COVID-19 in PID Survey (COPID19)
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|ClinicalTrials.gov Identifier: NCT04459689|
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
With the emergence of SARS-CoV-2 and the COVID-19 pandemic, there is an urgent need to understand the impact of infection on immunodeficient individuals. Whilst co-morbidities (such as diabetes, cancer, arterial hypertension, heart disease...) have been documented in people infected with SARS-CoV-2, there is currently no information on the consequences and outcomes for individuals with primary immunodeficiencies (PID).
Following the 1st phase of the survey (launched by Isabelle Meyts (ESID), Nizar Mahlaoui (CEREDIH & IPOPI) and Kate Sullivan with Stuart Tangye (IUIS), that gave an idea of the number of affected PID patients and the impact of SARS-CoV-2 and directly focusing on obtaining this top level of information), we are launching the 2nd phase: "COPID19".
COPID19 survey is a secured online GDPR compliant platform based in Paris (Imagine Institute). It has been approved by the Paris-Necker-Enfants malades IRB and Ethics Committee. However, this retrospective survey is designed for global distribution. Data can be entered by a health care professional (mostly clinicians) through a personal login and password.
Each documenting person will have access to his/her own patients' data. COPID19 require a greater level of information than the 1st phase. The eCRF will be open to evolutions depending on progresses in our knowledge of this pandemic.
|Condition or disease|
|Primary Immune Deficiency COVID|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||200 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Worldwide COVID-19 in Children and Adult Patients With Primary ImmunoDeficiencies (PID) Survey|
|Actual Study Start Date :||March 15, 2020|
|Estimated Primary Completion Date :||March 31, 2022|
|Estimated Study Completion Date :||March 31, 2022|
- Survival of patients with PID affected by COVID-19 [ Time Frame: Baseline ]
- Rate of admission to ICU of patients with PID affected by COVID-19 [ Time Frame: Baseline ]
- Rate of oxygen therapy of patients with PID affected by COVID-19 [ Time Frame: Baseline ]
- Sequelae of patients with PID affected by COVID-19 [ Time Frame: Baseline ]
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): NCT04459689
|Contact: Nizar MAHLAOUI, MD, MPH, PhDemail@example.com|
|Contact: Hassan FAOUR, BS||+33 1 42 75 44 firstname.lastname@example.org|
|Paris, France, 75015|
|Contact: Nizar MAHLAOUI, MD, MPH, PhD +33144494622 email@example.com|
|Study Chair:||Nizar MAHLAOUI, MD, MPH, PhD||Necker Enfants Malades University Hospital|