Back to resultsPreemptive Use of Convalescent Plasma for High-risk Patients With COVID-19
Primary Purpose
Covid19, Immuno-Deficiency, Old Age; Debility
Status
Unknown status
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
SARS-CoV-2 convalescent plasma
Sponsored by
About this trial
This is an interventional prevention trial for Covid19 focused on measuring SARS-CoV-2, Convalescent plasma
Eligibility Criteria
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
Sites / Locations
- Universitätsspital BaselRecruiting
- HFR-Fribourg Hôpital CantonalRecruiting
- Geneva University HospitalsRecruiting
- Ospedale Regionale di LuganoRecruiting
Outcomes
Primary Outcome Measures
Proportion of patient that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement)
Proportion of patient that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement)
Proportion of death
Secondary Outcome Measures
Proportion of patients with cleared nasopharyngeal viral load
Cleared viral load is defined as CT value ≥30
Proportion of patients with cleared nasopharyngeal viral load
Cleared viral load is defined as CT value ≥30
Full Information
NCT ID
NCT04836260
First Posted
April 6, 2021
Last Updated
April 6, 2021
Sponsor
University Hospital, Geneva
Collaborators
University Hospital, Basel, Switzerland, Ospedale Regionale di Lugano, Hôpital Fribourgeois
1. Study Identification
Unique Protocol Identification Number
NCT04836260
Brief Title
Preemptive Use of Convalescent Plasma for High-risk Patients With COVID-19
Official Title
Preemptive Use of Convalescent Plasma for High-risk Patients With SARS-CoV-2 Infection: Phase III-IV Non-controlled Non-randomised Swiss Multicentric Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 8, 2021 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
Collaborators
University Hospital, Basel, Switzerland, Ospedale Regionale di Lugano, Hôpital Fribourgeois
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Immuno-Deficiency, Old Age; Debility
Keywords
SARS-CoV-2, Convalescent plasma
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
open-label non-controlled, non-randomised interventional study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SARS-CoV-2 convalescent plasma
Intervention Description
Included patients will receive at least one unit of convalescent plasma with NTAB titer ≥1:160 at maximum 3-7 days after diagnosis by RT-PCR or symptom onset. A second unit of plasma from a different donor can be proposed 24h after the first unit if immunocompromised and/or the patient received less than 3-5ml/kg of plasma volume. Additional units can be exceptionnally infused, at the investigator discretion.
Primary Outcome Measure Information:
Title
Proportion of patient that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement)
Time Frame
7 days after plasma infusion
Title
Proportion of patient that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement)
Time Frame
14 days after plasma infusion
Title
Proportion of death
Time Frame
28 days after plasma infusion
Secondary Outcome Measure Information:
Title
Proportion of patients with cleared nasopharyngeal viral load
Description
Cleared viral load is defined as CT value ≥30
Time Frame
7 days after plasma infusion
Title
Proportion of patients with cleared nasopharyngeal viral load
Description
Cleared viral load is defined as CT value ≥30
Time Frame
14 days after plasma infusion
Other Pre-specified Outcome Measures:
Title
Proportion of patients that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement)
Time Frame
21 days after plasma infusion
Title
Proportion of patients with cleared nasopharyngeal viral load
Description
Will be evaluated if CT< 30 at 14 days
Time Frame
21 days after plasma infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diem-Lan Vu Cantero, MD, PhD
Phone
+41795535512
Email
diem-lan.vu@hcuge.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Nina Khanna, MD
Phone
+41613287325
Email
nina.khanna@usb.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Kaiser, MD
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Enos Bernasconi, MD
Organizational Affiliation
Ospedale Regionale di Lugano
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Véronique Erard, MD
Organizational Affiliation
HFR-Fribourg Hôpital Cantonal
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maja Weisser, MD
Organizational Affiliation
Klinik Infektiologie & Spitalhygiene
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsspital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nina Khanna, MD
Phone
+41613287325
Email
nina.khanna@usb.ch
First Name & Middle Initial & Last Name & Degree
Maja Weisser, MD
Phone
+413286742
Email
maja.weisser@usb.ch
First Name & Middle Initial & Last Name & Degree
Andreas Buser, MD
Facility Name
HFR-Fribourg Hôpital Cantonal
City
Fribourg
ZIP/Postal Code
1708
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Véronique Erard, MD
Phone
+41 26 3060836
Email
Veronique.erard@h-fr.ch
First Name & Middle Initial & Last Name & Degree
Emmanuel Levrat, MD
Facility Name
Geneva University Hospitals
City
Geneva
ZIP/Postal Code
1205
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diem-Lan Vu Cantero, MD, PhD
Phone
+41795535512
Email
diem-lan.vu@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Laurent Kaiser, MD
Phone
+41795533420
Email
laurent.kaiser@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Sophie Waldvogel-Abramowski, MD
Facility Name
Ospedale Regionale di Lugano
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enos Bernasconi, MD
Phone
+41918116022
Email
Enos.Bernasconi@eoc.ch
First Name & Middle Initial & Last Name & Degree
Stefano Fontana, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Preemptive Use of Convalescent Plasma for High-risk Patients With COVID-19
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