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

SARS-CoV-2 Infection Clinical Trial

— PREP-COVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04344379
• Other study ID #: APHP200386
• Secondary ID: 2020-001273-73
• Status: Completed
• Phase: Phase 3
• 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
• 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)

Related Conditions & MeSH terms

• Infection
• SARS-CoV-2 Infection

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