Trial reportJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology2022
RETRACTED: Evaluating the efficacy and safety of a novel prophylactic nasal spray in the prevention of SARS-CoV-2 infection: A multi-centre, double blind, placebo-controlled, randomised trial.
Trial report in Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It has been retracted, and should not be counted. Cited by 7 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 14 citations in OpenAlex.
- Washing Illness Away: A Systematic Review of the Impact of Nasal Irrigation and Spray on COVID-19.The Laryngoscope · 2025Pooled it
- Prophylaxis against covid-19: living systematic review and network meta-analysis.BMJ (Clinical research ed.) · 2021Pooled it
- Human monoclonal antibody F61 nasal spray effectively protected high-risk populations from SARS-CoV-2 variants during the COVID-19 pandemic from late 2022 to early 2023 in China.Emerging microbes & infections · 2024Trial
- Lung tropism in hospitalized patients following infection with SARS-CoV-2 variants from D614G to Omicron BA.2.Communications medicine · 2023Article
- Safety in Rats of a Novel Nasal Spray Formulation for the Prevention of Airborne Viral Infections.Pharmaceutics · 2023Article
- Review
- Phytochemicals in the Prevention and Treatment of SARS-CoV-2-Clinical Evidence.Antibiotics (Basel, Switzerland) · 2022Review
Corrections and comments
- Expression of concern · 2025-04-10Concerns/Issues about Results and/or Conclusions · Investigation by Journal/Publisher · Investigation by Third Party · Updated to Retraction · · see also: https://pubpeer.com/publications/626E12142DA77239E263D482DB56EF
- Retraction · 2025-05-15Concerns/Issues about Human Subject Welfare · Investigation by Journal/Publisher · Lack of IRB/IACUC Approval and/or Compliance · Unreliable Results and/or Conclusions · Upgrade/Update of Prior Notice(s) ·
- Expression of concern
- Retracted
Authors and funding
15 authors at 7 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
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.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.