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NCT Number: NCT04530435

PEP Flute-selfcare in COVID-19

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV-2 Signs and Symptoms Signs and Symptoms, Respiratory Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Unit for Dietary Studies at the Parker Institute, Bispebjerg and Frederiksberg Hospitals

Frederiksberg, 2000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEP flute

Device

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.

Primary outcomes

  1. Self-reported CAT-score (COPD Assessment Test)

    Time frame: Day 30.

    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.

Secondary outcomes

  1. Hospital admissions

    Time frame: Up to day 30, 90 and 180.

    Will be obtained from the Danish National Patient Registry, from which also data of comorbidity will be retrieved.

  2. Use of antibiotics

    Time frame: Up to day 30, 90 and 180.

    Will be obtained from the Danish National Prescription Registry.

  3. Self-reported CAT-score (COPD Assessment Test)

    Time frame: Day 90, Day 180.

    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.

Other outcomes

  1. Serious Adverse Events

    Time frame: During treatment, up to 30 days.

    Assessed by Common Terminology Criteria for Adverse Event (CTCAE).

  2. General and respiratory symptoms

    Time frame: Day 30, 90, Day 180.

    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.

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • Hvidovre University Hospital

Registry information

Official study title

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

Acronym: PEP-CoV

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 28, 2020
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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