SARS-CoV-2Covid-HUSNCT04405726
Prognostic Factors of COVID19
An observational study of SARS-CoV-2, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- SARS-CoV-2
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 27 Mar 2020to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult and pediatric with suspicion or a confirmed SARS-CoV-2 infection
Who may be able to join
- 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
Who cannot join
- Patient's explicit refusal to participate
- Subject deprived of liberty or subject to the protection of justice
- Subject under guardianship or trusteeship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Virologie - Hôpital Civil
Strasbourg, 67091
Samira FAFI-KREMER, PharmD, PhD, 33.3.69.55.14.38, Samira.fafi-kremer@chru-strasbourg.fr
Samira FAFI-KREMER, PharmD, PhD
About this study
Official title: 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
- Conditions
- SARS-CoV-2
- Keywords
- SARS-CoV-2, Covid-19, Prognostic factors, Genetic factors, T and B cell immune response
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Presentation and Incidence of Covid-19 Infection in patients hospitalised in Strasbourg Hospital
Measured: From 1st March 2020 to 1st March 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start27 Mar 2020
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samira FAFI-KREMER, PharmD, PhD, Study director, Laboratoire de Virologie Plateau Technique de Microbiologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405726
- Sponsor's protocol ID
- 7760
- Acronym
- Covid-HUS
- Status last verified
- May 2020
- First submitted
- 25 May 2020
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40397955Gallais 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.
PubMed 33261718
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Clinical, Biological and Genetic Prognostic Factors of SARS-CoV-2 Infection in Patients Admitted in the Strasbourg University Hospitals
- ClinicalTrials.gov ID
- NCT04405726
- Acronym / sponsor ID
- Covid-HUS / 7760
- Conditions
- SARS-CoV-2
- Keywords
- SARS-CoV-2, Covid-19, Prognostic factors, Genetic factors, T and B cell immune response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 27 Mar 2020 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult and pediatric with suspicion or a confirmed SARS-CoV-2 infection
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Patient's explicit refusal to participate
- Subject deprived of liberty or subject to the protection of justice
- Subject under guardianship or trusteeship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Presentation and Incidence of Covid-19 Infection in patients hospitalised in Strasbourg Hospital
Time frame: From 1st March 2020 to 1st March 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Derived from this study: PubMed 40397955Partouche 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.
- Derived from this study: PubMed 33261718Gallais 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samira FAFI-KREMER, PharmD, PhD study director
Laboratoire de Virologie Plateau Technique de Microbiologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samira FAFI-KREMER, PharmD, PhD (33.3.69.55.14.38, Samira.fafi-kremer@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Presentation and Incidence of Covid-19 Infection in patients hospitalised in Strasbourg Hospital (time frame: From 1st March 2020 to 1st March 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04405726, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2020.