Cohort of Patients Infected With SARS-CoV2 (COVID-19) or Suspected of Being

NCT ID: NCT04352348

Last Updated: 2021-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 2003 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-31
• Study Completion Date: 2022-05-31

Brief 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.

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.

Conditions

COVID-19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

COVID-19 negative

Patients with exclusion diagnosis for COVID-19 infection

Group Type: OTHER

blood samples

Intervention Type: OTHER

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)

Intervention Type: 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)

Intervention Type: OTHER

All arms:

2 sweat samples at inclusion (T0)

saliva samples

Intervention Type: OTHER

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

Urine samples

Intervention Type: OTHER

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

COVID-19 positive, not severe

Patients with confirmed diagnosis of COVID-19 infection or suspected of being and not requiring hospitalization

Group Type: OTHER

blood samples

Intervention Type: OTHER

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)

Intervention Type: 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)

Intervention Type: OTHER

All arms:

2 sweat samples at inclusion (T0)

saliva samples

Intervention Type: OTHER

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

Phone call

Intervention Type: OTHER

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 samples

Intervention Type: OTHER

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

COVID-19 positive, severe

Patients with confirmed diagnosis of COVID-19 infection or suspected of being and requiring hospitalization

Group Type: OTHER

blood samples

Intervention Type: OTHER

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)

Intervention Type: 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)

Intervention Type: OTHER

All arms:

2 sweat samples at inclusion (T0)

saliva samples

Intervention Type: OTHER

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 test

Intervention Type: OTHER

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 call

Intervention Type: OTHER

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 samples

Intervention Type: OTHER

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

Follow-up after COVID-19 hospitalization

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

Group Type: OTHER

blood samples

Intervention Type: OTHER

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

saliva samples

Intervention Type: OTHER

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 test

Intervention Type: OTHER

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 call

Intervention Type: OTHER

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 samples

Intervention Type: OTHER

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

Interventions

blood samples

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

Intervention Type: OTHER

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

Intervention Type: OTHER

sweat samples (COVIDOG ancillary study)

All arms:

2 sweat samples at inclusion (T0)

Intervention Type: OTHER

saliva samples

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

Intervention Type: OTHER

6 minutes walk test

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.

Intervention Type: OTHER

Phone call

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.

Intervention Type: OTHER

Urine samples

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Refusal of participation
• Patient under justice protection measure except guardianship and trusteeship

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre HAUSFATER, MD

Role: PRINCIPAL_INVESTIGATOR

GH Pitié Salpêtrière - Charles Foix

Locations

GH Pitié-Salpêtrière / Service d'Accueil des Urgences

Paris, Île-de-France Region, France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 39480645 (View on PubMed)

Matuozzo 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.

Reference Type: DERIVED

PMID: 37020259 (View on PubMed)

Other Identifiers

2020-A00754-35

Identifier Type: OTHER

Identifier Source: secondary_id

APHP200382

Identifier Type: -

Identifier Source: org_study_id