Status:
TERMINATED
Chemoprophylaxis of SARS-CoV-2 Infection (COVID-19) in Exposed Healthcare Workers
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Collaborating Sponsors:
Institut Pasteur
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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. ...
Detailed Description
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 allocati...
Eligibility Criteria
Inclusion
- Adult healthcare workers (HCWs) (for instance physicians, nurses, assistant nurses, dentists, physiotherapists, midwives, etc.)
- HCW involved at the time of enrolment in the care and the management of patients with confirmed or suspected SARS-CoV-2 infection in hospital settings, in outpatient care settings or in geriatric long-term care facilities. These HCWs have prolonged or repeated close contact to these patients.
- HCW tested negative for HIV
- HCW affiliated to the French health insurance system
- HCW women of childbearing age with an effective contraception (ethinylestradiol-containing contraceptive pills are not regarded as effective in the context of LPV/r treatment - COVIDAXIS 2)
- Willing to comply to study design and the follow-up
- Consent form signed
Exclusion
- For COVIDAXIS 1:
- HCW with positive SARS-CoV-2 RT-PCR of nasopharyngeal swab at the inclusion visit.
- HCW with past history of confirmed SARS-CoV-2 infection
- HCW with positive SARS-CoV-2 serology at the inclusion visit
- HCW with comorbidities such as hypothyroidism that need hormonal substitution, or retinopathy or with prior intermittent porphyria, or chronic renal failure (glomerular filtration rate \< 30mL/min) or prior hepatic failure or psoriasis.
- HCW with prior diagnosis of glucose-6-phosphate dehydrogenase (G6PD) deficiency
- HCW with known hypersensitivity/allergy to HCQ
- HCW with baseline QTc interval \> 450ms in men or \> 460ms in women and QTc \<320 ms (both gender)
- HCW with personal or family history of long QT syndrome, torsades de pointes, or sudden death
- Pregnant HCW
- Breastfeeding HCW
- HCW taking comedications known to have interactions with HCQ according to the official characteristics of the product
- For COVIDAXIS 2:
- HCW with positive SARS-CoV-2 RT-PCR of nasopharyngeal swab at the inclusion visit.
- HCW with past history of confirmed SARS-CoV-2 infection
- HCW with positive SARS-CoV-2 serology at the inclusion visit
- HCW with comorbidities such as chronic HCV infection treated by direct antiviral drugs or with hypothyroidism that need hormonal substitution, or known to have hypercholesterolemia hypertriglyceridemiaor chronic renal failure (glomerular filtration rate \< 30mL/min) or prior hepatic failure
- HCW with known hypersensitivity/allergy to LPV/r
- HCW with baseline QTc interval \> 450ms in men or \> 460ms in women and QTc \<320 ms (both gender)
- HCW with personal or family history of long QT syndrome, torsades de pointes, or sudden death
- Pregnant HCW
- Breastfeeding HCW
- HCW taking comedications known to have interactions with LPV/r according to the official characteristics of the product
Key Trial Info
Start Date :
April 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2022
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT04328285
Start Date
April 14 2020
End Date
March 30 2022
Last Update
March 1 2023
Active Locations (9)
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1
CHU d'Angers
Angers, France
2
CHU de Bordeaux
Bordeaux, France, 33000
3
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63000
4
CHU de Montpellier
Montpellier, France, 34000