Daily Home Spirometry for Early Detection of Pulmonary Complications in Patients With COVID19
A Descriptive Pilot Study of Daily Home Spirometry for Early Detection of Pulmonary Complications in High Risk Patients With COVID19
1 other identifier
observational
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2020
CompletedFirst Posted
Study publicly available on registry
June 19, 2020
CompletedStudy Start
First participant enrolled
August 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedNovember 29, 2021
November 1, 2021
1.4 years
June 17, 2020
November 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Hospitalization
participants that are hospitalized
number of participants hospitalized in a time frame of a year
Interventions
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 Criteria
confirmed COVID19 patients (hospitalized or not hospitalized) with mild to moderate symptoms. (low grade fever, cough, anosmia, fatigue, discomfort, anorexia or other gastrointestinal symptoms)
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba Medical Center
Ramat Gan, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Transplant pulmonologist
Study Record Dates
First Submitted
June 17, 2020
First Posted
June 19, 2020
Study Start
August 8, 2020
Primary Completion
January 1, 2022
Study Completion
January 1, 2022
Last Updated
November 29, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share