Functional Capacity in Patients Post Mild COVID-19

Functional Capacity in Patients Who Recovered From Mild COVID-19 With Exertional Dyspnea.

Patients recovered from mild coronavirus 2019 (COVID-19) disease without pulmonary involvement may experience long-term physical impairment and dyspnea. The investigators aim to characterize physiologic limitations in patients who recovered from mild COVID-19.

Methods: Pulmonary function tests (PFTs), 6-minute walk test (6MWT), echocardiography and cardiopulmonary exercise test (CPET) will be completed in patients recovered from mild COVID-19 disease with prolonged dyspnea (Subgroup "A") and compared to patients recovered from moderate/severe COVID-19 (subgroup "B") and to non-COVID-19 patients with unexplained dyspnea (subgroup "C").

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Device: Cardiopulmonary exercise test (CPET)

Detailed Description

Infection with severe acute respiratory syndrome coronavirus-2 leads to severe disease requiring hospitalization in 20% of the cases. Respiratory failure from severe acute respiratory syndrome coronavirus-2 infection can range from mild pneumonia and hypoxia to life threatening hypoxia secondary to severe acute respiratory distress syndrome requiring intensive care unit and mechanical ventilation in about 12-24% of the hospitalized patients. Most patients are discharged with minimal or no long-term oxygen therapy while others are discharged with ongoing respiratory symptoms and long-term oxygen therapy. In the longer term, there is a significant concern that severe coronavirus disease 2019 can lead to organizing pneumonia and severe acute lung injury with evolution to widespread fibrotic changes as seen in fatal cases of coronavirus disease showing pulmonary fibrosis at autopsy. Studies in severe acute respiratory syndrome survivors, another corona virus infection, showed persistent and significant impairment of exercise capacity and health status over 24 months based on PFTs, 6-minute walk test and health questionnaire. Infection with respiratory syndrome coronavirus-2 has been also associated with multiple direct and indirect cardiovascular complications including acute myocardial injury, myocarditis, arrhythmias, and venous thromboembolism. However, long term cardiovascular consequences from coronavirus disease 2019 are still unknown. The investigators sought to determine the pulmonary, cardiac and other physiologic limitations in patients who recovered from severe coronavirus disease 2019 with physiologic tests including PFTs, echocardiography and cardio-pulmonary exercise test which is currently the most comprehensive physiologic test that can differentiate between the different limitations and add novel data regarding short and long term physiologic consequences of coronavirus disease 2019.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ronen Bar-Yoseph, MD; Phone Number: +972-4-777-4360; Email: r_bar-yoseph@rambam.health.gov.il
• Study Contact Backup: Name: Yaniv Dotan, MD; Phone Number: +972-4-777-2650; Email: y_dotan@rambam.health.gov.il

Study Locations

• Israel
  • Haifa, Israel
    • Recruiting
    • Rambam Medical Center
    • Contact: Ronen Bar-Yoseph, MD; Phone Number: +972-4-777-4360; Email: r_bar-yoseph@rambam.health.gov.il
    • Contact: Yaniv Dotan, MD; Phone Number: +972-4-777-2650; Email: y_dotan@rambam.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients recovering from COVID-19 with a documented infection with severe acute respiratory syndrome coronavirus-2 and cognitive ability to sign informed consent and physical ability to participate in exercise tests.

Exclusion Criteria:

• Patients with severe pulmonary, cardiac disease prior to COVID-19, pregnant women, and patients with active infection or cancer.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cardiopulmonary exercise test (CPET); Cardiopulmonary exercise testing (CPET) using a Quark CPET metabolic cart (Rome, Italy) according to American Thoracic Society (ATS) guidelines. A symptom-limited test on a treadmill will be performed, using incremental ramp Bruce protocol up to exhaustion. Patients who will not be able to perform the test on a treadmill will be tested on a cycle ergometer beginning with a no-resistance warm-up lasting 2-3 minutes, followed by incrementing resistance (8-30 Watts/minute) adapted to the patient's functional capacities according to the examiner's free judgment, up to exhaustion.

Device: Cardiopulmonary exercise test (CPET); A symptom-limited test on a treadmill will be performed, using incremental ramp Bruce protocol up to exhaustion. Patients who will not be able to perform the test on a treadmill will be tested on a cycle ergometer beginning with a no-resistance warm-up lasting 2-3 minutes, followed by incrementing resistance (8-30 Watts/minute).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise capacity	Oxygen uptake evaluated by cardiopulmonary exercise testing (CPET)	Measured continuously during 15 minutes of the exercise test (CPET)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Echocardiography	Left ventricle shortening and ejection fraction, as well as possible cardiac structural or hemodynamic abnormalities will be evaluated by trans-thoracic echocardiography (iE33, Philips).	Ten minutes
Six minute walk test	The distance gained after six minute of habitual walking.	Six minutes of evaluation, completed pre cardiopulmonary exercise test.
Spirometry	Pulmonary function as assessed by spirometry.	Five minutes before and after the cardiopulmonary exercise testing

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 7, 2022
• First Submitted That Met QC Criteria: April 10, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 10, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; Cardiopulmonary Exercise Testing; Exertional dyspnea
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 0760-20-RMB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No