Clinical trial NCT04357639: Impact of Long-term Protease Inhibitors in Patients Living With HIV on the Incidence of COVID-19 ( COVIP )
Official title: Prospective Description Study of the Impact of Long-term Protease Inhibitors in Patients Living With HIV on the Incidence of COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Patients
Keywords: Protease inhibitor, antiretroviral drug, COVID-19
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Intercommunal Villeneuve St Georges
First posted: 2020-04-22
Enrollment: 1040
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be proposed to HIV patients treated with long-term antiretroviral drugs (ARDs) with or without protease inhibitors (PIs).

Brief summary: This is a prospective multicenter cohort study. The question arises as to whether treatment with protease inhibitors (PIs) could have a preventive role for COVID-19 infection, especially since patients living with HIV (PLWHIV) have not been described as more at risk of developing COVID-19 infection.

The aim of our study will therefore be to assess the impact of long-term protease inhibitors in PLWHIV on the incidence of COVID-19.

Detailed description: The symptomatic management of COVID-19 infections is currently at the forefront. The therapeutic efficacy of certain molecules is being evaluated in studies, in vitro and in vivo, such as remdesivir, hydroxychloroquine / chloroquine, and lopinavir / ritonavir. The latter has been used in the treatment of HIV for many years, like other PIs such as darunavir and atazanavir. In France, around 11% of PLWHIV are treated with long-term PIs.

Lopinavir / ritonavir has an inhibitory role on the protein endopeptidase of coronavirus C30 (CEP_C30). In humans, Cao et al did not demonstrate any superiority of efficacy of lopinavir / ritonavir compared to the control group receiving standard care (HR for clinical improvement: 1.24 (0.90-1, 72)), but the initiation of treatment in the study was mainly at late stages. Early initiation of lopinavir/r at the onset of SARS symptoms appears to be more effective. To our knowledge, the other PIs are under study, with a possible inhibition of the proteases of type-3-chemotrypsin or of the papain type of SARS-Cov2. Three open randomized studies in humans are underway in China, Spain, and Thailand. The question arises as to whether treatment with PIs could have a preventive role for COVID-19 infection, especially since PLWHIV have not been described as more at risk of developing COVID-19 infection.

The aim of our study will therefore be to assess the impact of long-term protease inhibitors in PLWHIV on the incidence of COVID-19.

This is a prospective multicenter cohort study. A random sample of 794 eligible individuals will be recruited from April 2020, consisting of 397 patients in the long-term PIs group and 397 patients in the long-term ARV regimen without PIs. The study will be offered to PLWHIV in Île-de-France, treated with long-term antiretroviral drugs with or without protease inhibitors.

For those who accept: i) they will receive phone calls (teleconsultation) to collect information regarding symptoms at M0, M1 and between M3 and M6 by a medical or paramedical person from their hospital center ; ii) in case of a high probability of infection with Covid-19, an on-site consultation will be offered to them, with a diagnostic test by PCR on a nasopharyngeal swab and eventually a chest scanner if indicated ; iii) a serology on a blood sample will be performed at the end of the epidemics to look for anti-COVID-19 antibodies.

Eligibility criteria: Inclusion Criteria:

* HIV patients over 18 years of age
* Follow-up for an HIV infection 1 or 2
* Treated with antiretroviral drugs
* Resident in France during the epidemics
* No change in antiretroviral drugs during the epidemics
* No-opposition to participate to the research

Exclusion Criteria:

* Patients under guardianship or curators
* Opportunistic classifying pathologies by the Control Disease Center (CDC)
* Patients unable to give a free and informed no-opposition consent to participate to the protocol
* Patients under safeguarding justice

Primary outcomes:
measure: Comparison of the incidence of COVID-19 infection in PLWHIV treated with long-term antiretroviral drugs including a protease inhibitor and those without a protease inhibitor
timeFrame: 1 month
Secondary outcomes:
measure: Determination of the seroprevalence of COVID-19 infection in both groups of the study
timeFrame: 6 months
measure: Comparison of the severity of COVID-19 infection symptoms in both groups of the study.
timeFrame: 6 months
measure: Identification of potential risk factors for COVID-19 infection in HIV patients treated with protease inhibitor or without protease inhibitor
timeFrame: 6 months
Other outcomes:
Locations:
city: Créteil
country: France
facility: CHI Créteil
city: Créteil
country: France
facility: CHU Henri Mondor
city: Melun
country: France
facility: Centre hospitalier de Melun (GHSIF)
city: Paris
country: France
facility: Hopital universitaire de Hotel Dieu
city: Paris
country: France
facility: Hopital Universitaire de Necker
city: Villeneuve-Saint-Georges
country: France
facility: CHI Villeneuve St Georges
Study officials:
References: