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Recruiting NCT04459689

COVID-19 in PID Survey

Observational Primary Immune Deficiency COVID

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Primary Immune Deficiency, COVID. Basic parameters: from 0 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Sequelae of patients with PID affected by COVID-19 [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Secondary Immune Deficiency
  • Other Coronovirus infection

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-only

Study locations

France · 1 center
  • Imagine Institute — Paris

Identifiers

NCT: NCT04459689 · COPID19

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗