Official Title
A Descriptive Pilot Study of Daily Home Spirometry for Early Detection of Pulmonary Complications in High Risk Patients With COVID19
Brief Summary

The aim of this preliminary study is to describe the potential decline in forcedexpiratory volume in 1 second (FEV1) or forced vital capacity (FVC) as measured by homespirometry in high-risk subjects infected with COVID-19. We hypothesize that themagnitude of such a decline in FEV1 and/or FVC may be associated with clinicaldeterioration and hospitalization. The study will ultimately inform a larger subsequentRCT that will evaluate the efficacy of home spirometry in the early detection (prerespiratory symptoms) of respiratory complications and therefore prompt early medicalattention which is a key for improving outcome.

Unknown status
COVID 19

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).

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 85 Years
Countries
Israel
Locations

Sheba Medical Center
Ramat Gan, Israel

Investigator: Gal Varshavsky
Contact: 972-3-5305997
Gal.Varshavsky@sheba.health.gov.il

Contacts

Gal Varshavsky
972-3-5305997
Gal.Varshavsky@sheba.health.gov.il

Sheba Medical Center
NCT Number
MeSH Terms
COVID-19