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

HIV Patients Clinical Trial

Official title:

Prospective Description Study of the Impact of Long-term Protease Inhibitors in Patients Living With HIV on the Incidence of COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04357639
• Other study ID #: COVIP
• Status: Completed
• Start date: May 28, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: July 2021
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1040
• Est. completion date: July 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Patients

Intervention

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

Locations

Country	Name	City	State
France	CHI Créteil	Créteil
France	CHU Henri Mondor	Créteil
France	Centre hospitalier de Melun (GHSIF)	Melun
France	Hopital universitaire de Hotel Dieu	Paris
France	Hopital Universitaire de Necker	Paris
France	CHI Villeneuve St Georges	Villeneuve-Saint-Georges

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil	Centre Hospitalier Intercommunal Villeneuve St Georges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Occurrence of COVID-19 infection during the epidemics (M0, M1) in both study groups	1 month
Secondary	Determination of the seroprevalence of COVID-19 infection in both groups of the study	Percentage of positive serological tests at the end of the epidemics in both study groups	6 months
Secondary	Comparison of the severity of COVID-19 infection symptoms in both groups of the study.	Proportion of severe forms in both study groups	6 months
Secondary	Identification of potential risk factors for COVID-19 infection in HIV patients treated with protease inhibitor or without protease inhibitor	Statistical association between a risk factor and the occurrence of COVID-19 infection in both study groups	6 months