A Phase 3 interventional study of Hydroxychloroquine and Placebo of Hydroxychloroquine in COVID-19, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Terminated at 9 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-01.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Phase 3, Interventional, and Prevention
Since December 2019, the emergence of a new coronavirus named SARS-Cov-2 in the city of Wuhan in China has been responsible for a major epidemic of respiratory infections, including severe pneumonia. Within weeks, COVID-19 became a pandemic.
In the absence of specific antiviral treatment, a special attention should be given to prevention. Personal protection equipments may be insufficiently protective, including in healthcare workers, a significant proportion of whom (around 4%) having been infected in the outbreaks described in China and more recently in Italy. Infection in healthcare workers could result from the contact with COVID-19 people in community or with infected colleagues or patients.
As it will take at least a year before vaccines against SARS-CoV-2 becomes available, chemoprophylaxis is an option that should be considered in this setting where prevention of SARS-CoV-2 infection in Health Care Workers.
The COVIDAXIS trial evaluates a chemoprophylaxis of SARS-CoV-2 infection in Health Care Workers. This trial is divided into two distinct studies that could start independently each with its own randomization process: COVIDAXIS 1 will study Hydroxychloroquine (HCQ) versus placebo; COVIDAXIS 2 will study Lopinavir/ritonavir (LPV/r) versus placebo.
Upon randomization healthcare workers (HCWs) involved in the management of suspected or confirmed COVID-19 cases will be assigned to one of the following 2 treatment groups:
The study COVIDAXIS 1(Hydroxychloroquine (HCQ) versus placebo) will be realized on 600 participants and will be implemented first in as many centers as possible.
Upon randomization, with 1:1 allocation ratio, healthcare workers involved in the management of suspected or confirmed COVID-19 cases will be assigned to one of the following 2 treatment groups:
The COVIDAXIS 2 (Lopinavir/ritonavir (LPV/r) versus placebo will be realized on 600 participants and will be implemented in already participating and newer centers in a second step (when LPV/r becomes available).
Upon randomization, with 1:1 allocation ratio, healthcare workers involved in the management of suspected or confirmed COVID-19 cases will be assigned to one of the following 2 treatment groups:
Participants will receive the randomized treatment for 2 months and will be followed upon a 2.5 months period.
NB: there is no randomization procedure for participant inclusion in either COVIDAXIS 1 or COVIDAXIS 2
7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's enrollment of 118 is above the median of 100 across 4,175 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.
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Exclusion Criteria:
For COVIDAXIS 1:
For COVIDAXIS 2:
Group 1.1: HCQ 200 mg : 2 tablets on the evening at Day 1 and 2 tablets on the morning at Day 2 and 1 tablet once daily afterwards Group 1.2: Placebo of HCQ, 2 tablets on the evening at Day 1 and 2 tablets on the morning at Day 2 and 1 tablet once daily afterwards.
Drug: Hydroxychloroquine · Drug: Placebo of Hydroxychloroquine
Group 2.1: LPV/r 200/50 mg, 2 tablets twice daily Group 2.2: Placebo of LPV/r, 2 tablets twice daily
Drug: Lopinavir and ritonavir · Drug: Placebo of LPV/r Tablets
Hydroxychloroquine Oral Tablets
Also known as: Plaquenil
Placebo of Hydroxychloroquine Oral Tablets Placebo manufactured to mimic Hydroxychloroquine tablets
LPV/r Oral Tablets
Also known as: Kaletra
Placebo of LPV/r Oral Tablets Placebo manufactured to mimic LPV/r tablets
Occurrence of an symptomatic or asymptomatic SARS-CoV-2 infection among healthcare workers (HCWs)
An infection by SARS-CoV-2 is defined by either: * a positive specific Reverse Transcription - Polymerase Chain Reaction (RT-PCR) on periodic systematic nasopharyngeal swab during follow-up OR * a positive specific RT-PCR on a respiratory sample in case of onset of symptoms consistent with COVID-19 during follow-up OR * a seroconversion to SARS-CoV-2 after randomization.
Time frame: Up to 2.5 months
Evaluation of the occurrence of adverse events in each arm,
Number of adverse events expected or unexpected, related and unrelated to the treatment, notably grades 2, 3 and 4 (moderate, severe and lifethreatening, according to the Adverse National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0) in each arm.
Time frame: Up to 2.5 months
Evaluation of the discontinuation rates of the investigational drug in each arm,
Number of treatment discontinuations in each arm
Time frame: Up to 2 months
Evaluation of the adherence of participants to study drug,
Treatment adherence rate will be assessed by: * measurement of LPV and HCQ plasma concentrations using LC-MS/MS or LC-Fluorimetric detection * the count of returned drugs at each visit.
Time frame: Up to 2 months
Evaluation of the incidence of symptomatic cases of SARS-CoV-2 infection in each arm,
Number of incident cases of symptomatic SARS-CoV-2 infections among HCWs in each arm. Symptomatic infection is defined as : * a positive specific RT-PCR on a respiratory or non respiratory sample OR * a thoracic CT scan with imaging abnormalities consistent with COVID-19. These investigations being performed in case of signs/symptoms consistent with COVID-19 during follow-up.
Time frame: Up to 2.5 months
Evaluation of the incidence of asymptomatic cases of SARS-CoV-2 infection in each arm
Number of incident cases of asymptomatic SARS-CoV-2 infection among HCWs in each randomization arm. Asymptomatic infection is defined as : * a positive specific RT-PCR on periodic systematic nasopharyngeal swab during clinical follow-up without consistent clinical signs/symptoms during follow-up OR * as seroconversion to SARS-CoV-2 between start and end of the study in HCWs that did not reported any consistent clinical symptoms during follow-up
Time frame: Up to 2.5 months
Evaluation of the incidence of severe cases of SARS-CoV-2 infection in each arm.
Number of incident cases of severe SARS-CoV-2 infections among HCWs in each randomization arm, defined as : * a positive specific RT-PCR on a respiratory sample OR * a thoracic CT scan with imaging abnormalities consistent with COVID-19 performed in case of onset of symptoms consistent with COVID-19 during follow-up in a participant who need to be hospitalized for respiratory distress. Respiratory distress defined as dyspnea with a respiratory frequency \> 30/min, blood oxygen saturation \<93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio \<300 and/or lung infiltrates \>50% (1).
Time frame: Up to 2.5 months
corrected QT interval (ms)
Safety. Electrocardiogram (ECG)
Time frame: At baseline, at D2 (only for COVIDAXIS 1) and every week up to 2 months.
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2020 to primary completion in May 2020, 0 months.
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This study is terminated, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hydroxychloroquine
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