COVID 19
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESThome 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).
Sponsors
Sheba Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization | number of participants hospitalized in a time frame of a year | participants that are hospitalized |
Countries
Israel
Contacts
Primary ContactGal Varshavsky
Outcome results
None listed