Prevention of SARS-CoV-2 in Hospital Workers s Exposed to the Virus

• Status: Completed
• Trial end date: 2020-06-18
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Azithromycin; Hydroxychloroquine

Criteria

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)