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Study stopped due to opening Expanded Access Protocol.
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Researchers are trying to assess the treatment potential and safety of anti-SARS-CoV-2 convalescent plasma in patients with acute respiratory symptoms with confirmed COVID-19.
High titer human convalescent plasma will be extracted from apheresis donations from twenty recently-sick and currently-recovered COVID-19 patients. An open-label, phase 2A clinical trial will then be conducted to administer convalescent plasma to twenty individuals with confirmed cases of COVID-19 to investigate the novel application of convalescent plasma in the treatment strategy of SARS-CoV-2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Convalescent Plasma Group | Experimental | Subjects will receive 1-2 units (300-600 mL) of plasma with an anti-SARS-CoV-2 titer of >1:64. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Convalescent Plasma | Biological | Anti-SARS-CoV-2 convalescent plasma obtained from patients identified as having recovered from COVID-19 with neutralizing antibody titers >1:64. |
| Measure | Description | Time Frame |
|---|---|---|
| RNA in SARS-CoV-2 | Change in RNA levels of SARS-CoV-2 from nasopharyngeal using RT-PCR (reverse transcriptase polymerase chain reaction) across time. | Days 0, 1, 3, 7, 14, 28, 60 and 90 after transfusion |
| ICU Admissions | Total number of subjects to be admitted to the ICU after the anti-SARS-CoV-2 convalescent plasma transfusion. | 90 days after transfusion |
| Hospital Mortality | Total number of subject deaths. | 90 days after transfusion |
| Hospital Length of Stay (LOS) | The total number of days subjects were admitted to the hospital. | 90 days after transfusion |
| Measure | Description | Time Frame |
|---|---|---|
| Type of respiratory support | The type of supplemental oxygen support (e.g. nasal cannula, high flow nasal cannula, noninvasive ventilation, intubation and invasive mechanical ventilation, rescue ventilation) of the anti-SARS-CoV-2 convalescent plasma group across time. | 90 days after transfusion or until hospital discharge (whichever comes first) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Joyner, MD | Mayo Clinic | Principal Investigator |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| Duration of respiratory support | The total number of days subjects required respiratory support. | 90 days after transfusion or until hospital discharge (whichever comes first) |
| D007239 |
| Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |