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

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ClinicalTrials.gov Identifier: NCT04344379
Recruitment Status : Completed
First Posted : April 14, 2020
Last Update Posted : August 3, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE March 27, 2020
First Posted Date  ICMJE April 14, 2020
Last Update Posted Date August 3, 2021
Actual Study Start Date  ICMJE April 17, 2020
Actual Primary Completion Date June 18, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2020)
  • 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
  • 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.
  • 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
  • Evaluation on work stopping of hospital workers [ Time Frame: 40 days ]
    Number of work stoppages over the period
  • Observance of treatment measured by plasmatic concentrations of hydroxychloroquine or azythromycine [ Time Frame: 40 days ]
    Plasmatic concentrations of treatments
  • Incidence of cardiologic events [ Time Frame: 40 days ]
    number of cardiac events, especialy ECG abnormalities (widening QT) due to treatments
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of SARS-CoV-2 in Hospital Workers s Exposed to the Virus
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE SARS-CoV-2 Infection
Intervention  ICMJE
  • Drug: hydroxychloroquine
    200 mg BID per day
  • Drug: azithromycin
    250 mg per day
  • Drug: hydroxychloroquine placebo
    200 mg BID per day
Study Arms  ICMJE
  • Active Comparator: Arm Title : hydroxychloroquine
    Intervention: Drug: hydroxychloroquine
  • Placebo Comparator: Placebo of hydroxychloroquine
    Intervention: Drug: hydroxychloroquine placebo
  • Active Comparator: azythromycin
    Intervention: Drug: azithromycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2020)
122
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2020)
900
Actual Study Completion Date  ICMJE June 18, 2020
Actual Primary Completion Date June 18, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04344379
Other Study ID Numbers  ICMJE APHP200386
2020-001273-73 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean Ma Treluyer, MD PhD Assitance publique - Hôpitaux de Paris.
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP