NCT04459689

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Mar 2020Feb 2027

Study Start

First participant enrolled

March 15, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2027

Last Updated

March 5, 2025

Status Verified

March 1, 2025

Enrollment Period

6.9 years

First QC Date

July 2, 2020

Last Update Submit

March 3, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Survival of patients with PID affected by COVID-19

    Baseline

  • Rate of admission to ICU of patients with PID affected by COVID-19

    Baseline

  • Rate of oxygen therapy of patients with PID affected by COVID-19

    Baseline

Secondary Outcomes (1)

  • Sequelae of patients with PID affected by COVID-19

    Baseline

Eligibility Criteria

Age0 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with Primary Immune Deficiency and COVID-19

You may qualify if:

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

You may not qualify if:

  • Secondary Immune Deficiency
  • Other Coronovirus infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imagine Institute

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Genetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Nizar MAHLAOUI, MD, MPH, PhD

    Necker Enfants Malades University Hospital

    STUDY CHAIR

Central Study Contacts

Nizar MAHLAOUI, MD, MPH, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 7, 2020

Study Start

March 15, 2020

Primary Completion (Estimated)

February 18, 2027

Study Completion (Estimated)

February 18, 2027

Last Updated

March 5, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations