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Evaluation of SARS-CoV-2 (COVID-19) Antibody-containing Plasma thErapy

NCT04361253 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2021-08-13

No results posted yet for this study

Summary

In this study, investigators will determine whether the early addition of HT-CCP to standard treatment improves the clinical outcome (as assessed by the Modified WHO Ordinal Scale) of patients with COVID-19 who are hospitalized but not yet in moderate or severe ARDS.

Conditions

Interventions

BIOLOGICAL

High-Titer COVID-19 Convalescent Plasma (HT-CCP)

250mL HT-CCP x2 doses given sequentially.

BIOLOGICAL

Standard Plasma (FFP)

250mL FFP or FP24 x2 doses given sequentially.

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Richard Kaufman, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-30
Primary Completion
2021-04-01
Completion
2021-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04361253 on ClinicalTrials.gov