Back to resultsCOVID19-Convalescent Plasma for Treating Patients With Active Symptomatic COVID 19 Infection (FALP-COVID) (FALP-COVID)
Primary Purpose
COVID-19 Infection, Cancer Patients, General Population
Status
Unknown status
Phase
Phase 2
Locations
Chile
Study Type
Interventional
Intervention
Convalescent Plasma from COVID-19 donors
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Infection focused on measuring convalescent plasma, COVID
Eligibility 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
Sites / Locations
- Fundacion Arturo Lopez PerezRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Cancer patients with COVID 19 infection and severity criteria
Cancer patients with COVID 19 infection and risk factors
Non-Cancer patients COVID 19 infection and severity criteria
Non-cancer patients COVID 19 (+) and risk factors
Arm Description
All patients will be treated with 1 or more convalescent plasma units
All patients will be treated with 1 or more convalescent plasma units
All patients will be treated with 1 or more convalescent plasma units
All patients will be treated with 1 or more convalescent plasma units
Outcomes
Primary Outcome Measures
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
safety of the use of convalescent plasma drom COVID 19 donors
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
any cause of mortality during these periods
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
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
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
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
Total number of days of mechanical ventilatory support
total number of days of mechanical ventilatory support
Total number of hospitalization days in patients treated with convalescent plasma
total number of hospitalization days in patients treated with convalescent plasma
Number of hospitalization days in patients after treatment with convalescent plasma
total number of hospitalization days in patients after treatment with convalescent plasma
Viral load measuring
Viral load measuring
Immunological response in treated patients (COVID19-Immunoglobulin M and Immunoglobulin G, neutralizing antibodies)
COVID19-Immunoglobulin M and Immunoglobulin G, neutralizing antibodies
Negativization of COVID 19 load since convalescent plasma use
negativization of COVID 19 load since convalescent plasma use
Negativization of COVID 19 load since hospitalization
negativization of COVID 19 load since hospitalization
Negativization of COVID 19 load since first reported symptoms COVID-19 related
negativization of COVID 19 load since first reported symptoms COVID-19 related
Donor Interferon Gamma profile characterization
Interferon Gamma measurement from donor
Donor Granulocyte Macrophage Colony Stimulating Factor characterization
Granulocyte Macrophage Colony Stimulating Factor measurement from donor
Donor Tumor Necrosis Factor Alfa characterization
Tumor Necrosis Factor Alfa measurement from donor
Donor Interleukin -1 beta characterization
Interleukin -1 beta measurement from donor
Donor Interleukin-2 characterization
Interleukin -2 measurement from donor
Donor Interleukin-4 characterization
Interleukin -4 measurement from donor
Donor Interleukin-6 characterization
Interleukin -6 measurement from donor
Donor Interleukin-8 characterization
Interleukin -8 measurement from donor
Donor Interleukin-10 characterization
Interleukin -10 measurement from donor
Receptor Interferon Gamma profile characterization
Interferon Gamma measurement from receptor
Receptor Granulocyte Macrophage Colony Stimulating Factor characterization
Granulocyte Macrophage Colony Stimulating Factor measurement from receptor
receptor Tumor Necrosis Factor Alfa characterization
Tumor Necrosis Factor Alfa measurement from receptor
receptor Interleukin -1 beta characterization
Interleukin -1 beta measurement from receptor
Receptor Interleukin-2 characterization
Interleukin -2 measurement from receptor
Receptor Interleukin-4 characterization
Interleukin -4 measurement from receptor
Receptor Interleukin-6 characterization
Interleukin -6 measurement from receptor
Receptor Interleukin-8 characterization
Interleukin -8 measurement from receptor
Receptor Interleukin-10 characterization
Interleukin -10 measurement from receptor
Full Information
NCT ID
NCT04384588
First Posted
April 29, 2020
Last Updated
May 9, 2020
Sponsor
Fundacion Arturo Lopez Perez
Collaborators
Confederación de la Producción y del Comercio (CPC), Bolsa de Santiago
1. Study Identification
Unique Protocol Identification Number
NCT04384588
Brief Title
COVID19-Convalescent Plasma for Treating Patients With Active Symptomatic COVID 19 Infection (FALP-COVID)
Acronym
FALP-COVID
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 7, 2020 (Actual)
Primary Completion Date
April 6, 2021 (Anticipated)
Study Completion Date
April 6, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion Arturo Lopez Perez
Collaborators
Confederación de la Producción y del Comercio (CPC), Bolsa de Santiago
4. Oversight
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
Data Monitoring Committee
Yes
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Infection, Cancer Patients, General Population
Keywords
convalescent plasma, COVID
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, non-randomized, 4 arms
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cancer patients with COVID 19 infection and severity criteria
Arm Type
Experimental
Arm Description
All patients will be treated with 1 or more convalescent plasma units
Arm Title
Cancer patients with COVID 19 infection and risk factors
Arm Type
Experimental
Arm Description
All patients will be treated with 1 or more convalescent plasma units
Arm Title
Non-Cancer patients COVID 19 infection and severity criteria
Arm Type
Experimental
Arm Description
All patients will be treated with 1 or more convalescent plasma units
Arm Title
Non-cancer patients COVID 19 (+) and risk factors
Arm Type
Experimental
Arm Description
All patients will be treated with 1 or more convalescent plasma units
Intervention Type
Biological
Intervention Name(s)
Convalescent Plasma from COVID-19 donors
Intervention Description
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
Primary Outcome Measure Information:
Title
in-hospital mortality secondary to COVID-19 among patients treated with convalescent plasma
Description
in-hospital mortality secondary to COVID-19 among patients treated with convalescent plasma
Time Frame
1 year
Title
safety of the use of convalescent plasma drom COVID 19 donors
Description
safety of convalescent plasma from COVID 19 donors (CTCAE V5.0)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Mortality at 30 days, 90 days, 6 months and 1 year
Description
any cause of mortality during these periods
Time Frame
1 year
Title
in-hospital Mortality COVID-19 related compared with non-treated population according to Chilean official reports
Description
based on results from this trial comparing with official information
Time Frame
through study completion, an average of 1 year
Title
Number of days of hospitalization in high complexity facilities after convalescent plasma use
Description
number of days of hospitalization in high complexity facilities after convalescent plasma use
Time Frame
1 year
Title
Number of days of hospitalization in intensive care unit after convalescent plasma use
Description
number of days of hospitalization in intensive care unit after convalescent plasma use
Time Frame
1 year
Title
Number of days of mechanical ventilatory support in patients after convalescent plasma use
Description
number of days of mechanical ventilatory support in patients after convalescent plasma use
Time Frame
1 year
Title
Total number of days of mechanical ventilatory support
Description
total number of days of mechanical ventilatory support
Time Frame
1 year
Title
Total number of hospitalization days in patients treated with convalescent plasma
Description
total number of hospitalization days in patients treated with convalescent plasma
Time Frame
1 year
Title
Number of hospitalization days in patients after treatment with convalescent plasma
Description
total number of hospitalization days in patients after treatment with convalescent plasma
Time Frame
1 year
Title
Viral load measuring
Description
Viral load measuring
Time Frame
14 days
Title
Immunological response in treated patients (COVID19-Immunoglobulin M and Immunoglobulin G, neutralizing antibodies)
Description
COVID19-Immunoglobulin M and Immunoglobulin G, neutralizing antibodies
Time Frame
day 1 of hospitalization
Title
Negativization of COVID 19 load since convalescent plasma use
Description
negativization of COVID 19 load since convalescent plasma use
Time Frame
14 days
Title
Negativization of COVID 19 load since hospitalization
Description
negativization of COVID 19 load since hospitalization
Time Frame
14 days
Title
Negativization of COVID 19 load since first reported symptoms COVID-19 related
Description
negativization of COVID 19 load since first reported symptoms COVID-19 related
Time Frame
14 days
Title
Donor Interferon Gamma profile characterization
Description
Interferon Gamma measurement from donor
Time Frame
1 day
Title
Donor Granulocyte Macrophage Colony Stimulating Factor characterization
Description
Granulocyte Macrophage Colony Stimulating Factor measurement from donor
Time Frame
1 day
Title
Donor Tumor Necrosis Factor Alfa characterization
Description
Tumor Necrosis Factor Alfa measurement from donor
Time Frame
1 day
Title
Donor Interleukin -1 beta characterization
Description
Interleukin -1 beta measurement from donor
Time Frame
1 day
Title
Donor Interleukin-2 characterization
Description
Interleukin -2 measurement from donor
Time Frame
1 day
Title
Donor Interleukin-4 characterization
Description
Interleukin -4 measurement from donor
Time Frame
1 day
Title
Donor Interleukin-6 characterization
Description
Interleukin -6 measurement from donor
Time Frame
1 day
Title
Donor Interleukin-8 characterization
Description
Interleukin -8 measurement from donor
Time Frame
1 day
Title
Donor Interleukin-10 characterization
Description
Interleukin -10 measurement from donor
Time Frame
1 day
Title
Receptor Interferon Gamma profile characterization
Description
Interferon Gamma measurement from receptor
Time Frame
1 day
Title
Receptor Granulocyte Macrophage Colony Stimulating Factor characterization
Description
Granulocyte Macrophage Colony Stimulating Factor measurement from receptor
Time Frame
1 day
Title
receptor Tumor Necrosis Factor Alfa characterization
Description
Tumor Necrosis Factor Alfa measurement from receptor
Time Frame
1 day
Title
receptor Interleukin -1 beta characterization
Description
Interleukin -1 beta measurement from receptor
Time Frame
1 day
Title
Receptor Interleukin-2 characterization
Description
Interleukin -2 measurement from receptor
Time Frame
1 day
Title
Receptor Interleukin-4 characterization
Description
Interleukin -4 measurement from receptor
Time Frame
1 day
Title
Receptor Interleukin-6 characterization
Description
Interleukin -6 measurement from receptor
Time Frame
1 day
Title
Receptor Interleukin-8 characterization
Description
Interleukin -8 measurement from receptor
Time Frame
1 day
Title
Receptor Interleukin-10 characterization
Description
Interleukin -10 measurement from receptor
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Caglevic, MD
Phone
56981369487
Email
christian.caglevic@falp.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raimundo Gazitua, MD
Organizational Affiliation
Fundacion Arturo Lopez Perez
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundacion Arturo Lopez Perez
City
Providencia
State/Province
Santiago
ZIP/Postal Code
7500921
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Caglevic, md
Email
christian.caglevic@falp.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
COVID19-Convalescent Plasma for Treating Patients With Active Symptomatic COVID 19 Infection (FALP-COVID)
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