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

NCT04357639 | Completed

• 1 other identifier: COVIP
• Study Type: observational
• Target: 1,040
• Locations: 1 country
• Sites: 6

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.

Conditions

HIV Patients

Keywords

Protease inhibitor, antiretroviral drug, COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Determination of the seroprevalence of COVID-19 infection in both groups of the study

  6 months

• Comparison of the severity of COVID-19 infection symptoms in both groups of the study.

  6 months

• Identification of potential risk factors for COVID-19 infection in HIV patients treated with protease inhibitor or without protease inhibitor

  6 months

Study Arms (2)

Protease inhibitor exposed

HIV patients treated with antiretroviral drugs including a protease inhibitor

Other: No intervention

Protease inhibitor non exposed

HIV patients treated with antiretroviral drugs without a protease inhibitor

Other: No intervention

Interventions

No intervention OTHER

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

Protease inhibitor exposed; Protease inhibitor non exposed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead
• Centre Hospitalier Intercommunal Villeneuve St Georges: collaborator

Study Sites (6)

CHI Créteil

Créteil, 94000, France

Location

CHU Henri Mondor

Créteil, 94010, France

Location

Centre hospitalier de Melun (GHSIF)

Melun, 77000, France

Location

Hopital universitaire de Hotel Dieu

Paris, 75004, France

Location

Hopital Universitaire de Necker

Paris, 75015, France

Location

CHI Villeneuve St Georges

Villeneuve-Saint-Georges, 94190, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 22, 2020
• Study Start: May 28, 2020
• Primary Completion: January 31, 2021
• Study Completion: July 31, 2021
• Last Updated: August 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)