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

NCT04934202 | Unknown

• 1 other identifier: COMEBAC 2
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sequelae; Fibrosis; Post-COVID Syndrome; Post-traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  6 months

• Association between patient characteristics and the prevalence of residual symptoms.

  6 months

• Association between residual symptoms and the type of SARS-CoV-2 variant

  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.

  6 months

Study Arms (2)

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; Other: Outpatient clinic

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; Other: Outpatient clinic

Interventions

Teleconsultation OTHER

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

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

Outpatient clinic OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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
• ◌ Presence of general, cognitive, psychological and respiratory symptoms during the assessment made at 4 months in COMEBAC "1st wave"
• Death occurring between the evaluation in COMEBAC "1st wave" and the re-evaluation
• Patient refusal

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Bicetre hospital

Le Kremlin-Bicêtre, 94270, France

RECRUITING

MeSH Terms

Conditions

Fibrosis; Stress Disorders, Post-Traumatic

Interventions

Remote Consultation; Ambulatory Care Facilities

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Referral and Consultation; Professional Practice; Organization and Administration; Health Services Administration; Telemedicine; Delivery of Health Care; Patient Care Management; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Tai PHAM

  Bicêtre Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tai PHAM

CONTACT

+33145217245; tai.pham@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: June 22, 2021
• Study Start: May 5, 2021
• Primary Completion: May 5, 2022
• Study Completion: May 5, 2022
• Last Updated: June 22, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)