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Completed

NCT Number: NCT04352348

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GH Pitié-Salpêtrière / Service d'Accueil des Urgences

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Samples

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)

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 Samples

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

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

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

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Clinical aggravation of the infection

    Time frame: 12 months

  2. Discharge of hospitalization

    Time frame: 12 months

  3. Death

    Time frame: 12 months

  4. Description of clinical manifestations

    Time frame: 12 months

  5. Description of biological manifestations

    Time frame: 12 months

  6. Description of radiological manifestations

    Time frame: 12 months

  7. Description of physiological manifestations

    Time frame: 12 months

  8. Patient-related prognostic factors

    Time frame: 12 months

  9. Virus-related risk factors

    Time frame: 12 months

  10. Comparison of the results of different diagnosis tests

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Cohort of Patients Infected With SARS-CoV2 or Suspected of Being (COVID-19 in Ile-de-France)

Acronym: COVIDeF

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 20, 2020
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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