Prevention of SARS-CoV-2 in Hospital Workers s Exposed to the Virus (NCT04344379) | Clinical Trial Compass
CompletedPhase 3
Prevention of SARS-CoV-2 in Hospital Workers s Exposed to the Virus
France122 participantsStarted 2020-04-17
Plain-language 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-Cov-2 hospital workers receiving preventively azithromycin, hydroxychloroquine or a Placebo
Who can participate
Age range18 Years
SexALL
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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 hydroxychloroquin…
What they're measuring
1
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.