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Acceptability of a COVID-19 pre-exposure prophylaxis trial with hydroxychloroquine in French healthcare workers during the first wave of COVID-19 pandemic

Gagneux-Brunon et al., Trials, doi:10.1186/s13063-021-05329-y, NCT04328285
Mar 2022  
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118 participant HCQ prophylaxis RCT with results not reported over 1 year after completion.
38 HCQ RCTs have results missing long after expected Abu-Helalah, Ajili, Akram, Al Ansari, Aston, Borrie, Burney, Butler, Chauffe, Connor, El-Sherbiny, Farooq, Gagneux-Brunon, Genton, Ghanem-Zoubi, González, Granados-Montiel, Gül, Hawari, James, Kara, Kim, Levi, Mežnar, Moraes, Morales-Asencio, Mordmüller, Nanni, Niriella, Okasha, Pellegrini, Pineda, Sarwar, Sarwar (B), Sow, Treluyer, WellStar, White
The trials report a total of 25,149 patients, with 13 trials having actual enrollment of 8,689, and the remainder estimated.
Gagneux-Brunon et al., 30 Mar 2022, Double Blind Randomized Controlled Trial, placebo-controlled, France, peer-reviewed, study period 14 April, 2020 - 30 March, 2022, trial NCT04328285 (history).
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Abstract: Gagneux-Brunon et al. Trials (2021) 22:373 LETTER Open Access Acceptability of a COVID-19 pre-exposure prophylaxis trial with hydroxychloroquine in French healthcare workers during the first wave of COVID-19 pandemic Amandine Gagneux-Brunon1,2, Clémentine Schilte3, Arnauld Garcin4, Nathalie Jolly3, Muriel Vray5, Laura Schaeffer5, Xavier Duval6, Bruno Hoen7 and Elisabeth Botelho-Nevers1,2* Keywords: Pre-exposure chemoprophylaxis trial, SARS-CoV-2 infection, Healthcare workers, Acceptability, Hydroxychloroquine Healthcare workers (HCWs) have been over-represented among people infected with Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2). In France, between March 1 and November 2, 2020, SARS-CoV-2 infection was diagnosed in more than 44,000 HCWs and killed 17 [1]. In the USA, HCWs accounted for around 20% of the confirmed cases of SARS-CoV-2 infections by April 2020 [2]. Protection of HCWs rapidly became a crucial challenge during the COVID-19 pandemics [3]. Pre- and post-exposure chemoprophylaxis was considered to be used in addition to personal protective equipment. More than 50 clinical trials aiming to assess chloroquine or hydroxychloroquine (HCQ) in HCWs and/or household contacts of COVID-19 cases have been registered worldwide with In France in April 2020, a multi-center randomized, double-blind, placebo-controlled trial to evaluate the efficacy of a 2-month pre-exposure prophylaxis with HCQ in 600 HCWs exposed to COVID-19 patients was started [4]. This trial was funded by the French hospital program for clinical research (PHRC) and sponsored by * Correspondence: 1 Department of Infectious diseases, University Hospital of Saint-Etienne, Saint-Etienne, 42055, France 2 CIC-1408 Vaccinology, INSERM, University Hospital of Saint-Etienne, Saint-Etienne, 42055, France Full list of author information is available at the end of the article the University Hospital of Saint-Etienne in collaboration with Institut Pasteur in Paris. For each participant, six visits at the investigation center, one weekly electrocardiogram, 5 blood samplings, and 4 nasopharyngeal swabs for SARS-CoV-2 RT-PCR were scheduled. Before the trial started, we conducted an anonymous online survey in ten of the investigation centers to evaluate the acceptability of the trial among HCWs, whether they worked in a hospital, an ambulatory setting, or a long-term care facility. Eight hundred and seventy-one HCWs completed the survey. Among respondents, 695 (79.8%) reported they were interested in participating in the trial. Intention to participate was not influenced by age or working place. Among the 695 potential volunteers, 430 (61.9%) were under 45 years of age and only 126 (18.1%) reported a significant comorbidity. The main reasons for declining participation in the study were the following: (1) fears about HCQ side effects in 121 of the 176 decliners (68.8%), (2) the perception that the individual risk of severe COVID-19 was low in 36 (20.5%), (3) the constraints resulting from the number of study visits in 29 (16.5%), and (4) the burden of nasopharyngeal swabs for SARS-CoV-2 RT-PCR in 25 (14.2%). Six hundred and ninety-five respondents reported being interested in participating in the chemoprophylaxis trial, and 117 were actually enrolled by May 27, 2020. In the first center where the trial was started, 342 HCWs reported being © The Author(s)...
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