Randomized Multicenter Study Evaluating the Efficacy of Azithromycin and Hydroxychloroquine in the Prevention of SARS-CoV-2 Infection in the Hospital Population Exposed to Virus
Overview
- Phase
- Phase 3
- Intervention
- hydroxychloroquine placebo
- Conditions
- SARS-CoV-2 Infection
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 122
- Locations
- 8
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 5 months ago
Overview
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-Cov-2 hospital workers receiving preventively azithromycin, hydroxychloroquine or a Placebo
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 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.
Investigators
Eligibility 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
Arms & Interventions
Placebo of hydroxychloroquine
Intervention: hydroxychloroquine placebo
azythromycin
Intervention: azithromycin
Outcomes
Primary Outcomes
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.
Time Frame: 3 months
The number of hospital workers with a positive serology or a positive PCR within 40 days of follow-up.
Secondary Outcomes
- Evaluation on work stopping of hospital workers(40 days)
- Reducing seroconversion for SARS-CoV-2 without any clinical sign(3 months)
- Evaluation of drug tolerance in the study(40 days)
- Observance of treatment measured by plasmatic concentrations of hydroxychloroquine or azythromycine(40 days)
- Incidence of cardiologic events(40 days)
- Reducing clinical episodes due to suspected SARS-2 CoV infection confirmed by PCR(40 days)