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

COVID-19 Infection Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04384588
• Other study ID #: FALP 001-2020
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 7, 2020
• Est. completion date: April 6, 2021

Study information

• Verified date: May 2020
• Source: Fundacion Arturo Lopez Perez
• Contact: Christian Caglevic, MD
• Phone: 56981369487
• Email: christian.caglevic[@]falp.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 6, 2021
• Est. primary completion date: April 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Patients
• COVID-19 Infection
• General Population
• Infection

Intervention

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

Locations

Country	Name	City	State
Chile	Fundacion Arturo Lopez Perez	Providencia	Santiago

Sponsors (3)

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

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Mortality at 30 days, 90 days, 6 months and 1 year	any cause of mortality during these periods	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Total number of days of mechanical ventilatory support	total number of days of mechanical ventilatory support	1 year
Secondary	Total number of hospitalization days in patients treated with convalescent plasma	total number of hospitalization days in patients treated with convalescent plasma	1 year
Secondary	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
Secondary	Viral load measuring	Viral load measuring	14 days
Secondary	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
Secondary	Negativization of COVID 19 load since convalescent plasma use	negativization of COVID 19 load since convalescent plasma use	14 days
Secondary	Negativization of COVID 19 load since hospitalization	negativization of COVID 19 load since hospitalization	14 days
Secondary	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
Secondary	Donor Interferon Gamma profile characterization	Interferon Gamma measurement from donor	1 day
Secondary	Donor Granulocyte Macrophage Colony Stimulating Factor characterization	Granulocyte Macrophage Colony Stimulating Factor measurement from donor	1 day
Secondary	Donor Tumor Necrosis Factor Alfa characterization	Tumor Necrosis Factor Alfa measurement from donor	1 day
Secondary	Donor Interleukin -1 beta characterization	Interleukin -1 beta measurement from donor	1 day
Secondary	Donor Interleukin-2 characterization	Interleukin -2 measurement from donor	1 day
Secondary	Donor Interleukin-4 characterization	Interleukin -4 measurement from donor	1 day
Secondary	Donor Interleukin-6 characterization	Interleukin -6 measurement from donor	1 day
Secondary	Donor Interleukin-8 characterization	Interleukin -8 measurement from donor	1 day
Secondary	Donor Interleukin-10 characterization	Interleukin -10 measurement from donor	1 day
Secondary	Receptor Interferon Gamma profile characterization	Interferon Gamma measurement from receptor	1 day
Secondary	Receptor Granulocyte Macrophage Colony Stimulating Factor characterization	Granulocyte Macrophage Colony Stimulating Factor measurement from receptor	1 day
Secondary	receptor Tumor Necrosis Factor Alfa characterization	Tumor Necrosis Factor Alfa measurement from receptor	1 day
Secondary	receptor Interleukin -1 beta characterization	Interleukin -1 beta measurement from receptor	1 day
Secondary	Receptor Interleukin-2 characterization	Interleukin -2 measurement from receptor	1 day
Secondary	Receptor Interleukin-4 characterization	Interleukin -4 measurement from receptor	1 day
Secondary	Receptor Interleukin-6 characterization	Interleukin -6 measurement from receptor	1 day
Secondary	Receptor Interleukin-8 characterization	Interleukin -8 measurement from receptor	1 day
Secondary	Receptor Interleukin-10 characterization	Interleukin -10 measurement from receptor	1 day