Phase 3 Open-Label Controlled Trial of Convalescent Plasma in Early COVID-19 Infection
Public ClinicalTrials.gov record NCT06084351. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The expanded access program for investigational convalescent plasma (CP) is being utilized nationwide despite its unproven benefit and optimal timing of transfusion. The optimal administration of CP during a viral pandemic must consider the supply of the product, ideal patient selection, and appropriate timing in order to produce maximum benefit with a scarce resource \[2\]. Currently, the FDA suggested guidelines for use include "severe", "critical" or at risk for critical disease. The optimal administration of CP with anti-SARS-CoV-2 antibodies is theoretically early in the course of the illness \[1\], before multiorgan failure or a maladaptive immune response, like seen in the cytokine release syndrome, occurs. Our open-label trial will randomize COVID-19+ patients admitted to the hospital who are at high risk for severe disease to receive 1 dose CP ordered within 48 hours of admission plus standard of care vs. standard of care. The primary clinical endpoint will be time to clinical improvement within 28 days after randomization (based on the ordinal scale as specified below). The purpose of this trial will be to obtain data which can be further utilized in future clinical trials and help clinicians understand the effectiveness of CP.
Study identification
- NCT ID
- NCT06084351
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 11, 2020
- Primary completion
- Oct 29, 2020
- Completion
- Oct 29, 2020
- Last update posted
- Oct 15, 2023
2020
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Larkin Community Hospital | South Miami | Florida | 33143 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06084351, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 15, 2023 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06084351 live on ClinicalTrials.gov.