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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| home spirometry | Diagnostic Test | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization | participants that are hospitalized | number of participants hospitalized in a time frame of a year |
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Inclusion Criteria:
Exclusion Criteria:
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confirmed COVID19 patients (hospitalized or not hospitalized) with mild to moderate symptoms.
(low grade fever, cough, anosmia, fatigue, discomfort, anorexia or other gastrointestinal symptoms)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gal Varshavsky | Contact | 972-3-5305997 | Gal.Varshavsky@sheba.health.gov.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Recruiting | Ramat Gan | Israel |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |