SequelaeCOMEBAC 2NCT04934202
Cohort Follow-up of Survivors of Hospitalization for COVID-19 During the 2nd Wave of the Epidemic in France
An observational study of Sequelae and Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sequelae, Fibrosis, Post-COVID Syndrome
- What is being tested?
- Teleconsultation and Outpatient clinic
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2021to 5 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from the 1st epidemic wave Patients from the 2nd epidemic wave
Who may be able to join
- 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
- ◌ Presence of general, cognitive, psychological and respiratory symptoms during the assessment made at 4 months in COMEBAC "1st wave"
Who cannot join
- 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
- Death occurring between the evaluation in COMEBAC "1st wave" and the re-evaluation
- Patient refusal
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Bicetre hospital
Le Kremlin-Bicêtre, 94270
Tai PHAM, 0145217245, tai.pham@aphp.fr
About this study
Official title: 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.
Read the 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".
- Being tested
- Teleconsultation, Outpatient clinic
- Medical subject headings
- Fibrosis, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeleconsultationOther
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 clinicOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Teleconsultation; Other: Outpatient clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
risk factors for the various sequelae of COVID-19
Measured: 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.
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start5 May 2021
- Primary completion5 May 2022 (estimated)
- Study completion5 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SequelaeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tai PHAM, Principal investigator, Bicêtre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934202
- Sponsor's protocol ID
- COMEBAC 2
- Acronym
- COMEBAC 2
- Status last verified
- Jun 2021
- First submitted
- 18 Jun 2021
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04934202
- Acronym / sponsor ID
- COMEBAC 2 / COMEBAC 2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 5 May 2021 (actual)
- Primary completion
- 5 May 2022 (estimated)
- Study completion
- 5 May 2022 (estimated)
- First posted
- 22 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients from the 1st epidemic wave | – | Other: Teleconsultation, Other: Outpatient clinicOne 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. |
| Patients from the 2nd epidemic wave | – | Other: Teleconsultation, Other: Outpatient clinicAs 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the 1st epidemic wave Patients from the 2nd epidemic wave
Key inclusion criteria (5 listed)
- ◌ Presence of general, cognitive, psychological and respiratory symptoms during the assessment made at 4 months in COMEBAC "1st wave"
Key exclusion criteria (7 listed)
- For the 12-month evaluation of patients from the 1st epidemic wave
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeleconsultationTeleconsulting 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 | Patients from the 1st epidemic wave, Patients from the 2nd epidemic wave |
| Outpatient clinicDuring 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 | Other | Patients from the 1st epidemic wave, Patients from the 2nd epidemic wave |
Primary outcome
Prevalence of respiratory, cognitive and psychological symptoms presented at 6 months of hospitalization for COVID-19.
Time frame: 6 months
nature and prevalence of symptoms persisting at 6 months of an episode of COVID-19 requiring hospitalization
4 secondary outcomes
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
Time frame: 6 months
Association between patient characteristics and the prevalence of residual symptoms.
Time frame: 6 months
Association between residual symptoms and the type of SARS-CoV-2 variant
Time frame: 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.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tai PHAM principal investigator
Bicêtre Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sequelae and Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tai PHAM (+33145217245, tai.pham@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of respiratory, cognitive and psychological symptoms presented at 6 months of hospitalization for COVID-19. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2021.