2021‐000166‐15/HU.

Study name	A randomized, double‐blind, placebo‐controlled study to assess the safety and efficacy of ivermectin in asymptomatic and mild severity COVID‐19 patients
Methods	Trial design: double‐blind RCT with 2 parallel arms Type of record: trial register entry Sample size: 140 Setting: outpatient Country: Hungary Language: English Number of centres:NR Study purpose (treatment, prevention): treatment Trial registration number: 2021‐000166‐15/HU Date of registration: 25 January 2021
Participants	Inclusion criteria Both gender, 18‐75 years old Ambulatory patients with confirmed SARS‐CoV‐2 infection by RAT or PCR, regardless whether they show symptoms or are asymptomatic Asymptomatic or mild COVID‐19 cases: no dyspnoe and no tachypnoe (respiratory rate < 22/ min), no need for oxygen‐supplementation; no radiological findings of pneumonia (note: no medical imaging will be conducted within the scope of the study. If previous medical imaging report is available, its result however be utilized) BMI: ≤ 20 kg/m2 to ≤ 28 kg/m2 Subjects who are able to communicate with the Investigator and research staff, who understand the study, are able to comply with all study procedures, and willing to provide written informed consent prior to screening examinations Exclusion criteria Moderate or severe or critical COVID‐19 cases High‐risk patient for progression of COVID‐19 Concomitant or previous administration of any experimental, non‐established COVID‐19 therapy, either in off‐label indication of a registered medicinal product or as a non‐registered drug candidate in a clinical trial setting or compassionate use programme (or equivalents thereof) No previous COVID‐19 therapies allowed Concomitant administration of coumarin‐derivatives or warfarin Concomitant administration of cytochrom‐P450 or membrane drug transporter Any clinically‐significant abnormality identified during screening full physical examination, vital signs, laboratory tests and ECG which is deemed by the investigator to be incompatible/inappropriate for study participation Current or recent history of drug or substance abuse, including alcohol Patients who regularly consume more than 4 cups daily of beverage containing caffeine Current strong smoker ( > 10 cigarettes a day, or its equivalent) Positive pregnancy test Women who are pregnant or nursing, or who are planning to get pregnant within 3 months after the last dose of study drug History of allergy, intolerance or sensitivity to ivermectin or any component of the study drug formulation Exhibiting any pathology, contraindicated with ivermectin administration Undergone surgery or have donated blood within 12 weeks prior to the start of the study History of bleeding diathesis or other bleeding disorders Investigational drug administration or investigational device application within 1 month preceding study entry, or within 5 terminal half‐life of the investigational drug of the previous study, whichever is the longer History of malignancy within 5 years from screening visit, with the exception of resected basal cell carcinoma or squamous cell carcinoma of the skin, or resected cervical intraepithelial neoplasia Particular central nervous system interventions and disorders, which may cause breakdown of the blood‐brain‐barrier (BBB) and result in transport of ivermectin to brain
Interventions	Details of intervention Type and dose: ivermectin, no information on dose or frequency scheme Route of administration: oral Treatment details of control group Placebo Concomitant therapy: NR
Outcomes	Primary study outcome Percentage of SARS‐CoV‐2 virus at day 7 compared to baseline Relevant review outcomes planned Time to virus clearance, defined as days from randomization (day 1) to negative SARS‐CoV‐2 RT‐PCR test Time to recovery in patients who have developed symptoms Time to resolution from fever, cough burden, dysgeusia‐ageusia, anosmia, fatigue Percentage of patients hospitalized due to progression of COVID‐19 Additional study outcomes Time to virus clearance, defined as days from randomization (day 1) to negative SARS‐CoV‐2 RT‐PCR test Time to recovery in patients who have developed symptoms Time to resolution from fever, cough burden, dysgeusia‐ageusia, anosmia, fatigue Percentage of patients hospitalized due to progression of COVID‐19 Absenteeism, by self‐reporting, expressed in days absent from workplace, due to COVID‐19
Starting date	3 March 2021
Contact information	Cortex Pharma Services CRO Jozsef nador ter 5‐6 1051 Budapest Hungary info@cortexps.hu
Notes	Recruitment status: NR Prospective completion date: NR Planned completion date more than 6 months ago: unclear Date last update posted: NR Sponsor/funding: Meditop Gyógyszeripari Kft