COVID-19 in PID Survey

Recruiting

• Conditions: COVID; Primary Immune Deficiency

• Registration Number: NCT04459689
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-15
• Study First Submitted: 2020-07-02
• Study First Submitted QC: 2020-07-03
• Study First Posted: 2020-07-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05
• Primary Completion: 2027-02-18
• Study Completion: 2027-02-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• Secondary Immune Deficiency
• Other Coronovirus infection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of admission to ICU of patients with PID affected by COVID-19	Baseline
Survival of patients with PID affected by COVID-19	Baseline
Rate of oxygen therapy of patients with PID affected by COVID-19	Baseline

Secondary Outcome Measures

Name	Time	Method
Sequelae of patients with PID affected by COVID-19	Baseline

Trial Locations

Locations (1)

Imagine Institute; 🇫🇷 Paris, France