Clinical trial NCT04406324: COVID-19: Respiratory and Sleep Follow-up
Official title: COVID-19: Prospective Follow-up of Pulmonary Function, Sleep Disorders, Quality of Life and Post-traumatic Stress
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19
Keywords: COVID-19
Pulmonary function
Sleep disorders
Post-traumatic stress
Cardiac function
Sleep Apnea
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 395
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients infected by SARS-CoV-2

Brief summary: The current project is a prospective, multicentric cohort study aiming at a multidisciplinary assessment (pulmonary, cardiometabolic, sleep and mental health) of the consequences of infection by SARS-CoV-2, 3 months after the diagnosis in order to better characterize these complications. 400 patients with a positive diagnosis of SARS-CoV-2 will be included in the study 3 months after their diagnosis: They will be followed at 6 months, 1 year, 3 years, and 5 years, as function of their after-effects discovered at 3 months and their evolution.

Detailed description: Europe and in particular Italy, Spain and France are currently affected by the coronavirus 2019-nCoV pandemic, whose immediate prognosis is linked to the development of acute respiratory distress syndrome (ARDS). Beyond the long-term adverse effects on respiratory health and reduced exercise capacity, other complications will occur. These include a more rapid progression of cardiometabolic diseases, a secondary epidemic of disabling post-traumatic stress disorder, and severe sleep disorders. The current project aims at a multidisciplinary assessment of respiratory, cardiac, sleep and mental health sequelae, three months after SARS-CoV-2 diagnosis in order to better characterize these complications.

Three aspects will be targeted in this study : (i) long-term monitoring of deterioration in lung function, (ii) screening for sleep respiratory disorders (sleep apnea syndrome, obesity hypoventilation syndrome) and iii) characterization of sleep disorders and design of specialized intervention to improve sleep quality.

This study is a prospective, multicentric cohort study that aims at constituting a cohort of 400 patients who will be screened for pulmonary, cardiac, sleep, or psychological sequelae 3 months after their diagnosis. They will be then followed for 5 years. The primary outcome will be the diffusion capacity of carbon monoxide (DLCO) 3 months after the diagnosis. Other secondary outcomes will include:

* prevalence of sleep disorders and sleep disordered breathing 3 months after diagnosis and their evolution until 5 years;
* prevalence of cardiac, exercise capacity, respiratory and ventilatory muscles impairments at 3 months and their evolution until 5 years;
* characterization of homogeneous groups of patients who were infected with SARS-CoV-2 and have respiratory, cardiometabolic and/or sleep complications, 3 months after diagnosis (latent class analysis) and evaluate their evolution until 5 years
* determine the prevalence of radiological sequelae at 3 months, and their evolution until 5 years
* determine the psycho-social impact (quality of life, post-traumatic stress, anxiety, productivity at work) at 3 months and its evolution until 5 years

Eligibility criteria: Inclusion Criteria:

* Male or Female, aged \> 18 years
* With a positive diagnosis for SARS-COVID-19, confirmed by RT-PCR or with compatible symptoms
* Signed informed consent by patient
* Affiliated to a French social and health insurance system or equivalent
* For biological collection: patient eligible for sampling (weight \>50kg and hemoglobin \>7g/dL) and signed inform consent for collection

Exclusion Criteria:

* Pregnant or breastfeeding women
* Prisoners or patients who require protection by the law
* Patients not affiliated to a French social and health insurance system or equivalent
* Ages \<18 years
* Diagnosis of infection by other pathogen than SARS-COVID-19 or no indication of infection by COVID-19

Primary outcomes:
measure: Diffusion Capacity for Carbon Monoxide (CO) 3 months after COVID diagnosis
timeFrame: 3 months after COVID diagnosis
Secondary outcomes:
measure: Prevalence of Sleep Disordered Breathing (SDB) 3 months after COVID diagnosis
timeFrame: 3 months after COVID diagnosis
measure: Prevalence of sleep disorders 3 months after COVID diagnosis
timeFrame: 3 months after COVID diagnosis
measure: Prevalence of ventilatory muscle function impairments, 3 months after COVID diagnosis
timeFrame: 3 months after COVID diagnosis
measure: Prevalence of cardiac impairments 3 months after COVID diagnosis
timeFrame: 3 months after COVID diagnosis
measure: Follow-up of pulmonary diffusion capacity of carbon monoxide
timeFrame: From Baseline (3 months after COVID diagnosis) to 5 years
measure: Follow-up of sleep disorders treatment compliance
timeFrame: From Baseline (3 months after COVID diagnosis) to 5 years
measure: Follow-up of sleep disorders treatments efficacy
timeFrame: From Baseline (3 months after COVID diagnosis) to 5 years
measure: HLA alleles aspect of COVID clinical presentation
timeFrame: 3 months after COVID diagnosis
measure: KIR loci aspect of COVID clinical presentation
timeFrame: 3 months after COVID diagnosis
measure: metabolomic aspect of COVID clinical presentation
timeFrame: 3 months after COVID diagnosis
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Hôpital Avicenne
city: Créteil
country: France
facility: Centre Hospitalier Henri Mondor, APHP
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Nancy
country: France
facility: CHRU Nancy
Study officials:
affiliation: University Hospital Grenoble Aples
name: Renaud Tamisier, MD, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
citation: Hui DS, Joynt GM, Wong KT, Gomersall CD, Li TS, Antonio G, Ko FW, Chan MC, Chan DP, Tong MW, Rainer TH, Ahuja AT, Cockram CS, Sung JJ. Impact of severe acute respiratory syndrome (SARS) on pulmonary function, functional capacity and quality of life in a cohort of survivors. Thorax. 2005 May;60(5):401-9. doi: 10.1136/thx.2004.030205.
citation: Burnham EL, Hyzy RC, Paine R 3rd, Coley C 2nd, Kelly AM, Quint LE, Lynch D, Janssen WJ, Moss M, Standiford TJ. Chest CT features are associated with poorer quality of life in acute lung injury survivors. Crit Care Med. 2013 Feb;41(2):445-56. doi: 10.1097/CCM.0b013e31826a5062.
citation: Herridge MS, Moss M, Hough CL, Hopkins RO, Rice TW, Bienvenu OJ, Azoulay E. Recovery and outcomes after the acute respiratory distress syndrome (ARDS) in patients and their family caregivers. Intensive Care Med. 2016 May;42(5):725-738. doi: 10.1007/s00134-016-4321-8. Epub 2016 Mar 30.
citation: Luyt CE, Combes A, Becquemin MH, Beigelman-Aubry C, Hatem S, Brun AL, Zraik N, Carrat F, Grenier PA, Richard JM, Mercat A, Brochard L, Brun-Buisson C, Chastre J; REVA Study Group. Long-term outcomes of pandemic 2009 influenza A(H1N1)-associated severe ARDS. Chest. 2012 Sep;142(3):583-592. doi: 10.1378/chest.11-2196.