Status:
COMPLETED
Prevention of SARS-CoV-2 in Hospital Workers s Exposed to the Virus
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
URC-CIC Paris Descartes Necker Cochin
Conditions:
SARS-CoV-2 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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-...
Detailed Description
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 inv...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2020
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT04344379
Start Date
April 17 2020
End Date
June 18 2020
Last Update
November 20 2025
Active Locations (8)
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1
Hopial Avicenne
Bobigny, France, 93000
2
Hôpital GHU Paris Saclay
Le Kremlin-Bicêtre, France, 92100
3
Hôpital Saint Antoine
Paris, France, 75012
4
Hôpital Broca
Paris, France, 75013