disease Age ≥ 18 years BMI 18 kg/m2 to 28 kg/m2 Exclusion criteria Allergy to any drug Comorbidities: any pre‐existing cardiac disease, pulmonary disease Arrhythmias Pregnancy RT‐PCR performed > 3 days prior to enrolment
Interventions	Details of intervention Type and dose Intervention 1: ivermectin 0.2 mg/kg subcutaneous injection once every 48 hours Intervention 2: ivermectin 0.2 mg/kg subcutaneous injection once every 48 hours with zinc sulphate Intervention 3: ivermectin 0.2 mg/kg, oral once daily Intervention 4: ivermectin 0.2 mg/kg, oral once daily with zinc sulphate Route of administration: subcutaneous or oral Treatment details of control group Control for interventions 1 and 3: placebo injection and capsule Control for interventions 2 and 4: placebo with zinc sulphate Concomitant therapy: standard of care administered in all study arms
Outcomes	Primary study outcome Time needed to turn positive COVID‐19 PCR to negative within 14 days Time taken for alleviation of symptoms within 14 days Severity of symptoms up to 14 days Relevant review outcomes planned Time needed to turn positive COVID‐19 PCR to negative within 14 days Time taken for alleviation of symptoms within 14 days Time needed to make participants clinically well within 14 days Additional study outcomes Time needed to make participants clinically well within 14 days
Starting date	14 November 2020, postponed from 14 Juli 2020
Contact information	Shoaib Ashraf, PhD Harvard University Boston USA sashraf@mgh.harvard.edu
Notes	Recruitment status: recruiting Prospective completion date: October 2021, postponed from September 2020 Planned completion date more than 6 months ago: no Date last update posted: 17 February 2021 Sponsor/funding: Sohaib Ashraf