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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
Sponsor:
Information provided by (Responsible Party):
Imagine Institute

Brief Summary:

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
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





Primary Outcome Measures :
  1. Survival of patients with PID affected by COVID-19 [ Time Frame: Baseline ]
  2. Rate of admission to ICU of patients with PID affected by COVID-19 [ Time Frame: Baseline ]
  3. Rate of oxygen therapy of patients with PID affected by COVID-19 [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Sequelae of patients with PID affected by COVID-19 [ Time Frame: Baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All patients with Primary Immune Deficiency and COVID-19
Criteria

Inclusion Criteria:

  • Diagnosed with a Primary Immune Deficiency
  • COVID-19 (proven or probable)

Exclusion Criteria:

  • Secondary Immune Deficiency
  • Other Coronovirus infection

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): NCT04459689


Contacts
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Contact: Nizar MAHLAOUI, MD, MPH, PhD +33144494622 nizar.mahlaoui@aphp.fr
Contact: Hassan FAOUR, BS +33 1 42 75 44 73 supportdatabase@institutimagine.org

Locations
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France
Imagine Institute Recruiting
Paris, France, 75015
Contact: Nizar MAHLAOUI, MD, MPH, PhD    +33144494622    nizar.mahlaoui@aphp.fr   
Sponsors and Collaborators
Imagine Institute
Investigators
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Study Chair: Nizar MAHLAOUI, MD, MPH, PhD Necker Enfants Malades University Hospital
Additional Information:
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Responsible Party: Imagine Institute
ClinicalTrials.gov Identifier: NCT04459689    
Other Study ID Numbers: COPID19
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Immunologic Deficiency Syndromes
Immune System Diseases