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

• Sponsor: Sheba Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04438863
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Anticipated Duration (Months): 16.8
• Patients Per Site Per Month: 5.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID 19	Diagnostic Test: home spirometry

Study Design

• Study Type: Observational
• Anticipated Enrollment: 90 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Descriptive Pilot Study of Daily Home Spirometry for Early Detection of Pulmonary Complications in High Risk Patients With COVID19
• Actual Study Start Date: Aug 8, 2020
• Anticipated Primary Completion Date: Jan 1, 2022
• Anticipated Study Completion Date: Jan 1, 2022

Outcome Measures

Primary Outcome Measures

1. Hospitalization [number of participants hospitalized in a time frame of a year]

   participants that are hospitalized

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sheba Medical Center	Ramat Gan		Israel

Sponsors and Collaborators

• Sheba Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Liran Levy, Transplant pulmonologist, Sheba Medical Center
• ClinicalTrials.gov Identifier: NCT04438863
• Other Study ID Numbers: SHEBA-20-7022-SMC-LL-CTIL
• First Posted: Jun 19, 2020
• Last Update Posted: Nov 29, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Nov 29, 2021