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Prognostic Factors of COVID19 (Covid-HUS)

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ClinicalTrials.gov Identifier: NCT04405726
Recruitment Status : Recruiting
First Posted : May 28, 2020
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease
SARS-CoV-2

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Study of Clinical, Biological and Genetic Prognostic Factors of SARS-CoV-2 Infection in Patients Admitted in the Strasbourg University Hospitals
Actual Study Start Date : March 27, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine





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


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult and pediatric with suspicion or a confirmed SARS-CoV-2 infection
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04405726


Contacts
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Contact: Samira FAFI-KREMER, PharmD, PhD 33.3.69.55.14.38 Samira.fafi-kremer@chru-strasbourg.fr
Contact: Saïd CHAYER, PhD, HDR 33 3 88 11 66 90 said.chayer@chru-strasbourg.fr

Locations
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France
Service de Virologie - Hôpital Civil Recruiting
Strasbourg, France, 67091
Contact: Samira FAFI-KREMER, PharmD, PhD    33.3.69.55.14.38    Samira.fafi-kremer@chru-strasbourg.fr   
Principal Investigator: Samira FAFI-KREMER, PharmD, PhD         
Principal Investigator: Yves HANSMANN, MD         
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: Nicolas LEFEBVRE, MD         
Sub-Investigator: François DANION, MD         
Sub-Investigator: Yvon RUCH, MD         
Sub-Investigator: Nicolas MEYER, MD, PhD         
Sub-Investigator: Aurélie VELAY, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Study Director: Samira FAFI-KREMER, PharmD, PhD Laboratoire de Virologie Plateau Technique de Microbiologie
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT04405726    
Other Study ID Numbers: 7760
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
SARS-CoV-2
Covid-19
Prognostic factors
Genetic factors
T and B cell immune response