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COVID19-Convalescent Plasma for Treating Patients With Active Symptomatic COVID 19 Infection (FALP-COVID)

COVID19-Convalescent Plasma for Treating Patients With Active Symptomatic COVID 19 Infection (FALP-COVID)

Recruiting
15 years and older
All
Phase 2/3

Overview

COVID-19 infection has spread worldwide causing several deaths in few months Convalescent Plasma from COVID 19 donors has shown huge activity in small series from Chinese patients and currently many centers from USA and the European Union are assessing its use looking to avoid mortality and prolonged hospitalizations COVID-19-related

Description

This is a collaborative, 4 arms , non randomized clinical trial assessing the use of Convalescent Plasma from COVID-19 recovered donors to be used in oncological and non-oncological patients with current severe COVID-19 infection or in patients with risk factors of major complications secondary to COVID-19 infection

Eligibility

Inclusion Criteria:

For all patients:

  1. Patient must sign an informed consent to participate in this trial
  2. Signed consent to participate in this trial must be given not after 14 days from the first day of symptoms COVID-19 related
  3. Patients with severity criteria must have any of the following: dyspnea and or respiratory rate >=30 per min and or saturation <= 93% with fraction of inspired oxygen 21% and or ratio of partial pressure arterial oxygen and fraction of inspired oxygen (PaFi )<300 and or lung images showing worsening in 24-48 hours

or

2. Patients without severity criteria but with 2 or more factor risks:

  1. 50 years or older
  2. any of the following comorbidities: Diabetes Mellitus, Hypertension, Chronic Obstructive Pulmonary Disease, Chronic Kidney Failure, non-oncological related chronic immunosuppression
  3. Total bilirubin>1,2 mg/dl or Blood Urea Nitrogen> 20 mg/dl or Lactate Dehydrogenase>245 U/L
  4. D-dimer > 1mg/L
  5. Neutrophils 7.3 x 10 or greater and or Lymphocytes lesser than 0,8 x 10 l
  6. C reactive protein >9,5 mg/dl and ferritin > 300 ug/ml
  7. Interleukin-6 >7 pg/mL
  8. antineoplastic treatment such as radiotherapy- cytotoxic chemotherapy- immunotherapymolecular therapy- oncological surgery during the last 8 weeks

Exclusion Criteria:

  • known allergy to plasma
  • Severe multiple organic failure
  • Active intra brain hemorrhage
  • Disseminated intravascular coagulation with blood products requirements
  • Patient with an adult respiratory distress longer than 10 days
  • patients with active cancer and life expectancy shorter than 12 months according with medical criteria

Study details
    General Population
    COVID-19 Infection
    Cancer Patients

NCT04384588

Fundacion Arturo Lopez Perez

5 August 2020

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