NCT04405726

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 27, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

June 25, 2020

Status Verified

May 1, 2020

Enrollment Period

1.9 years

First QC Date

May 25, 2020

Last Update Submit

June 23, 2020

Conditions

SARS-CoV-2

Keywords

SARS-CoV-2Covid-19Prognostic factorsGenetic factorsT and B cell immune response

Outcome Measures

Primary Outcomes (1)

  • Clinical Presentation and Incidence of Covid-19 Infection in patients hospitalised in Strasbourg Hospital

    From 1st March 2020 to 1st March 2021

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Patient's explicit refusal to participate
  • Subject deprived of liberty or subject to the protection of justice
  • Subject under guardianship or trusteeship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Virologie - Hôpital Civil

Strasbourg, 67091, France

RECRUITING

Related Publications (2)

  • Partouche N, Maumy M, Chamaraux-Tran TN, Bertrand F, Schneider F, Meyer N, Solis M, Fafi-Kremer S, Noll E, Pottecher J. Does the IL-6/KL-6 ratio distinguish different phenotypes in COVID-19 Acute Respiratory Distress Syndrome? An observational study stemmed from prospectively derived clinical, biological, and computed tomographic data. PLoS One. 2025 May 21;20(5):e0321533. doi: 10.1371/journal.pone.0321533. eCollection 2025.

    PMID: 40397955DERIVED

  • Gallais F, Velay A, Nazon C, Wendling MJ, Partisani M, Sibilia J, Candon S, Fafi-Kremer S. Intrafamilial Exposure to SARS-CoV-2 Associated with Cellular Immune Response without Seroconversion, France. Emerg Infect Dis. 2021 Jan;27(1):113-21. doi: 10.3201/eid2701.203611. Epub 2020 Dec 1.

    PMID: 33261718DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Samira FAFI-KREMER, PharmD, PhD

    Laboratoire de Virologie Plateau Technique de Microbiologie

    STUDY DIRECTOR

Central Study Contacts

Samira FAFI-KREMER, PharmD, PhD

CONTACT

33.3.69.55.14.38Samira.fafi-kremer@chru-strasbourg.fr

Saïd CHAYER, PhD, HDR

CONTACT

33 3 88 11 66 90said.chayer@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2020

First Posted

May 28, 2020

Study Start

March 27, 2020

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

June 25, 2020

Record last verified: 2020-05

Locations

FR(1)