Trials / Terminated
TerminatedNCT04361253
Evaluation of SARS-CoV-2 (COVID-19) Antibody-containing Plasma thErapy
A Prospective, Randomized, Double-Masked, Placebo-Controlled Trial of High-Titer COVID-19 Convalescent Plasma (HT-CCP) for the Treatment of Hospitalized Patients With COVID-19 of Moderate Severity
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Brigham and Women's Hospital · Academic / Other
- Sex
- All
- Age
- 12 Months
- Healthy volunteers
- Not accepted
Summary
In this study, investigators will determine whether the early addition of HT-CCP to standard treatment improves the clinical outcome (as assessed by the Modified WHO Ordinal Scale) of patients with COVID-19 who are hospitalized but not yet in moderate or severe ARDS.
Detailed description
Investigators are doing this research to learn more about high-titer COVID-19 convalescent plasma (HT-CCP) transfusion as a possible treatment for people who have COVID-19, the coronavirus infection. "HT-CCP" is plasma that contains a high amount of antibodies that were made to fight off COVID-19 because it is donated by another person who has also been infected with coronavirus but has recovered, so their immune system has had enough time to make these antibodies. This study is being done to determine whether HT-CCP will help people with COVID-19 recover from their infection more quickly and lower their risk of having to go on a ventilator or reduce the time they need to stay on a ventilator. It is not yet known whether HT-CCP helps people with COVID-19, which is why the study needs to be randomized, meaning some subjects will be randomly selected to receive HT-CCP while others will be randomly selected to receive FFP.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | High-Titer COVID-19 Convalescent Plasma (HT-CCP) | 250mL HT-CCP x2 doses given sequentially. |
| BIOLOGICAL | Standard Plasma (FFP) | 250mL FFP or FP24 x2 doses given sequentially. |
Timeline
- Start date
- 2020-04-30
- Primary completion
- 2021-04-01
- Completion
- 2021-06-30
- First posted
- 2020-04-24
- Last updated
- 2021-08-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04361253. Inclusion in this directory is not an endorsement.