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

COVID 19 Clinical Trial

Official title:

A Descriptive Pilot Study of Daily Home Spirometry for Early Detection of Pulmonary Complications in High Risk Patients With COVID19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04438863
• Other study ID #: SHEBA-20-7022-SMC-LL-CTIL
• Status: Recruiting
• Start date: August 8, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: November 2021
• Source: Sheba Medical Center
• Contact: Gal Varshavsky
• Phone: 972-3-5305997
• Email: Gal.Varshavsky[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID 19
• COVID-19

Intervention

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).

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization	participants that are hospitalized	number of participants hospitalized in a time frame of a year