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

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

Study Overview

• Status: Unknown
• Conditions: Cancer Patients; COVID-19 Infection; General Population
• Intervention / Treatment: Biological: Convalescent Plasma from COVID-19 donors

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Christian Caglevic, MD; Phone Number: 56981369487; Email: christian.caglevic@falp.org

Study Locations

• Chile
  • Santiago
    • Providencia, Santiago, Chile, 7500921
      • Recruiting
      • Fundacion Arturo Lopez Perez
      • Contact: Christian Caglevic, md; Email: christian.caglevic@falp.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

1. 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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cancer patients with COVID 19 infection and severity criteria; All patients will be treated with 1 or more convalescent plasma units	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
EXPERIMENTAL: Cancer patients with COVID 19 infection and risk factors; All patients will be treated with 1 or more convalescent plasma units	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
EXPERIMENTAL: Non-Cancer patients COVID 19 infection and severity criteria; All patients will be treated with 1 or more convalescent plasma units	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
EXPERIMENTAL: Non-cancer patients COVID 19 (+) and risk factors; All patients will be treated with 1 or more convalescent plasma units	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
in-hospital mortality secondary to COVID-19 among patients treated with convalescent plasma	in-hospital mortality secondary to COVID-19 among patients treated with convalescent plasma	1 year
safety of the use of convalescent plasma drom COVID 19 donors	safety of convalescent plasma from COVID 19 donors (CTCAE V5.0)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality at 30 days, 90 days, 6 months and 1 year	any cause of mortality during these periods	1 year
in-hospital Mortality COVID-19 related compared with non-treated population according to Chilean official reports	based on results from this trial comparing with official information	through study completion, an average of 1 year
Number of days of hospitalization in high complexity facilities after convalescent plasma use	number of days of hospitalization in high complexity facilities after convalescent plasma use	1 year
Number of days of hospitalization in intensive care unit after convalescent plasma use	number of days of hospitalization in intensive care unit after convalescent plasma use	1 year
Number of days of mechanical ventilatory support in patients after convalescent plasma use	number of days of mechanical ventilatory support in patients after convalescent plasma use	1 year
Total number of days of mechanical ventilatory support	total number of days of mechanical ventilatory support	1 year
Total number of hospitalization days in patients treated with convalescent plasma	total number of hospitalization days in patients treated with convalescent plasma	1 year
Number of hospitalization days in patients after treatment with convalescent plasma	total number of hospitalization days in patients after treatment with convalescent plasma	1 year
Viral load measuring	Viral load measuring	14 days
Immunological response in treated patients (COVID19-Immunoglobulin M and Immunoglobulin G, neutralizing antibodies)	COVID19-Immunoglobulin M and Immunoglobulin G, neutralizing antibodies	day 1 of hospitalization
Negativization of COVID 19 load since convalescent plasma use	negativization of COVID 19 load since convalescent plasma use	14 days
Negativization of COVID 19 load since hospitalization	negativization of COVID 19 load since hospitalization	14 days
Negativization of COVID 19 load since first reported symptoms COVID-19 related	negativization of COVID 19 load since first reported symptoms COVID-19 related	14 days
Donor Interferon Gamma profile characterization	Interferon Gamma measurement from donor	1 day
Donor Granulocyte Macrophage Colony Stimulating Factor characterization	Granulocyte Macrophage Colony Stimulating Factor measurement from donor	1 day
Donor Tumor Necrosis Factor Alfa characterization	Tumor Necrosis Factor Alfa measurement from donor	1 day
Donor Interleukin -1 beta characterization	Interleukin -1 beta measurement from donor	1 day
Donor Interleukin-2 characterization	Interleukin -2 measurement from donor	1 day
Donor Interleukin-4 characterization	Interleukin -4 measurement from donor	1 day
Donor Interleukin-6 characterization	Interleukin -6 measurement from donor	1 day
Donor Interleukin-8 characterization	Interleukin -8 measurement from donor	1 day
Donor Interleukin-10 characterization	Interleukin -10 measurement from donor	1 day
Receptor Interferon Gamma profile characterization	Interferon Gamma measurement from receptor	1 day
Receptor Granulocyte Macrophage Colony Stimulating Factor characterization	Granulocyte Macrophage Colony Stimulating Factor measurement from receptor	1 day
receptor Tumor Necrosis Factor Alfa characterization	Tumor Necrosis Factor Alfa measurement from receptor	1 day
receptor Interleukin -1 beta characterization	Interleukin -1 beta measurement from receptor	1 day
Receptor Interleukin-2 characterization	Interleukin -2 measurement from receptor	1 day
Receptor Interleukin-4 characterization	Interleukin -4 measurement from receptor	1 day
Receptor Interleukin-6 characterization	Interleukin -6 measurement from receptor	1 day
Receptor Interleukin-8 characterization	Interleukin -8 measurement from receptor	1 day
Receptor Interleukin-10 characterization	Interleukin -10 measurement from receptor	1 day

Collaborators and Investigators

• Sponsor: Fundacion Arturo Lopez Perez
• Collaborators: Confederación de la Producción y del Comercio (CPC); Bolsa de Santiago
• Investigators: Principal Investigator: Raimundo Gazitua, MD, Fundacion Arturo Lopez Perez

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 7, 2020
• Primary Completion (ANTICIPATED): April 6, 2021
• Study Completion (ANTICIPATED): April 6, 2021

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: May 9, 2020
• First Posted (ACTUAL): May 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 9, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: COVID; convalescent plasma
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Infections
• Other Study ID Numbers: FALP 001-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No