Chemoprophylaxis of SARS-CoV-2 Infection (COVID-19) in Exposed Healthcare Workers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-14

Study Completion Date

2022-03-30

Brief Summary

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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:

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Detailed Description

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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:

* 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.

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:

* Group 2.1: LPV/r 200/50 mg : 2 tablets twice daily
* Group 2.2: Placebo of LPV/r, 2 tablets twice daily

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

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized double-blind placebo-controlled clinical trial

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Hydroxychloroquine (HCQ) vs Placebo

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.

Group Type EXPERIMENTAL

Hydroxychloroquine

Intervention Type DRUG

Hydroxychloroquine Oral Tablets

Placebo of Hydroxychloroquine

Intervention Type DRUG

Placebo of Hydroxychloroquine Oral Tablets Placebo manufactured to mimic Hydroxychloroquine tablets

Lopinavir/ritonavir (LPV/r) vs Placebo

Group 2.1: LPV/r 200/50 mg, 2 tablets twice daily

Group 2.2: Placebo of LPV/r, 2 tablets twice daily

Group Type EXPERIMENTAL

Lopinavir and ritonavir

Intervention Type DRUG

LPV/r Oral Tablets

Placebo of LPV/r Tablets

Intervention Type DRUG

Placebo of LPV/r Oral Tablets Placebo manufactured to mimic LPV/r tablets

Interventions

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Hydroxychloroquine

Hydroxychloroquine Oral Tablets

Intervention Type DRUG

Placebo of Hydroxychloroquine

Placebo of Hydroxychloroquine Oral Tablets Placebo manufactured to mimic Hydroxychloroquine tablets

Intervention Type DRUG

Lopinavir and ritonavir

LPV/r Oral Tablets

Intervention Type DRUG

Placebo of LPV/r Tablets

Placebo of LPV/r Oral Tablets Placebo manufactured to mimic LPV/r tablets

Intervention Type DRUG

Other Intervention Names

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Plaquenil Kaletra

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes