Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Characterisation Protocol for COVID-19 in People Living With HIV (COVIDHIV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04361604
Recruitment Status : Unknown
Verified April 2020 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

There is very little data so far to determine whether people living with HIV (PLWHIV) are at greater risk of COVID-19 acquisition or severe disease. HIV infection is associated with deficiencies in both humoral and cell-mediated immunity that could potentially alter the course and severity of common infections. The investigators will study the correlation between clinical and immunovirological data. The singularity of this work is to have an in-depth immunovirological approach linked to the clinical characteristics in COVID-19 HIV co-infected patients. COVIDHIV is the only study to date to offer this combined approach in PLWHIV.

This protocol is a historical and prospective cohort study of PLWHIV presenting COVID-19 The primary objectives are to describe the course of COVID-19 disease in patients infected with HIV


Condition or disease Intervention/treatment
Adult Patients Living With HIV (PLWHIV) With Confirmed Infection With SARS-CoV-2 Since 1st January 2020 Biological: Biological collection (patients co infected HIV Sras-CoV-2) Other: Auto-questionnaires (patients co infected HIV Sras-CoV-2) Other: Qualitative interviews (in 40 patients : 20 with COVID-19 and 20 without COVID-19)

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 270 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Clinical Characterisation Protocol for COVID-19 in People Living With HIV
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
250 Patients co infected HIV and SRAS-CoV2
Cohort of Patient co infected HIV AND SRAS-CoV2
Biological: Biological collection (patients co infected HIV Sras-CoV-2)
Biological sampling (blood,saliva, tear urine, stool, respiratory tract, semen only for 20 patients, or other samples if indicated.)

Other: Auto-questionnaires (patients co infected HIV Sras-CoV-2)
4 autoquestionnaires will be collected : HADS Hospital anxiety and depression scale, PCL-5 (post-traumatic stress disorder checklist version DSM-5), symptoms with the modified Justice Symptom Index PROQOL-HIV

Other: Qualitative interviews (in 40 patients : 20 with COVID-19 and 20 without COVID-19)
Qualitative interviews will be realized in 40 patients (20 with COVID-19 and 20 without COVID-19)

20 patients infected HIV without COVID-19
Group of 20 comparative patients PLWHIV without COVID-19. This group will realise only the interview of the research.
Other: Qualitative interviews (in 40 patients : 20 with COVID-19 and 20 without COVID-19)
Qualitative interviews will be realized in 40 patients (20 with COVID-19 and 20 without COVID-19)




Primary Outcome Measures :
  1. Describe the course of COVID-19 disease in patients infected with HIV, [ Time Frame: 6 months ]
    Biological sample collection


Biospecimen Retention:   Samples Without DNA

Biological collection for the research :

blood, saliva, rectal swab (stool swab), urine, nasopharyngeal swab, conjonctival swab, semen (for 20 PLWHIV).

CSF or other samples if indicated as part of standard care requires



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

This study will enroll 250 adult patients living with HIV (PLWHIV) with confirmed infection with SARS-CoV-2 since 1st January 2020. Recruitment of patients with Day 1 (enrolment) data is the priority.

Twenty adult patients living with HIV (PLWHIV) without confirmed infection with SARS-CoV-2 will be enrolled only for qualitative interview.

In order to be the most representative of PLHIV population and reach the number of patients to be included people who do not have social security affiliation or who are eligible may be included in the study. A derogation will be requested from the CPP for this.

Criteria

Inclusion Criteria:

Inclusion criteria for the 250 patients with COVID19

  • Patient living with HIV (PLWHIV)
  • Patient with confirmed infection with SARS-CoV-2 since 1st January 2020 with and without criteria of hospitalisation.

Inclusion criteria for the 20 patients without COVID19 (who will only realize the qualitative interview)

  • Patient living with HIV (PLWHIV)
  • Patient who did not have COVID-19

Exclusion Criteria:

Exclusion criteria for the 250 patients with COVID19

  • Confirmed diagnosis of another pathogen than SARS-CoV-2
  • Refusal by participant, or appropriate representative.
  • Being under guardianship or trusteeship mandate for future protection
  • Participate to another study without consent of the promoter
  • Patients less than 18 years old
  • No Beneficiary or entitled to a social security scheme or state medical aid.

Exclusion criteria for the 20 patients without COVID19 (who will only realize the qualitative interview)

  • Refusal by participant, or appropriate representative.
  • Being under guardianship or trusteeship mandate for future protection
  • Participate to another study without consent of the promoter
  • Patients less than 18 years old
  • No Beneficiary or entitled to a social security scheme or state medical aid.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04361604


Locations
Layout table for location information
France
Department of Internal Medicine and Clinical Immunology of Professor Cécile Goujard
Le Kremlin-Bicêtre, France
Contact: Antoine Chéret, Dr    0145212586    antoine.cheret@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04361604    
Other Study ID Numbers: 2020-A00984-35
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No