NCT04344379

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

April 17, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2020

Completed
Last Updated

November 20, 2025

Status Verified

October 1, 2025

Enrollment Period

2 months

First QC Date

March 27, 2020

Last Update Submit

November 17, 2025

Conditions

SARS-CoV-2 Infection

Keywords

COVID-19SARS-CoV-2hydroxychloroquineazithromycincaregivers

Outcome Measures

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.

    The number of hospital workers with a positive serology or a positive PCR within 40 days of follow-up.

    3 months

Secondary Outcomes (6)

  • Reducing clinical episodes due to suspected SARS-2 CoV infection confirmed by PCR

    40 days

  • Reducing seroconversion for SARS-CoV-2 without any clinical sign

    3 months

  • Evaluation of drug tolerance in the study

    40 days

  • Evaluation on work stopping of hospital workers

    40 days

  • Observance of treatment measured by plasmatic concentrations of hydroxychloroquine or azythromycine

    40 days

  • +1 more secondary outcomes

Study Arms (3)

Arm Title : hydroxychloroquine

ACTIVE COMPARATOR

Placebo of hydroxychloroquine

PLACEBO COMPARATOR
Drug: hydroxychloroquine placebo

azythromycin

ACTIVE COMPARATOR
Drug: azithromycin

Interventions

hydroxychloroquineDRUG

200 mg BID per day

azithromycinDRUG

250 mg per day

azythromycin
hydroxychloroquine placeboDRUG

200 mg BID per day

Placebo of hydroxychloroquine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospital workers working at AP-HP hospitals over the age of 18
  • Hospital workers who have signed consent
  • No signs of COVID-19 infection
  • Affiliated or beneficiary of Social Security

You may not qualify if:

  • 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
  • Hypokaliemia (\<= 3.5 mmol/L), Increase in creatinine (\>=120 micromol/Ll, Increase in transaminases at baseline (\>=2N)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hopial Avicenne

Bobigny, 93000, France

Location

Hôpital GHU Paris Saclay

Le Kremlin-Bicêtre, 92100, France

Location

Hôpital Saint Antoine

Paris, 75012, France

Location

Hôpital Broca

Paris, 75013, France

Location

Hôpital La Pitié-Salpétrière

Paris, 75013, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Hôpital européen Georges Pompidou

Paris, 75015, France

Location

Hôpital Necker

Paris, 75015, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

HydroxychloroquineAzithromycin

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Jean Ma Treluyer, MD PhD

    Assitance publique - Hôpitaux de Paris.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2020

First Posted

April 14, 2020

Study Start

April 17, 2020

Primary Completion

June 18, 2020

Study Completion

June 18, 2020

Last Updated

November 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(8)