ISRCTN86534580.

Study name	PRINCIPLE: A clinical trial evaluating treatments for suspected and confirmed COVID‐19 for recovery at home
Methods	Trial design: open‐label RCT, dynamic platform trial with mulitple arms; only 2 arms relevant Type of record: trial register entry Sample size: 8523 Setting: outpatient Country: UK Language: English Number of centres: NR Study purpose (treatment, prevention): treatment Trial registration number: ISRCTN86534580 Date of registration of ivermectin arm: 12 May 2021
Participants	Inclusion criteria Participant willing and able to give informed consent for participation in the study Participant willing to comply with all trial procedures Suspected COVID‐19 using the National Health Service syndromic definition, or symptoms consistent with COVID‐19 (including, but are not limited to, shortness of breath, general feeling of being unwell, muscle pain, diarrhoea and vomiting) and with a positive test for SARS‐CoV‐2 infection within the past 14 days Aged ≥ 65 years or over, aged 18‐64 and is experiencing shortness of breath as part of COVID‐19 illnesses, or aged 18‐64 and has underlying health conditions Exclusion criteria Patient currently admitted to hospital Almost recovered (generally much improved and symptoms now mild or almost absent) Judgement of the recruiting clinician deems ineligible Previous randomization to an arm of the PRINCIPLE trial Additional intervention‐specific exclusion criteria
Interventions	Details of intervention Type and dose: ivermectin 0.3 mg/kg, once daily for 3 days Route of administration: oral Treatment details of control group No treatment except standard of care Concomitant therapy: standard of care (no details provided) administered in both study arms
Outcomes	Primary study outcome Reducing time to recovery Reducing the incidence of hospitalization and/or death Relevant review outcomes planned Hospitalization and/or death Time taken to self‐reported recovery Additional study outcomes Time taken to self‐reported recovery Hospitalization and/or death
Starting date	12 March 2020
Contact information	Prof. Christopher Butler Chief Investigator principle@phc.ox.ac.uk
Notes	Recruitment status: recruiting Prospective completion date: September 2022; ivermectin arm is temporarily stopped due to delayed ivermectin shipment (information provided by trialist via personal communication) Planned completion date more than 6 months ago: no Date last update posted: 16 August 2021 Sponsor/funding: University of Oxford/UK Research and Innovation, National Institute for Health and Care Research (NIHR)