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This study will provide investigational convalescent plasma for patients infected with the SARS-CoV-2 with mild to moderate symptoms who meet inclusion criteria as judged by physician evaluation.
This study will provide investigational convalescent plasma for patients infected with the SARS-CoV-2 with mild to moderate symptoms who meet inclusion criteria as judged by physician evaluation.
Following patient enrollment into the study, completion of informed consent and randomization, the patient will receive one unit of convalescent COVID plasma or standard of care. The plasma will be infused in an outpatient infusion center by highly trained and experienced staff. Vitalant will be providing the plasma as per their normal screening and distribution protocols. Patients will be monitored for safety during the infusion and per protocol following the infusion for a period of 28 days. Primary efficacy and safety endpoints will be statistically analyzed and compared between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | No Intervention | Patient will receive standard of care therapy. | |
| Treatment Arm | Active Comparator | Patient will receive convalescent plasma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CCP | Biological | Randomized open label study to receive 2:1 CCP to standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Resolution of Symptoms | a. Time to resolution of symptoms will be defined as time from randomization (day 0) to a successful outcome. c. A successful outcome is defined as symptom improvement of 3 numbers or down to zero on the memory aid for all symptoms noted. | 28 days |
| SAEs within 24 hours of plasma infusion | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in Inflammatory Markers | A 50% decrease at day 28 in C-Reactive Protein (mg/mL) | 28 days |
| Decrease in Inflammatory Markers | A 50% decrease at day 28 in D-Dimer (ng/mL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metro Infectious Disease Consultants | Burr Ridge | Illinois | 60527 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 11, 2024 | Apr 8, 2024 | 4 | ||
| May 5, 2025 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Outpatient open label randomized study
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| 28 days |
| Decrease in Inflammatory Markers | A 50% decrease at day 28 in Ferritin (ng/mL) | 28 days |
| Decrease in Inflammatory Markers | A 50% decrease at day 28 in Lactate Dehydrogenase (U/L) | 28 days |
| Hospitalization within 28 days | 28 days |
| May 20, 2025 |
| 5 |
| Sep 30, 2025 | Oct 16, 2025 | 6 |
| Oct 29, 2025 | Nov 12, 2025 | 7 |
| Nov 14, 2025 | Nov 25, 2025 | 8 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |