COPLA Study: Treatment of Severe Forms of COronavirus Infection With Convalescent PLAsma

Overview

COVID-19 disease has become a very serious global health problem. Treatments for severe forms are urgently needed to lower mortality. Any procedure that improves these forms should be considered, especially those devoid of serious side effects.There is not enough published information on the use of allogeneic convalescent plasma (ACP) in the treatment of severe forms of COVID-19. The use of ACP can be combined with other treatments and has very few adverse effects. It takes 10-14 days for SARS-CoV2-infected patients to produce virus-neutralizing antibodies: within that time they can develop serious complications and die. Injecting PAC into patients with severe forms of COVID-19 shortens the period of risk while the patient produces the antibodies.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2020

Interventions

  • Biological: Convalescent plasma
    • Convalescent plasma obtained by aphaeresis from recovered patients.

Arms, Groups and Cohorts

  • Experimental: Convalescent Plasma
    • 200 ml of convalescent plasma, single dose.

Clinical Trial Outcome Measures

Primary Measures

  • Lung injury
    • Time Frame: 7 days
    • PaO2/FiO2 relation
  • Overall survival
    • Time Frame: 15-30 days
    • Patients survival after therapy

Secondary Measures

  • Adverse reactions to plasma
    • Time Frame: 7 days
    • Determine the incidence of side effects from plasma administration

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with SARS-CoV2 infection who have had a serious evolution and are in an ICU – With or without ventilatory assistance – Treated or not with hydroxychloroquine 200 mg. every 12 hours – Indistinct sex – Older than 18 years – Signed informed consent Exclusion Criteria:

  • Patients treated with the following medications: azithromycin, ritonavir / lopinavir, remdesivir, interferons, ruxolinitib, tocilizumab. – Patients with severe kidney failure who require replacement therapy.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centro de Hematología y Medicina Interna
  • Collaborator
    • Laboratorios Clínicos de Puebla (Laboratorios Ruiz)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Guillermo J. RUIZ-ARGÜELLES, Dr. Guillermo J. Ruiz-Argüelles – Centro de Hematología y Medicina Interna
  • Overall Contact(s)
    • Juan Carlos Olivares-Gazca, MD, MPH, 2222438100, jolivares@hsctmexico.com

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