NCT04352348

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,003

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

March 31, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

July 8, 2021

Status Verified

June 1, 2021

Enrollment Period

2.2 years

First QC Date

March 31, 2020

Last Update Submit

July 5, 2021

Conditions

COVID-19

Keywords

COVID-19cohortprognostic factorssevere forms

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (10)

  • Clinical aggravation of the infection

    12 months

  • Discharge of hospitalization

    12 months

  • Death

    12 months

  • Description of clinical manifestations

    12 months

  • Description of biological manifestations

    12 months

  • +5 more secondary outcomes

Study Arms (4)

COVID-19 negative

OTHER

Patients with exclusion diagnosis for COVID-19 infection

Other: blood samplesOther: feces samples (COVI-BIOME ancillary study)Other: sweat samples (COVIDOG ancillary study)Other: saliva samplesOther: Urine samples

COVID-19 positive, not severe

OTHER

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

Other: blood samplesOther: feces samples (COVI-BIOME ancillary study)Other: sweat samples (COVIDOG ancillary study)Other: saliva samplesOther: Phone callOther: Urine samples

COVID-19 positive, severe

OTHER

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

Other: blood samplesOther: feces samples (COVI-BIOME ancillary study)Other: sweat samples (COVIDOG ancillary study)Other: saliva samplesOther: 6 minutes walk testOther: Phone callOther: 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

Other: blood samplesOther: saliva samplesOther: 6 minutes walk testOther: Phone callOther: Urine samples

Interventions

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

COVID-19 negativeCOVID-19 positive, not severeCOVID-19 positive, severeFollow-up after COVID-19 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

COVID-19 negativeCOVID-19 positive, not severeCOVID-19 positive, severe
sweat samples (COVIDOG ancillary study)OTHER

All arms: 2 sweat samples at inclusion (T0)

COVID-19 negativeCOVID-19 positive, not severeCOVID-19 positive, severe
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

COVID-19 negativeCOVID-19 positive, not severeCOVID-19 positive, severeFollow-up after COVID-19 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.

COVID-19 positive, severeFollow-up after COVID-19 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.

COVID-19 positive, not severeCOVID-19 positive, severeFollow-up after COVID-19 hospitalization
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

COVID-19 negativeCOVID-19 positive, not severeCOVID-19 positive, severeFollow-up after COVID-19 hospitalization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GH Pitié-Salpêtrière / Service d'Accueil des Urgences

Paris, Île-de-France Region, 75013, France

Location

Related Publications (2)

  • 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.

    PMID: 39480645DERIVED

  • 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.

    PMID: 37020259DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Pierre HAUSFATER, MD

    GH Pitié Salpêtrière - Charles Foix

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 20, 2020

Study Start

March 31, 2020

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

July 8, 2021

Record last verified: 2021-06

Locations

FR(1)