Primary Immune DeficiencyCOPID19NCT04459689
COVID-19 in PID Survey
An observational study of Primary Immune Deficiency and COVID, run by Imagine Institute at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Primary Immune Deficiency, COVID
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2020to 18 Feb 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- Child, Adult, Older adult
Study population: All patients with Primary Immune Deficiency and COVID-19
Who may be able to join
- Diagnosed with a Primary Immune Deficiency
- COVID-19 (proven or probable)
Who cannot join
- Secondary Immune Deficiency
- Other Coronovirus infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Imagine Institute
Paris, 75015
Nizar MAHLAOUI, MD, MPH, PhD, +33144494622, nizar.mahlaoui@aphp.fr
About this study
Official title: Worldwide COVID-19 in Children and Adult Patients With Primary ImmunoDeficiencies (PID) Survey
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".
Read more
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.
- Conditions
- Primary Immune Deficiency, COVID
- Medical subject headings
- Primary Immunodeficiency Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of patients with PID affected by COVID-19
Measured: Baseline
Rate of admission to ICU of patients with PID affected by COVID-19
Measured: Baseline
Rate of oxygen therapy of patients with PID affected by COVID-19
Measured: Baseline
Secondary outcomes (1)
Sequelae of patients with PID affected by COVID-19
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start15 Mar 2020
- Primary completion18 Feb 2027 (estimated)
- Study completion18 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Imagine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nizar MAHLAOUI, MD, MPH, PhD, Study chair, Necker Enfants Malades University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459689
- Sponsor's protocol ID
- COPID19
- Acronym
- COPID19
- Status last verified
- Sep 2026
- First submitted
- 2 Jul 2020
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Worldwide COVID-19 in Children and Adult Patients With Primary ImmunoDeficiencies (PID) Survey
- ClinicalTrials.gov ID
- NCT04459689
- Acronym / sponsor ID
- COPID19 / COPID19
- Conditions
- Primary Immune Deficiency, COVID
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Imagine InstituteUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 18 Feb 2027 (estimated)
- Study completion
- 18 Feb 2027 (estimated)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with Primary Immune Deficiency and COVID-19
Key inclusion criteria (2 listed)
- Diagnosed with a Primary Immune Deficiency
- COVID-19 (proven or probable)
Key exclusion criteria (2 listed)
- Secondary Immune Deficiency
- Other Coronovirus infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Sequelae of patients with PID affected by COVID-19
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nizar MAHLAOUI, MD, MPH, PhD study chair
Necker Enfants Malades University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Immune Deficiency and COVID, run by Imagine Institute at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nizar MAHLAOUI, MD, MPH, PhD (+33144494622, nizar.mahlaoui@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of patients with PID affected by COVID-19 (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.