Trial | NCT04384588  Report issue

Title

COVID19-Convalescent Plasma for Treating Patients With Active Symptomatic COVID 19 Infection (FALP-COVID)
Investigational- Compassionate Use of Convalescent Plasma From COVID-19 Donors in Oncological and Non-Oncological Patients With Severity Criteria: FALP 001-2020 Trial (FALP-COVID)

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    100
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
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
Study Started
Apr 07
2020
Primary Completion
Apr 06
2021
Anticipated
Study Completion
Apr 06
2021
Anticipated
Last Update
May 12
2020

Biological Convalescent Plasma from COVID-19 donors

Patients that will participate in this clinical trial will be treated with Convalescent Plasma from COVID-19 donors regardless of the arm where they will be included

Cancer patients with COVID 19 infection and severity criteria Experimental

All patients will be treated with 1 or more convalescent plasma units

Cancer patients with COVID 19 infection and risk factors Experimental

All patients will be treated with 1 or more convalescent plasma units

Non-Cancer patients COVID 19 infection and severity criteria Experimental

All patients will be treated with 1 or more convalescent plasma units

Non-cancer patients COVID 19 (+) and risk factors Experimental

All patients will be treated with 1 or more convalescent plasma units

Criteria 

Inclusion Criteria:

For all patients:

A. Patient must sign an informed consent to participate in this trial

B. Signed consent to participate in this trial must be given not after 14 days from the first day of symptoms COVID-19 related

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

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

A. 50 years or older

B. any of the following comorbidities: Diabetes Mellitus, Hypertension, Chronic Obstructive Pulmonary Disease, Chronic Kidney Failure, non-oncological related chronic immunosuppression

C. Total bilirubin>1,2 mg/dl or Blood Urea Nitrogen> 20 mg/dl or Lactate Dehydrogenase>245 U/L

D. D-dimer > 1mg/L

E. Neutrophils 7.3 x 10³ or greater and or Lymphocytes lesser than 0,8 x 10³ µl

F. C reactive protein >9,5 mg/dl and ferritin > 300 ug/ml

G. Interleukin-6 >7 pg/mL

H. antineoplastic treatment such as radiotherapy- cytotoxic chemotherapy- immunotherapy- molecular 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
No Results Posted