Daily Home Spirometry for Early Detection of Pulmonary Complications in Patients With COVID19
- Conditions
- COVID 19
- Registration Number
- NCT04438863
- Lead Sponsor
- Sheba Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
- without dyspnea and with no evidence of pneumonia, ARDS, organ failure or requiring admission to ICU.
- 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
- Patients unable to perform spirometry
- contraindications for spirometry (hemoptysis, active tuberculosis, syncope associated with forced exhalation or increased risk for spirometry)
- adhere to the follow-up protocol.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hospitalization number of participants hospitalized in a time frame of a year participants that are hospitalized
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sheba Medical Center
🇮🇱Ramat Gan, Israel