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This project investigates individual treatments using convalescent severe acute respiratory Syndrome Coronavirus 2 (SARS-CoV-2) plasma in SARS-CoV-2 infected patients at risk for disease progression. In addition to standard of care, SARS-CoV-2 infected patients for whom blood group compatible convalescent plasma is available and who are willing to sign the informed consent receive convalescent plasma. Only patients with moderate to severe disease at risk for transfer to intensive care unit or patients at the intensive care unit with limited treatment options will be treated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| convalescent plasma treatment | Experimental | After confirmation of negative SARS-CoV-2 polymerase chain reaction (PCR) in two consecutive nasal swabs or 28 days after resolution of symptoms, donor check is performed and plasma donation occurs by apheresis. The plasma is photochemically pathogen reduced using the INTERCEPT Blood System. In addition to standard of care, SARS-CoV-2 infected patients for whom blood group compatible convalescent plasma is available and who are willing to sign the informed consent receive convalescent plasma as follows: 200ml at enrolment and 200ml at 12-24 hours follow-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| convalescent plasma application to SARS-CoV-2 infected patients | Other | In addition to standard of care, SARS-CoV-2 infected patients for whom blood group compatible convalescent plasma is available and who are willing to sign the informed consent receive convalescent plasma as follows: 200ml at enrolment and 200ml at 12-24 hours follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Serious adverse events in convalescent plasma treated patients | Serious adverse events during the study period include transfusion reaction (fever, rash), transfusion related acute lung injury (TRAU) , transfusion associated circulatory overload (TACO) , transfusion related infection | From baseline (enrolment) to 24 hours follow-up |
| Virologic clearance in nasopharyngeal swab of convalescent plasma treated patients | Change in SARS-CoV2 quantitative in nasopharyngeal swab | at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28 |
| Transfer to ICU | Transfer to ICU | at Baseline (admission to Covid-ward) until day 28 |
| in-hospital death | in-hospital death | at Baseline (admission to Covid-ward) until day 28 |
| Virologic clearance in plasma of convalescent plasma treated patients | Change in SARS-CoV2 quantitative in plasma | at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to discharge from hospital after enrolment | Duration of hospitalisation | at Baseline (admission to Covid-ward) until discharge (approx. 28 days) |
| Humoral immune response | Rise of SARS-CoV-2 antibody titers (on day 1, 7, 14 and 28) |
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Inclusion Criteria for donors:
Exclusion Criteria for donors:
Inclusion Criteria for COVID-19 infected patients:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Buser, Prof. Dr. med. | Blutspendezentrum SRK beider Basel, Universitätsspital Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blutspendezentrum SRK beider Basel, University Hospital Basel | Basel | 4031 | Switzerland |
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|
| at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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