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NCT04344535

Convalescent Plasma vs. Standard Plasma for COVID-19

Terminated Phase 1, PHASE2 Results posted Last updated 6 December 2021
What this trial tests

Phase 1, PHASE2 trial testing Convalescent Plasma in COVID in 82 participants. Terminated before completion.

Timeline
8 April 2020
Primary endpoint
1 January 2021
1 February 2021

Quick facts

Lead sponsorStony Brook University
PhasePhase 1, PHASE2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment82
Start date8 April 2020
Primary completion1 January 2021
Estimated completion1 February 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Stony Brook University

Who can join

18 and older, any sex, with COVID. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

28 Day Ventilator Free Days Primary · 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.

GroupValue95% CI
Convalescent Donor Plasma282 – 28
Standard Donor Plasma280 – 28
90 Day All-cause Mortality Secondary · 90 days

All cause mortality from randomization until 90 days post randomization

GroupValue95% CI
Convalescent Donor Plasma16
Standard Donor Plasma5

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events (death, infusion reaction requiring termination of study plasma infusion, or Grade 4 or greater Organ Failure) were collected for the first 28 days. All-cause mortality was also assessed at 90 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Convalescent Donor Plasma
Serious: 8/59 (14%)
Deaths: 16/59
Standard Donor Plasma
Serious: 1/15 (7%)
Deaths: 5/15

Serious adverse events (5 terms)

ReactionSystemConvalescent Donor PlasmaStandard Donor Plasma
Renal FailureRenal and urinary disorders
Liver FailureHepatobiliary disorders
Pulmonary FailureRespiratory, thoracic and mediastinal disorders
Hematologic FailureBlood and lymphatic system disorders
Infusion ReactionBlood and lymphatic system disorders

Most-reported serious reactions: Renal Failure, Liver Failure, Pulmonary Failure, Hematologic Failure, Infusion Reaction.

Data from ClinicalTrials.gov NCT04344535 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Treatment for COVID-19: An overview.
    Stasi C, Fallani S, Voller F, Silvestri C. · · 2020 · cited 194× · PMID 33053381 · DOI 10.1016/j.ejphar.2020.173644
  2. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review.
    Piechotta V, Chai KL, Valk SJ, Doree C, et al · · 2020 · cited 148× · PMID 32648959 · DOI 10.1002/14651858.cd013600.pub2
  3. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a rapid review.
    Valk SJ, Piechotta V, Chai KL, Doree C, et al · · 2020 · cited 126× · PMID 32406927 · DOI 10.1002/14651858.cd013600
  4. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review.
    Piechotta V, Iannizzi C, Chai KL, Valk SJ, et al · · 2021 · cited 106× · PMID 34013969 · DOI 10.1002/14651858.cd013600.pub4
  5. Convalescent Plasma Therapy for COVID-19: State of the Art.
    Focosi D, Anderson AO, Tang JW, Tuccori M. · · 2020 · cited 88× · PMID 32792417 · DOI 10.1128/cmr.00072-20
  6. COVID-19 Convalescent Plasma and Clinical Trials: Understanding Conflicting Outcomes.
    Focosi D, Franchini M, Pirofski LA, Burnouf T, et al · · 2022 · cited 79× · PMID 35262370 · DOI 10.1128/cmr.00200-21
  7. Severe Acute Respiratory Syndrome Coronavirus 2 Convalescent Plasma Versus Standard Plasma in Coronavirus Disease 2019 Infected Hospitalized Patients in New York: A Double-Blind Randomized Trial.
    Bennett-Guerrero E, Romeiser JL, Talbot LR, Ahmed T, et al · · 2021 · cited 60× · PMID 33870923 · DOI 10.1097/ccm.0000000000005066
  8. Treatment of COVID-19 with convalescent plasma: lessons from past coronavirus outbreaks.
    Wooding DJ, Bach H. · · 2020 · cited 55× · PMID 32791241 · DOI 10.1016/j.cmi.2020.08.005

Verify or expand the search:

Other trials of Convalescent Plasma

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Other Stony Brook University trials

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04344535.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing