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NCT04456413 · ClinicalTrials.gov registry record · Phase 2

Convalescent Plasma as Treatment for Subjects With Early COVID-19 Infection

A Phase 2 study, sponsored by Hackensack Meridian Health.

Terminated
Registry status
Phase 2
Development phase
21
Enrollment target

NCT04456413: Clinical Trial Phase 2 study, sponsored by Hackensack Meridian Health.

NCT04456413 is a Phase 2 study that was terminated before completion, run by Hackensack Meridian Health. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04456413, a Phase 2 study, was terminated before completion, sponsored by Hackensack Meridian Health.

TERMINATED
Registry status
Phase 2
Development phase
21 participants
Enrollment target

Study Summary

* This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications. * Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first. * Subjects will be randomized to receiving convalescent plasma or best supportive care. * Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease. * The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study.

Primary Outcome

The hospitalization rate will be summarized by frequency (%) and compared between the Treatment and Control arms by Mantel-Haenszel test.

Interventions

  • OTHER Best Supportive Care
  • BIOLOGICAL Convalescent Plasma

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2020-11-06
Est. Completion 2021-05-04
Phase Phase 2
Hackensack Meridian Health

90 total trials

Why NCT04456413 stopped before completion

NCT04456413 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).

The record links to 0 conditions, and to 2 interventions - of which Best Supportive Care is the first listed.

NCT04456413 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04456413 about?

NCT04456413 is a clinical study titled "Convalescent Plasma as Treatment for Subjects With Early COVID-19 Infection". * This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications. * Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first. * ...

What is the current status of trial NCT04456413?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2020-11-06. Estimated completion is 2021-05-04.

What interventions are being tested in trial NCT04456413?

The interventions under investigation include: Best Supportive Care (OTHER), Convalescent Plasma (BIOLOGICAL).

Who is sponsoring clinical trial NCT04456413?

This trial is sponsored by Hackensack Meridian Health, which has 90 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04456413's enrollment target sits among peer trials

21 1794th of 2000 higher than 196 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04456413, the US trial registry maintained by the National Library of Medicine. NCT04456413 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.