COVID-19 in People With Primary Ciliary Dyskinesia

Primary Ciliary Dyskinesia Clinical Trial

Official title:

COVID-19 in People With Primary Ciliary Dyskinesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04602481
• Other study ID #: COVID-PCD
• Status: Recruiting
• Start date: May 31, 2020
• Est. completion date: May 31, 2030

Study information

• Verified date: October 2023
• Source: University of Bern
• Contact: Claudia E Kuehni, Prof.
• Phone: +41 31 684 35 07
• Email: claudia.kuehni[@]unibe.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The COVID-PCD is a participatory research project that aims to study how COVID-19 affects people with primary ciliary dyskinesia (PCD). The study is advertised through patient support groups and participants register online and answer a baseline questionnaire with details on PCD diagnosis, habitual symptoms, and COVID-19 episodes occurring before study entry. A short weekly follow-up questionnaire includes questions on incident SARS-CoV-2 infections, current symptoms, social contact behaviour, and physical activity. Occasionally, participants receive extra questionnaires focused on special topics. The study is hosted at the University of Bern and recruitment started on May 30th, 2020.

Description:

Background: The current pandemic of Coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 virus is a public health emergency of international concern. The severity of COVID-19 ranges from asymptomatic to severe. Patients with chronic lung disease such as primary ciliary dyskinesia (PCD) are thought to be at increased risk, but no data support this. Disease course and optimal treatment strategies might differ depending on the underlying disease. The lack of knowledge hampers optimal treatment, and it leads to insecurity and fear among persons affected by PCD and their family. PCD patient organisations initiated the idea of a survey that gathers essential knowledge on effects of COVID-19 on people with PCD and makes it available to patients, physicians, and policy makers in real time.

Aims: To set up an online surveillance system of COVID-19 for people with PCD. For people with PCD, the study aims to:

1. Describe incidence of COVID-19, symptoms, course of disease, duration of illness, treatments, and outcomes;

2. Identify risk factors for prognosis for a severe disease course;

3. Assess the experiences of patients, and their wishes and needs such as availability of preventive measures, medicines, therapies, and official communication and government policies in relation to the COVID-19 outbreak.

Methods: The study population includes all patients with PCD who can be contacted via patient organisations. Local organisations invite their contacts using social media and mailing lists. People with PCD can participate via a link on the study website (www.covid19pcd.ispm.ch), where they can read the study information and give consent. Once registered, participants receive a link via e-mail to the baseline questionnaire with questions on prior COVID-19, PCD diagnosis and treatment, and environment and living conditions. 7 days after completing the baseline questionnaire, and in regular intervals thereafter, participants receive a link to a short follow-up questionnaire with questions on COVID-19, current symptoms, and contact behaviour. Throughout the study, occasional questionnaires are sent out focusing on emerging questions of interest such as official information and policy issues, availability of treatments, or anxieties and fears. Occasional questionnaires can also focus on topics relevant for people with PCD that are not related to COVID-19. In case of hospitalisation, patients or family members are asked to obtain a hospital report. Results are continuously analysed and summaries are published on the study website. Specific analyses are possible on request to inform involved persons, physicians, and policymakers.

This study uses an innovative approach to assess information relevant for risk, disease course, treatments, and outcomes of COVID-19 directly from persons with a rare lung disease and make the information available in real time. It will inform and empower patients and be a resource to relieve anxiety and provide hands-on evidence to physicians and policymakers. It adds no burden to health care professionals and will provide people with PCD and their families specialised information, which they can pass on to their physicians.

Current status

By October 2023, 759 people with PCD from 49 countries registered to participate in COVID-PCD. Results from the study, publications, and plain language summaries are listed on the study website (https://covid19pcd.ispm.ch/en/publications/)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 31, 2030
• Est. primary completion date: May 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• People of any age with reported suspected or confirmed Primary Ciliary Dyskinesia who gave consent to participate in the study

Exclusion Criteria:

• People who report not to have suspected or confirmed Primary Ciliary Dyskinesia

Related Conditions & MeSH terms

• Ciliary Motility Disorders
• Dyskinesias
• Primary Ciliary Dyskinesia

Locations

Country	Name	City	State
Switzerland	Institute of Social and Preventive Medicine (ISPM), University of Bern	Bern

Sponsors (12)

Lead Sponsor

Collaborator

University of Bern

Asociación Nacional de Pacientes con Discinesia Ciliar Primaria, Association Dyskinésie Ciliaire Primitive ADCP, Associazione Italiana Discinesia Ciliare Primaria Sindrome di Kargagener APS, European Lung Foundation, PCD Australia, PCD Foundation, PCD Support UK, Selbsthilfegruppe Kartagener Syndrom und Primäre Ciliäre Dyskinesie, Universität Luzern, University of Southampton, Verein Kartagener Syndrom und PCD

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SARS-CoV-2	Number of people with PCD who report an infection with SARS-CoV-2	6 months
Primary	COVID-19	Number of people with PCD who report an infection with SARS-CoV-2 and report symptoms	6 months
Primary	COVID-19 hospitalisation	Number of people with PCD who report a hospital stay due to COVID-19	6 months
Primary	COVID-19 intensive care	Number of people with PCD who report a hospital stay due to COVID-19 and treatment in intensive care	6 months
Primary	COVID-19 fatal outcome	Number of people with PCD who reported an infection with SARS-CoV-2 and died	6 months

External Links

•   Study website