Chemoprophylaxis of SARS-CoV-2 infection (COVID-19) in exposed healthcare workers: a randomized double-blind placebo-controlled clinical trial

Phase 1

• Conditions: Healthcare workers; MedDRA version: 21.1Level: LLTClassification code 10008434Term: Chemoprophylaxis NOSSystem Organ Class: 100000004865; MedDRA version: 20.0Level: LLTClassification code 10061986Term: SARSSystem Organ Class: 100000004862; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2020-001188-96-FR
• Lead Sponsor: CHU de Saint Etienne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-24
• Last Update Posted: 14 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

-Adult Healthcare workers (HCWs) (physicians, nurses, assistant nurses, dentists, physiotherapists, and midwives)
-HCWs involved at the time of enrolment in the care of patients with confirmed or suspected SARS-CoV-2 infection in hospital settings in outpatient care settings or in geriatric long-term care facilities
-HCWs 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)
-Willing to comply to study design and the follow-up

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-HCWs 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 (if the serology is available at inclusion time, if SARS-CoV-2 serology is not available, it will be a secondary exclusion criteria)
-HCW with comorbidities such as chronic HCV infection treated by direct antiviral drugs or with hypothyroidism that need hormonal substitution, or retinopathy or known to have hypercholesterolemia hypertriglyceridemia
-Pregnant HCW
-Breastfeeding HCW
-HCW taking comedications known to have interactions with LPV/r according to the official characteristics of the product
See sessions 4.3 Contraindications and 4.5 Interaction with other medicinal products and other forms of interaction
Lopinavir and ritonavir are both inhibitors of the P450 isoform CYP3A in vitro. Co-administration of LPV/r and medicinal products primarily metabolised by CYP3A may result in increased plasma concentrations of the other medicinal product, which could increase or prolong its therapeutic and adverse reactions. LPV/r does not inhibit CYP2D6, CYP2C9, CYP2C19, CYP2E1, CYP2B6 or CYP1A2 at clinically relevant concentrations (see section 4.3).
LPV/r has been shown in vivo to induce its own metabolism and to increase the biotransformation of some medicinal products metabolised by cytochrome P450 enzymes (including CYP2C9 and CYP2C19) and by glucuronidation. This may result in lowered plasma concentrations and potential decrease of efficacy of co-administered medicinal products
-HCW taking comedications known to have interactions with hydroxychloroquine according to the official characteristics of the product

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified