ABSTRACT
Background: Positive expiratory pressure (PEP) has been shown to prevent pneumonia in leukaemia patients. We hypothesised that PEP selfcare could be effective in reducing respiratory symptoms and urgent care visits among non-hospitalised individuals with SARS-CoV-2 infection and COVID-19 symptoms.Methods: PEP-CoV was a randomised, controlled, open-label trial with two parallel groups, comparing PEP selfcare as add-on to usual care to usual care only. The randomisation was based on permuted random blocks in a 1:1 ratio, stratified for sex and age (< 60 or ≥ 60 years). The intervention group was instructed to use a PEP flute three times daily during the 30-day intervention. The primary outcome was 30-day change in the COPD Assessment Test (CAT)-score, a validated questionnaire designed to evaluate respiratory symptom severity. Secondary outcomes were self-reported urgent care visits due to COVID-19 during the observation period, number of COVID-19 related symptoms, and 30-day change in self-rated health. The study is registered with ClinicalTrials.gov, NCT04530435.Findings: Between Oct 6, 2020, and Feb 26, 2021, 378 participants were randomly assigned to the PEP intervention (n=190) or usual care (n=188). In the PEP selfcare group, the median number of days with PEP flute use was 21 days (IQR 13-25). For the intention-to-treat population, we observed a group difference in changes from baseline in CAT-scores of -1.2 points (95%CI, -2.1 to -0.2; P=0.017) in favour of the PEP selfcare group. This group also reported less chest tightness, less dyspnoea, more vigour, and higher level of daily activities at day 30. We found no consistent effects on the secondary outcomes. No serious adverse events were reported.Interpretation: PEP flute-selfcare is safe at low cost and appears to have small beneficial effects on respiratory symptom severity in early COVID-19.Trial Registration: NCT04530435Funding: Innovation Fund Denmark, the Danish Nursing Council and the Oak Foundation.Declaration of Interests: None of the authors declared any conflict of interest.Ethics Approval Statement:The study was approved by the local Health Research Ethics Committee (H-20035929) and the Danish Data Protection Agency (Capital Region: P-2020-879). Although the PEP flute is classified as a medical device, no approval from the Danish Medicines Agency was needed, as the device was applied for purposes within the CE- classification (Agency reference number: 2020051572).