2020‐001971‐33/ES.

Methods	Trial design: double‐blind RCT with 3 parallel arms Type of record: trial register entry Sample size: 45 Setting: outpatient Country: Spain Language: English Number of centres: 1 Study purpose (treatment, prevention): treatment Trial registration number: 2020‐001971‐33/ES Date of registration: 22 July 2020
Participants	Inclusion criteria People aged > 50 years with comorbidities, diagnosed with SARS‐CoV‐2 infection by PCR or another diagnostic test performed in the emergency department, who are in the first week of clinic, without pneumonia and without admission criteria People aged 18–70 years inclusive with pneumonia associated to SARS‐Co2 infection: cough or expectoration or fever > 38 °C with or without radiological infiltrate in Rxtórax; with SARS‐CoV‐2 PCR or radiological, clinical and analytical findings of COVID‐19 Evolution time of initial symptoms between 3 and 8 days Basal oxygen saturation ≥ 93% by breathing ambient air Have signed the informed consent Exclusion criteria People with pneumonia due to SARS‐CoV‐2 that requires hospital admission, due to multilobar involvement, respiratory failure PO2 < 93% ambient air or < 92% for people with COPD; with analytical criteria of severity (D‐dimer > 600, CRP > 50, lymphopenia < 900, ferritin > 700 mg/dL, interleukin‐6 or organ failure of the organ or who have significant comorbidities: renal insufficiency > 3B; immunosuppression, cancer; chronic cirrhosis or liver disease, diabetes mellitus, atherosclerosis of any territory, heart rhythm disturbances (including prolonged QT), poorly controlled hypertension) People with QT range > 500 mseconds People aged < 18 years Child‐Pugh C liver failure Impossibility of giving treatment for non‐suppressible drugs with the risk of QT prolongation or interactions (antidepressants, antihistamines, quinolones, statins except pitavastatin) or allergy to the drug Taking any of the drugs in the trial within 7 days prior to inclusion in the study Pregnancy, lactation
Interventions	Details of intervention Type and dose: ivermectin 0.2–0.4 mg/kg, no details on frequency scheme Route of administration: oral Treatment details of control group Placebo, azithromycin, hydroxychloroquine are named in the protocol as comparatory, but unclear design of study arms Concomitant therapy: unclear
Outcomes	Primary study outcome Efficacy will be measured by comparing clinical cure, microbiology, need for hospital admission due to clinical or analytical, blood gas, radiological deterioration, or a combination of these for each arm. Relevant review outcomes planned To assess the clinical cure rate after 2 weeks of treatment To evaluate the microbiological cure rate 72 hours after treatment To analyze adverse events to treatment Additional study outcomes To analyze the improvement in clinical parameters (symptoms and physical examination) To assess the failure rate and admission requirements for disease progression To analyze the factors of weak or poor response to ivermectin
Notes	Reason for awaiting classification: unclear control arms Recruitment status: NR Prospective completion date: NR Date last update posted: NR Sponsor/funding: Carmen Hidalgo