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| Name | Class |
|---|---|
| University Hospital, Basel, Switzerland | OTHER |
| Ospedale Regionale di Lugano | OTHER |
| Hôpital Fribourgeois | OTHER |
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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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 convalescent plasma | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patient that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement) | 7 days after plasma infusion | |
| Proportion of patient that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement) | 14 days after plasma infusion | |
| Proportion of death | 28 days after plasma infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with cleared nasopharyngeal viral load | Cleared viral load is defined as CT value ≥30 | 7 days after plasma infusion |
| Proportion of patients with cleared nasopharyngeal viral load |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement) | 21 days after plasma infusion | |
| Proportion of patients with cleared nasopharyngeal viral load | Will be evaluated if CT< 30 at 14 days |
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
Older adults defined as Age ≥ 75 years old or ≥ 65 years old with at least one co-existing condition
Exclusion criteria:
Seroconversion at the time of inclusion
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diem-Lan Vu Cantero, MD, PhD | Contact | +41795535512 | diem-lan.vu@hcuge.ch | |
| Nina Khanna, MD | Contact | +41613287325 | nina.khanna@usb.ch |
| Name | Affiliation | Role |
|---|---|---|
| Laurent Kaiser, MD | University Hospital, Geneva | Principal Investigator |
| Enos Bernasconi, MD | Ospedale Regionale di Lugano | Principal Investigator |
| Véronique Erard, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsspital Basel | Recruiting | Basel | 4031 | Switzerland |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000093522 | COVID-19 Serotherapy |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
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open-label non-controlled, non-randomised interventional study
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Cleared viral load is defined as CT value ≥30
| 14 days after plasma infusion |
| 21 days after plasma infusion |
| HFR-Fribourg Hôpital Cantonal |
| Principal Investigator |
| Maja Weisser, MD | Klinik Infektiologie & Spitalhygiene | Principal Investigator |
| HFR-Fribourg Hôpital Cantonal | Recruiting | Fribourg | 1708 | Switzerland |
|
| Geneva University Hospitals | Recruiting | Geneva | 1205 | Switzerland |
|
| Ospedale Regionale di Lugano | Recruiting | Lugano | 6900 | Switzerland |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D056747 |
| Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |