PEP Flute-selfcare in COVID-19 (PEP-CoV)

Bispebjerg Hospital

Status: Completed

Conditions: COVID-19; SARS-CoV-2

Treatments: Device: PEP flute

Study type: Interventional

Funder types: Other

Identifiers

NCT04530435

0211-00023B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 378 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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378 participants in 2 patient groups

Treatment group

Experimental group

Description:

The participants will be handed three airway resistances equivalent to a resistance of 10-20 cm H2O alongside one PEP flute. Two videos will guide the participants in use of the PEP flute; one with instructions of the rationale and how to use the flute, including how to choose the suitable resistance and one video, which gives instructions of hygienic maintenance. Participants in the intervention group will be advised to continue use of their PEP flute in the active intervention period of 30 days or at least if they still have respiratory symptoms. They will receive daily text-messages to prompt their reporting and to use the PEP flute according to instructions.

Treatment:

Device: PEP flute

Control group

No Intervention group

Description:

The participants in the control group will receive daily text-messages to prompt their reporting of CAT-scores. To avoid attrition of the trial due to early recovery of symptoms, the project manager will call the participants by phone at day 15 to ask them about their present condition (i.e. CAT-score) and address potential concerns of continued participation of the trial. Otherwise, they will only receive usual care.