PEP Flute-selfcare in COVID-19

COVID-19 Clinical Trial

— PEP-CoV  

Official title:

PEP Flute-selfcare to Prevent Respiratory Deterioration and Hospitalization Among COVID-19 Patients: a Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04530435
• Other study ID #: 0211-00023B
• Status: Completed
• Phase: N/A
• Start date: October 6, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: March 2022
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Most research on the coronavirus SARS-CoV-2 and COVID-19 disease relate to screening measures, development of vaccines and optimising treatment of hospitalised patients. It is likely that this pandemic will be ongoing for several years until a high level of immunity is reached in the population or a vaccine has been developed. Thus, there is a need of measures to help the SARS-CoV-2 infected individual at home to overcome the course of disease with less symptoms and strain. A Positive Expiratory Pressure (PEP) flute is feasible for home use and it is possible that regular use of PEP flute may prevent the progression of respiratory symptoms in non-hospitalized individuals with COVID-19 disease. The primary objective of the study is to examine the effect of PEP flute use among SARS-CoV-2 infected, non-hospitalized patients on self-reported change in COPD Assessment Test (CAT) score during 30 days of follow-up. The secondary objectives are to compare the development in hospitalization rates and use of antibiotics in the intervention group and the control group during the follow-up period.

Description:

It is hypothesized that the PEP flute has positive effects on SARS-CoV-2 infected individual's self-reported respiratory symptoms such as dyspnoea, coughing and perceived mucus clearance through beneficial effects on lung function and airway clearance. Furthermore, the investigators expect a lower rate of hospitalization and use of antibiotics in the intervention group as compared to the control group. Finally, potential subgroup effects by gender, age, comorbidity and BMI at study entry will be explored for all outcomes. Based upon a sample size estimation the investigators assess that inclusion of 200 participants in each intervention arm will be an adequate number. Based on the present testing strategy and COVID-19 incidence, current expectations are that two months should be enough to recruit 400 patients. The investigators will allow for recruitment to the end of December 2020, but will terminate enrolment at n = 400. Link to detailed protocol paper will be added once published.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 378
• Est. completion date: September 1, 2021
• Est. primary completion date: March 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Positive SARS-CoV-2
• Symptoms of SARS-CoV-2 infection e.g. fever, cough and shortness of breath.
• Access to use a smartphone
• Can reply to a questionnaire (sent on email, text messages or via telephone interview) in Danish
• Given informed consent

Exclusion Criteria:

• Age < 18 years.
• Any condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or which obstruct participation, such as psychiatric disorders.
• Hospitalised patients or citizens living in nursing homes

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2

Intervention

Device:
• PEP flute
Participants are advised to use a PEP flute at least three times daily at an appropriate resistance. Ideally, each session consists of 15 breaths (for approximately 1 minute) repeated twice at an upright position.

Locations

Country	Name	City	State
Denmark	Research Unit for Dietary Studies at the Parker Institute, Bispebjerg and Frederiksberg Hospitals	Frederiksberg

Sponsors (2)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serious Adverse Events	Assessed by Common Terminology Criteria for Adverse Event (CTCAE).	During treatment, up to 30 days.
Other	General and respiratory symptoms	Measured according to the COVIDmeter from Statens Serum Institut using a telephone or email-administered questionnaire. The outcome assessment can be taken within + 1 week for the scheduled visit.	Day 30, 90, Day 180.
Primary	Self-reported CAT-score (COPD Assessment Test)	CAT-scores will be measured using a telephone administered questionnaire. The CAT-score is validated to evaluate symptoms in COPD patients. Eight items covers symptoms of cough, sputum, chest pain, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms (modified for the present study from feeling safe at leaving home despite symptoms), sleep quality and vigour. The eight items sum up to a range of 0-40 with higher scores indicating more respiratory impairment. Although validated for COPD-use, the CAT-scale is considered useful in the present study because several of the items (dyspnoea, cough, fatigue, sputum and pleuritic chest pain) previously have been used as outcome variables in pneumonia studies. The outcome assessment can be taken within + 1 week for the scheduled visit.	Day 30.
Secondary	Hospital admissions	Will be obtained from the Danish National Patient Registry, from which also data of comorbidity will be retrieved.	Up to day 30, 90 and 180.
Secondary	Use of antibiotics	Will be obtained from the Danish National Prescription Registry.	Up to day 30, 90 and 180.
Secondary	Self-reported CAT-score (COPD Assessment Test)	CAT-scores will be measured using a telephone or email-administered questionnaire. The outcome assessment can be taken within + 1 week for the scheduled visit.	Day 90, Day 180.