Phase 2
N=12
Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04434131 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: NAb Dose Titer in the Convalescent Plasma (CP), Pre-treatment, and Day One in Hospitalized Patients With Documented COVID-19 Infection — 56.7; 390; 413 titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Convalescent Plasma (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of New Mexico
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY NAb Dose Titer in the Convalescent Plasma (CP), Pre-treatment, and Day One in Hospitalized Patients With Documented COVID-19 Infection |
56.7; 390; 413 | — |
| SECONDARY Number of Participants With Rapid Deterioration as Evidenced by Increase in Ordinal Score |
— | — |
| SECONDARY Number of Participants With Clearance of Viral Shedding of SARS CoV-2 in Nasopharyngeal Samples |
— | — |
Summary
This is an open label pilot study designed to provide access to treatment with investigational convalescent plasma and assess the relationship between NAb titers in the investigational convalescent plasma compared to changes in NAb levels in the recipient in hospitalized patients with COVID-19.
Eligibility Criteria
Inclusion Criteria
- Patients must be 18 years of age or older.
- Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. If COVID-19 test results are pending or done at enrolment, test results must be positive prior to administration of convalescent plasma.
- Patient (or legally authorized representative, LAR) is willing and able to provide written informed consent and comply with all protocol requirements.
- For patients unable to consent, consent by the legally authorized representative (LAR) may be obtained by phone.
Exclusion Criteria
- Female subjects with positive pregnancy test or breastfeeding.
- Receipt of pooled immunoglobulin in past 30 days.
- Contraindication to transfusion or history of prior severe allergic reactions to transfused blood products.
- On ECMO or in refractory shock at entry
Data sourced from ClinicalTrials.gov (NCT04434131). 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.