Prevention of SARS-CoV-2 in Hospital Workers s Exposed to the Virus
- Conditions
- SARS-CoV-2 Infection
- Interventions
- Registration Number
- NCT04344379
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 122
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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo of hydroxychloroquine hydroxychloroquine placebo - Arm Title : hydroxychloroquine hydroxychloroquine - azythromycin azithromycin -
- Primary Outcome Measures
Name Time Method 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. 3 months The number of hospital workers with a positive serology or a positive PCR within 40 days of follow-up.
- Secondary Outcome Measures
Name Time Method Evaluation on work stopping of hospital workers 40 days Number of work stoppages over the period
Reducing seroconversion for SARS-CoV-2 without any clinical sign 3 months number of seroconversion by serology between Day 0 and Day 40.
Evaluation of drug tolerance in the study 40 days number of cardiological severe adverse events assessed (ECG abnormalities : widening QT, ventricular arythmia, and cardiac arrests), other serious adverse events including hospitalizations, and deaths
Observance of treatment measured by plasmatic concentrations of hydroxychloroquine or azythromycine 40 days Plasmatic concentrations of treatments
Incidence of cardiologic events 40 days number of cardiac events, especialy ECG abnormalities (widening QT) due to treatments
Reducing clinical episodes due to suspected SARS-2 CoV infection confirmed by PCR 40 days Clinical signs suggesting SARS-2 CoV infection confirmed by positive endonasal PCR
Trial Locations
- Locations (8)
Hopial Avicenne
🇫🇷Bobigny, France
Hôpital GHU Paris Saclay
🇫🇷Le Kremlin-Bicêtre, France
Hôpital Saint Antoine
🇫🇷Paris, France
Hôpital La Pitié-Salpétrière
🇫🇷Paris, France
Hôpital Broca
🇫🇷Paris, France
Hôpital Cochin
🇫🇷Paris, France
Hôpital Necker
🇫🇷Paris, France
Hôpital européen Georges Pompidou
🇫🇷Paris, France