Trials / Completed
CompletedNCT04373460
Convalescent Plasma to Limit SARS-CoV-2 Associated Complications
Comparison of the Efficacy and Safety of Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune) Plasma Among Outpatients With Symptomatic COVID-19
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1,225 (actual)
- Sponsor
- Johns Hopkins University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The purpose of this randomized, double-blind, controlled, phase 2 trial is to evaluate the efficacy of treatment with HCIP in reducing hospitalization and death prior to hospitalization among outpatient adults who have RNA detection test-confirmed COVID-19 AND have developed any symptoms of COVID-19 including but not limited to fever, cough, or other COVID associated symptoms like anosmia. Ambulatory/outpatient adults subjects 18 years of age or older, regardless of risk factors for severe illness may participate. A total of approximately 1344 eligible subjects stratified with a target goal (but not binding) of 50:50 in the \<65 vs ≥ 65 age range will be randomized in a 1:1 ratio to receive either HCIP or control plasma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SARS-CoV-2 convalescent plasma | SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma. |
| BIOLOGICAL | Plasma from a volunteer donor | Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative. |
Timeline
- Start date
- 2020-06-03
- Primary completion
- 2022-01-14
- Completion
- 2022-12-14
- First posted
- 2020-05-04
- Last updated
- 2023-06-02
- Results posted
- 2023-01-31
Locations
29 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04373460. Inclusion in this directory is not an endorsement.