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

Phase 2

• Conditions: COVID-19 Infection; General Population; Cancer Patients
• Interventions: Biological: Convalescent Plasma from COVID-19 donors

• Registration Number: NCT04384588
• Lead Sponsor: Fundacion Arturo Lopez Perez

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

Study Timeline

• Study Start: 2020-04-07
• Study First Submitted: 2020-04-29
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-09
• Last Update Submitted: 2020-05-09
• Study First Posted: 2020-05-12
• Last Update Posted: 2020-05-12
• Primary Completion: 2021-04-06
• Study Completion: 2021-04-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-cancer patients COVID 19 (+) and risk factors	Convalescent Plasma from COVID-19 donors	All patients will be treated with 1 or more convalescent plasma units
Cancer patients with COVID 19 infection and risk factors	Convalescent Plasma from COVID-19 donors	All patients will be treated with 1 or more convalescent plasma units
Non-Cancer patients COVID 19 infection and severity criteria	Convalescent Plasma from COVID-19 donors	All patients will be treated with 1 or more convalescent plasma units
Cancer patients with COVID 19 infection and severity criteria	Convalescent Plasma from COVID-19 donors	All patients will be treated with 1 or more convalescent plasma units

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Negativization of COVID 19 load since convalescent plasma use	14 days	negativization of COVID 19 load since convalescent plasma use
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
Viral load measuring	14 days	Viral load measuring
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
Mortality at 30 days, 90 days, 6 months and 1 year	1 year	any cause of mortality during these periods
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
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 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 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

Trial Locations

Locations (1)

Fundacion Arturo Lopez Perez; 🇨🇱 Providencia, Santiago, Chile