Clinical trial NCT04405726: Prognostic Factors of COVID19
Official title: Study of Clinical, Biological and Genetic Prognostic Factors of SARS-CoV-2 Infection in Patients Admitted in the Strasbourg University Hospitals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV-2
Keywords: SARS-CoV-2
Covid-19
Prognostic factors
Genetic factors
T and B cell immune response
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult and pediatric with suspicion or a confirmed SARS-CoV-2 infection

Brief summary: COVID-19 is an emerging disease, for which no specific treatment options are currently available. Since the end of February 2020, and due to a SARS-CoV-2 superspreading event (religious meeting), the Strasbourg University Hospital (HUS) had faced a sudden increase of the number of COVID-19-positive patients in serious condition requiring hospitalization. At the same time, many people develop only mild or moderate symptoms. To date, the prognostic factors for the course of SARS-CoV-2 infection are unknown. The primary purpose of the "COVID-HUS" protocol is to investigate viral and host-related factors to understand the pathophysiology of COVID infection and to open the way for new diagnostic, prognostic and therapeutic strategies against SARS CoV-2 .

The secondary objectives are

* Monitoring of viral replication of SARS-CoV-2 in the blood and respiratory tract in infected patients
* Monitoring of the humoral and cellular response directed against SARS-CoV-2
* Identification of factors leading to significant and / or prolonged viral replication of SARS-CoV-2 in the blood or respiratory samples
* Evaluation of the benefit of possible treatments implemented following the diagnosis of SARS-CoV-2 infection
* Exploration of the B and T immune repertoire sequences targeting SARS-CoV-2 in infected patients
* Typing of the HLA system in infected patients


Eligibility criteria: Inclusion Criteria:

* Adult and pediatric with suspicion or a confirmed SARS-CoV-2 infection
* Patient who has signed a non-opposition form (or a form signed by a family member or a support person if the seriousness of the patient's condition and the emergency situation do not allow it) or who has given his oral agreement to the doctor

Exclusion Criteria:

* Patient's explicit refusal to participate
* Subject deprived of liberty or subject to the protection of justice
* Subject under guardianship or trusteeship

Primary outcomes:
measure: Clinical Presentation and Incidence of Covid-19 Infection in patients hospitalised in Strasbourg Hospital
timeFrame: From 1st March 2020 to 1st March 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Virologie - Hôpital Civil
Study officials:
affiliation: Laboratoire de Virologie Plateau Technique de Microbiologie
name: Samira FAFI-KREMER, PharmD, PhD
role: STUDY_DIRECTOR
References:
citation: Gallais F, Velay A, Nazon C, Wendling MJ, Partisani M, Sibilia J, Candon S, Fafi-Kremer S. Intrafamilial Exposure to SARS-CoV-2 Associated with Cellular Immune Response without Seroconversion, France. Emerg Infect Dis. 2021 Jan;27(1):113-21. doi: 10.3201/eid2701.203611. Epub 2020 Dec 1.