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PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and
Annette Mollerup1,2, Sofus Christian Larsen3, Anita Selmer Bennetzen3
1Research Unit for Dietary Studies, The Parker Institute, Frederiksberg, Copenhagen University Hospital, Frederiksberg, Denmark annette.mollerup@regionh.dk.
Insights
This study investigates if Positive Expiratory Pressure (PEP) flute use can reduce COVID-19 symptoms and hospitalizations in non-hospitalized patients. Early findings suggest PEP flute self-care may be effective in managing respiratory symptoms and preventing severe disease progression.
Area of Science:
- Pulmonology
- Infectious Diseases
- Clinical Trials
Background:
- COVID-19 can lead to severe pulmonary disease, necessitating preventative strategies.
- Positive Expiratory Pressure (PEP) self-care is established for managing chronic lung conditions and preventing pneumonia.
- The PEP-CoV trial aims to assess PEP flute effectiveness in early-stage, non-hospitalized COVID-19 patients.
Purpose of the Study:
- To evaluate if daily PEP flute usage, in addition to usual care, improves symptom severity in COVID-19 patients.
- To determine the effect of PEP flute use on reducing hospital admissions among individuals with early COVID-19 symptoms.
- To assess the impact on respiratory symptoms using the COPD Assessment Test (CAT) score.
Main Methods:
- A randomized controlled trial involving 400 participants with confirmed SARS-CoV-2 infection and COVID-19 symptoms.
- Intervention group receives PEP flutes and instructional materials; control group receives usual care.
- Daily symptom severity measured via COPD Assessment Test (CAT) through text message surveys; hospital admissions tracked via register data.
Main Results:
- The study is a pre-results analysis, with data collection ongoing.
- Primary outcome: COPD Assessment Test (CAT) score at 30-day follow-up.
- Secondary outcome: Hospital admission rates.
Conclusions:
- The study is expected to provide evidence on the efficacy of PEP flute self-care for managing early COVID-19.
- Findings will inform strategies to prevent respiratory deterioration and reduce healthcare system burden.
- Results will be disseminated through scientific publications.
Introduction:
Infection with SARS-CoV-2 may progress to severe pulmonary disease, COVID-19. Currently, patients admitted to hospital because of COVID-19 have better prognosis than during the first period of the pandemic due to improved treatment. However, the overall societal susceptibility of being infected makes it pivotal to prevent severe courses of disease to avoid high mortality rates and collapse of the healthcare systems. Positive expiratory pressure (PEP) self-care is used in chronic pulmonary disease and has been shown to prevent pneumonia in a high-risk cohort of patients with leukaemia. PEP flute self-care to prevent respiratory deterioration and hospitalisation in early COVID-19: a randomised trial (The PEP-CoV trial) examines the effectiveness on respiratory symptoms and need of hospital admission by regular PEP flute use among non-hospitalised individuals with confirmed SARS-CoV-2 infection and COVID-19 symptoms.
Methods And Analysis:
In this randomised controlled trial, we hypothesise that daily PEP flute usage as add-on to usual care is superior to usual care as regards symptom severity measured by the COPD Assessment Test (CAT) at 30-day follow-up (primary outcome) and hospital admission through register data (secondary outcome). We expect to recruit 400 individuals for the trial. Participants in the intervention group receive a kit of 2 PEP flutes and adequate resistances and access to instruction videos. A telephone hotline offers possible contact to a nurse. The eight-item CAT score measures cough, phlegm, chest tightness, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms, sleep quality and vigour. The CAT score is measured daily in both intervention and control arms by surveys prompted through text messages.
Ethics And Dissemination:
The study was registered prospectively at www.clinicaltrials.gov on 27 August 2020 (NCT04530435). Ethical approval was granted by the local health research ethics committee (Journal number: H-20035929) on 23 July 2020. Enrolment of participants began on 6 October 2020. Results will be published in scientific journals.
Trial Registration Number:
NCT04530435; Pre-results.
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