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Prognostic Factors of COVID19 (Covid-HUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04405726
Recruitment Status : Recruiting
First Posted : May 28, 2020
Last Update Posted : June 25, 2020
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Tracking Information
First Submitted Date May 25, 2020
First Posted Date May 28, 2020
Last Update Posted Date June 25, 2020
Actual Study Start Date March 27, 2020
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 25, 2020)
Clinical Presentation and Incidence of Covid-19 Infection in patients hospitalised in Strasbourg Hospital [ Time Frame: From 1st March 2020 to 1st March 2021 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title 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
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 Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult and pediatric with suspicion or a confirmed SARS-CoV-2 infection
Condition SARS-CoV-2
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 25, 2020)
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
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
Sexes Eligible for Study: All
Ages 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contact: Samira FAFI-KREMER, PharmD, PhD
Contact: Saïd CHAYER, PhD, HDR 33 3 88 11 66 90
Listed Location Countries France
Removed Location Countries  
Administrative Information
NCT Number NCT04405726
Other Study ID Numbers 7760
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Strasbourg, France
Study Sponsor University Hospital, Strasbourg, France
Collaborators Not Provided
Study Director: Samira FAFI-KREMER, PharmD, PhD Laboratoire de Virologie Plateau Technique de Microbiologie
PRS Account University Hospital, Strasbourg, France
Verification Date May 2020