| NCT ID | NCT04459689 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Imagine Institute |
| Condition | Primary Immune Deficiency |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2020-03-15 |
| Primary Completion | 2027-02-18 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2020-03-15 with a primary completion date of 2027-02-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Diagnosed with a Primary Immune Deficiency * COVID-19 (proven or probable) Exclusion Criteria: * Secondary Immune Deficiency * Other Coronovirus infection
Contact & Investigator
Nizar MAHLAOUI, MD, MPH, PhD
STUDY CHAIR
Necker Enfants Malades University Hospital
Frequently Asked Questions
Who can join the NCT04459689 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, studying Primary Immune Deficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04459689 currently recruiting?
Yes, NCT04459689 is actively recruiting participants. Contact the research team at nizar.mahlaoui@aphp.fr for enrollment information.
Where is the NCT04459689 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT04459689 clinical trial?
NCT04459689 is sponsored by Imagine Institute. The principal investigator is Nizar MAHLAOUI, MD, MPH, PhD at Necker Enfants Malades University Hospital. The trial plans to enroll 200 participants.