Early Phase 1
N=10
COVID-19 Convalescent Plasma
Coronavirus
Bottom Line
View on ClinicalTrials.gov: NCT04340050 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Success of Administering Plasma — 10; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- anti-SARS-CoV-2 convalescent plasma (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success of Administering Plasma |
10; 0 | — |
| PRIMARY Type of Respiratory Support |
2; 1; 1; 5; 1; 0 | — |
| SECONDARY Cardiac Arrest |
0; 10 | — |
| SECONDARY Transfer to ICU |
1; 5; 1; 3 | — |
| SECONDARY ICU Mortality |
2; 5; 3 | — |
| SECONDARY ICU Length of Stay |
20 | — |
| SECONDARY Hospital Mortality |
2; 8 | — |
| SECONDARY Hospital Length of Stay |
36.2 | — |
| SECONDARY Ventilator-free Days |
21.7 | — |
| SECONDARY Overall Survival (28-day Mortality) |
0; 10 | — |
Summary
The purpose of this study is to assess the feasibility of delivering anti-SARS-CoV-2 convalescent plasma to hospitalized patients with severe or life-threatening COVID-19.
Beyond supportive care, there are currently no proven treatment options for coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19 and could be rapidly available when there are sufficient numbers of people who have recovered and can donate high titer neutralizing immunoglobulin-containing plasma.
Hypothesis: Collecting and administering convalescent plasma requires a level of logistical coordination that is not available in all centers.
Objective: To establish feasibility for a hospital-based integrated system to collect and administer convalescent plasma to patients with severe or life-threatening COVID-19.
Eligibility Criteria
Donor Inclusion Criteria:
- Age greater or equal to 18
- Able to donate blood per blood bank standard guidelines
- Prior diagnosis of COVID-19 documented by a laboratory test (confirmed)
- Complete resolution of symptoms at least 28 days prior to donation
- Female donors who have never been pregnant, previously pregnant female donors negative for HLA antibodies (HLA screening), or male donors
Donor Exclusion Criteria:
- Does not provide consent
- Does not meet standard blood bank donation guidelines
- Unsuccessful blood donation
Recipient Inclusion Criteria:
- Patients must be 18 years of age or older
- Must have laboratory-confirmed COVID-19
- Must have severe or immediately life-threatening COVID-19
- Severe defined as dyspnea, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio 50% within 24 to 48 hours
- Life-threatening defined as respiratory failure, septic shock, and/or multiple organ dysfunction or failure. Lower priority should be given to patients with septic shock or multiple organ dysfunction or failure since their disease may have progressed to a point where they are not able to benefit from convalescent plasma therapy.
- Must be less than 21 days from the start of illness
- Patient is willing and able to provide written informed consent and comply with all protocol requirements. If the patient is not able to consent, we will obtain consent from the power of attorney or a health care proxy for the patient as determined by the Illinois Healthcare Surrogate Act
- Patient, power of attorney or health care proxy agrees to storage of specimens for future testing.
- Of note, eIND application for each recipient subject will need to be approved before administration of convalescent plasma
Recipient Exclusion Criteria:
- Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period
- Receipt of pooled immunoglobulin in past 30 days
- Contraindication to transfusion or history of prior reactions to transfusion blood products
- Patients currently enrolled in other drug trials that preclude investigational treatment with anti-SARS-CoV-2 convalescent plasma
Data sourced from ClinicalTrials.gov (NCT04340050). 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.