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RECRUITING Phase 3

Convalescent Plasma Collection and Treatment in Pediatrics and Adults

NCT04376034 · View on ClinicalTrials.gov ↗

Study Summary

This is a prospective study, involving contacting potential plasma donors and the use of their plasma to help fight off infections of those suffering from COVID19 in accordance to collection guidelines for plasma and FDA IND requirement. This study will include up to 240 participants potentially receiving convalescent plasma and up to 1000 potential donors. There are 3 basic arms to the study: mild, moderate and severe/critical severity. All 3 severity groups are eligible for enrollment, but mild severity will not be given plasma unless there is progression. Moderate severity will given up to 1 unit of plasma and severe/critical severity up to 2 units. There is no placebo group, however given the excepted issues of shortages of plasma, intention to treat will be used for analysis.

Interventions

  • OTHER Standard of Care
  • BIOLOGICAL Convalescent Plasma 1 Unit
  • BIOLOGICAL Convalescent Plasma 2 Units

Study Locations (1)

West Virginia

  • WVU Medicine — Morgantown

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2020-04-16
Est. Completion 2021-03-30
Phase Phase 3

Sponsor

West Virginia University

93 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04376034

The ClinicalTrials.gov registry entry for NCT04376034 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is West Virginia University, which has 93 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Coronavirus appearing as the primary indexed condition, and to 3 interventions — of which Standard of Care is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04376034 reports 1 study location spanning 1 distinct geographic area — top geographies include West Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04376034 about?

NCT04376034 is a clinical study titled "Convalescent Plasma Collection and Treatment in Pediatrics and Adults". This is a prospective study, involving contacting potential plasma donors and the use of their plasma to help fight off infections of those suffering from COVID19 in accordance to collection guidelines for plasma and FDA IND requirement. This study will include up to 240 participants potentially rec...

What is the current status of trial NCT04376034?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2020-04-16. Estimated completion is 2021-03-30.

What conditions does trial NCT04376034 study?

This clinical trial studies the following conditions: Coronavirus, Coronavirus Infection, Virus Diseases, COVID19, RNA Virus Infections. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04376034?

The interventions under investigation include: Standard of Care (OTHER), Convalescent Plasma 1 Unit (BIOLOGICAL), Convalescent Plasma 2 Units (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04376034?

This trial is sponsored by West Virginia University, which has 93 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04376034 being conducted?

This trial has 1 study location across West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial