Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04934202
Other study ID # COMEBAC 2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 5, 2021
Est. completion date May 5, 2022

Study information

Verified date June 2021
Source Assistance Publique - Hôpitaux de Paris
Contact Tai PHAM
Phone +33145217245
Email tai.pham@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Description:

From 15th July to 18th September, 2020, in a first uncontrolled cohort study (Multi-Expertise Consultation of BicĂȘtre After Covid-19, COMEBAC), we evaluated at four months the surviving patients who were hospitalized at the BicĂȘtre 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".


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date May 5, 2022
Est. primary completion date May 5, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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
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

Locations

Country Name City State
France Bicetre hospital Le Kremlin-Bicêtre

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Recruiting NCT04317820 - Deep Brain Reorienting in Post-traumatic Stress Disorder N/A
Completed NCT05112003 - Translingual Neurostimulation for the Virtual Treatment of Post-Traumatic Stress Disorder: A Feasibility Pilot N/A
Recruiting NCT04518267 - Anger and Psychotrauma: Data From Military and Civilians
Completed NCT02502604 - Cognitive Training Program for Individuals With Depression and Post-Traumatic Stress Disorder N/A
Completed NCT02256566 - Cognitive Training for Mood and Anxiety Disorders N/A
Terminated NCT02234687 - A mGlu2/3 Agonist in the Treatment of PTSD Phase 1
Terminated NCT02520726 - PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims Phase 4
Completed NCT01738308 - The Effects of Healing Touch on Post Operative Pediatric Patients N/A
Completed NCT02213900 - Preventing Post-Operative Delirium in Patients Undergoing a Pneumonectomy, Esophagectomy or Thoracotomy Phase 4
Completed NCT01517711 - Tramadol Extended-Release (ER) for Posttraumatic Stress Disorder (PTSD) Phase 4
Completed NCT01437891 - Sentra AM® and Sentra PM® for Post-traumatic Stress Disorder (PTSD) and Gulf War Fibromyalgia (GWF) N/A
Completed NCT01199107 - Maximizing Treatment Outcome and Examining Sleep in Post-traumatic Stress Disorder (PTSD) Phase 3
Completed NCT01998100 - Maximizing Treatment Outcome in Post-Traumatic Stress Disorder (PTSD) Phase 3
Completed NCT01231711 - Improving Quality-of-life and Depressive Symptoms of Combat Veterans Via Internet-based Intervention Phase 1
Completed NCT00680524 - Telephone-based Care for OEF/OIF Veterans With PTSD N/A
Completed NCT00348036 - Group Intervention for Interpersonal Trauma N/A
Completed NCT00838006 - Psychophysiologic Predictors of Post-deployment Mental Health Outcomes N/A
Completed NCT00525226 - Evaluating the Effects of Stress in Pregnancy N/A
Completed NCT00127673 - Comparison of Two Treatments for Post-Traumatic Stress Disorder Phase 3
Completed NCT00158262 - Effect of Propranolol on Preventing Posttraumatic Stress Disorder Phase 4