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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
122
Hopial Avicenne
Bobigny, France
Hôpital GHU Paris Saclay
Le Kremlin-Bicêtre, France
Hôpital Saint Antoine
Paris, France
Hôpital Broca
Paris, France
To assess the impact of hydroxychloroquine and azithromycin on the prevention of SARS-CoV-2 contamination in hospital workers exposed to 40 days of treatment.
The number of hospital workers with a positive serology or a positive PCR within 40 days of follow-up.
Time frame: 3 months
Reducing clinical episodes due to suspected SARS-2 CoV infection confirmed by PCR
Clinical signs suggesting SARS-2 CoV infection confirmed by positive endonasal PCR
Time frame: 40 days
Reducing seroconversion for SARS-CoV-2 without any clinical sign
number of seroconversion by serology between Day 0 and Day 40.
Time frame: 3 months
Evaluation of drug tolerance in the study
number of cardiological severe adverse events assessed (ECG abnormalities : widening QT, ventricular arythmia, and cardiac arrests), other serious adverse events including hospitalizations, and deaths
Time frame: 40 days
Evaluation on work stopping of hospital workers
Number of work stoppages over the period
Time frame: 40 days
Observance of treatment measured by plasmatic concentrations of hydroxychloroquine or azythromycine
Plasmatic concentrations of treatments
Time frame: 40 days
Incidence of cardiologic events
number of cardiac events, especialy ECG abnormalities (widening QT) due to treatments
Time frame: 40 days
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Hôpital La Pitié-Salpétrière
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Hôpital européen Georges Pompidou
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Hôpital Necker
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