NCT04881214: COVISQAR

COVID-19 Pneumonia: Pulmonary Physiology, Health-related Quality of Life and Benefit of a Rehabilitation Program

Status unknown NA Last updated 23 September 2022

What this trial tests

NA trial testing Pulmonary rehabilitation in Covid19 Pneumonia in 60 participants. Status unknown.

Timeline

1 July 2020

Primary endpoint
30 June 2023

30 June 2023

Quick facts

Lead sponsor	University Hospital, Geneva
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 July 2020
Primary completion	30 June 2023
Estimated completion	30 June 2023
Sites	1 location across Switzerland

Drugs / interventions tested

• Pulmonary rehabilitation

Conditions studied

• Covid19 Pneumonia — all drugs for Covid19 Pneumonia →
• Chronic Thromboembolic Pulmonary Hypertension — all drugs for Chronic Thromboembolic Pulmonary Hypertension →
• Myopathy — all drugs for Myopathy →
• Restrictive Lung Disease — all drugs for Restrictive Lung Disease →

Sponsor

University Hospital, Geneva

Who can join

18 and older, any sex, with Covid19 Pneumonia or Chronic Thromboembolic Pulmonary Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The pathophysiological processes involved in COVID-19 pneumonia are not fully understood. Specific alterations of the airways, lung parenchyma and pulmonary vascular tree could explain a severe ventilation/perfusion heterogeneity resulting in severe hypoxemia during the active phase of the disease. Additional skeletal muscle impairment related to systemic inflammation may also explain persisting symptoms in the follow-up phase. The first aim of the present project is to explore these different processes by evaluating the impact of the COVID-19 pneumonia on exercise capacity, pulmonary function and perfusion by a physiological and radiologic study. An ambulatory pulmonary rehabilitation will also be studied to assess its impact on the physiological parameter mentioned and the health-related quality of life questionnaire as a potential long-term treatment. The investigators propose a single center randomized controlled study at the University Hospitals of Geneva. 60 adult patients having suffered a hypoxemic COVID-19 pneumonia with persistent symptoms at 3-months after hospital discharge will be included. A functional and physiological study will be performed, including a six-minute walk test, pulmonary function testing, diffusing capacity for carbon monoxide, maximal inspiratory pressure and sniff nasal inspiratory pressure. Those with at least one abnormal value will be invited to fill the Saint Georges Respiratory Questionnaire, the Short Form 36 and the Hospital Anxiety and Depression Scale and will undergo a chest dual energy computed tomography (DECT), a cardiopulmonary exercise testing with non-invasive cardiac output and stroke volume evaluation and an evaluation of the pulmonary shunt by hyperoxia (100% oxygen breathing) at rest and during light effort. Then patients will be randomized on a 1:1 basis for pulmonary rehabilitation program or usual care. All work-up except DECT will be repeated at 6 and 12 months after hospital discharge. The investigators hypothesize that our study will allow a better understanding of pathophysiological mechanisms involved in COVID-19. This will potentially determine therapeutic target for patients with persisting symptoms and functional decay after COVID-19. The investigators also expect to see an improvement of exercise capacity and physiological parameters in the pulmonary rehabilitation group, as compared to the control group, suggesting pulmonary rehabilitation as a possible long-term treatment of this condition.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Exercise ventilatory response after COVID-19: comparison between ambulatory and hospitalized patients.
   Guerreiro I, Bringard A, Nehme M, Guessous I, et al · · 2023 · cited 3× · PMID 37874657 · DOI 10.1152/ajplung.00142.2023