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

Sponsor

Fundacion Arturo Lopez Perez (Other)

Overall Status

Unknown status

CT.gov ID

NCT04384588

Collaborator

Confederación de la Producción y del Comercio (CPC) (Other), Bolsa de Santiago (Other)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Infection Cancer Patients General Population	Biological: Convalescent Plasma from COVID-19 donors	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Multicenter, non-randomized, 4 armsMulticenter, non-randomized, 4 arms

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Apr 7, 2020

Anticipated Primary Completion Date :

Apr 6, 2021

Anticipated Study Completion Date :

Apr 6, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

For all patients:

Patient must sign an informed consent to participate in this trial
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

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

50 years or older
any of the following comorbidities: Diabetes Mellitus, Hypertension, Chronic Obstructive Pulmonary Disease, Chronic Kidney Failure, non-oncological related chronic immunosuppression
Total bilirubin>1,2 mg/dl or Blood Urea Nitrogen> 20 mg/dl or Lactate Dehydrogenase>245 U/L
D-dimer > 1mg/L
Neutrophils 7.3 x 10³ or greater and or Lymphocytes lesser than 0,8 x 10³ µl
C reactive protein >9,5 mg/dl and ferritin > 300 ug/ml
Interleukin-6 >7 pg/mL
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fundacion Arturo Lopez Perez	Providencia	Santiago	Chile	7500921

Sponsors and Collaborators

Fundacion Arturo Lopez Perez
Confederación de la Producción y del Comercio (CPC)
Bolsa de Santiago

Investigators

Principal Investigator: Raimundo Gazitua, MD, Fundacion Arturo Lopez Perez

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fundacion Arturo Lopez Perez

ClinicalTrials.gov Identifier:

NCT04384588

Other Study ID Numbers:

FALP 001-2020

First Posted:

May 12, 2020

Last Update Posted:

May 12, 2020

Last Verified:

May 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Fundacion Arturo Lopez Perez

convalescent plasma

COVID

Additional relevant MeSH terms:

Infections

COVID-19

Study Results

No Results Posted as of May 12, 2020