2020‐001994‐66/ES.

Study name	Randomised clinical trial of ivermectin for treatment and prophylaxis of COVID‐19
Methods	Trial design: double‐blind RCT with 2 parallel arms Type of record: trial register entry Sample size: 266 Setting Substudy treatment: outpatient Substudy prevention: after high‐risk exposure Country: Spain Language: English Number of centres: NR Study purpose (treatment, prevention): treatment and prevention Trial registration number: 2020‐001994‐66/ES Date of registration: 8 May 2020
Participants	Inclusion criteria Substudy treatment Symptomatic (respiratory) participants with a positive RT‐PCR test for COVID‐19 and a clinical condition of < 5 days of evolution Age ≥ 18 years In women of childbearing age, negative pregnancy test and use of contraceptive method during the study period Accept to take the medication and the complementary test procedures during the study, including analysis and nasal sampling Able to provide informed consent (oral or written) Substudy prevention Contacts of symptomatic (respiratory) people with a positive RT‐PCR test for COVID‐19 and a diagnosis of < 5 days of evolution Of legal age In women of childbearing age, negative pregnancy test and use of contraceptive method during the study period Accept to take the medication and the complementary test procedures during the study, including analysis and nasal sampling Able to provide informed consent (oral or written) Exclusion criteria Substudy treatment Moderate or severe forms of infection requiring hospital admission Respiratory distress with respiratory rate ≥ 30 breaths per minute, SaO2 ≤ 93% at rest, PaO2/FIO2 ≤ 300 mmHg Participants taking medications that may interfere with the study medication such as anticoagulants Inability to take oral medication Severe liver disorders (Child‐Pugh C) Impairment of severe renal function (with glomerular filtration rate ≤ 30 mL/minute/1.73 m2) or requiring dialysis Participants with coagulation disorders Participants with severe neurological or mental impairment Pregnant or lactating women Unable to consent to the study protocol People with known hypersensitivity to ivermectin People who have been treated in any other study in the previous 30 days Concomitant administration of enzyme inducers (such as carbamazepine) that could affect the effectiveness of the drug and those receiving CYP3A4 substrates (such as statins) due to the risk of increased toxicity Any other contraindication according to the technical sheet for ivermectin Substudy prevention Participants taking medications that may interfere with study medication Inability to take oral medication Severe liver disorders (Child‐Pugh C) or alcoholism Impaired severe renal function (with glomerular filtration rate ≤ 30 mL/minute/1.73 m2) or requiring dialysis Participants with coagulation disorders Participants with severe neurological or mental impairment Pregnant or lactating women Unable to consent to study protocol People with known hypersensitivity to ivermectin People who have been treated in any other study in the previous 30 days Concomitant administration of enzyme inducers (such as carbamazepine) that could affect the effectiveness of the drug and those receiving CYP3A4 substrates (such as statins) due to the risk of increased toxicity Any other contraindication according to the technical data sheet for Ivermectin
Interventions	Details of intervention Type and dose: ivermectin 3 mg, no information on frequency scheme Route of administration: oral Treatment details of control group Placebo Concomitant therapy: NA
Outcomes	Primary study outcome Substudy treatment: compare viral clearance in people with SARS‐CoV‐2 treated with ivermectin and placebo, time point unclear Substudy prevention: compare contagion rate between home contacts of people with COVID‐19 receiving prophylaxis with ivermectin and placebo, time point unclear Relevant review outcomes planned None Additional study outcomes Substudy treatment: compare clinical evolution and complications between people with COVID‐19 receiving ivermectin and placebo Substudy prevention: compare clinical evolution and complications between home contacts of people with COVID‐19 receiving ivermectin and placebo prophylaxis
Starting date	NR
Contact information	Fundació Assistencial Mútua Terrassa Passeig Olabarria s/n Valldoreix 08197 Spain tomas.perez.porcuna@gmail.com
Notes	Recruitment status: NR Prospective completion date: NR Date last update posted: NR Sponsor/funding: Fundació Assistencial Mútua Terrassa