Phase 2
N=131
Efficacy and Safety of Convalescent Plasma in Treating COVID-19 Hospitalized Patients
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04354831 ↗Enrolled (actual)
131
Serious AEs
20.0%
Results posted
Apr 2024
Primary outcome: Primary: Overall Mortality — 22; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- anti-SARS-CoV-2 convalescent plasma (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Mortality |
22; 7 | — |
| SECONDARY Length of Admission After Plasma Infusion |
13.24; 7.85 | — |
| SECONDARY Length of ICU Stay After Convalescent Plasma Infusion |
11.98 | — |
Summary
This is a Phase II study. This research study is being conducted to use convalescent donor plasma in seriously ill patients who have COVID-19.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years or older
- Hospitalized as an in-patient with positive COVID-19 test by PCR
- Presence of respiratory symptoms with any of severe features as below:
- Respiratory Rate ≥ 24/min
- Oxygen Support >3L/min by nasal cannula
- New onset or worsening of respiratory symptoms with radiologic confirmation of bilateral ground glass opacities that cannot be attributed to another cause
- Patient / HCPOA must agree to storage of blood specimens for future testing.
- Patient / HCPOA is willing and able to provide electronic informed consent and comply with all protocol requirements. If patient is unable to consent due to incapacity, health care POA should be defined and able to consent for the patient.
- Patients are allowed to receive all standard of care. Co enrollment in other clinical trials is permitted.
Exclusion Criteria
- FCBP with positive pregnancy test (mandatory)
- Breastfeeding females
- Receipt of pooled immunoglobulin (e.g. IVIG or other hyperimmune globulin products) in past 14 days. This does not apply to monoclonal antibodies .
- Mechanical ventilation for > 14 days
- Days from symptom onset >21 days
- Expected survival < 72 hours
- Contraindication to transfusion or history of prior reactions to transfusion blood products including any proven history of TRALI
- Patients who were previously admitted to ICU cannot be enrolled in the non-ICU cohort. These patients could need ICU level care subsequently and at that time point could be considered for ICU cohort .
Data sourced from ClinicalTrials.gov (NCT04354831). 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.