Phase 2
N=1,225
Convalescent Plasma to Limit SARS-CoV-2 Associated Complications
SARS-CoV 2
Bottom Line
View on ClinicalTrials.gov: NCT04373460 ↗Enrolled (actual)
1,225
Serious AEs
7.5%
Results posted
Jan 2023
Primary outcome: Primary: Cumulative Number of Hospitalizations or Deaths Prior to Hospitalization — 17; 37 Participants — p=0.005
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SARS-CoV-2 convalescent plasma (Biological); Plasma from a volunteer donor (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Number of Hospitalizations or Deaths Prior to Hospitalization |
17; 37 | 0.005 sig |
| PRIMARY Cumulative Incidence of Severe Infusion Reactions |
0.05; 0.00 | 0.16 |
| PRIMARY Cumulative Incidence of Treatment-related Grade 3 or Higher Adverse Events |
0.25; 0.43 | 0.02 sig |
| PRIMARY Cumulative Incidence of Treatment-related Acute Respiratory Distress Syndrome (ARDS) |
0.00; 0.01 | 0.32 |
| SECONDARY Serum SARS-CoV-2 Antibody Titers by Visit |
345; 316; 8595; 9868; 10980; 12241 | — |
Summary
To assess the efficacy and safety of Human coronavirus immune plasma (HCIP) to reduce the risk of hospitalization or death, the duration of symptoms and duration of nasopharyngeal or oropharyngeal viral shedding.
Eligibility Criteria
Inclusion Criteria
- ≥ 18 years of age
- Competent and capable to provide informed consent
- • Positive molecular test for presence of SARS-CoV-2 in fluid collected by saliva for antigen, oropharyngeal or nasopharyngeal swab
- Experiencing any symptoms of COVID-19 including but not limited to fever(T> 100.5º F), cough, or other COVID associated symptoms like anosmia
- ≤ 8 days since the first symptoms of COVID-19
- ≤ 8 days since first positive SARS-CoV-2 RNA test
- Able and willing to comply with protocol requirements listed in the informed consent
Exclusion Criteria
- Hospitalized or expected to be hospitalized within 24 hours of enrollment
- Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance
- History of prior reactions to transfusion blood products
- Inability to complete therapy with the study product within 24 hours after enrollment
- Receiving any treatment drug for COVID-19 within 14 days prior to screening evaluation (monoclonal antibodies, compassionate use or study trial related). Steroid treatment at any time does not affect study eligibility
Data sourced from ClinicalTrials.gov (NCT04373460). 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.