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OpenTrials
Completed

NCT Number: NCT04344379

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hopial Avicenne, Bobigny, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hydroxychloroquine

Drug

200 mg BID per day

Azithromycin

Drug

250 mg per day

hydroxychloroquine placebo

Drug

200 mg BID per day

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study 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

Acronym: PREP-COVID

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 14, 2020
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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