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

NCT05247307 | Terminated Phase 3 DMC

• 1 other identifier: SARS VOC 2 GALDAKAO 02
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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:
• Hospital admission
• Clinical course
• Mortality
• Complications and/or adverse effects of plasma.

Conditions

COVID-19

Keywords

COVID-19; Clinical Trial Protocol; Immunization, Passive

Outcome Measures

Primary Outcomes (4)

• Rate of hospital admission

  Rate of hospital admission (among patients whose admission was not indicated prior to plasma infusion

  28 days

• Rate of severity of the disease

  Rate of improvement / stable / deterioration of the disease on the 7th and 14th days after plasma infusion.

  28 days

• Rate of of deaths

  Rate of of deaths (in-hospital and out-of-hospital)

  120 days

• Rate of complications

  Rate of complications and/or adverse effects of plasma.

  28 days

Study Arms (2)

Intervention

EXPERIMENTAL

Treatment in the intervention group: Infusion of 300 cc of convalescent donor plasma from COVID 19, administered within more than 168 hours from the onset of symptoms Treatments in both arms of the study 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 by the Department of Health, or by the Osakidetza Directorate, in each moment.

Biological: convalescent plasma infusion covid 19

Control

ACTIVE COMPARATOR

Treatment in the control group: 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. Treatments in both arms of the study 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 by the Department of Health, or by the Osakidetza Directorate, in each moment.

Biological: convalescent plasma infusion covid 19

Interventions

convalescent plasma infusion covid 19 BIOLOGICAL

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.

Control; Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• SARS CoV 2 infection, confirmed by PCR or technique of similar specificity.
• Symptom onset, or positive PCR (whichever comes first) within 7 days (168 hours) prior to planned plasma infusion.
• years of age or older.
• All patients, or the guardian appointed by the judge, in the case of recognized judicial incapacity, must sign the informed consent document.

You may not qualify if:

• Less than 65 years of age
• Symptom onset, or positive PCR (whichever comes first), more than 7 days (168 hours) prior to planned plasma infusion.
• Severe dementia, or other significant comorbidity, that generates a serious deterioration of the baseline functional status, with a life expectancy of less than 6 months.
• Participation in another clinical trial or study.
• History of allergy to amotosalen or psoralens

Sponsors & Collaborators

• Hospital Galdakao-Usansolo: lead

Study Sites (1)

Hospital Galdakao-Usansolo

Galdakao, Bizkaia, 48960, Spain

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jose Enrique de la Puerta Rueda, MD

  Hospital Cruz Roja de Bilbao

  PRINCIPAL INVESTIGATOR

• Maria Cristina Martinez Bilbao, MD

  Hospital Universitario Galdakao Usansolo

  PRINCIPAL INVESTIGATOR

• Amaia Uresandi Iruin, MD

  Hospital Universitario de Cruces

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Treatment in the intervention group: Infusion of 300 cc of convalescent donor plasma from COVID 19, administered within more than 168 hours from the onset of symptoms Treatment in the control group: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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. The convalescent plasma will be contrasted with fresh frozen plasma, available at the Basque Transfusion and Tissue Center of the Basque Autonomous Community (CVTTH), obtained before 12/31/2019.

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: February 18, 2022
• Study Start: March 31, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Around this year 2022
• Access Criteria: Contact with principal investigator

Locations

ES (1)