Trials / Completed
CompletedNCT04362176
Passive Immunity Trial for Our Nation to Treat COVID-19 in Hospitalized Adults
Passive Immunity Trial for Our Nation (PassItOn)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 974 (actual)
- Sponsor
- Vanderbilt University Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to test the safety and efficacy of convalescent donor plasma to treat COVID-19 in hospitalized adults in a randomized, placebo-controlled setting. The effect of convalescent plasma will be compared to placebo on clinical outcomes, measured using the COVID-19 7-point Ordinal Clinical Progression Outcomes Scale at Day 15, among adults with COVID-19 requiring hospitalization.
Detailed description
After being informed about the study and potential risks, participants confirmed to meet all eligibility criteria who have provided informed consent will be randomized 1:1 to convalescent plasma versus placebo. Transfusion of convalescent plasma or placebo will be administered by clinical or research personnel while the patient is hospitalized on Study Day 1. On Study Days 1-7, participants will be monitored for adverse reactions to the transfusion. Research personnel will also assess patients at Day 14 and Day 28; these assessments will be completed by phone if the participant has been discharged from the hospital.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | pathogen reduced SARS-CoV-2 convalescent plasma | Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection. |
| BIOLOGICAL | Placebo | Lactated Ringer's solution with multivitamins |
Timeline
- Start date
- 2020-04-24
- Primary completion
- 2021-07-06
- Completion
- 2021-08-06
- First posted
- 2020-04-24
- Last updated
- 2022-11-03
- Results posted
- 2022-11-03
Locations
26 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04362176. Inclusion in this directory is not an endorsement.