COVID-19 Convalescent Plasma TreatmentCovid-ICNCT05905380
Covid-19 Convalescent Plasma and Monoclonal Antibodies Treatment of Immunocompromised Patients
An observational study of COVID-19 Convalescent Plasma Treatment, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Data on the use of convalescent plasma in the treatment of covid-19 are scarce: the results of randomized studies involving mainly immunocompetent patients are disappointing, while case series or retrospective data on more selected patients , in particular immunocompromised patients suggest a benefit in these patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Convalescent Plasma Treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2023to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patient immunocompromised patient hospitalized between 25/02/2020 and 15/01/2023
Who may be able to join
- Adult patient
- Immunocompromised patient (solid neoplasia, malignant hemopathy, solid organ transplantation, primary immune deficiency, systemic disease, chronic inflammatory disease, etc.)
- Hospitalized between 25/02/2020 and 15/01/2023 at HUS, ICANS, CH Colmar and CH Mulhouse
- Having received curative monoclonal antibody treatment or convalescent plasma treatment for SARS-Cov2 infection
- Patient who has not expressed, after being informed, his opposition to the reuse of his data for scientific research purposes.
Who cannot join
- Subject who expressed their opposition to participating in the study
- Subject under guardianship, curatorship or safeguard of justice
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France
Strasbourg, 67091
François DANION, MD, 33 3 69 55 15 88, francois.danion@chru-strasbourg.fr
François DANION, MD
About this study
Official title: Analysis of the Efficacy and Tolerance of Covid-19 Convalescent Plasma and Monoclonal Antibodies in the Treatment of SARS-Cov2 Infections in Immunocompromised Patients
Data on the use of convalescent plasma in the treatment of covid-19 are scarce: the results of randomized studies involving mainly immunocompetent patients are disappointing, while case series or retrospective data on more selected patients , in particular immunocompromised patients suggest a benefit in these patients whose clinical manifestation seems essentially related to the uncontrolled infection and not the cytokine storm.
- Conditions
- COVID-19 Convalescent Plasma Treatment
- Keywords
- Covid-19, SARS-Cov2, Immunosuppression, Cytokine, Convalescent Plasma, Monoclonal, Antibodies
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective analysis of the tolerance of Covid-19 convalescent plasma and monoclonal antibodies in the treatment of SARS-Cov2 infections in immunocompromised patients
This is a retrospective study on patient data from medical records from February 25, 2020 to January 15, 2023
Measured: Files analysed retrospectively from February 25, 2020 to January 15, 2023 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start2 Mar 2023
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Convalescent Plasma TreatmentStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905380
- Sponsor's protocol ID
- 8784
- Acronym
- Covid-IC
- Status last verified
- Jun 2023
- First submitted
- 14 Jun 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Efficacy and Tolerance of Covid-19 Convalescent Plasma and Monoclonal Antibodies in the Treatment of SARS-Cov2 Infections in Immunocompromised Patients
- ClinicalTrials.gov ID
- NCT05905380
- Acronym / sponsor ID
- Covid-IC / 8784
- Conditions
- COVID-19 Convalescent Plasma Treatment
- Keywords
- Covid-19, SARS-Cov2, Immunosuppression, Cytokine, Convalescent Plasma, Monoclonal, Antibodies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 15 Jun 2023 (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.
Data on the use of convalescent plasma in the treatment of covid-19 are scarce: the results of randomized studies involving mainly immunocompetent patients are disappointing, while case series or retrospective data on more selected patients , in particular immunocompromised patients suggest a benefit in these patients whose clinical manifestation seems essentially related to the uncontrolled infection and not the cytokine storm.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patient immunocompromised patient hospitalized between 25/02/2020 and 15/01/2023
Key inclusion criteria (5 listed)
- Adult patient
- Immunocompromised patient (solid neoplasia, malignant hemopathy, solid organ transplantation, primary immune deficiency, systemic disease, chronic inflammatory disease, etc.)
- Hospitalized between 25/02/2020 and 15/01/2023 at HUS, ICANS, CH Colmar and CH Mulhouse
- Having received curative monoclonal antibody treatment or convalescent plasma treatment for SARS-Cov2 infection
- Patient who has not expressed, after being informed, his opposition to the reuse of his data for scientific research purposes.
Key exclusion criteria (2 listed)
- Subject who expressed their opposition to participating in the study
- Subject under guardianship, curatorship or safeguard of justice
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
Retrospective analysis of the tolerance of Covid-19 convalescent plasma and monoclonal antibodies in the treatment of SARS-Cov2 infections in immunocompromised patients
Time frame: Files analysed retrospectively from February 25, 2020 to January 15, 2023 will be examined
This is a retrospective study on patient data from medical records from February 25, 2020 to January 15, 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
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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. This study is not recruiting at the moment.
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 COVID-19 Convalescent Plasma Treatment, run by University Hospital, Strasbourg, France 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 5 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: status not confirmed, as of the sponsor's last update on 18 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François DANION, MD (33 3 69 55 15 88, Francois.danion@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective analysis of the tolerance of Covid-19 convalescent plasma and monoclonal antibodies in the treatment of SARS-Cov2 infections in immunocompromised patients (time frame: Files analysed retrospectively from February 25, 2020 to January 15, 2023 will be examined). 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 18 Jun 2023.