Prevention of SARS-CoV-2 in Hospital Workers s Exposed to the Virus (PREP-COVID)
Primary Purpose
SARS-CoV-2 Infection
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
hydroxychloroquine
azithromycin
hydroxychloroquine placebo
Sponsored by
About this trial
This is an interventional prevention trial for SARS-CoV-2 Infection focused on measuring COVID-19, SARS-CoV-2, hydroxychloroquine, azithromycin, caregivers
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
- 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)
Sites / Locations
- Hopial Avicenne
- Hôpital GHU Paris Saclay
- Hôpital Saint Antoine
- Hôpital Broca
- Hôpital La Pitié-Salpétrière
- Hôpital Cochin
- Hôpital européen Georges Pompidou
- Hôpital Necker
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
Arm Title : hydroxychloroquine
Placebo of hydroxychloroquine
azythromycin
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Reducing seroconversion for SARS-CoV-2 without any clinical sign
number of seroconversion by serology between Day 0 and Day 40.
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
Evaluation on work stopping of hospital workers
Number of work stoppages over the period
Observance of treatment measured by plasmatic concentrations of hydroxychloroquine or azythromycine
Plasmatic concentrations of treatments
Incidence of cardiologic events
number of cardiac events, especialy ECG abnormalities (widening QT) due to treatments
Full Information
NCT ID
NCT04344379
First Posted
March 27, 2020
Last Updated
July 31, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04344379
Brief Title
Prevention of SARS-CoV-2 in Hospital Workers s Exposed to the Virus
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 17, 2020 (Actual)
Primary Completion Date
June 18, 2020 (Actual)
Study Completion Date
June 18, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 Infection
Keywords
COVID-19, SARS-CoV-2, hydroxychloroquine, azithromycin, caregivers
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm Title : hydroxychloroquine
Arm Type
Active Comparator
Arm Title
Placebo of hydroxychloroquine
Arm Type
Placebo Comparator
Arm Title
azythromycin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
hydroxychloroquine
Intervention Description
200 mg BID per day
Intervention Type
Drug
Intervention Name(s)
azithromycin
Intervention Description
250 mg per day
Intervention Type
Drug
Intervention Name(s)
hydroxychloroquine placebo
Intervention Description
200 mg BID per day
Primary Outcome Measure Information:
Title
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.
Description
The number of hospital workers with a positive serology or a positive PCR within 40 days of follow-up.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Reducing clinical episodes due to suspected SARS-2 CoV infection confirmed by PCR
Description
Clinical signs suggesting SARS-2 CoV infection confirmed by positive endonasal PCR
Time Frame
40 days
Title
Reducing seroconversion for SARS-CoV-2 without any clinical sign
Description
number of seroconversion by serology between Day 0 and Day 40.
Time Frame
3 months
Title
Evaluation of drug tolerance in the study
Description
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
Title
Evaluation on work stopping of hospital workers
Description
Number of work stoppages over the period
Time Frame
40 days
Title
Observance of treatment measured by plasmatic concentrations of hydroxychloroquine or azythromycine
Description
Plasmatic concentrations of treatments
Time Frame
40 days
Title
Incidence of cardiologic events
Description
number of cardiac events, especialy ECG abnormalities (widening QT) due to treatments
Time Frame
40 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Ma Treluyer, MD PhD
Organizational Affiliation
Assitance publique - Hôpitaux de Paris.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopial Avicenne
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
Hôpital GHU Paris Saclay
City
Le Kremlin-Bicêtre
ZIP/Postal Code
92100
Country
France
Facility Name
Hôpital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hôpital Broca
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital La Pitié-Salpétrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hôpital européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hôpital Necker
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Prevention of SARS-CoV-2 in Hospital Workers s Exposed to the Virus
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