Cohort Follow-up of Survivors of Hospitalization for COVID-19 During the 2nd Wave of the Epidemic in France
NCT ID: NCT04934202
Last Updated: 2021-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
500 participants
OBSERVATIONAL
2021-05-05
2022-05-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Remote Video Consultation for Quality of Life Assessment in Patients Hospitalised After COVID-19 Infection
NCT04714138
Evaluation of the Effectiveness of Breathing Control Technique on Long COVID Symptoms at the Reunion University Hospital
NCT05851859
Evaluation of Virtual Reality to Reduce Anxiety, Pain and Duration of Non-emergency Vigile Bronchial Fibroscopy (AVATAR)
NCT05973201
Description of Patient Adherence to Heart Failure Remote Monitoring and Its Determinants
NCT06723509
Tele-monitoring of COVID-19 Survivors for Long-Term Impacts
NCT04644341
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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".
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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
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.
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
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
◌ Presence of general, cognitive, psychological and respiratory symptoms during the assessment made at 4 months in COMEBAC "1st wave"
Exclusion Criteria
* 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
* Death occurring between the evaluation in COMEBAC "1st wave" and the re-evaluation
* Patient refusal
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tai PHAM
Role: PRINCIPAL_INVESTIGATOR
Bicêtre Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bicetre hospital
Le Kremlin-Bicêtre, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
COMEBAC 2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.