> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-efficacy-and-safety-of-ivermectin-in-7bbc20db-d3b2-4aa4-a5b4-0969c425eb0e > Record changed: 2026-10-13 # A Study to Evaluate the Efficacy and Safety of Ivermectin in COVID-19 Prevention NCT05305560 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) Participants 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) Lead sponsor MedinCell S.A Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) Start date 2022-03-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) ## Title and summary **Summary** A multicenter, randomized, double-blind, placebo-controlled, study to evaluate the efficacy and safety of oral ivermectin tablets versus placebo for COVID-19 prophylaxis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) **Acronym** SAIVE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) **Short title** A Study to Evaluate the Efficacy and Safety of Ivermectin in COVID-19 Prevention Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) **Official title** A Multicentre Randomised, Double-Blind, Placebo-controlled, Study to Evaluate the efficAcy and Safety of Oral IVErmectin Tablets in the Prevention of COVID-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) ## Dates **Completion date** 2022-10-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) **First posted** 2022-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) **Registry last updated** 2024-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) **Primary completion date** 2022-09-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) **Start date** 2022-03-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) ## Size and sites **Actual participants** 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) **Participants** 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) **Lead sponsor** MedinCell S.A Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) ## Identifiers **Registry ID** NCT05305560 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) **ClinicalTrials.gov ID** NCT05305560 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) ## Outcomes ### Primary outcomes 1. COVID-19 Prophylaxis Timeframe: From Day 1 to Day 28 Number of laboratory-confirmed COVID-19 infections in each group between baseline and Day 28 ### Secondary outcomes 1. COVID-19 Symptoms Development Timeframe: From Day 1 to Day 28 Number of symptomatic Participants according to the WHO COVID-18 scale 2. COVID-19 Prophylaxis Timeframe Timeframe: From Day 1 to Day 28 Time to change from baseline in negative RT-PCR to positive RT-PCR 3. COVID-19 Hospitalisations Timeframe: From Day 1 to Day 56 Proportion of COVID-19 related hospitalisations 4. COVID-19 Mortality Timeframe: From Day 1 to Day 56 Proportion of COVID-19 related mortality 5. To Assess the Safety and Tolerability of IVM Given for a Period of 28 Days Timeframe: 56 days Descriptive comparison of AE rates and severity/seriousness between IVM and placebo Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** No ### Inclusion criteria 1. Age between 18 and 65 years, inclusive. 2. Body weight >45 kg. 3. Body Mass Index >18.5. 4. Close contact with a person who has a PCR-confirmed SARS-CoV-2 infection within 5 days before screening. 5. Only one member in the same household will be enrolled. 6. Participants must be able to give informed consent and comply with the study's scheduled events/visits and study assessments. 7. SARS-CoV-2 positive index case must be able to give consent to enable collection of the documented positive PCR test. 8. Female participants of childbearing potential must use a highly effective method of contraception for the duration of the trial. ### Exclusion criteria 1. Pregnant or breast-feeding. 2. Participants who have been administered COVID-19 vaccine prior to the inclusion or have a planned vaccination during the duration of the study. 3. A positive COVID-19 result (PCR or antigen test) within 8 days of screening. 4. Presence of typical COVID-19 symptoms (fever >38°C, SpO2 below 93%, dyspnoea, difficulty breathing, chills, repeated shaking with chills, ageusia, anosmia, cough, myalgia, headache) in the past 48 hours prior to screening. 5. Hypersensitivity to any component of ivermectin. 6. Participants who have been administered ivermectin within 30 days prior to screening. 7. Participation in another interventional trial within the last 30 days or 5 half-lives of the IMP of the other trial, whichever comes first. 8. Participants with gastrointestinal erosions and ulcers (e.g. erosive esophagitis, stomach ulcers, ulcerative colitis etc.). 9. History of neurotoxicity with ivermectin or other para-glycoprotein (p-gp) substrates or inhibitors. 10. Current use of monoclonal antibodies for the treatment of COVID-19. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) ## Sites - Medical Center Medic Ltd.Sofia, Bulgaria Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) ## References ### Other registry identifiers - 2021-001938-19 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305560) ## Related records ### Drugs (1) - [Ivermectin](https://trialight.com/data/asset/ivermectin-92b3d34e-69c8-464b-98da-d0f165a74513.md) ### Collaborators (1) - Violaine Desort-Henin, DVM ### Lead sponsors (1) - [MedinCell S.A](https://trialight.com/data/company/medincell-s-a-caddf925-8056-4d48-83f7-5589bcf20bfc.md) ### Conditions (1) - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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