Prognostic Factors of COVID19 | NCT04405726

Studies
Prognostic Factors of COVID19

NCT04405726

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Jun 25, 2020Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

SARS-CoV-2

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 27, 2020Actual

Primary Completion Date

Mar 2022Estimated

Completion Date

Mar 2022Estimated

First Submitted Date

May 25, 2020

First Submission Date that Met QC Criteria

May 25, 2020

First Posted Date

May 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2020

Last Update Posted Date

Jun 25, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Samira FAFI-KREMER, PharmD, PhD	Contact	33.3.69.55.14.38		Samira.fafi-kremer@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR	Contact	33 3 88 11 66 90		said.chayer@chru-strasbourg.fr

Overall Officials

Name	Affiliation	Role
Samira FAFI-KREMER, PharmD, PhD	Laboratoire de Virologie Plateau Technique de Microbiologie	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Virologie - Hôpital Civil	Recruiting	Strasbourg		67091	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40397955	Derived	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.
33261718

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections