Convalescent Plasma vs. Standard Plasma for COVID-19
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04344535 |
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Recruitment Status :
Terminated
(Insufficient eligible and consenting patients)
First Posted : April 14, 2020
Results First Posted : December 6, 2021
Last Update Posted : December 6, 2021
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The purpose of this study is to find out if transfusion of blood plasma containing antibodies against COVID-19 (anti-SARS-CoV-2), which were donated from a patient who recovered from COVID-19 infection, is safe and can treat COVID-19 in hospitalized patients.
Antibodies are blood proteins produced by the body in response to a virus and can remain in the person's bloodstream (plasma) for a long time after they recover. Transferring plasma from a person who recovered from COVID-19 may help neutralize the virus in sick patients' blood, and/or reduce the chances of the infection getting worse.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COVID | Biological: Convalescent Plasma Biological: Standard Donor Plasma | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 82 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | Staff in Transfusion Services (Blood Bank) at Stony Brook will be unblinded so they can collect, store, and dispense either convalescent plasma or standard plasma. They will affix an approved label with all required information, e.g. bar code, blood type, expiration date, and will indicate that the bag contains convalescent plasma/standard plasma. |
| Primary Purpose: | Treatment |
| Official Title: | Convalescent Plasma to Reduce Complications Associated With COVID-19 Infection: A Randomized Trial Comparing the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma vs. Standard Plasma in Hospitalized Patients With COVID- 19 Infection |
| Actual Study Start Date : | April 8, 2020 |
| Actual Primary Completion Date : | January 1, 2021 |
| Actual Study Completion Date : | February 1, 2021 |
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Convalescent Donor Plasma |
Biological: Convalescent Plasma
450-550 mL of plasma containing anti-SARS-CoV-2 antibody titer ideally > 1:320, but meeting minimum titer per FDA Guidelines for convalescent plasma. |
| Placebo Comparator: Standard Donor Plasma |
Biological: Standard Donor Plasma
450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies |
- 28 Day Ventilator Free Days [ Time Frame: 28 days post randomization ]Number of days a patient is receiving mechanical invasive ventilation through 28 days post randomization. Patients who die during this time period are assigned 0 ventilator free days.
- 90 Day All-cause Mortality [ Time Frame: 90 days ]All cause mortality from randomization until 90 days post randomization
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
There are 2 groups of research subjects: plasma donor and recipients
Volunteer plasma donors can donate Convalescent Plasma if they:
- have adequate antibody levels against COVID-19 per FDA Guidelines
- have had no symptoms of COVID-19 for at least 14 days
- meet routine plasma donation criteria
Inclusion Criteria for Plasma Recipients:
- Adults 18 years of age or older
- Hospitalized with PCR+ COVID-19 infection
- If female must not be pregnant and/or breastfeeding.
Exclusion Criteria for Plasma Recipients:
- Unable to randomize patient within 14 days of admission to Stony Brook Hospital (or any other hospital if a transfer to Stony Brook Hospital).
- In the treating physician's opinion, the patient cannot tolerate a 450-550 mL infusion of plasma over up to 8 hours (4 hours max per unit), even if prophylaxed with intravenous diuretic
- Contraindication to transfusion or history of prior reactions to blood transfusions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04344535
| United States, New York | |
| Stony Brook University Hospital | |
| Stony Brook, New York, United States, 11794 | |
| Principal Investigator: | Elliott Bennett-Guerrero, MD | Stony Brook Hospital |
Documents provided by Elliott Bennett-Guerrero, Stony Brook University:
| Responsible Party: | Elliott Bennett-Guerrero, Professor of Anesthesiology, Stony Brook University |
| ClinicalTrials.gov Identifier: | NCT04344535 |
| Other Study ID Numbers: |
SBU-COVID19-ConvalescentPlasma |
| First Posted: | April 14, 2020 Key Record Dates |
| Results First Posted: | December 6, 2021 |
| Last Update Posted: | December 6, 2021 |
| Last Verified: | December 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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COVID-19 Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |