Cohort Follow-up of Survivors of Hospitalization for COVID-19 During the 2nd Wave of the Epidemic in France (COMEBAC 2)

Cohort Follow-up at 6-12 Months of Survivors of Hospitalization for COVID-19 During the 2nd Wave of the Epidemic From a University Hospital in France

From July to September 2020, in a first uncontrolled cohort study, 478 patients who were hospitalized at Bicêtre hospital for COVID-19 and who survived were evaluated at 4 months (publication accepted at JAMA). The current project aims to bring together the means to continue this work during the 2nd epidemic wave.

Study Overview

• Status: Recruiting
• Conditions: Fibrosis; Post-traumatic Stress Disorder; Post-COVID Syndrome; Sequelae
• Intervention / Treatment: Other: Teleconsultation; Other: Outpatient clinic

Detailed Description

From 15th July to 18th September, 2020, in a first uncontrolled cohort study (Multi-Expertise Consultation of Bicêtre After Covid-19, COMEBAC), we evaluated at four months the surviving patients who were hospitalized at the Bicêtre hospital for COVID-19 during the 1st wave of the epidemic in France and having survived this hospitalization. This cohort included 478 patients. The article resulting from the analysis of the data collected is accepted for publication in JAMA.

This evaluation, the aim of which was both clinical and scientific, was carried out largely thanks to human and material resources then demobilized because of the epidemic and thanks to the investment of doctors and psychologists who carried out the work in addition to their usual work.

The response to the current call for projects aims to bring together the means to continue this monitoring work during the 2nd epidemic wave, while the means and staff are this time completely mobilized by the care of patients with COVID-19 and other. It also aims to raise funds that will allow an in-depth analysis of the residual symptoms presented by the patients.

The current project aims to continue the work started with the COMEBAC "1st wave" cohort with:

• The inclusion of patients hospitalized after the 1st wave.
• An assessment of symptoms according to the SARS-CoV-2 variant.
• A 12-month follow-up of symptomatic patients during the evaluation in COMEBAC "1st wave".

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Tai PHAM; Phone Number: +33145217245; Email: tai.pham@aphp.fr

Study Locations

• France
  • Le Kremlin-Bicêtre, France, 94270
    • Recruiting
    • Bicetre Hospital
    • Contact: Tai PHAM; Phone Number: 0145217245; Email: tai.pham@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients from the 1st epidemic wave Patients from the 2nd epidemic wave

Description

For the 6-month evaluation of patients from the 2nd epidemic wave

• Inclusion criteria

  • Age ≥18 years old
  • COVID-19 defined either by a reverse transcriptase-polymerase chain reaction (RT-PCR) or by a combination of clinical signs and compatible lung CT scan
  • Hospitalization for COVID-19 after 1st July 2020
  • Living out of the hospital

• Exclusion criteria

  • Death occurring between index hospitalization and reassessment
  • Patient refusal
  • Discovery of a positive RT-PCR for SARS-CoV-2 during hospitalization for a reason other than COVID-19
  • Nosocomial COVID-19

For the 12-month evaluation of patients from the 1st epidemic wave

• Inclusion criteria

  ◌ Presence of general, cognitive, psychological and respiratory symptoms during the assessment made at 4 months in COMEBAC "1st wave"

• Exclusion criteria

  • Death occurring between the evaluation in COMEBAC "1st wave" and the re-evaluation
  • Patient refusal

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients from the 1st epidemic wave; One year after their discharge from the initial hospitalization, patients who presented symptoms during the evaluation in COMEBAC "1st wave" in summer 2020 will benefit from a telephone assessment on the same schedule as that detailed above. If symptoms persist, they will be called to the day hospital for an assessment similar to the one detailed above.	Other: Teleconsultation; Teleconsulting physicians will subject patients to a standardized questionnaire that will look for the following symptoms: General signs: Anorexia, fatigue, new hospitalization, weight loss,; Respiratory signs: recent dyspnoea, chest discomfort, chest pain, new cough, abnormal lung CT scan since discharge; Neurological signs: headache, paraesthesia, anosmia, limb paralysis; Digestive signs: abdominal pain, diarrhoea, constipation, nausea, vomiting Edition 2021 ◌ Cognitive signs using the Q3PC questionnaire (10): memory loss, slowness in reasoning, activity planning or problem solving, concentration, attention difficulties; Other: Outpatient clinic; During a day hospitalization planned during the teleconsultation, patients will benefit from the following multidisciplinary assessment.; General clinical examination; Assessment of the state of health; Respiratory assessment; Pulmonary CT assessment; Cognitive evaluation; Cardiological evaluation; Renal assessment; Immunological evaluation
Patients from the 2nd epidemic wave; As during the evaluation carried out during the 1st wave, the detection of persistent symptoms will be done in two stages: During a teleconsultation, to which all eligible patients will be invited, systematically looking for general, neurological, cognitive and respiratory symptoms; During a hospitalization in an outpatient clinic to which all survivors who have stayed in an intensive care unit (ICU) will be invited and, among patients who have not stayed in an ICU, those who have residual symptoms detected during the teleconsultation.	Other: Teleconsultation; Teleconsulting physicians will subject patients to a standardized questionnaire that will look for the following symptoms: General signs: Anorexia, fatigue, new hospitalization, weight loss,; Respiratory signs: recent dyspnoea, chest discomfort, chest pain, new cough, abnormal lung CT scan since discharge; Neurological signs: headache, paraesthesia, anosmia, limb paralysis; Digestive signs: abdominal pain, diarrhoea, constipation, nausea, vomiting Edition 2021 ◌ Cognitive signs using the Q3PC questionnaire (10): memory loss, slowness in reasoning, activity planning or problem solving, concentration, attention difficulties; Other: Outpatient clinic; During a day hospitalization planned during the teleconsultation, patients will benefit from the following multidisciplinary assessment.; General clinical examination; Assessment of the state of health; Respiratory assessment; Pulmonary CT assessment; Cognitive evaluation; Cardiological evaluation; Renal assessment; Immunological evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of respiratory, cognitive and psychological symptoms presented at 6 months of hospitalization for COVID-19.	nature and prevalence of symptoms persisting at 6 months of an episode of COVID-19 requiring hospitalization	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between the prevalence of residual symptoms between patients hospitalized during the 1st wave of the epidemic in France (from the COMEBAC "1st wave" study) and those of the current study	risk factors for the various sequelae of COVID-19	6 months
Association between patient characteristics and the prevalence of residual symptoms.	effect of the therapeutic changes that occurred between the 1st and 2nd wave of COVID-19 on these persistent symptoms.	6 months
Association between residual symptoms and the type of SARS-CoV-2 variant	residual symptoms of COVID-19 according to the SARS-CoV-2 variants responsible	6 months
Prevalence of respiratory, neurological, cognitive and psychological symptoms presented at 6 months of hospitalization for COVID-19 which occurred during the 1st epidemic wave.	residual symptoms of COVID-19 one year after COVID-19 that occurred during the 1st epidemic wave	6 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Tai PHAM, Bicetre Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2021
• Primary Completion (Anticipated): May 5, 2022
• Study Completion (Anticipated): May 5, 2022

Study Registration Dates

• First Submitted: June 18, 2021
• First Submitted That Met QC Criteria: June 18, 2021
• First Posted (Actual): June 22, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 18, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: COMEBAC 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No