Daily Home Spirometry for Early Detection of Pulmonary Complications in Patients With COVID19

Sheba Medical Center90 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

COVID 19

Interventions

home spirometryDIAGNOSTIC_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).

Eligibility

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Hospitalization

participants that are hospitalized

Time frame: number of participants hospitalized in a time frame of a year