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

NCT04438863 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2021-11-29

No results posted yet for this study

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.

Conditions

  • COVID 19

Interventions

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).

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-08
Primary Completion
2022-01-01
Completion
2022-01-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04438863 on ClinicalTrials.gov