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

A

Assistance Publique - Hôpitaux de Paris

Status

Unknown

Conditions

COVID-19

Treatments

Other: sweat samples (COVIDOG ancillary study)
Other: feces samples (COVI-BIOME ancillary study)
Other: blood samples
Other: 6 minutes walk test
Other: saliva samples
Other: Phone call
Other: Urine samples

Study type

Interventional

Funder types

Other

Identifiers

NCT04352348
APHP200382
2020-A00754-35 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Read more

Enrollment

2,003 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2,003 participants in 4 patient groups

COVID-19 negative
Other group
Description:
Patients with exclusion diagnosis for COVID-19 infection
Treatment:
Other: sweat samples (COVIDOG ancillary study)
Other: feces samples (COVI-BIOME ancillary study)
Other: saliva samples
Other: Urine samples
Other: blood samples
COVID-19 positive, not severe
Other group
Description:
Patients with confirmed diagnosis of COVID-19 infection or suspected of being and not requiring hospitalization
Treatment:
Other: Phone call
Other: sweat samples (COVIDOG ancillary study)
Other: feces samples (COVI-BIOME ancillary study)
Other: saliva samples
Other: Urine samples
Other: blood samples
COVID-19 positive, severe
Other group
Description:
Patients with confirmed diagnosis of COVID-19 infection or suspected of being and requiring hospitalization
Treatment:
Other: Phone call
Other: sweat samples (COVIDOG ancillary study)
Other: 6 minutes walk test
Other: feces samples (COVI-BIOME ancillary study)
Other: saliva samples
Other: Urine samples
Other: blood samples
Follow-up after COVID-19 hospitalization
Other group
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
Treatment:
Other: Phone call
Other: 6 minutes walk test
Other: saliva samples
Other: Urine samples
Other: blood samples

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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