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NCT04340050

COVID-19 Convalescent Plasma

Completed EARLY_PHASE1 Results posted Last updated 28 February 2024
What this trial tests

EARLY_PHASE1 trial testing anti-SARS-CoV-2 convalescent plasma in Coronavirus in 10 participants. Completed in 23 December 2020.

Timeline
10 April 2020
Primary endpoint
23 December 2020
23 December 2020

Quick facts

Lead sponsorUniversity of Chicago
PhaseEARLY_PHASE1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment10
Start date10 April 2020
Primary completion23 December 2020
Estimated completion23 December 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Chicago

Who can join

18 and older, any sex, with Coronavirus. 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.

Success of Administering Plasma Primary · At time of administration

Number of patients who receive convalescent plasma

GroupValue95% CI
Treatment With Anti-SARS-CoV-2 Convalescent Plasma10
Treatment With Anti-SARS-CoV-2 Convalescent Plasma0
Type of Respiratory Support Primary · Until discharge from hospital

Levels of respiratory support will be graded (e.g. room air, high flow oxygen, intubation) to determine the change in type of respiratory support at 28 days.

At time of administration
GroupValue95% CI
Plasma Recipients2
Plasma Recipients1
Plasma Recipients1
Plasma Recipients5
At time of discharge
GroupValue95% CI
Plasma Recipients0
Plasma Recipients0
Plasma Recipients0
Plasma Recipients3
Cardiac Arrest Secondary · 28 days after plasma administration

Number of patients experiencing cardiac arrest.

GroupValue95% CI
Plasma Recipient0
Plasma Recipient10
Transfer to ICU Secondary · 28 days

Number of patients transferred to ICU

GroupValue95% CI
Plasma Recipient1
Plasma Recipient5
Plasma Recipient1
Plasma Recipient3
ICU Mortality Secondary · Until discharge

Number of patients dying in the ICU

GroupValue95% CI
Treatment With Anti-SARS-CoV-2 Convalescent Plasma2
Treatment With Anti-SARS-CoV-2 Convalescent Plasma5
Treatment With Anti-SARS-CoV-2 Convalescent Plasma3
ICU Length of Stay Secondary · Up to 50 days

This will be a continuous outcome defined by the amount of time between plasma administration and discharge from ICU. This will be treated as a time-to-event.

GroupValue95% CI
Treatment With Anti-SARS-CoV-2 Convalescent Plasma202 – 50
Hospital Mortality Secondary · Until discharge

Mortality during course of illness

GroupValue95% CI
Treatment With Anti-SARS-CoV-2 Convalescent Plasma2
Treatment With Anti-SARS-CoV-2 Convalescent Plasma8
Hospital Length of Stay Secondary · Until discharge

This will be a continuous outcome defined by the amount of time between plasma administration and discharge from hospital.

GroupValue95% CI
Treatment With Anti-SARS-CoV-2 Convalescent Plasma36.232 – 50
Ventilator-free Days Secondary · 28 days

This will be a continuous outcome defined by the amount of time between plasma administration and the transition from mechanical ventilation to non-invasive respiratory support.

GroupValue95% CI
Treatment With Anti-SARS-CoV-2 Convalescent Plasma21.70 – 28
Overall Survival (28-day Mortality) Secondary · 28 days

28-Day Overall Survival is defined as the status of the patient at the end of 28 days, beginning from the time of plasma administration.

GroupValue95% CI
Treatment With Anti-SARS-CoV-2 Convalescent Plasma0
Treatment With Anti-SARS-CoV-2 Convalescent Plasma10

Sponsor's own description

The purpose of this study is to assess the feasibility of delivering anti-SARS-CoV-2 convalescent plasma to hospitalized patients with severe or life-threatening COVID-19. Beyond supportive care, there are currently no proven treatment options for coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19 and could be rapidly available when there are sufficient numbers of people who have recovered and can donate high titer neutralizing immunoglobulin-containing plasma. Hypothesis: Collecting and administering convalescent plasma requires a level of logistical coordination that is not available in all centers. Objective: To establish feasibility for a hospital-based integrated system to collect and administer convalescent plasma to patients with severe or life-threatening COVID-19.

Publications & conference data

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

  1. COVID-19 and Cancer: a Comprehensive Review.
    Gosain R, Abdou Y, Singh A, Rana N, et al · · 2020 · cited 187× · PMID 32385672 · DOI 10.1007/s11912-020-00934-7
  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. Profiling B cell immunodominance after SARS-CoV-2 infection reveals antibody evolution to non-neutralizing viral targets.
    Dugan HL, Stamper CT, Li L, Changrob S, et al · · 2021 · cited 130× · PMID 34022127 · DOI 10.1016/j.immuni.2021.05.001
  4. 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
  5. SARS-CoV-2 Infection Severity Is Linked to Superior Humoral Immunity against the Spike.
    Guthmiller JJ, Stovicek O, Wang J, Changrob S, et al · · 2021 · cited 88× · PMID 33468695 · DOI 10.1128/mbio.02940-20
  6. 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
  7. COVID-19: pathophysiology, diagnosis, complications and investigational therapeutics.
    Azer SA. · · 2020 · cited 68× · PMID 32834902 · DOI 10.1016/j.nmni.2020.100738
  8. COVID-19 and thrombotic microangiopathies.
    Tiwari NR, Phatak S, Sharma VR, Agarwal SK. · · 2021 · cited 64× · PMID 33894421 · DOI 10.1016/j.thromres.2021.04.012

Verify or expand the search:

Other trials of anti-SARS-CoV-2 convalescent plasma

Trials testing the same drug.

Other recruiting trials for Coronavirus

Currently open trials in the same condition.

Other University of Chicago trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT04340050.

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