Prognostic Factors of COVID19

• Conditions: SARS-CoV-2

• Registration Number: NCT04405726
• Lead Sponsor: University Hospital, Strasbourg, France

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-27
• Status Verified: 2020-05
• Study First Submitted: 2020-05-25
• Study First Submitted QC: 2020-05-25
• Study First Posted: 2020-05-28
• Last Update Submitted: 2020-06-23
• Last Update Posted: 2020-06-25
• Primary Completion: 2022-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Presentation and Incidence of Covid-19 Infection in patients hospitalised in Strasbourg Hospital	From 1st March 2020 to 1st March 2021

Trial Locations

Locations (1)

Service de Virologie - Hôpital Civil; 🇫🇷 Strasbourg, France