COVID-19 in People With Primary Ciliary Dyskinesia
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|ClinicalTrials.gov Identifier: NCT04602481|
Recruitment Status : Recruiting
First Posted : October 26, 2020
Last Update Posted : November 16, 2022
|Condition or disease|
|Primary Ciliary Dyskinesia|
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:
- Describe incidence of COVID-19, symptoms, course of disease, duration of illness, treatments, and outcomes;
- Identify risk factors for prognosis for a severe disease course;
- 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.
By October 2022, 747 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/)
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||COVID-19 in People With Primary Ciliary Dyskinesia|
|Actual Study Start Date :||May 31, 2020|
|Estimated Primary Completion Date :||May 31, 2030|
|Estimated Study Completion Date :||May 31, 2030|
- SARS-CoV-2 [ Time Frame: 6 months ]Number of people with PCD who report an infection with SARS-CoV-2
- COVID-19 [ Time Frame: 6 months ]Number of people with PCD who report an infection with SARS-CoV-2 and report symptoms
- COVID-19 hospitalisation [ Time Frame: 6 months ]Number of people with PCD who report a hospital stay due to COVID-19
- COVID-19 intensive care [ Time Frame: 6 months ]Number of people with PCD who report a hospital stay due to COVID-19 and treatment in intensive care
- COVID-19 fatal outcome [ Time Frame: 6 months ]Number of people with PCD who reported an infection with SARS-CoV-2 and died
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04602481
|Contact: Claudia E Kuehni, Prof.||+41 31 631 35 firstname.lastname@example.org|
|Contact: Eva SL Pedersen, Dr.||+41 31 631 email@example.com|
|Institute of Social and Preventive Medicine (ISPM), University of Bern||Recruiting|
|Bern, Switzerland, 3012|
|Contact: Claudia E Kuehni, Prof. +41 (0)31 631 35 07 firstname.lastname@example.org|
|Contact: Eva SL Pedersen, Dr. +41 (0)31 631 59 79 email@example.com|
|Principal Investigator:||Claudia E Kuehni, Prof.||University of Bern|