COVID-19COVIDeFNCT04352348
Cohort of Patients Infected With SARS-CoV2 (COVID-19) or Suspected of Being
A study testing blood samples, feces samples (COVI-BIOME ancillary study) and sweat samples (COVIDOG ancillary study) in people with COVID-19, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
On 17th March 2020, 198 193 confirmed cases (7 730 in France) of COVID-19 infections and 7 854 deaths (175 in France) have been reported from 8th December 2019 in 157 countries. The rapid increase in cases on french territory has led to the transition of France to level 3 of the epidemic on 14th March 2020. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- blood samples, feces samples (COVI-BIOME ancillary study) and sweat samples (COVIDOG ancillary study)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,003 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2020to 31 May 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Patient admitted in an emergency unit or hospitalized, infected with SARS-CoV2 or suspected of being (the recruitment can occured during acute episode or during a follow-up visit)
- Written informed consent or emergency procedure
- Affiliated to health insurance system
Who cannot join
- Refusal of participation
- Patient under justice protection measure except guardianship and trusteeship
Trial locations and contacts
1 site in 1 country.
France1 site
GH Pitié-Salpêtrière / Service d'Accueil des Urgences
Paris, Île-de-France Region, 75013
About this study
Official title: Cohort of Patients Infected With SARS-CoV2 or Suspected of Being (COVID-19 in Ile-de-France)
On 17th March 2020, 198 193 confirmed cases (7 730 in France) of COVID-19 infections and 7 854 deaths (175 in France) have been reported from 8th December 2019 in 157 countries. The rapid increase in cases on french territory has led to the transition of France to level 3 of the epidemic on 14th March 2020.
The natural history of the disease is still poorly understood, especially prognostic factors, which are crucial for the best medical care of patients in times of epidemics, when hospital capacities are under pressure.
A better knowledge of natural history, of prognostic factors, the development and validation of new diagnostic tests, the evaluation of medical care, will lead to a better medical care of patients infected with COVID-19.
Read the detailed description
The principal goal of the research is to assess the prognostic factors of the progression toward severe forms of the COVID-19 infection.
The secondary aims of the study are to contribute to answer some of the WHO research priority goals on COVID-19 infections:
- description of the natural history of the disease, its different forms, its clinical characterisation, its progression profile, the natural history of the disease linked to patient profiles
- evaluation and to comparison of different diagnostic methods, linked to the medical case
- description of the progression of the immune response during the infection and related to its outcome
- description of the replication and the excretion of the virus
- description of the progression of the biological markers during the infection and related to its outcome
- identification of the prognostic factors of the evolutive profile, especially if negative
- description of the patients care
- evaluation of the impact of the different therapeutic managements on the clinical outcome, the immune response, the viral load and the biomarkers.
- modeling of the epidemiologic impact
- identification of targets for treatment development
- analysis of cost data linked to the progression The population will include all patients infected with SARS-CoV2 ou suspected of being, who are taken care of at hospital.
The research is based on the collection of clinical and biological data from routine cares and on the biological analysis of blood samples.
The principal goal of the COVI-BIOME ancillary study is to identify gastrointestinal predictive factors for a severe form of the COVID-19 infection.
The principal goal of the COVIDOG ancillary study is to evaluate the sensibility and the specificity of canine olfactory detection for the volatile organic compounds of SARS-CoV2.
- Conditions
- COVID-19
- Being tested
- blood samples, feces samples (COVI-BIOME ancillary study), sweat samples (COVIDOG ancillary study), saliva samples, 6 minutes walk test
- Keywords
- COVID-19, cohort, prognostic factors, severe forms
- 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 samplesOther
All arms:
1 blood sample at inclusion (T0)
COVID-19 positive, severe only:
1 blood sample at D3, at D7, in case of transfer to intensive care unit or in case of aggravation of symptoms, eventually, at discharge from hospital if the last blood sample was more than 3 days old, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization.
Follow-up after COVID-19 hospitalization only:
1 blood sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization
feces samples (COVI-BIOME ancillary study)Other
All arms:
1 feces sample at inclusion (T0)
COVID-19 positive, severe only:
1 feces sample at D3, at D7, in case of transfer to intensive care unit or in case of aggravation of symptoms and, eventually, at discharge from hospital
sweat samples (COVIDOG ancillary study)Other
All arms:
2 sweat samples at inclusion (T0)
saliva samplesOther
All arms:
1 saliva sample at inclusion (T0)
COVID-19 positive, severe only:
1 saliva sample at D7, at discharge from hospital, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization.
Follow-up after COVID-19 hospitalization only:
1 blood sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization
6 minutes walk testOther
COVID-19 positive, severe only:
6 minutes walk test in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization.
Follow-up after COVID-19 hospitalization only:
6 minutes walk test at inclusion (T0) and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization.
Phone callOther
All arms except COVID-19 negative:
1 phone call 3 months after COVID-19 infection.
All arms except COVID-19 negative:
1 phone call 6 months after COVID-19 infection.
All arms except COVID-19 negative:
1 phone call 12 months after COVID-19 infection.
Urine samplesOther
All arms:
1 urine sample at inclusion (T0)
COVID-19 positive, severe only:
1 urine sample at D3, at D7, at discharge from hospital, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization.
Follow-up after COVID-19 hospitalization only:
1 urine sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 negative | Other | Patients with exclusion diagnosis for COVID-19 infection Receives: Other: blood samples; Other: feces samples (COVI-BIOME ancillary study); Other: sweat samples (COVIDOG ancillary study); Other: saliva samples; Other: Urine samples |
| COVID-19 positive, not severe | Other | Patients with confirmed diagnosis of COVID-19 infection or suspected of being and not requiring hospitalization Receives: Other: blood samples; Other: feces samples (COVI-BIOME ancillary study); Other: sweat samples (COVIDOG ancillary study); Other: saliva samples; Other: Phone call; Other: Urine samples |
| COVID-19 positive, severe | Other | Patients with confirmed diagnosis of COVID-19 infection or suspected of being and requiring hospitalization Receives: Other: blood samples; Other: feces samples (COVI-BIOME ancillary study); Other: sweat samples (COVIDOG ancillary study); Other: saliva samples; Other: 6 minutes walk test; Other: Phone call; Other: Urine samples |
| Follow-up after COVID-19 hospitalization | Other | Patients previously hospitalized for COVID-19 infection but not recruited for the study can be recruited during a follow-up visit in hospital scheduled in standard care at 3 to 6 months after the hospitalization.
For this arm, T0 = 3 to 6 months post-COVID-19 follow-up visit Receives: Other: blood samples; Other: saliva samples; Other: 6 minutes walk test; Other: Phone call; Other: Urine samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of prognostic factors for progression to a severe form of COVID-19 infection
Research of prognostic factors which could be implicated in the progression to severe form of COVID-19 infection.
Measured: 12 months
Secondary outcomes (10)
Clinical aggravation of the infection
Measured: 12 months
Discharge of hospitalization
Measured: 12 months
Death
Measured: 12 months
Description of clinical manifestations
Measured: 12 months
Description of biological manifestations
Measured: 12 months
Description of radiological manifestations
Measured: 12 months
Description of physiological manifestations
Measured: 12 months
Patient-related prognostic factors
Measured: 12 months
Virus-related risk factors
Measured: 12 months
Comparison of the results of different diagnosis tests
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start31 Mar 2020
- Primary completion31 May 2022
- Study completion31 May 2022
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 COVID-19Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,003 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre HAUSFATER, MD, Principal investigator, GH Pitié Salpêtrière - Charles Foix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352348
- Sponsor's protocol ID
- APHP200382
- Other IDs
- 2020-A00754-35
- Acronym
- COVIDeF
- Status last verified
- Sep 2026
- First submitted
- 31 Mar 2020
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deindentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Publications
Cancella de Abreu M, Ropers J, Oueidat N, Pieroni L, Frere C, Fontenay M, Torelino K, Chauvin A, Hekimian G, Marcelin AG, Parfait B, Tubach F, Hausfater P; COVIDeF study group. Biomarkers of COVID-19 short-term worsening: a multiparameter analysis within the prospective multicenter COVIDeF cohort. Eur J Emerg Med. 2024 Dec 1;31(6):429-437. doi: 10.1097/MEJ.0000000000001175. Epub 2024 Sep 12.
PubMed 39480645Matuozzo D, Talouarn E, Marchal A, Zhang P, Manry J, Seeleuthner Y, Zhang Y, Bolze A, Chaldebas M, Milisavljevic B, Gervais A, Bastard P, Asano T, Bizien L, Barzaghi F, Abolhassani H, Abou Tayoun A, Aiuti A, Alavi Darazam I, Allende LM, Alonso-Arias R, Arias AA, Aytekin G, Bergman P, Bondesan S, Bryceson YT, Bustos IG, Cabrera-Marante O, Carcel S, Carrera P, Casari G, Chaibi K, Colobran R, Condino-Neto A, Covill LE, Delmonte OM, El Zein L, Flores C, Gregersen PK, Gut M, Haerynck F, Halwani R, Hancerli S, Hammarstrom L, Hatipoglu N, Karbuz A, Keles S, Kyheng C, Leon-Lopez R, Franco JL, Mansouri D, Martinez-Picado J, Metin Akcan O, Migeotte I, Morange PE, Morelle G, Martin-Nalda A, Novelli G, Novelli A, Ozcelik T, Palabiyik F, Pan-Hammarstrom Q, de Diego RP, Planas-Serra L, Pleguezuelo DE, Prando C, Pujol A, Reyes LF, Riviere JG, Rodriguez-Gallego C, Rojas J, Rovere-Querini P, Schluter A, Shahrooei M, Sobh A, Soler-Palacin P, Tandjaoui-Lambiotte Y, Tipu I, Tresoldi C, Troya J, van de Beek D, Zatz M, Zawadzki P, Al-Muhsen SZ, Alosaimi MF, Alsohime FM, Baris-Feldman H, Butte MJ, Constantinescu SN, Cooper MA, Dalgard CL, Fellay J, Heath JR, Lau YL, Lifton RP, Maniatis T, Mogensen TH, von Bernuth H, Lermine A, Vidaud M, Boland A, Deleuze JF, Nussbaum R, Kahn-Kirby A, Mentre F, Tubiana S, Gorochov G, Tubach F, Hausfater P; COVID Human Genetic Effort; COVIDeF Study Group; French COVID Cohort Study Group; CoV-Contact Cohort; COVID-STORM Clinicians; COVID Clinicians; Orchestra Working Group; Amsterdam UMC Covid-19 Biobank; NIAID-USUHS COVID Study Group; Meyts I, Zhang SY, Puel A, Notarangelo LD, Boisson-Dupuis S, Su HC, Boisson B, Jouanguy E, Casanova JL, Zhang Q, Abel L, Cobat A. Rare predicted loss-of-function variants of type I IFN immunity genes are associated with life-threatening COVID-19. Genome Med. 2023 Apr 5;15(1):22. doi: 10.1186/s13073-023-01173-8.
PubMed 37020259
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort of Patients Infected With SARS-CoV2 or Suspected of Being (COVID-19 in Ile-de-France)
- ClinicalTrials.gov ID
- NCT04352348
- Acronym / sponsor ID
- COVIDeF / APHP200382
- Conditions
- COVID-19
- Keywords
- COVID-19, cohort, prognostic factors, severe forms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,003 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 20 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.
On 17th March 2020, 198 193 confirmed cases (7 730 in France) of COVID-19 infections and 7 854 deaths (175 in France) have been reported from 8th December 2019 in 157 countries. The rapid increase in cases on french territory has led to the transition of France to level 3 of the epidemic on 14th March 2020.
The natural history of the disease is still poorly understood, especially prognostic factors, which are crucial for the best medical care of patients in times of epidemics, when hospital capacities are under pressure.
A better knowledge of natural history, of prognostic factors, the development and validation of new diagnostic tests, the evaluation of medical care, will lead to a better medical care of patients infected with COVID-19.
Detailed description
The principal goal of the research is to assess the prognostic factors of the progression toward severe forms of the COVID-19 infection.
The secondary aims of the study are to contribute to answer some of the WHO research priority goals on COVID-19 infections:
- description of the natural history of the disease, its different forms, its clinical characterisation, its progression profile, the natural history of the disease linked to patient profiles
- evaluation and to comparison of different diagnostic methods, linked to the medical case
- description of the progression of the immune response during the infection and related to its outcome
- description of the replication and the excretion of the virus
- description of the progression of the biological markers during the infection and related to its outcome
- identification of the prognostic factors of the evolutive profile, especially if negative
- description of the patients care
- evaluation of the impact of the different therapeutic managements on the clinical outcome, the immune response, the viral load and the biomarkers.
- modeling of the epidemiologic impact
- identification of targets for treatment development
- analysis of cost data linked to the progression The population will include all patients infected with SARS-CoV2 ou suspected of being, who are taken care of at hospital.
The research is based on the collection of clinical and biological data from routine cares and on the biological analysis of blood samples.
The principal goal of the COVI-BIOME ancillary study is to identify gastrointestinal predictive factors for a severe form of the COVID-19 infection.
The principal goal of the COVIDOG ancillary study is to evaluate the sensibility and the specificity of canine olfactory detection for the volatile organic compounds of SARS-CoV2.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| COVID-19 negative | Other | Other: blood samples, Other: feces samples (COVI-BIOME ancillary study), Other: sweat samples (COVIDOG ancillary study), Other: saliva samples, Other: Urine samplesPatients with exclusion diagnosis for COVID-19 infection |
| COVID-19 positive, not severe | Other | Other: blood samples, Other: feces samples (COVI-BIOME ancillary study), Other: sweat samples (COVIDOG ancillary study), Other: saliva samples, Other: Phone call, Other: Urine samplesPatients with confirmed diagnosis of COVID-19 infection or suspected of being and not requiring hospitalization |
| COVID-19 positive, severe | Other | Other: blood samples, Other: feces samples (COVI-BIOME ancillary study), Other: sweat samples (COVIDOG ancillary study), Other: saliva samples, Other: 6 minutes walk test, Other: Phone call, Other: Urine samplesPatients with confirmed diagnosis of COVID-19 infection or suspected of being and requiring hospitalization |
| Follow-up after COVID-19 hospitalization | Other | Other: blood samples, Other: saliva samples, Other: 6 minutes walk test, Other: Phone call, Other: Urine samplesPatients previously hospitalized for COVID-19 infection but not recruited for the study can be recruited during a follow-up visit in hospital scheduled in standard care at 3 to 6 months after the hospitalization. For this arm, T0 = 3 to 6 months post-COVID-19 follow-up visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18
- Patient admitted in an emergency unit or hospitalized, infected with SARS-CoV2 or suspected of being (the recruitment can occured during acute episode or during a follow-up visit)
- Written informed consent or emergency procedure
- Affiliated to health insurance system
Key exclusion criteria (2 listed)
- Refusal of participation
- Patient under justice protection measure except guardianship and trusteeship
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 samplesAll arms: 1 blood sample at inclusion (T0) COVID-19 positive, severe only: 1 blood sample at D3, at D7, in case of transfer to intensive care unit or in case of aggravation of symptoms, eventually, at discharge from hospital if the last blood sample was more than 3 days old, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 1 blood sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization | Other | COVID-19 negative, COVID-19 positive, not severe, COVID-19 positive, severe, Follow-up after COVID-19 hospitalization |
| feces samples (COVI-BIOME ancillary study)All arms: 1 feces sample at inclusion (T0) COVID-19 positive, severe only: 1 feces sample at D3, at D7, in case of transfer to intensive care unit or in case of aggravation of symptoms and, eventually, at discharge from hospital | Other | COVID-19 negative, COVID-19 positive, not severe, COVID-19 positive, severe |
| sweat samples (COVIDOG ancillary study)All arms: 2 sweat samples at inclusion (T0) | Other | COVID-19 negative, COVID-19 positive, not severe, COVID-19 positive, severe |
| saliva samplesAll arms: 1 saliva sample at inclusion (T0) COVID-19 positive, severe only: 1 saliva sample at D7, at discharge from hospital, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 1 blood sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization | Other | COVID-19 negative, COVID-19 positive, not severe, COVID-19 positive, severe, Follow-up after COVID-19 hospitalization |
| 6 minutes walk testCOVID-19 positive, severe only: 6 minutes walk test in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 6 minutes walk test at inclusion (T0) and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. | Other | COVID-19 positive, severe, Follow-up after COVID-19 hospitalization |
| Phone callAll arms except COVID-19 negative: 1 phone call 3 months after COVID-19 infection. All arms except COVID-19 negative: 1 phone call 6 months after COVID-19 infection. All arms except COVID-19 negative: 1 phone call 12 months after COVID-19 infection. | Other | COVID-19 positive, not severe, COVID-19 positive, severe, Follow-up after COVID-19 hospitalization |
| Urine samplesAll arms: 1 urine sample at inclusion (T0) COVID-19 positive, severe only: 1 urine sample at D3, at D7, at discharge from hospital, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization. Follow-up after COVID-19 hospitalization only: 1 urine sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization | Other | COVID-19 negative, COVID-19 positive, not severe, COVID-19 positive, severe, Follow-up after COVID-19 hospitalization |
Primary outcome
Identification of prognostic factors for progression to a severe form of COVID-19 infection
Time frame: 12 months
Research of prognostic factors which could be implicated in the progression to severe form of COVID-19 infection.
10 secondary outcomes
Clinical aggravation of the infection
Time frame: 12 months
Discharge of hospitalization
Time frame: 12 months
Death
Time frame: 12 months
Description of clinical manifestations
Time frame: 12 months
Description of biological manifestations
Time frame: 12 months
Description of radiological manifestations
Time frame: 12 months
Description of physiological manifestations
Time frame: 12 months
Patient-related prognostic factors
Time frame: 12 months
Virus-related risk factors
Time frame: 12 months
Comparison of the results of different diagnosis tests
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 39480645Cancella de Abreu M, Ropers J, Oueidat N, Pieroni L, Frere C, Fontenay M, Torelino K, Chauvin A, Hekimian G, Marcelin AG, Parfait B, Tubach F, Hausfater P; COVIDeF study group. Biomarkers of COVID-19 short-term worsening: a multiparameter analysis within the prospective multicenter COVIDeF cohort. Eur J Emerg Med. 2024 Dec 1;31(6):429-437. doi: 10.1097/MEJ.0000000000001175. Epub 2024 Sep 12.
- Derived from this study: PubMed 37020259Matuozzo D, Talouarn E, Marchal A, Zhang P, Manry J, Seeleuthner Y, Zhang Y, Bolze A, Chaldebas M, Milisavljevic B, Gervais A, Bastard P, Asano T, Bizien L, Barzaghi F, Abolhassani H, Abou Tayoun A, Aiuti A, Alavi Darazam I, Allende LM, Alonso-Arias R, Arias AA, Aytekin G, Bergman P, Bondesan S, Bryceson YT, Bustos IG, Cabrera-Marante O, Carcel S, Carrera P, Casari G, Chaibi K, Colobran R, Condino-Neto A, Covill LE, Delmonte OM, El Zein L, Flores C, Gregersen PK, Gut M, Haerynck F, Halwani R, Hancerli S, Hammarstrom L, Hatipoglu N, Karbuz A, Keles S, Kyheng C, Leon-Lopez R, Franco JL, Mansouri D, Martinez-Picado J, Metin Akcan O, Migeotte I, Morange PE, Morelle G, Martin-Nalda A, Novelli G, Novelli A, Ozcelik T, Palabiyik F, Pan-Hammarstrom Q, de Diego RP, Planas-Serra L, Pleguezuelo DE, Prando C, Pujol A, Reyes LF, Riviere JG, Rodriguez-Gallego C, Rojas J, Rovere-Querini P, Schluter A, Shahrooei M, Sobh A, Soler-Palacin P, Tandjaoui-Lambiotte Y, Tipu I, Tresoldi C, Troya J, van de Beek D, Zatz M, Zawadzki P, Al-Muhsen SZ, Alosaimi MF, Alsohime FM, Baris-Feldman H, Butte MJ, Constantinescu SN, Cooper MA, Dalgard CL, Fellay J, Heath JR, Lau YL, Lifton RP, Maniatis T, Mogensen TH, von Bernuth H, Lermine A, Vidaud M, Boland A, Deleuze JF, Nussbaum R, Kahn-Kirby A, Mentre F, Tubiana S, Gorochov G, Tubach F, Hausfater P; COVID Human Genetic Effort; COVIDeF Study Group; French COVID Cohort Study Group; CoV-Contact Cohort; COVID-STORM Clinicians; COVID Clinicians; Orchestra Working Group; Amsterdam UMC Covid-19 Biobank; NIAID-USUHS COVID Study Group; Meyts I, Zhang SY, Puel A, Notarangelo LD, Boisson-Dupuis S, Su HC, Boisson B, Jouanguy E, Casanova JL, Zhang Q, Abel L, Cobat A. Rare predicted loss-of-function variants of type I IFN immunity genes are associated with life-threatening COVID-19. Genome Med. 2023 Apr 5;15(1):22. doi: 10.1186/s13073-023-01173-8.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deindentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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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.
Pierre HAUSFATER, MD principal investigator
GH Pitié Salpêtrière - Charles Foix
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood samples, feces samples (COVI-BIOME ancillary study) and sweat samples (COVIDOG ancillary study) in people with COVID-19, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 21 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of prognostic factors for progression to a severe form of COVID-19 infection (time frame: 12 months). 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 NCT04352348, 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 21 Sep 2026.