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

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

— COVIDHIV  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04361604
• Other study ID #: 2020-A00984-35
• Status: Not yet recruiting
• Start date: April 2020
• Est. completion date: October 2020

Study information

• Verified date: April 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

Infectious diseases are a major cause of death worldwide. Recently a new coronavirus named SARS-CoV-2 has been identified as responsible of an initial epidemic respiratory disease, named COVID-19, in China since the 31 December 20191. COVID-19 has developed into a pandemic, with small chains of transmission in many countries and large chains resulting in extensive spread in a some countries, such as Italy, Iran, South Korea, and Japan 2 . Most countries are likely to have spread of COVID-19, at least in the early stages, before any mitigation measures have an impact and the COVID -19 epidemic is gradually taking hold in France 3.

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. Although use of cART partially restores immune system, HIV-infected persons may remain at increased risk for morbidity associated with viral illnesses, especially if the ability to generate antigen-specific responses remains impaired

5. Additional factors, such as the high prevalence of smoking and chronic lung diseases among such patients, may further predispose HIV-infected patients to respiratory tract infections. Finally, they could be considered more vulnerable to SARS-CoV-2 infection because their immune systems are already under strain and cannot avoid the possibility of atypical presentations in these patients. Thus, we would like to implement a research as soon as possible concerning PLWHIV in order to adapt the care of these patients as fast as possible.

The investigator 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-1, and more specifically to:

• Describe the clinical and the biological features of the COVID-19 disease in PLWHIV

• Correlate the clinical characteristics with the immunovirological characteristics

• Describe the major complications and determine the factors associated with a worse evolution in PLWHIV

• Compare the data obtained to those of the similar works in progress in non PLWHIV

• Evaluate post-infectious clinical effects at a distance from the acute phase 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.

Research interventions include prospective collection of clinical data and biological sampling (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.). Auto-Questionnaires will be collected. Qualitative interviews will be realized in 40 patients (20 with COVID-19 and 20 without COVID-19)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 270
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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
• 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)

Locations

Country	Name	City	State
France	Department of Internal Medicine and Clinical Immunology of Professor Cécile Goujard	Le Kremlin-Bicêtre

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Describe the course of COVID-19 disease in patients infected with HIV,	Biological sample collection	6 months