Gonzalez 2021.

Study characteristics
Methods	Trial design: double‐blind RCT with 3 parallel arms, only 2 arms relevant; the third arm investigated hydroxychloroquine Type of publication: preprint Setting: inpatient Recruitment dates: May to August 2020 Country: Mexico Language: English Number of centres: 1 Study purpose (treatment, prevention): treatment Trial registration number: NCT04391127 Date of registration: 18 May 2020
Participants	Number of participants (randomized/analysed): 108/106 (relevant arms: NR/73s Age (mean): overall 54 (SD 16.9) years Males, n: overall 66 (62%) Severity of condition according to study definition: hospitalized, with need for supplemental oxygen, but not high flow oxygen high flow oxygen Severity of condition according to WHO scale: 5 Time from symptom onset to enrolment: NR Comorbidities: any pre‐existing condition, diabetes, hypertension, respiratory disease Virus detection performed at baseline (test‐positive at baseline): RT‐PCR (100%) Vaccination status: NR, study period before vaccination was available Inclusion criteria: positive RT‐PCR for SARS‐CoV‐2 by nasal and oropharyngeal swabbing; pneumonia, diagnosed by X‐ray or high‐resolution chest CT scan, with a pattern suggesting involvement due to coronavirus; recently established hypoxaemic respiratory failure or acute clinical deterioration of pre‐existing lung or heart disease Exclusion criteria: requirement of high oxygen volumes (face mask > 10 L/minute); predictors of a poor response to high‐flow oxygen nasal prong therapy or requirement mechanical ventilation
Interventions	Details of intervention for relevant arms Type and dose: ivermectin 12 mg to 18 mg (weight‐adjusted), once daily for 5 days Route of administration: oral Treatment details of control group Placebo Concomitant therapy: standard of care including dexamethasone, thromboprophylaxis and antibiotics administered in both study arms Duration of follow‐up: 28 days Treatment cross‐overs: none
Outcomes	Primary study outcome Hospitalization duration until discharge due to clinical improvement Total duration of hospitalization Duration of hospitalization until respiratory deterioration or death Relevant review outcomes reported Mortality at 28 days Improvement of clinical status – patients discharged without respiratory deterioration or death at 28 days (outcome provided by study author via personal communication) Worsening of clinical status – need for invasive mechanical ventilation or death at 28 days (outcome provided by study author via personal communication) Additional study outcomes reported None
Notes	Date of publication: 23 February 2021 Sponsor/funding: departmental resources Correspondence with the author team: author request sent (publication status, proportion of participants with confirmed SARS‐CoV‐2 infection (RT‐PCR) at baseline, patient status at baseline, randomization method, review relevant outcome data); response received from author Information on ethics votum: ethics committee approval number reported by a nationally‐recognized ethics committee, as defined in the country's clinical trial regulations