Acceptability of a COVID-19 pre-exposure prophylaxis trial with hydroxychloroquine in French healthcare workers during the first wave of COVID-19 pandemic
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, WhiteThe 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).
Contact:
elisabeth.botelho-nevers@chu-saint-etienne.fr (corresponding author), Arnauld.Garcin@chu-st-etienne.fr, nathalie.jolly@pasteur.fr.
Abstract: Gagneux-Brunon et al. Trials
(2021) 22:373
https://doi.org/10.1186/s13063-021-05329-y
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 ClinicalTrials.gov. 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: elisabeth.botelho-nevers@chu-saint-etienne.fr
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
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