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

NCT04361604 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 270

Last updated 2020-04-24

No results posted yet for this study

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

Conditions

  • Adult Patients Living With HIV (PLWHIV) With Confirmed Infection With SARS-CoV-2 Since 1st January 2020

Interventions

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)

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-30
Primary Completion
2020-10-31
Completion
2020-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04361604 on ClinicalTrials.gov