A Pilot, Randomised, Placebo-Controlled, Double-Blind Trial of a Single Oral Dose of Ivermectin for Post-Exposure Prophylaxis of SARS-CoV-2

DOI record: { "DOI": "10.3390/pharmaceutics17091205", "ISSN": [ "1999-4923" ], "URL": "http://dx.doi.org/10.3390/pharmaceutics17091205", "abstract": "<jats:p>Background: The efficacy of a single oral dose of Ivermectin as prophylaxis for SARS-CoV-2 is uncertain. This trial sought to evaluate the effectiveness of a single oral low dose of Ivermectin to prevent SARS-CoV-2 infection or reduce symptoms if infection did occur. Methods: Asymptomatic community-dwelling adults were enrolled in this study within 72 h of close contact with a case of SARS-CoV-2. Participants were randomised, stratified by vaccination status and exposure site, to a single oral 200 µg/kg dose of Ivermectin or placebo. The primary outcome was conversion to a positive polymerase chain reaction (PCR) or rapid antigen test (RAT) for SARS-CoV-2 within 14 days of close contact. Secondary outcomes were restricted to those who met the primary outcome. They included the following: days alive free of symptoms in the 14 (DAFS1-14) and 28 (DAFS1-28) days following intervention and days from close contact until a positive PCR or RAT for SARS-CoV-2. Results: A total of 536 participants registered for this trial. Of these, 86 met inclusion criteria and were randomised. 68 adhered to the trial protocol and were included in the analysis. A total of 11/36 (Ivermectin arm) and 11/32 (placebo arm) met the primary outcome. After controlling for age and prior SARS-CoV-2 infection, the estimate (95% confidence interval (95% CI)) of the effect of Ivermectin (compared to placebo) on the absolute value of the proportion of participants converting to a positive PCR or RAT was −0.051 (−0.26 to 0.16), p = 0.63. After controlling for prior SARS-CoV-2 infection, age, body mass index, hypertension and lung disease, the average treatment effect (Ivermectin versus placebo) on DAFS1-14 was 2.5 days (95%CI 1.1 to 4.5), p = 0.036, and for DAFS1-28, was 2.3 days (95% CI 0.7 to 3.3), p = 0.35. The mean (standard deviation) number of days from close contact until a positive PCR or RAT was 5.0 (4.1) days for the Ivermectin group versus 2.6 (0.8) days for the placebo group. After controlling for age and prior SARS-CoV-2 infection, the average treatment effect (95%CI), Ivermectin versus placebo, on days from close contact until a positive PCR or RAT was 2.3 days (95% CI 1.1 to 3.4), p = 0.033. Conclusions: We did not demonstrate that a single oral low dose of Ivermectin administered to asymptomatic adults within 72 h of close contact with a case of SARS-CoV-2 prevents conversion to a positive PCR or RAT. However, the trial had a small sample size and does not exclude a clinically meaningful effect of Ivermectin on conversion to a positive PCR or RAT. Amongst those who did convert to a positive PCR or RAT, the use of Ivermectin significantly lengthened the time from close contact to conversion and increased the number of days alive free of symptoms following intervention.</jats:p>", "alternative-id": [ "pharmaceutics17091205" ], "author": [ { "affiliation": [ { "name": "Biomedicine Discovery Institute, Monash University, Clayton, VIC 3800, Australia" } ], "family": "Wagstaff", "given": "Kylie M.", "sequence": "first" }, { "affiliation": [ { "name": "Knox Private Hospital, Wantirna, VIC 3152, Australia" }, { "name": "Holmesglen Private Hospital, Moorabbin, VIC 3189, Australia" } ], "family": "Stein", "given": "Mark S.", "sequence": "additional" }, { "ORCID": "https://orcid.org/0009-0004-2061-4787", "affiliation": [ { "name": "School of Public Health and Preventative Medicine, Monash University, Melbourne, VIC 3004, Australia" } ], "authenticated-orcid": false, "family": "Herschtal", "given": "Alan", "sequence": "additional" }, { "affiliation": [ { "name": "Pulmonary and Sleep Consultants, 1001 South Andrews Ave, Fort Lauderdale, FL 33316, USA" } ], "family": "Rajter", "given": "Jean-Jacques", "sequence": "additional" }, { "affiliation": [ { "name": "Pulmonary and Sleep Consultants, 1001 South Andrews Ave, Fort Lauderdale, FL 33316, USA" } ], "family": "Rajter", "given": "Juliana Cepelowicz", "sequence": "additional" }, { "affiliation": [ { "name": "Neuroscience Trials Australia, 30 Royal Parade, Parkville, VIC 3052, Australia" } ], "family": "Sallaberger", "given": "Michele", "sequence": "additional" }, { "affiliation": [ { "name": "Neuroscience Trials Australia, 30 Royal Parade, Parkville, VIC 3052, Australia" } ], "family": "Smileski", "given": "Alexia", "sequence": "additional" }, { "affiliation": [ { "name": "Neuroscience Trials Australia, 30 Royal Parade, Parkville, VIC 3052, Australia" } ], "family": "Kanagalingam", "given": "Amala", "sequence": "additional" }, { "ORCID": "https://orcid.org/0000-0001-5115-4745", "affiliation": [ { "name": "Biomedicine Discovery Institute, Monash University, Clayton, VIC 3800, Australia" } ], "authenticated-orcid": false, "family": "Jans", "given": "David A.", "sequence": "additional" } ], "container-title": "Pharmaceutics", "container-title-short": "Pharmaceutics", "content-domain": { "crossmark-restriction": false, "domain": [] }, "created": { "date-parts": [ [ 2025, 9, 16 ] ], "date-time": "2025-09-16T11:19:31Z", "timestamp": 1758021571000 }, "deposited": { "date-parts": [ [ 2025, 9, 16 ] ], "date-time": "2025-09-16T11:23:12Z", "timestamp": 1758021792000 }, "funder": [ { "DOI": "10.13039/100007028", "doi-asserted-by": "crossref", "id": [ { "asserted-by": "crossref", "id": "10.13039/100007028", "id-type": "DOI" } ], "name": "Leona M. and Harry B. 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