Prognostic Factors of COVID19 (Covid-HUS)

June 23, 2020 updated by: University Hospital, Strasbourg, France

Study of Clinical, Biological and Genetic Prognostic Factors of SARS-CoV-2 Infection in Patients Admitted in the Strasbourg University Hospitals

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Virologie - Hôpital Civil
        • Sub-Investigator:
          • Yvon Ruch, MD
        • Contact:
        • Principal Investigator:
          • Samira FAFI-KREMER, PharmD, PhD
        • Sub-Investigator:
          • Floriane GALLAIS, MD
        • Sub-Investigator:
          • Ilies BENOTMANE, MD
        • Sub-Investigator:
          • Héloïse DELAGREVERIE, MD
        • Sub-Investigator:
          • Morgane SOLIS, MD
        • Sub-Investigator:
          • Eric SOULIER, InG
        • Sub-Investigator:
          • François Danion, MD
        • Sub-Investigator:
          • Aurélie VELAY, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult and pediatric with suspicion or a confirmed SARS-CoV-2 infection

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical Presentation and Incidence of Covid-19 Infection in patients hospitalised in Strasbourg Hospital
Time Frame: From 1st March 2020 to 1st March 2021
From 1st March 2020 to 1st March 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Study Director: Samira FAFI-KREMER, PharmD, PhD, Laboratoire de Virologie Plateau Technique de Microbiologie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2020

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

May 25, 2020

First Submitted That Met QC Criteria

May 25, 2020

First Posted (Actual)

May 28, 2020

Study Record Updates

Last Update Posted (Actual)

June 25, 2020

Last Update Submitted That Met QC Criteria

June 23, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 7760

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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