COVID-19 in PID Survey

COVID Clinical Trial

— COPID19  

Official title:

Worldwide COVID-19 in Children and Adult Patients With Primary ImmunoDeficiencies (PID) Survey

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04459689
• Other study ID #: COPID19
• Status: Recruiting
• Start date: March 15, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: September 2021
• Source: Imagine Institute
• Contact: Nizar MAHLAOUI, MD, MPH, PhD
• Phone: +33144494622
• Email: nizar.mahlaoui[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosed with a Primary Immune Deficiency

• COVID-19 (proven or probable)

Exclusion Criteria:

• Secondary Immune Deficiency

• Other Coronovirus infection

Related Conditions & MeSH terms

• COVID
• Immunologic Deficiency Syndromes
• Primary Immune Deficiency

Locations

Country	Name	City	State
France	Imagine Institute	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Imagine Institute

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival of patients with PID affected by COVID-19		Baseline
Primary	Rate of admission to ICU of patients with PID affected by COVID-19		Baseline
Primary	Rate of oxygen therapy of patients with PID affected by COVID-19		Baseline
Secondary	Sequelae of patients with PID affected by COVID-19		Baseline

External Links

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