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

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 Overview

• Status: Recruiting
• Conditions: COVID 19
• Intervention / Treatment: Diagnostic test: home spirometry

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel
    • Recruiting
    • Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

confirmed COVID19 patients (hospitalized or not hospitalized) with mild to moderate symptoms.

(low grade fever, cough, anosmia, fatigue, discomfort, anorexia or other gastrointestinal symptoms)

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization	participants that are hospitalized	number of participants hospitalized in a time frame of a year

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2020
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2021
• Last Update Submitted That Met QC Criteria: November 25, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: SHEBA-20-7022-SMC-LL-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No