Phase 3
Completed N=117
Convalescent Plasma Collection and Treatment in Pediatrics and Adults
Covid19 · coronavirus infection · Coronavirus · Virus Diseases
Source: ClinicalTrials.gov NCT04376034 ↗
Enrolled (actual)
117
Serious AEs
13.7%
Results posted
May 2026
Primary outcomePrimary: Time of Meeting Infusion Criteria to Infusion — 1 days
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is a prospective study, using plasma to help fight off infections of those suffering from COVID-19 in accordance with collection guidelines for plasma and FDA IND requirements. This study included up to 240 participants potentially receiving convalescent plasma.
NOTE: West Virginia does not have any entity with the required FDA registration/licensure or necessary equipment to collect convalescent plasma for transfusion. Therefore, the plasma donation portion of this study was not completed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time of Meeting Infusion Criteria to Infusion |
1 | — |
| PRIMARY Plasma Recipient Survival |
90 | — |
| PRIMARY Identify Plasma Donor |
— | — |
| PRIMARY Outreach to Plasma Donor |
— | — |
| PRIMARY Plasma Donor Time Until Donated |
— | — |
| SECONDARY Plasma Recipient Mortality |
22 | — |
| SECONDARY Plasma Recipient LOS |
23.6 | — |
| SECONDARY Plasma Recipient AE (Day 1) |
4 | — |
| SECONDARY Plasma Recipient AE (Day 2) |
— | — |
| SECONDARY Plasma Recipient AE (Day 3) |
— | — |
| SECONDARY Plasma Recipient AE (Day 4) |
1 | — |
| SECONDARY Plasma Recipient AE (Day 5) |
— | — |
| SECONDARY Plasma Recipient AE (Day 6) |
1 | — |
| SECONDARY Plasma Recipient AE (Day 7) |
— | — |
| SECONDARY Plasma Recipient AE (Day 30) |
— | — |
Eligibility Criteria
Inclusion Criteria: (NOTE: It is important to note that West Virginia, as a state, does not have any entity with the required FDA registration or licensure, nor the necessary on-site equipment, to collect convalescent plasma for the purpose of plasma transfusion. Therefore, the plasma donation portion of this study was not completed).
- Plasma donation:
- Prior diagnosis of COVID-19 documented by a laboratory test
- Abbott RealTime SARS-CoV-2 real-time reverse transcription polymerase chain reaction (rRT-PCR) test on the Abbott m2000 System (Inpatient WVU testing)
- Other testing methods and vendors using FDA approved detection methods of SARS-CoV-2 under the Emergency Use Authorization (EUA)
- Complete resolution of symptoms at least 28 days prior to donation
- Complete resolution of symptoms for at least 14 days with negative repeat COVID-19 testing approved by the FDA EUA
- Female donors age 18+ that have never been pregnant or negative for HLA antibodies
- Male donors age 18+
- Negative results for COVID-19 either from one or more nasopharyngeal swab specimens or by a molecular diagnostic test from blood. A partial list of available tests can be accessed at https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations.
- Defined SARS-CoV-2 neutralizing antibody titers, if testing can be conducted (e.g., of at least 1:1602, 1:360 up to 1:640 is preferred. In shortage case 1:80 is acceptable)
- At least or greater than 50kg of weight
- Plasma Recipients:
- Individuals of any age above 30 days of life, sex, or pregnancy status suffering from confirmed COVID19 and in rapid progression, severe or critical condition meeting the FDA IND guidelines.
- Must have laboratory confirmed COVID19
- Must have severe or immediately life-threatening COVID19
- Must provide informed consent/assent
Exclusion Criteria
- Plasma donation:
- Individuals that do not meet the requirement from the American Red Cross for plasma donation or equivalent
- Individuals plasma that has not passed safety screening after procurement by the American Red Cross for plasma donation or equivalent
- Plasma Recipients
- Individuals with COVID19 who are not in clinical concern for rapid progression, severe or critical condition
- Individuals who are in critical condition that are not confirmed to have COVID19
- Individuals with known Selective IgA Deficiency, that has not been found to be absent of anti-IgA antibodies
Data sourced from ClinicalTrials.gov (NCT04376034). 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.