2020‐002091‐12/BG.

Methods	Trial design: double‐blind RCT with 2 parallel arms Type of record: trial register entry Sample size: 120 Setting: inpatient Country: Bulgaria Language: English Number of centres: NR Study purpose (treatment, prevention): treatment Trial registration number: 2020‐002091‐12/BG Date of registration: 5 May 2020
Participants	Inclusion criteria Men or women aged ≥ 18 years Signed informed consent Admitted to hospital for treatment of COVID‐19 Hospitalization must be for medical and not for social reasons Patient within 7 days from symptom onset and within 72 hours after laboratory diagnosis (SARS‐CoV‐2 RT‐PCR) Mild‐to‐moderate COVID‐19 disease defined as clinical status category 3 or 4 on the WHO 9‐point ordinal scale hospitalized, no oxygen treatment oxygen by mask or nasal prongs Presence of ≥ 1 symptom characteristic for COVID‐19 disease, e.g. fever, cough, sore throat, myalgia, fatigue, gastrointestinal; disorders, skin lesions, etc. In women of childbearing potential, negative pregnancy test and commitment to use contraceptive method throughout study Exclusion criteria Critical patients with expected survival time < 72 hours Presence of respiratory failure, shock, combined failure of other organs that requires ICU monitoring, or a combination Participation in the trial is not in the person's best interest based on the judgement of the investigator Presence of the following laboratory values at screening white blood cell count < 1.5 × 109/L platelet count < 100,000 mm3 (< 1.00 × 109/L) total bilirubin > 2 × ULN ALT or GGT > 3 × ULN Clinical suspicion for a bacterial superinfection at screening Allergic or hypersensitive to the investigational medicinal product or any of the ingredients Patients who cannot take drugs orally, or have severe gastrointestinal disorders, extensive bowel resection or bowel obstruction Previous (in the past 3 months) or concurrent use of any other investigational product Use of prohibited medications during treatment with investigational product, as defined in the protocol People with end‐stage liver disease (Child‐Pugh C score) History or presence of serious or acute heart disease, such as uncontrolled cardiac dysrhythmia or arrhythmia, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure (New York Heart Association class III or IV) Presence of acute stroke at screening or a history of acute stroke within the last 6 months Pregnant or breastfeeding Legal incapacity, limited legal capacity, or any other condition that makes the patient unable to provide consent for the trial Patients who are institutionalized due to judicial order Employee or immediate relative of the investigator or sponsor Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including asthma and COPD), renal, hepatic, endocrine (including uncontrolled diabetes mellitus) or gastrointestinal disorder, that according to investigator could jeopardize the safety of the patient, or the integrity of the study
Interventions	Details of intervention Type and dose: ivermectin 0.4 mg/kg, single dose Route of administration: oral Treatment details of control group Placebo with standard of care Concomitant therapy: standard of care (no details provided) administered in both study arms
Outcomes	Primary study outcome Rate of participant's conversion to negative SARS‐CoV‐2 (qualitative) test on day 7 Relevant review outcomes planned Rate of participant's conversion to negative SARS‐CoV‐2 (qualitative) test on day 7 Rate of subjects conversion converted to a negative SARS‐CoV‐2 (qualitative) test on day 4 Rate of subjects conversion converted to a negative SARS‐CoV‐2 (qualitative) test on day 14 Number of patients who have needed ICU treatment Additional study outcomes Number of participants achieving clinical recovery on day 7 Number of participants achieving clinical recovery on day 14 Time to conversion to a negative SARS‐CoV‐2 test within 28 days Time to achieving clinical improvement within 28 days Time to achieving clinical recovery until Day 28 Time to hospital discharge Number of patients who have needed high‐flow oxygen therapy Inflammatory and full blood count markers
Notes	Reason for awaiting classification: study completed, but results not published yet Recruitment status: completed Prospective completion date: October 2020, study completed Planned completion date more than 6 months ago: yes Date last update posted: NR Sponsor/funding: HUVEPHARMA EOOD, Bulgaria Study report on the drug company's website is not an eligible publication format for this review