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Convalescent Plasma Therapy vs. SOC for the Treatment of COVID-19 in Hospitalized Patients

NCT04345523 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2024-12-02

No results posted yet for this study

Summary

A total of 278 patients are planned.

All patients will be in an early-stage of COVID-19. They must be adults and hospitalized.

In this study, all participating patients will receive the standard treatment provided according to the current treatment protocols for coronavirus disease. In addition to this treatment, each patient will be randomly assigned to receive additional treatment with convalescent plasma transfusion (CP; blood plasma from patients who have been cured of coronavirus), or continue with standard treatment but without adding transfusion.

50% of the chances of additional treatment with CP, and 50% of the chances of receiving only the standard treatment for coronavirus.

The duration of the study shall be one month from the assignment of the treatment.

The patient and the doctor will know the treatment assigned.

Conditions

Interventions

OTHER

Blood and derivatives.

Administration of fresh plasma from donor immunized against COVID-19

DRUG

Standard of Care

Standard of care for the treatment of COVID-19 in hospitalized patients

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Cristina Avendaño Solá

    lead OTHER

Principal Investigators

  • Cristina Avendaño Solá, MD, PhD · Hospital Universitario Puerta de Hierro Majadahonda

  • Rafael Duarte Palomino, MD, PhD · Hospital Universitario Puerta de Hierro Majadahonda

  • Antonio Ramos, MD, PhD · Hospital Universitario Puerta de Hierro Majadahonda

  • José Luis Bueno, MD · Hospital Universitario Puerta de Hierro Majadahonda

  • Inmaculada Casas Flecha, PharmD, PhD · Centro Nacional de Microbiología, Instituto de Salud Carlos III

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-03
Primary Completion
2021-02-05
Completion
2021-04-05

Countries

  • Spain

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 NCT04345523 on ClinicalTrials.gov