SARS-CoV-2COVIDothèqueNCT04347850
A Cohort of Patients With Possible or Confirmed SARS-CoV-2 (COVID-19)
An observational study of SARS-CoV-2 and COVID-19, run by University Hospital, Montpellier at 1 site in France.
Trial summary
SARV-CoV-2 infection was considered pandemic on March 11, 2020. The SARV-CoV-2 epidemic affected France from the beginning of March, spreading in particular from a 4-day large evangelical meeting of 2500 people on February 17 in the city of Mulhouse (North East of France). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2, COVID-19
- What is being tested?
- blood sample
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2020to 30 Dec 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with a possible or confirmed SARS-CoV -2 infection, from diagnosis to long-term follow-up.
Who may be able to join
- Patients care at the Montpellier University Hospital suspected of a COVID-19 infection
Who cannot join
- Patient opposed to the use of his data for research purposes
- Patient deprived of liberty by judicial decision
- Patient not affiliated to a social security scheme
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uh Montpellier
Montpellier, 34280
Edouard TUAILLON, MD; PhD, 467 338 469 ext. 33, e-tuaillon@chu-montpellier.fr
About this study
Official title: A Cohort of Patients With Possible or Confirmed SARS-CoV-2 (COVID-19) Infection, From Diagnosis to Long-term Follow-up
SARV-CoV-2 infection was considered pandemic on March 11, 2020. The SARV-CoV-2 epidemic affected France from the beginning of March, spreading in particular from a 4-day large evangelical meeting of 2500 people on February 17 in the city of Mulhouse (North East of France). The Montpellier University Hospital has set up a clinical pathway for people suspected of being infected with SARV-CoV-2 because of signs compatible with pneumonia (screening criteria in France during the study period). This includes an emergency department, an infectious disease department dedicated to the surveillance of infected people requiring hospital treatment, and an intensive care unit for the most severe cases. The diagnosis of infection with SARV-CoV-2 was confirmed in approximately 20% of people initially referred in this special care system.
The main objective of this cohorte is the collection of clinical data and biological samples from care for non-interventional research on the patients with a possible or confirmed SARS-CoV -2 infection, from diagnosis to long-term follow-up.
- Conditions
- SARS-CoV-2, COVID-19
- Being tested
- blood sample
- Keywords
- presence of COVID-19 symptoms, COVID-19 infection
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleOther
Collection
| Study group | Role | What they receive |
|---|---|---|
| Patient with Covid-19 confirmed (middle form) | Covid-19 confirmed: middle form Receives: Other: blood sample | |
| Patient with Covid-19 confirmed (severe form) | Covid-19 confirmed : severe form Receives: Other: blood sample | |
| Patient with Covid-19 not confirmed | Covid-19 not confirmed Receives: Other: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of confirmed COVID-19
Number of confirmed COVID-19
Measured: 1 day
Secondary outcomes (14)
Number of severe COVID-19
Number of severe COVID-19
Measured: 1 day
Identification and validation of predictive biomarkers of a poorer respiratory evolution associated with positive testing for SARS-CoV-2 infection
CORO-TRI substudy
Measured: 1 day
Evaluate the morbidity and mortality and these risk factors linked to Covid-19 in the congenital heart disease population in France
COVID-CHD substudy
Measured: 1 day
Identify the characteristics of physiotherapy care for patients with COVID-19 in intensive care
Physio-Covid substudy
Measured: 1 day
To assess the accuracy and prognostic performance of clinical and biological parameters measured on admission to the emergency department to stratify patients suspected of COVID-19
Covida substudy
Measured: 1 day
Evaluate diagnostic tests for olfactory function in relation to the RT-PCR procedure
Olfa-covid substudy
Measured: 1 day
Assessment of Extra Vascular Lung Water and Pulmonary Permeability by transpulmonary thermodilution in critically ill patients with Coronavirus Disease 2019 pneumonia under invasive mechanical ventilation
PiCCOVID substudy
Measured: 1 day
Description of trans pulmonary motor pressure in COVID 19+ patients in severe stage in intensive care
TRANSPULMONARY-COVID19 substudy
Measured: 1 day
Immuno-monitoring of COVID-19 positive patients
CytoCOVID substudy
Measured: 1 day
Characterization in clinical proteomics of the SARS-CoV-2 spike protein
ProteoCOVID substudy
Measured: 1 day
Diagnosis of endocrine dysfunctions in Covid-19
Dyhor-19 substudy
Measured: 1 day
describe the occurrence of Covid19 infection in patients with systemic lupus erythematosus treated with hydroxychloroquine over the long term
Lupus substudy
Measured: 1 day
Acral cutaneous thrombotic vasculopathy and Covid-19 infection : search for acquired thrombophilia and interferon-alpha signature
Vasculopathy substudy
Measured: 1 day
Evaluation of a COVID-19 screening strategy combining chest low dose CT and RT-PCR test for patients admitted for surgical or interventional procedures during the COVID 19 outbreak
COVID-Scan study
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start1 Feb 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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, MontpellierThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edouard TUAILLON, MD; PhD, Study director, UH MONTPELLIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347850
- Sponsor's protocol ID
- RECHMPL20_0185
- Acronym
- COVIDothèque
- Status last verified
- Jul 2020
- First submitted
- 9 Apr 2020
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: NC
Publications
Capelli N, Domitien Payet L, Alcocer Cordellat C, Pisoni A, Engelmann I, Van de Perre P, Jeziorski E, Tuaillon E. SARS-CoV-2 nucleocapsid antigen in plasma of children hospitalized for COVID-19 or with incidental detection of SARS-CoV-2 infection. J Med Virol. 2024 Jan;96(1):e29358. doi: 10.1002/jmv.29358.
PubMed 38180230
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort of Patients With Possible or Confirmed SARS-CoV-2 (COVID-19) Infection, From Diagnosis to Long-term Follow-up
- ClinicalTrials.gov ID
- NCT04347850
- Acronym / sponsor ID
- COVIDothèque / RECHMPL20_0185
- Conditions
- SARS-CoV-2, COVID-19
- Keywords
- presence of COVID-19 symptoms, COVID-19 infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 15 Apr 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.
SARV-CoV-2 infection was considered pandemic on March 11, 2020. The SARV-CoV-2 epidemic affected France from the beginning of March, spreading in particular from a 4-day large evangelical meeting of 2500 people on February 17 in the city of Mulhouse (North East of France). The Montpellier University Hospital has set up a clinical pathway for people suspected of being infected with SARV-CoV-2 because of signs compatible with pneumonia (screening criteria in France during the study period). This includes an emergency department, an infectious disease department dedicated to the surveillance of infected people requiring hospital treatment, and an intensive care unit for the most severe cases. The diagnosis of infection with SARV-CoV-2 was confirmed in approximately 20% of people initially referred in this special care system.
The main objective of this cohorte is the collection of clinical data and biological samples from care for non-interventional research on the patients with a possible or confirmed SARS-CoV -2 infection, from diagnosis to long-term follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient with Covid-19 confirmed (middle form) | – | Other: blood sampleCovid-19 confirmed: middle form |
| Patient with Covid-19 confirmed (severe form) | – | Other: blood sampleCovid-19 confirmed : severe form |
| Patient with Covid-19 not confirmed | – | Other: blood sampleCovid-19 not confirmed |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a possible or confirmed SARS-CoV -2 infection, from diagnosis to long-term follow-up.
Key inclusion criteria (1 listed)
- Patients care at the Montpellier University Hospital suspected of a COVID-19 infection
Key exclusion criteria (3 listed)
- Patient opposed to the use of his data for research purposes
- Patient deprived of liberty by judicial decision
- Patient not affiliated to a social security scheme
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampleCollection | Other | Patient with Covid-19 confirmed (middle form), Patient with Covid-19 confirmed (severe form), Patient with Covid-19 not confirmed |
Primary outcome
Number of confirmed COVID-19
Time frame: 1 day
Number of confirmed COVID-19
14 secondary outcomes
Number of severe COVID-19
Time frame: 1 day
Identification and validation of predictive biomarkers of a poorer respiratory evolution associated with positive testing for SARS-CoV-2 infection
Time frame: 1 day
Evaluate the morbidity and mortality and these risk factors linked to Covid-19 in the congenital heart disease population in France
Time frame: 1 day
Identify the characteristics of physiotherapy care for patients with COVID-19 in intensive care
Time frame: 1 day
To assess the accuracy and prognostic performance of clinical and biological parameters measured on admission to the emergency department to stratify patients suspected of COVID-19
Time frame: 1 day
Evaluate diagnostic tests for olfactory function in relation to the RT-PCR procedure
Time frame: 1 day
Assessment of Extra Vascular Lung Water and Pulmonary Permeability by transpulmonary thermodilution in critically ill patients with Coronavirus Disease 2019 pneumonia under invasive mechanical ventilation
Time frame: 1 day
Description of trans pulmonary motor pressure in COVID 19+ patients in severe stage in intensive care
Time frame: 1 day
Immuno-monitoring of COVID-19 positive patients
Time frame: 1 day
Characterization in clinical proteomics of the SARS-CoV-2 spike protein
Time frame: 1 day
Diagnosis of endocrine dysfunctions in Covid-19
Time frame: 1 day
describe the occurrence of Covid19 infection in patients with systemic lupus erythematosus treated with hydroxychloroquine over the long term
Time frame: 1 day
Acral cutaneous thrombotic vasculopathy and Covid-19 infection : search for acquired thrombophilia and interferon-alpha signature
Time frame: 1 day
Evaluation of a COVID-19 screening strategy combining chest low dose CT and RT-PCR test for patients admitted for surgical or interventional procedures during the COVID 19 outbreak
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Derived from this study: PubMed 38180230Capelli N, Domitien Payet L, Alcocer Cordellat C, Pisoni A, Engelmann I, Van de Perre P, Jeziorski E, Tuaillon E. SARS-CoV-2 nucleocapsid antigen in plasma of children hospitalized for COVID-19 or with incidental detection of SARS-CoV-2 infection. J Med Virol. 2024 Jan;96(1):e29358. doi: 10.1002/jmv.29358.
- Individual participant dataSharing planned: No. NC
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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.
Edouard TUAILLON, MD; PhD study director
UH MONTPELLIER
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 and COVID-19, run by University Hospital, Montpellier 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 1 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 8 Jul 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 Edouard TUAILLON, MD; PhD (467 338 469 ext. 33, e-tuaillon@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of confirmed COVID-19 (time frame: 1 day). 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 NCT04347850, which also lists 1 linked publication.
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 8 Jul 2020.