NCT04729140.

Study name	An outpatient clinical trial using ivermectin and doxycycline in COVID‐19 positive patients at high risk to prevent COVID‐19 related hospitalization
Methods	Trial design: double‐blind RCT with 3 parallel arms, only 2 arms relevant; the third arm investigates doxycycline Type of record: trial register entry Sample size: 150 Setting: outpatient Country: USA Language: English Number of centres: NR Study purpose (treatment, prevention): treatment Trial registration number: NCT04729140 Date of registration: 28 January 2021
Participants	Inclusion criteria Age ≥ 18 years Willing and able to provide verbal/telephonic/personal or computer‐based informed consent Experiencing symptoms of COVID‐19 illness and tested positive for SARS‐CoV‐2 with PCR, NAAT, or antigen testing Residents in a nursing home or long‐term care facility Immunocompromised state, including solid organ transplant, HIV infection, other immune deficiency, immunosuppressant medication including systemic corticosteroids Chronic lung disease, including COPD, moderate‐to‐severe asthma, cystic fibrosis, pulmonary fibrosis Cardiovascular disease Cancer Hypertension Obesity (body mass index ≥ 30 kg/m2) Diabetes mellitus Chronic kidney disease Chronic liver disease Cerebrovascular disease Neurological disorders including dementia Tobacco use disorders Haematological disorders, including sickle cell disease and thalassaemia Exclusion criteria Age < 18 years Received any COVID vaccine within the last 30 days Contraindications to ivermectin or doxycycline History of seizure disorder or epilepsy History of myocardial infarction within last month Already receiving ivermectin or doxycycline for treatment of any other disease or disorder Allergies to ivermectin or doxycycline including angio‐oedema, severe asthma, exfoliative dermatitis, Steven Johnson syndrome, or psoriasis History of angio‐oedema, exfoliative dermatitis, Steven Johnson syndrome, psoriasis Currently pregnant or planning to conceive Breastfeeding History of prior Clostridium difficile infection
Interventions	Details of intervention for relevant arms Type and dose: ivermectin 0.2 mg/kg, once daily for 2 days Route of administration: oral Treatment details of control group Placebo Concomitant therapy: NA
Outcomes	Primary study outcome Decreased admission rate to the hospital secondary to respiratory illness related to COVID‐19 within 5 weeks Relevant review outcomes planned Mortality at 5 weeks Additional study outcomes Decrease in total duration of symptoms secondary to respiratory illness related to COVID‐19 within 5 weeks Assessment of various blood biomarkers (e.g. cytokines, glucose, electrolytes, CRP, liver enzymes, etc.) within 2 weeks Measurement of participants with new onset of various physical and psychological symptoms secondary to respiratory illness related to COVID‐19 within 5 weeks
Starting date	28 December 2020
Contact information	Werther Marciales, MD MAX HEALTH, Subsero Health 2055 Wood Street, Suite 100 Sarasota, Florida, 34237 US werther40@msn.com
Notes	Recruitment status: recruiting Prospective completion date: 28 March 2021 Date last update posted: 1 April 2021 Sponsor/funding: Max Health, Subsero Health