- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04357639
Impact of Long-term Protease Inhibitors in Patients Living With HIV on the Incidence of COVID-19 ( COVIP )
Prospective Description Study of the Impact of Long-term Protease Inhibitors in Patients Living With HIV on the Incidence of COVID-19
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Créteil, France, 94000
- Chi Creteil
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Créteil, France, 94010
- CHU Henri Mondor
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Melun, France, 77000
- Centre hospitalier de Melun (GHSIF)
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Paris, France, 75004
- Hopital universitaire de Hotel Dieu
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Paris, France, 75015
- Hopital Universitaire de Necker
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Villeneuve-Saint-Georges, France, 94190
- CHI Villeneuve St Georges
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Protease inhibitor exposed
HIV patients treated with antiretroviral drugs including a protease inhibitor
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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
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No intervention: Usual care for nasopharyngeal sampling and blood sampling for COVID-19 detection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 1 month
|
Occurrence of COVID-19 infection during the epidemics (M0, M1) in both study groups
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determination of the seroprevalence of COVID-19 infection in both groups of the study
Time Frame: 6 months
|
Percentage of positive serological tests at the end of the epidemics in both study groups
|
6 months
|
Comparison of the severity of COVID-19 infection symptoms in both groups of the study.
Time Frame: 6 months
|
Proportion of severe forms in both study groups
|
6 months
|
Identification of potential risk factors for COVID-19 infection in HIV patients treated with protease inhibitor or without protease inhibitor
Time Frame: 6 months
|
Statistical association between a risk factor and the occurrence of COVID-19 infection in both study groups
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COVIP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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