NCT04673214.

Methods	Trial design: RCT with 2 parallel arms, unclear blinding method Type of publication: trial registry entry with posted results Setting: outpatient Recruitment dates: December 2020 to February 2021 Country: Mexico Language: English Number of centres: 1 Study purpose (treatment, prevention): treatment Trial registration number: NCT04673214 Date of registration: 17 December 2020
Participants	Number of participants (randomized/analysed): 114/111; unclear if participants were actually randomized Age (mean): NR Males, n: overall 53 (47.7%) Severity of condition according to study definition: patients in a mild COVID‐19 phase Severity of condition according to WHO scale: presumably 1 to 3 Time from symptom onset to enrolment: NR Comorbidities: NR Virus detection performed at baseline (test‐positive at baseline): NR, but RT‐PCR positivity defined as inclusion criterion Inclusion criteria: eligible for family medicine unit No.20 and family medicine unit No.13 belonging to the Northern District of the Mexican Institute for Social Security; men and women; age > 18 years; compliance with the operational definition COVID‐19 and confirmatory test of PCR positive within the first days of the illness; comorbidities such as type 2 diabetes mellitus, systemic arterial hypertension, overweight, or obesity; agree to sign an informed consent, related to video call: that the family medicine unit No.20 and the family medicine unit No.13 belonging to the Northern District of the Mexican Institute for Social Security have installation of electronic equipment for Internet use Exclusion criteria: people with severe COVID‐19 (sent immediately to second level of care, hospital); any personal pathological history of haematological diseases; allergy to macrolides (azithromycin) and ivermectin
Interventions	Details of intervention Type and dose: ivermectin 0.2 mg/kg, once daily for 2 days Route of administration: oral Treatment details of control group No treatment except standard of care Concomitant therapy Standard of care including azithromycin, ribaroxaban and paracetamol administered in both study arms Duration of follow‐up: 14 days Treatment cross‐overs: none
Outcomes	Primary study outcome Average days with COVID‐19 symptoms by type of therapy at 14 days Statistical differences between clinical evolution vs therapeutic failure by type of treatment were evaluated at 14 days Relevant review outcomes reported None Additional study outcomes reported Number of participants who were alive and had COVID‐19 symptoms by type of therapy during a 14‐day follow‐up Average days of COVID‐19 symptoms under treatment of early intervention due to outcome in family medicine unit 13 and 20 of the Mexican Institute for Social Security at 14 days
Notes	Reason for awaiting classification: study did not pass reseach integrity check, because relevant information to assure trustworthiness is missing. Trialist was contacted for clarification. Only a partial response was received which could not fully clarify the issue up until now. Date of results first posted: August 2021 Sponsor/funding: Gilberto Cruz Arteaga, Coordinación de Investigación en Salud, Mexico