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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 : October 26, 2020
Sponsor:
Collaborators:
Selbsthilfegruppe Kartagener Syndrom und Primäre Ciliäre Dyskinesie
Verein Kartagener Syndrom und PCD
PCD Family Support Group
PCD Foundation
PCD Australia
European Lung Foundation
University of Southampton
University of Lucerne
Information provided by (Responsible Party):
University of Bern

Brief 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, contact behaviour, and physical activity. The study is hosted at the University of Bern and recruitment started on May 30th, 2020.

Condition or disease
Primary Ciliary Dyskinesia

Detailed 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. 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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COVID-19 in People With Primary Ciliary Dyskinesia
Actual Study Start Date : May 31, 2020
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2025

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. SARS-CoV-2 [ Time Frame: 6 months ]
    Number of people with PCD who report an infection with SARS-CoV-2

  2. COVID-19 [ Time Frame: 6 months ]
    Number of people with PCD who report an infection with SARS-CoV-2 and report symptoms

  3. COVID-19 hospitalisation [ Time Frame: 6 months ]
    Number of people with PCD who report a hospital stay due to COVID-19

  4. 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

  5. COVID-19 fatal outcome [ Time Frame: 6 months ]
    Number of people with PCD who reported an infection with SARS-CoV-2 and died



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study includes all persons with primary ciliary dyskinesia who can be contacted via patient organisation networks worldwide.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Claudia E Kuehni, Prof. +41 31 631 35 07 claudia.kuehni@ispm.unibe.ch
Contact: Eva SL Pedersen, Dr. +41 31 631 5975 eva.pedersen@ispm.unibe.ch

Locations
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Switzerland
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    claudia.kuehni@ispm.unibe.ch   
Contact: Eva SL Pedersen, Dr.    +41 (0)31 631 59 75    eva.pedersen@ispm.unibe.ch   
Sponsors and Collaborators
University of Bern
Selbsthilfegruppe Kartagener Syndrom und Primäre Ciliäre Dyskinesie
Verein Kartagener Syndrom und PCD
PCD Family Support Group
PCD Foundation
PCD Australia
European Lung Foundation
University of Southampton
University of Lucerne
Investigators
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Principal Investigator: Claudia E Kuehni, Prof. University of Bern
Additional Information:
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Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT04602481    
Other Study ID Numbers: COVID-PCD
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Researchers who wish to use data should submit a concept sheet describing the planned analysis and send it to Prof. Claudia Kuehni (Claudia.kuehni@ispm.unibe.ch). The concept sheet will be discussed with the patient advisory group and if agreed, a partial dataset will be prepared by the research team.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ciliary Motility Disorders
Dyskinesias
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Ciliopathies
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn