Phase 2
Completed N=29
Convalescent Plasma for Treatment of COVID-19 Patients With Pneumonia
Corona Virus Infection · SARS-CoV-2 infection · SARS Pneumonia · Pneumonia
Source: ClinicalTrials.gov NCT04374565 ↗
Enrolled (actual)
29
Serious AEs
13.8%
Results posted
Apr 2022
Primary outcomePrimary: Number of Participants Transferred to Intensive Care Unit (ICU) — 4 Participants
Summary
This is a single arm phase II trial to assess efficacy and confirm safety of infusions of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms,with or without confirmed interstitial COVID-19 pneumonia by chest Xray or CT. A total of 29 eligible subjects will be enrolled to receive anti-SARS-CoV-2 plasma.Outcomes will be compared to hospitalized controls with confirmed COVID-19 disease through retrospective chart review.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Transferred to Intensive Care Unit (ICU) |
4 | — |
| PRIMARY 28 Day Mortality |
2 | — |
| SECONDARY Number of Participants With Serious Adverse Events |
4 | — |
| SECONDARY Duration of SARS-CoV-2 Positivity |
20.4 | — |
| SECONDARY Serum of Plasma Antibody Titer to SARS-CoV-2 |
7.7 | — |
| SECONDARY Cellular and Humoral Immune Response |
58.0 | — |
| SECONDARY Supplemental Oxygen Free Days |
23.5 | — |
| SECONDARY Ventilator Free Days |
24.93 | — |
| SECONDARY ICU Free Days |
24.59 | — |
| SECONDARY Sequential Organ Failure Assessment Score Improvement |
27 | — |
| SECONDARY Number of Participants Who Needed for Vasopressors |
4 | — |
| SECONDARY Number of Participants Who Needed Renal Replacement Therapy |
1 | — |
| SECONDARY Number of Participants Who Needed Extracorporeal Membrane Oxygenation (ECMO) |
1 | — |
| SECONDARY Hospital Length of Stay (LOS) |
9.39 | — |
| SECONDARY ICU LOS |
2.93 | — |
| SECONDARY Number of Participants Who Had a Grade 3 or 4 Adverse Events (AEs) |
6 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must be 18 years of age or older
- Patients hospitalized with COVID-19 respiratory symptoms within 72 hours of admission to a"floor" bed (non-ICU bed) and confirmation via SARS-CoV-2 RT-PCR testing.
- Patient and/or surrogate is willing and able to provide written informed consent and comply with all protocol requirements.
- Patients with hematologic malignancies or solid tumors are eligible.
- Patients with autoimmune disorders are eligible.
- Patients with immunodeficiency and organ or stem cell transplant recipients are eligible.
- Patients who have received or are receiving hydroxychloroquine or chloroquine are eligible (but will be taken off the drug)
- Prior use of IVIG is allowed but the investigator should consider the potential for a hypercoagulable state.
Exclusion Criteria
- Patients requiring mechanical ventilation or >6 liters per minute nasal cannula oxygen
- Patients on other anti-COVID-19 trials being treated with tocilizumab (anti-IL-6 receptor), Siltuximab (anti-IL-2), Remdesivir, or other pharmacological trials that may be initiated hereafter.
- A pre-existing condition or use of a medication that, in the opinion of the site investigator, may place the individual at a substantially increased risk of thrombosis (e.g., cryoglobulinemia, severe refractory hypertriglyceridemia, or clinically significant monoclonal gammopathy).
- Contraindication to transfusion or history of prior reactions to transfusion blood products.
- Medical conditions for which receipt of 500-600 mL of intravenous fluid may be dangerous to the subject (e.g., decompensated congestive heart failure).
Data sourced from ClinicalTrials.gov (NCT04374565). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.