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

Primary Purpose

COVID-19

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood samples
feces samples (COVI-BIOME ancillary study)
sweat samples (COVIDOG ancillary study)
saliva samples
6 minutes walk test
Phone call
Urine samples
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for COVID-19 focused on measuring COVID-19, cohort, prognostic factors, severe forms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GH Pitié-Salpêtrière / Service d'Accueil des Urgences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

COVID-19 negative

COVID-19 positive, not severe

COVID-19 positive, severe

Follow-up after COVID-19 hospitalization

Arm Description

Patients with exclusion diagnosis for COVID-19 infection

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinical aggravation of the infection
Discharge of hospitalization
Death
Description of clinical manifestations
Description of biological manifestations
Description of radiological manifestations
Description of physiological manifestations
Patient-related prognostic factors
Virus-related risk factors
Comparison of the results of different diagnosis tests

Full Information

First Posted
March 31, 2020
Last Updated
July 5, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04352348
Brief Title
Cohort of Patients Infected With SARS-CoV2 (COVID-19) or Suspected of Being
Acronym
COVIDeF
Official Title
Cohort of Patients Infected With SARS-CoV2 or Suspected of Being (COVID-19 in Ile-de-France)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 31, 2020 (Actual)
Primary Completion Date
May 31, 2022 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, cohort, prognostic factors, severe forms

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2003 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COVID-19 negative
Arm Type
Other
Arm Description
Patients with exclusion diagnosis for COVID-19 infection
Arm Title
COVID-19 positive, not severe
Arm Type
Other
Arm Description
Patients with confirmed diagnosis of COVID-19 infection or suspected of being and not requiring hospitalization
Arm Title
COVID-19 positive, severe
Arm Type
Other
Arm Description
Patients with confirmed diagnosis of COVID-19 infection or suspected of being and requiring hospitalization
Arm Title
Follow-up after COVID-19 hospitalization
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
blood samples
Intervention Description
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
Intervention Name(s)
feces samples (COVI-BIOME ancillary study)
Intervention Description
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
Intervention Name(s)
sweat samples (COVIDOG ancillary study)
Intervention Description
All arms: 2 sweat samples at inclusion (T0)
Intervention Type
Other
Intervention Name(s)
saliva samples
Intervention Description
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
Intervention Name(s)
6 minutes walk test
Intervention Description
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
Intervention Name(s)
Phone call
Intervention Description
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
Intervention Name(s)
Urine samples
Intervention Description
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
Primary Outcome Measure Information:
Title
Identification of prognostic factors for progression to a severe form of COVID-19 infection
Description
Research of prognostic factors which could be implicated in the progression to severe form of COVID-19 infection.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Clinical aggravation of the infection
Time Frame
12 months
Title
Discharge of hospitalization
Time Frame
12 months
Title
Death
Time Frame
12 months
Title
Description of clinical manifestations
Time Frame
12 months
Title
Description of biological manifestations
Time Frame
12 months
Title
Description of radiological manifestations
Time Frame
12 months
Title
Description of physiological manifestations
Time Frame
12 months
Title
Patient-related prognostic factors
Time Frame
12 months
Title
Virus-related risk factors
Time Frame
12 months
Title
Comparison of the results of different diagnosis tests
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre HAUSFATER, MD
Organizational Affiliation
GH Pitié Salpêtrière - Charles Foix
Official's Role
Principal Investigator
Facility Information:
Facility Name
GH Pitié-Salpêtrière / Service d'Accueil des Urgences
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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