The Investigators propose to set up a preventive trial of infection in hospital workers at risk of coronavirus infection by comparing the rate of SARS-Cov-2 infection in a population of negative SARS-Cov-2 hospital workers receiving preventively azithromycin, hydroxychloroquine or a Placebo
Randomized clinical trial with 3 arms : hydroxychloroquine group, 300 subjects/azithromycin
group, 300 subjects/ placebo of hydroxychloroquine group, 300 subjects. Hospital workers
workers will be invited to participate in the study in each hospital and they will be
included after giving their consent, assessment of their eligibility criteria, endonasal PCR
and serolology at baseline. They will be randomized in one of the 3 arms, receive their
treatment and will be followed by physical visit (at Day 2, Day 5, Day 15, Day 28) and by
phone (at Day) 40 days with clinical data collection (tolerance and clinical signs of
infection). At the end of treatment, another serology will be collected.
Drug: hydroxychloroquine
200 mg BID per day
Drug: azithromycin
250 mg per day
Drug: hydroxychloroquine placebo
200 mg BID per day
Inclusion Criteria:
Hospital workers working at AP-HP hospitals over the age of 18
- Hospital workers who have signed consent
- No signs of COVID-19 infection
- Women who are likely to procreate should have a negative pregnancy test on inclusion
day. In addition, they should use at least one effective contraceptive method before
starting treatment, during treatment and up to 8 months after the last drug tested
during the trial. Sexually active men should also have effective contraception during
treatment and for at least 8 months after the last drug tested during the trial.
- Affiliated or beneficiary of Social Security
Exclusion Criteria:
- History of SARS-CoV-2 infection confirmed by PCR or serology is available at inclusion
- A history of clinical episode suspecting a PCR-confirmed or unconfirmed COVID-19
infection.
- Pregnancy and breastfeeding
- Allergy or contraindications to one of the 2 drugs in the study
- Known retinopathy
- Long congenital QT syndrome (or known in the family)
- QTc or 450 ms in men, or 460 ms in women, if Fc 55/mn (except in case of intense sport
practice), if ESV on baseline ECG, if QRS - or 120 ms, if AC/FA, if the PR or BAV
lengthening
- History of severe ischemic heart disease or unbalanced heart failure.
- Clinically significant bradycardia known
- Known kidney or liver failure
- Known G6PD deficit
- Subject who received antiviral treatment in the 14 days prior to inclusion
- Subject who had treatment with azithromycin or hydroxychloroquine, in the 14 days
prior to inclusion
- Hypokaliemia (<= 3.5 mmol/L), Increase in creatinine (>=120 micromol/Ll, Increase in
transaminases at baseline (>=2N)
Hopial Avicenne
Bobigny, France
Hôpital GHU Paris Saclay
Le Kremlin-Bicêtre, France
Hôpital Saint Antoine
Paris, France
Hôpital Broca
Paris, France
Hôpital La Pitié-Salpétrière
Paris, France
Hôpital Cochin
Paris, France
Hôpital européen Georges Pompidou
Paris, France
Hôpital Necker
Paris, France
Jean Ma Treluyer, MD PhD, Principal Investigator
Assitance publique - Hôpitaux de Paris.