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

Study Overview
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Brief Summary
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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
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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

Official Title
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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)

Conditions
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COVID-19 Infection, Cancer Patients, General Population

Intervention / Treatment
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* Biological: Convalescent Plasma from COVID-19 donors


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter, non-randomized, 4 arms
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cancer patients with COVID 19 infection and severity criteria<br>All patients will be treated with 1 or more convalescent plasma units | Biological: Convalescent Plasma from COVID-19 donors<br>* 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<br>|
| Experimental: Cancer patients with COVID 19 infection and risk factors<br>All patients will be treated with 1 or more convalescent plasma units | Biological: Convalescent Plasma from COVID-19 donors<br>* 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<br>|
| Experimental: Non-Cancer patients COVID 19 infection and severity criteria<br>All patients will be treated with 1 or more convalescent plasma units | Biological: Convalescent Plasma from COVID-19 donors<br>* 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<br>|
| Experimental: Non-cancer patients COVID 19 (+) and risk factors<br>All patients will be treated with 1 or more convalescent plasma units | Biological: Convalescent Plasma from COVID-19 donors<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID, convalescent plasma