HIV PatientsNCT04357639
Impact of Long-term Protease Inhibitors in Patients Living With HIV on the Incidence of COVID-19 ( COVIP )
An observational study of HIV Patients, run by Centre Hospitalier Intercommunal Creteil at 6 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Patients
- How many people
- 1,040 participants
- Where
- 6 sitesFrance
- Study dates
- 28 May 2020to 31 Jul 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be proposed to HIV patients treated with long-term antiretroviral drugs (ARDs) with or without protease inhibitors (PIs).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHI Créteil
Créteil, 94000
CHU Henri Mondor
Créteil, 94010
Centre hospitalier de Melun (GHSIF)
Melun, 77000
Hopital universitaire de Hotel Dieu
Paris, 75004
Hopital Universitaire de Necker
Paris, 75015
CHI Villeneuve St Georges
Villeneuve-Saint-Georges, 94190
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV Patients
- Being tested
- No intervention
- Keywords
- Protease inhibitor, antiretroviral drug, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention: Usual care for nasopharyngeal sampling and blood sampling for COVID-19 detection
| Study group | Role | What they receive |
|---|---|---|
| Protease inhibitor exposed | HIV patients treated with antiretroviral drugs including a protease inhibitor Receives: Other: No intervention | |
| Protease inhibitor non exposed | HIV patients treated with antiretroviral drugs without a protease inhibitor Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (3)
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
Measured: 6 months
Comparison of the severity of COVID-19 infection symptoms in both groups of the study.
Proportion of severe forms in both study groups
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start28 May 2020
- Primary completion31 Jan 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,040 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Intercommunal Villeneuve St Georges
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357639
- Sponsor's protocol ID
- COVIP
- Status last verified
- Jul 2021
- First submitted
- 20 Apr 2020
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Description Study of the Impact of Long-term Protease Inhibitors in Patients Living With HIV on the Incidence of COVID-19
- ClinicalTrials.gov ID
- NCT04357639
- Acronym / sponsor ID
- COVIP
- Conditions
- HIV Patients
- Keywords
- Protease inhibitor, antiretroviral drug, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,040 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Collaborators
- Centre Hospitalier Intercommunal Villeneuve St Georges
- Study start
- 28 May 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protease inhibitor exposed | – | Other: No interventionHIV patients treated with antiretroviral drugs including a protease inhibitor |
| Protease inhibitor non exposed | – | Other: No interventionHIV patients treated with antiretroviral drugs without a protease inhibitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be proposed to HIV patients treated with long-term antiretroviral drugs (ARDs) with or without protease inhibitors (PIs).
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention: Usual care for nasopharyngeal sampling and blood sampling for COVID-19 detection | Other | Protease inhibitor exposed, Protease inhibitor non exposed |
Primary outcome
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
3 secondary outcomes
Determination of the seroprevalence of COVID-19 infection in both groups of the study
Time frame: 6 months
Comparison of the severity of COVID-19 infection symptoms in both groups of the study.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Patients, run by Centre Hospitalier Intercommunal Creteil at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021; AzTrials last refreshed its copy on 8 Nov 2026.