Abstract
Background The COVID-19 pandemic continues to devastate communities all over the world. The aim of this study was to evaluate the efficacy and safety of the test agent as a prophylaxis against SARS-CoV-2 infection in a population of high-risk healthcare workers. Methods The study was a multi-centre, prospective, double blind, randomized, placebo-controlled trial. Key eligibility criteria included absence of significant co-morbidity and no previous SARS-CoV-2 infection or vaccination. Participants were randomised to either the active agent nasal spray or placebo using computer generated random number tables. The nasal spray was administered 3 times daily over a 45 day course. The primary end point was the percentage of subjects who tested positive for IgGS (anti-spike, immunoglobulin G specific to the spike protein of SARS-CoV-2) at day 45. Results Between 16th April 2021 and 26th July 2021, 556 participants were analysed for the primary endpoint (275 Test; 281 Placebo). The test agent significantly reduced SARS-CoV-2 infection compared to placebo [36 cases (13.1%) Vs 97 cases (34.5%); OR 0.29 (95% CI; 0.18-0.45), p < 0.0001]. Fewer clinical symptoms were also seen in the test group [57 cases (17.6%) vs 112 cases (34.6%); OR 0.40, (95% CI; 0.27-0.59), p < 0.0001]. No harmful effects were associated with taking the test agent. Conclusion The test agent significantly reduced SARS-CoV-2 infection in healthcare workers, with 62% fewer infections when compared to placebo. It was found to be safe and well tolerated and offers a novel treatment option for prophylaxis against SARS-CoV-2 infection.
Keywords: COVID-19; Clinical trial; Prophylaxis; SARS-CoV-2.
【저자키워드】 COVID-19, clinical trial, SARS-CoV-2., Prophylaxis, 【초록키워드】 Treatment, SARS-CoV-2, vaccination, randomised, SARS-COV-2 infection, COVID-19 pandemic, Infection, nasal, Randomized, Immunoglobulin, clinical, healthcare, placebo-controlled trial, co-morbidity, Community, Efficacy and safety, double blind, Placebo, eligibility criteria, Anti-spike, Safe, subject, clinical symptom, participant, primary end point, random, positive, offer, Administered, Effect, Course, Result, tested, evaluate, significantly, analysed, reduced, absence, the spike protein, the primary endpoint, 【제목키워드】 SARS-CoV-2, nasal, Prophylactic, Efficacy and safety, double blind, placebo-controlled, Randomised trial, Evaluating,