SARS-CoV-2 Clinical Trial
— Covid-HUSOfficial title:
Study of Clinical, Biological and Genetic Prognostic Factors of SARS-CoV-2 Infection in Patients Admitted in the Strasbourg University Hospitals
| NCT number | NCT04405726 |
| Other study ID # | 7760 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 27, 2020 |
| Est. completion date | March 2022 |
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
| Status | Recruiting |
| Enrollment | 500 |
| Est. completion date | March 2022 |
| Est. primary completion date | March 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 1 Year and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Service de Virologie - Hôpital Civil | Strasbourg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical Presentation and Incidence of Covid-19 Infection in patients hospitalised in Strasbourg Hospital | From 1st March 2020 to 1st March 2021 |
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|---|---|---|---|
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