Efficacy of the Infusion of Donor Plasma in COVID-19 Infection

Summary

Objectives Primary objectives To assess the superiority or not of the infusion of anti-COVID immune plasma infusion versus a placebo (non-immune plasma) to patients over 65 years of age recently infected with the SARS-CoV-2 coronavirus, to prevent progression to severe forms of the disease with hospital admission.

Secondary objectives To assess if the intervention improves the clinical evolution of the target patient.

* Improvement of the disease.
* Disease deterioration Methodology Design Prospective, randomized (1:1; experimental group: control group), double-blind study, in which the doctors who prescribe the treatments and those who assess the results do not know the treatment received by the patient.

Methods. Patients 65 years of age or older will be included, diagnosed with SARS-CoV-2 coronavirus infection, in which no more than 7 days have elapsed since the onset of symptoms or diagnosis to plasma infusion.All patients included in the study will receive the same standard treatment that is deemed appropriate at any time, understanding as standard treatment that established at any time by the guidelines established.Infusion of 300 cc of convalescent donor plasma from COVID 19, administered within more than 168 hours from the onset of symptoms. For the study to be blind, the infusion of non-convalescent donor plasma, obtained before the start of the epidemic, is required to guarantee the absence of anti-COVID antibodies in the plasma of the control group.

Analysis of data:

Initially, the homogenization of the data referring to the two groups of studies will be evaluated. Classical statistical tests will be applied, such as Wilcoxon's non-parametric tests for the comparison of means of continuous variables, as well as the Chi-square test (or Fisher's exact test) to evaluate the association between categorical variables. The result variables are:

1. Hospital admission
2. Clinical course
3. Mortality
4. Complications and/or adverse effects of plasma.

Conditions

• COVID-19

Interventions

BIOLOGICAL

convalescent plasma infusion covid 19

Operating process * A single dose of plasma (300 mL) immune anti-coronavirus or not, depending on what corresponds will be infused. * The collaborating staff will enter the initial and follow-up data in Red Cap based on the information contained in the medical record, or by talking to the patient by telephone to clarify any doubts.

Sponsors & Collaborators

• Hospital Galdakao-Usansolo

  lead OTHER_GOV

Principal Investigators

• Jose Enrique de la Puerta Rueda, MD · Hospital Cruz Roja de Bilbao

• Maria Cristina Martinez Bilbao, MD · Hospital Universitario Galdakao Usansolo

• Amaia Uresandi Iruin, MD · Hospital Universitario de Cruces

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-31

Primary Completion

2021-12-31

Completion

2021-12-31

Countries

• Spain

Study Locations