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

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)