Hydroxychloroquine
Drug200 mg BID per day
NCT Number: NCT04344379
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
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Hopial Avicenne, Bobigny, France
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Hospital workers working at AP-HP hospitals over the age of 18
Exclusion criteria
200 mg BID per day
250 mg per day
200 mg BID per day
Time frame: 3 months
The number of hospital workers with a positive serology or a positive PCR within 40 days of follow-up.
Time frame: 40 days
Clinical signs suggesting SARS-2 CoV infection confirmed by positive endonasal PCR
Time frame: 3 months
number of seroconversion by serology between Day 0 and Day 40.
Time frame: 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
Time frame: 40 days
Number of work stoppages over the period
Time frame: 40 days
Plasmatic concentrations of treatments
Time frame: 40 days
number of cardiac events, especialy ECG abnormalities (widening QT) due to treatments
Assistance Publique - Hôpitaux de Paris
Other
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
Acronym: PREP-COVID
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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