NCT04768179.

Study name	Safety & Efficacy of Low Dose aspirin / Ivermectin Combination Therapy for Treatment of Covid‐19 Patients (IVCOM)
Methods	Trial design: RCT open‐label, phase 2 + 3 Type of publication: trial registry Setting: hospital Recruitment dates: not yet recruiting Country: Uganda Language: English Number of centres: NR Inclusion criteria: provision of signed and dated informed consent form, willingness to comply with all study procedures and availability over the study duration, patients aged above 18 years to 64 years Exclusion criteria: participants with known hypersensitivity to ivermectin, clinical diagnosis of severe renal and hepatic impairment, pregnancy or breastfeeding, co‐treatment with either strong cytochrome p‐450 inducers including: rifampicin, carbamazepine and barbiturates or inhibitors: isoniazid, clofazimine that might potentially affect ivermectin disposition and clinical outcomes, comorbidities including asthma, loa loa as assessed by travel history to Angola, Cameroon, Chad, Central African Republic, Congo, DR Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan in the last 4 years, persons clinically diagnosed with and receiving treatment for any diathesis and PUD, active participation in another clinical trial, PCR positive for SARS‐CoV‐2 (COVID‐19) from any of the MOH COVID‐19 accredited testing laboratories, moderately ill COVID‐19 patients score 3 (hospitalised with no oxygen therapy) to 4 (hospitalised with oxygen by mask or nasal prongs) according to the WHO ordinal scale for clinical improvement which translates to moderate to severe COVID‐19 patients according to the Ministry of Health Uganda COVID‐19 disease category Trial registration number: NCT04768179 Date of trial registration: 24 February 2021 Prospective completion date: 30 September 2021
Participants	Age: 18 to 64 years Gender: NR Ethnicity: NR Number of participants (recruited/allocated/evaluated): 490/NR/NR Severity of disease: SARS‐CoV‐2 infection (COVID‐19) Additional diagnoses: NR Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): NR
Interventions	Intervention: 3‐day ivermectin 200 μg/kg/day + 14‐day 75 mg aspirin/day + standard care Intervention: 3‐day ivermectin 600 μg/kg/day + 14‐day 75 mg aspirin/day + standard care Control: standard care Concomitant therapy: NR Treatment cross‐overs: NR Duration of follow‐up: NR Treatment cross‐overs: NR Compliance with assigned treatment: NR
Outcomes	Primary outcomes SARS COV 2 Viral clearance World Health Organization COVID‐19 ordinal improvement score Secondary outcomes Clinical recovery Spectrum and severity of adverse events Maximum Plasma concentration Minimum Plasma concentration Area Under the Curve
Starting date	19 February 2020
Contact information	Contact: Jackson Mukonzo, PhD 256758113468 mukojack@yahoo.co.uk Contact: Rita Nakato, MSc nakato.ritah@gmail.com
Notes	Sponsor/funding: Makerere University COIs: NR Other: NR