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Prevention of SARS-CoV-2 in Hospital Workers s Exposed to the Virus (PREP-COVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04344379
Recruitment Status : Suspended (suspension of clinical trials with hydroxychloroquine by health authorities)
First Posted : April 14, 2020
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Infection Drug: hydroxychloroquine Drug: azithromycin Drug: hydroxychloroquine placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : April 17, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 15, 2020


Arm Intervention/treatment
Active Comparator: Arm Title : hydroxychloroquine Drug: hydroxychloroquine
200 mg BID per day

Placebo Comparator: Placebo of hydroxychloroquine Drug: hydroxychloroquine placebo
200 mg BID per day

Active Comparator: azythromycin Drug: azithromycin
250 mg per day




Primary Outcome Measures :
  1. 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. [ Time Frame: 3 months ]
    The number of hospital workers with a positive serology or a positive PCR within 40 days of follow-up.


Secondary Outcome Measures :
  1. Reducing clinical episodes due to suspected SARS-2 CoV infection confirmed by PCR [ Time Frame: 40 days ]
    Clinical signs suggesting SARS-2 CoV infection confirmed by positive endonasal PCR

  2. Reducing seroconversion for SARS-CoV-2 without any clinical sign [ Time Frame: 3 months ]
    number of seroconversion by serology between Day 0 and Day 40.

  3. Evaluation of drug tolerance in the study [ 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

  4. Evaluation on work stopping of hospital workers [ Time Frame: 40 days ]
    Number of work stoppages over the period

  5. Observance of treatment measured by plasmatic concentrations of hydroxychloroquine or azythromycine [ Time Frame: 40 days ]
    Plasmatic concentrations of treatments

  6. Incidence of cardiologic events [ Time Frame: 40 days ]
    number of cardiac events, especialy ECG abnormalities (widening QT) due to treatments



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04344379


Locations
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France
Hopial Avicenne
Bobigny, France, 93000
Hôpital GHU Paris Saclay
Le Kremlin-Bicêtre, France, 92100
Hôpital Saint Antoine
Paris, France, 75012
Hôpital Broca
Paris, France, 75013
Hôpital La Pitié-Salpétrière
Paris, France, 75013
Hôpital Cochin
Paris, France, 75014
Hôpital européen Georges Pompidou
Paris, France, 75015
Hôpital Necker
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Jean Ma Treluyer, MD PhD Assitance publique - Hôpitaux de Paris.
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04344379    
Other Study ID Numbers: APHP200386
2020-001273-73 ( EudraCT Number )
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Assistance Publique - Hôpitaux de Paris:
COVID-19
SARS-CoV-2
hydroxychloroquine
azithromycin
caregivers
Additional relevant MeSH terms:
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Hydroxychloroquine
Infection
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents