Table 1.

WHO trial registration data set

Data category	Information
Primary registry and trial identifying number	ClinicalTrials.gov NCT04530435
Date of registration in primary registry	27 August 2020
Secondary identifying numbers	Danish Data Protection Agency (P-2020–879) Health Research Ethics (H-20035929)
Sources of monetary or material support	Innovation Fund Denmark (0211-00023B) and the Danish Nursing Council (grant number: n/a)
Sponsor	The Parker Institute, Copenhagen, Denmark
Contact for public queries	Annette Mollerup, PhD (annette.mollerup@regionh.dk) The Parker Institute Copenhagen University Hospital Bispebjerg-Frederiksberg Ndr. Fasanvej 57, 2000 Frederiksberg, Denmark +45 38163102
Contact for scientific queries	Annette Mollerup, PhD (annette.mollerup@regionh.dk)
Public title	COVID-19: symptoms and respiratory self-care (in Danish: COVID-19 sygdom: symptomer og vejrtrækningsøvelser)
Scientific title	PEP flute self-care to prevent respiratory deterioration and hospitalisation in early Covid-19: a randomised trial (acronym: The PEP-CoV trial)
Countries of recruitment	Denmark
Health condition(s)	Adults aged 18 or older with a positive SARS-CoV-2 test and symptoms of COVID-19
Intervention	Active comparator: daily use of PEP flute and daily self-monitoring of symptoms for 30 days as add-on to usual care Comparator: daily self-monitoring of symptoms and usual care including self-care recommended by the Danish Health Authorities (self-quarantine, sufficient intake of liquid especially in case of high body temperature, over-the-counter symptom relieving medication)
Key inclusion and exclusion criteria	Inclusion criteria: Aged 18 years or older. Positive SARS-CoV test. Symptoms of COVID-19 according to the COVIDmeter; at least one respiratory symptom (cough, sneezing, shortness of breath, chest pain or runny nose) and one general symptom. Access to use a smartphone. Can reply to a questionnaire in Danish (sent on email, text-message or via telephone interview) as assessed by the investigator. Given informed consent. Exclusion criteria: 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, individuals, habitually using a PEP flute, participation in other clinical COVID trials or persons living in the same household as existing participants in the trial. Hospitalised patients or nursing home residents.
Study type	Interventional, open-label trial with randomisation to two parallel groups Primary purpose: prevention of respiratory deterioration of symptoms and hospitalisation
Data of first enrolment	October 2020
Target sample size	400
Recruitment status	Recruiting
Primary outcome	Day 30 CAT score (modified for the present study)
Key secondary outcomes	Hospital admissions on days 30, 90 and 180. Use of antibiotics in case of superinfection. COVID-19 symptoms, days 30, 90 and 180. CAT score, days 90 and 180. Number of participants with serious adverse events during the 30-day intervention period. Compliance assessment.

COVIDmeter, the Danish Health Authority surveillance of symptoms reported by the public to a designated website; CAT, COPD Assessment Test consisting of eight items on a scale from 0 to 5: cough, phlegm, chest tightness, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms (because of actual self-quarantine, modified for the present study from feeling safe at leaving home despite symptoms), sleep quality and vigour.

CAT, COPD Assessment Test; PEP, positive expiratory pressure.