The aim of this preliminary study is to describe the potential decline in forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) as measured by home spirometry in high-risk subjects infected with COVID-19. We hypothesize that the magnitude of such a decline in FEV1 and/or FVC may be associated with clinical deterioration and hospitalization. The study will ultimately inform a larger subsequent RCT that will evaluate the efficacy of home spirometry in the early detection (pre respiratory symptoms) of respiratory complications and therefore prompt early medical attention which is a key for improving outcome.
Diagnostic Test: home spirometry
portable hand-held spirometer to collect and store daily spirometric data (including FVC, FEV1, forced expiratory flow after 25 to 75% of vital capacity has been expelled, and peak flow).
Inclusion Criteria:
1. without dyspnea and with no evidence of pneumonia, ARDS, organ failure or requiring
admission to ICU.
2. All patients ≥55 years age or ≥1 risk factor for disease complications (prior
pulmonary, kidney or cardiovascular disease, diabetes mellitus, hypertension, bone
merrow suppression, solid organ transplant, HIV with CD4<250, heavy smoker, BMI >30).
All participants will sign a written informed consent.
Exclusion Criteria:
1. Patients unable to perform spirometry
2. contraindications for spirometry (hemoptysis, active tuberculosis, syncope associated
with forced exhalation or increased risk for spirometry)
3. adhere to the follow-up protocol.
Sheba Medical Center
Ramat Gan, Israel
Investigator: Gal Varshavsky
Contact: 972-3-5305997
Gal.Varshavsky@sheba.health.gov.il
Gal Varshavsky
972-3-5305997
Gal.Varshavsky@sheba.health.gov.il