- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04836260
Preemptive Use of Convalescent Plasma for High-risk Patients With COVID-19
Preemptive Use of Convalescent Plasma for High-risk Patients With SARS-CoV-2 Infection: Phase III-IV Non-controlled Non-randomised Swiss Multicentric Trial
Convalescent plasma therapy has been recognized as safe and plasma transfusion is routinely used in clinical practice. A recent study showed that early administration of convalescent plasma can decrease the risk of complications in specific high-risk population.
The aim of the present study is to offer convalescent plasma therapy to immunocompromised patients and older adults in the early phase of a SARS-Cov-2 infection in order to accelerate viral clearance and prevent complication
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is an open-label non-controlled, non-randomised interventional study. Study population consist in immunocompromised patients and older adults with or without co-morbidities.
Included patients will receive at least one unit of convalescent plasma with NTAB titer ≥1:160 or equivalent at maximum 3-7 days after diagnosis by RT-PCR or symptom onset or if having mild-moderate disease (WHO scale <4).
Patients will be followed-up up to 28 days to assess progression to WHO scale 4 disease, and 28-days mortality and viral load kinetics.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Diem-Lan Vu Cantero, MD, PhD
- Phone Number: +41795535512
- Email: diem-lan.vu@hcuge.ch
Study Contact Backup
- Name: Nina Khanna, MD
- Phone Number: +41613287325
- Email: nina.khanna@usb.ch
Study Locations
-
-
-
Basel, Switzerland, 4031
- Recruiting
- Universitatsspital Basel
-
Contact:
- Nina Khanna, MD
- Phone Number: +41613287325
- Email: nina.khanna@usb.ch
-
Contact:
- Maja Weisser, MD
- Phone Number: +413286742
- Email: maja.weisser@usb.ch
-
Sub-Investigator:
- Andreas Buser, MD
-
Fribourg, Switzerland, 1708
- Recruiting
- HFR-Fribourg Hôpital Cantonal
-
Contact:
- Véronique Erard, MD
- Phone Number: +41 26 3060836
- Email: Veronique.erard@h-fr.ch
-
Sub-Investigator:
- Emmanuel Levrat, MD
-
Geneva, Switzerland, 1205
- Recruiting
- Geneva University Hospitals
-
Contact:
- Diem-Lan Vu Cantero, MD, PhD
- Phone Number: +41795535512
- Email: diem-lan.vu@hcuge.ch
-
Contact:
- Laurent Kaiser, MD
- Phone Number: +41795533420
- Email: laurent.kaiser@hcuge.ch
-
Sub-Investigator:
- Sophie Waldvogel-Abramowski, MD
-
Lugano, Switzerland, 6900
- Recruiting
- Ospedale Regionale di Lugano
-
Contact:
- Enos Bernasconi, MD
- Phone Number: +41918116022
- Email: Enos.Bernasconi@eoc.ch
-
Sub-Investigator:
- Stefano Fontana, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Immunocompromised patients defined as
- Solid organ transplant ≤1 year before inclusion or treated for acute or chronic rejection episode or
- Allogeneic stem cell transplant recipients ≤2 years before inclusion or treated for acute GvHD ≥grade 2 or chronic moderate-severe GvHD or
- Active solid or haematological oncological disease with curative perspectives or
- HIV infection with CD4<350 or
- Hypogammaglobulinemia and other severe genetic immunological defect or
- Auto-immune disease with biological immunosuppressive treatment* or
Other significant immunosuppressive condition such as IgG <6, treamtent with Rituximab or other biological lymphopenic treatment AND
- Age ≥ 18 years old and
- 2 distinct ABO group determination and
- Positive RT-PCR for SARS-CoV-2 on a respiratory tract sample of ≤ 7 days and days post symptom onset (DPOS) ≤ 7 days at inclusion and/or
- No oxygen requirement (WHO 8 ordinal scale < 4): asymptomatic, mild or moderate disease, or O2 saturation ≥ 90% at room temperature and
- Compatible ABO donor with neutralizing antibodies (NTAB) ≥1 :160 or equivalent according to predefined antibody commercial assays cut-offs (see Study procedures)
- RT-PCR on a respiratory tract sample with CT value<20 or ascending kinetics at the time of infusion (highly suggested but not necessary)
Older adults defined as Age ≥ 75 years old or ≥ 65 years old with at least one co-existing condition
- Arterial hypertension under pharmacological treatment
- Diabetes in treatment
- Obesity (BMI ≥ 30 kg/m2)
- Chronic obstructive pulmonary disease stade GOLD ≥2
- Respiratory insufficiency due to any pneumopathy or neurologic disease.
- Cardiovascular disease as defined by either known coronary heart disease, history of ischemic or hemorrhagic stroke or cardiac insufficiency (ejection fraction <40%)
- Chronic kidney disease (GFR<60 ml/min) AND
- 2 distinct ABO group determination and
- Positive RT-PCR for SARS-CoV-2 on a respiratory tract sample of ≤ 3 days and days post symptom onset (DPOS) ≤ 3 days at inclusion or RT-PCR on a respiratory tract sample with CT value<20 or ascending kinetics at the time of perfusion and
- No additional oxygen requirement compared to baseline (WHO 8 ordinal scale < 4): asymptomatic, mild or moderate disease and
- Compatible ABO donor with neutralizing antibodies (NTAB) ≥1 :160 or equivalent according to predefined antibody commercial assays cut-offs (see Study procedures)
Exclusion criteria:
Seroconversion at the time of inclusion
- Palliative care
- No signed informed consent
- History of previous transfusion-related Grade 3 adverse event according to Swissmedic definitions
- Disseminated intravascular coagulopathy (depending on specialist evaluation)
- Uncontrolled acute hypervolemia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patient that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement)
Time Frame: 7 days after plasma infusion
|
7 days after plasma infusion
|
Proportion of patient that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement)
Time Frame: 14 days after plasma infusion
|
14 days after plasma infusion
|
Proportion of death
Time Frame: 28 days after plasma infusion
|
28 days after plasma infusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients with cleared nasopharyngeal viral load
Time Frame: 7 days after plasma infusion
|
Cleared viral load is defined as CT value ≥30
|
7 days after plasma infusion
|
Proportion of patients with cleared nasopharyngeal viral load
Time Frame: 14 days after plasma infusion
|
Cleared viral load is defined as CT value ≥30
|
14 days after plasma infusion
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement)
Time Frame: 21 days after plasma infusion
|
21 days after plasma infusion
|
|
Proportion of patients with cleared nasopharyngeal viral load
Time Frame: 21 days after plasma infusion
|
Will be evaluated if CT< 30 at 14 days
|
21 days after plasma infusion
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Laurent Kaiser, MD, University Hospital, Geneva
- Principal Investigator: Enos Bernasconi, MD, Ospedale Regionale di Lugano
- Principal Investigator: Véronique Erard, MD, HFR-Fribourg Hôpital Cantonal
- Principal Investigator: Maja Weisser, MD, Klinik Infektiologie & Spitalhygiene
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Frailty
- Immunologic Deficiency Syndromes
Other Study ID Numbers
- 2020-02989
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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