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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04344379
Other study ID # APHP200386
Secondary ID 2020-001273-73
Status Completed
Phase Phase 3
First received
Last updated
Start date April 17, 2020
Est. completion date June 18, 2020

Study information

Verified date July 2021
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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 information / eligibility

Status Completed
Enrollment 122
Est. completion date June 18, 2020
Est. primary completion date June 18, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
hydroxychloroquine
200 mg BID per day
azithromycin
250 mg per day
hydroxychloroquine placebo
200 mg BID per day

Locations

Country Name City State
France Hopial Avicenne Bobigny
France Hôpital GHU Paris Saclay Le Kremlin-Bicêtre
France Hôpital Broca Paris
France Hôpital Cochin Paris
France Hôpital européen Georges Pompidou Paris
France Hôpital La Pitié-Salpétrière Paris
France Hôpital Necker Paris
France Hôpital Saint Antoine Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. The number of hospital workers with a positive serology or a positive PCR within 40 days of follow-up. 3 months
Secondary Reducing clinical episodes due to suspected SARS-2 CoV infection confirmed by PCR Clinical signs suggesting SARS-2 CoV infection confirmed by positive endonasal PCR 40 days
Secondary Reducing seroconversion for SARS-CoV-2 without any clinical sign number of seroconversion by serology between Day 0 and Day 40. 3 months
Secondary Evaluation of drug tolerance in the study number of cardiological severe adverse events assessed (ECG abnormalities : widening QT, ventricular arythmia, and cardiac arrests), other serious adverse events including hospitalizations, and deaths 40 days
Secondary Evaluation on work stopping of hospital workers Number of work stoppages over the period 40 days
Secondary Observance of treatment measured by plasmatic concentrations of hydroxychloroquine or azythromycine Plasmatic concentrations of treatments 40 days
Secondary Incidence of cardiologic events number of cardiac events, especialy ECG abnormalities (widening QT) due to treatments 40 days
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