SARS-CoV-2 InfectionPhase 3PREP-COVIDNCT04344379
Prevention of SARS-CoV-2 in Hospital Workers s Exposed to the Virus
A Phase 3 study testing hydroxychloroquine and azithromycin in people with SARS-CoV-2 Infection, run by Assistance Publique - Hôpitaux de Paris at 8 sites in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- hydroxychloroquine and azithromycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 8 sitesFrance
- Study dates
- 17 Apr 2020to 18 Jun 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Hopial Avicenne
Bobigny, 93000
Hôpital GHU Paris Saclay
Le Kremlin-Bicêtre, 92100
Hôpital Saint Antoine
Paris, 75012
Hôpital Broca
Paris, 75013
Hôpital La Pitié-Salpétrière
Paris, 75013
Hôpital Cochin
Paris, 75014
Hôpital européen Georges Pompidou
Paris, 75015
Hôpital Necker
Paris, 75015
About this study
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
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
Read the 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.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- hydroxychloroquine, azithromycin, hydroxychloroquine placebo
- Keywords
- COVID-19, SARS-CoV-2, hydroxychloroquine, azithromycin, caregivers
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
200 mg BID per day
azithromycinDrug
250 mg per day
hydroxychloroquine placeboDrug
200 mg BID per day
| Study group | Role | What they receive |
|---|---|---|
| Arm Title : hydroxychloroquine | Active comparator | Not described |
| Placebo of hydroxychloroquine | Placebo comparator | Not described Receives: Drug: hydroxychloroquine placebo |
| azythromycin | Active comparator | Not described Receives: Drug: azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (6)
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
Measured: 40 days
Reducing seroconversion for SARS-CoV-2 without any clinical sign
number of seroconversion by serology between Day 0 and Day 40.
Measured: 3 months
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
Measured: 40 days
Evaluation on work stopping of hospital workers
Number of work stoppages over the period
Measured: 40 days
Observance of treatment measured by plasmatic concentrations of hydroxychloroquine or azythromycine
Plasmatic concentrations of treatments
Measured: 40 days
Incidence of cardiologic events
number of cardiac events, especialy ECG abnormalities (widening QT) due to treatments
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start17 Apr 2020
- Primary completion18 Jun 2020
- Study completion18 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Jean Ma Treluyer, MD PhD, Principal investigator, Assitance publique - Hôpitaux de Paris.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344379
- Sponsor's protocol ID
- APHP200386
- Other IDs
- 2020-001273-73
- Acronym
- PREP-COVID
- Status last verified
- Oct 2025
- First submitted
- 27 Mar 2020
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04344379
- Acronym / sponsor ID
- PREP-COVID / APHP200386
- Conditions
- SARS-CoV-2 Infection
- Keywords
- COVID-19, SARS-CoV-2, hydroxychloroquine, azithromycin, caregivers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 17 Apr 2020 (actual)
- Primary completion
- 18 Jun 2020 (actual)
- Study completion
- 18 Jun 2020 (actual)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm Title : hydroxychloroquine | Active comparator | – |
| Placebo of hydroxychloroquine | Placebo comparator | Drug: hydroxychloroquine placebo |
| azythromycin | Active comparator | Drug: azithromycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydroxychloroquine200 mg BID per day | Drug | – |
| azithromycin250 mg per day | Drug | azythromycin |
| hydroxychloroquine placebo200 mg BID per day | Drug | Placebo of hydroxychloroquine |
Primary outcome
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.
6 secondary outcomes
Reducing clinical episodes due to suspected SARS-2 CoV infection confirmed by PCR
Time frame: 40 days
Reducing seroconversion for SARS-CoV-2 without any clinical sign
Time frame: 3 months
Evaluation of drug tolerance in the study
Time frame: 40 days
Evaluation on work stopping of hospital workers
Time frame: 40 days
Observance of treatment measured by plasmatic concentrations of hydroxychloroquine or azythromycine
Time frame: 40 days
Incidence of cardiologic events
Time frame: 40 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Ma Treluyer, MD PhD principal investigator
Assitance publique - Hôpitaux de Paris.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing hydroxychloroquine and azithromycin in people with SARS-CoV-2 Infection, run by Assistance Publique - Hôpitaux de Paris at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.