Impact of Long-term Protease Inhibitors in Patients Living With HIV on the Incidence of COVID-19 ( COVIP )

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

COMPLETED

Total Enrollment

1040 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-28

Study Completion Date

2021-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Protease inhibitor exposed

HIV patients treated with antiretroviral drugs including a protease inhibitor

No intervention

Intervention Type OTHER

No intervention: Usual care for nasopharyngeal sampling and blood sampling for COVID-19 detection

Protease inhibitor non exposed

HIV patients treated with antiretroviral drugs without a protease inhibitor

No intervention

Intervention Type OTHER

No intervention: Usual care for nasopharyngeal sampling and blood sampling for COVID-19 detection

Interventions

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No intervention

No intervention: Usual care for nasopharyngeal sampling and blood sampling for COVID-19 detection

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No