Clinical trial NCT04384588: COVID19-Convalescent Plasma for Treating Patients With Active Symptomatic COVID 19 Infection (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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: COVID-19 Infection
Cancer Patients
General Population
Keywords: convalescent plasma
COVID
Lead sponsor: Fundacion Arturo Lopez Perez
Sponsor class: OTHER
Collaborators: name: Confederación de la Producción y del Comercio (CPC)
name: Bolsa de Santiago
First posted: 2020-05-12
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, non-randomized, 4 arms
Primary purpose: TREATMENT

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

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

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

Primary outcomes:
measure: in-hospital mortality secondary to COVID-19 among patients treated with convalescent plasma
timeFrame: 1 year
measure: safety of the use of convalescent plasma drom COVID 19 donors
timeFrame: 1 year
Secondary outcomes:
measure: Mortality at 30 days, 90 days, 6 months and 1 year
timeFrame: 1 year
measure: in-hospital Mortality COVID-19 related compared with non-treated population according to Chilean official reports
timeFrame: through study completion, an average of 1 year
measure: Number of days of hospitalization in high complexity facilities after convalescent plasma use
timeFrame: 1 year
measure: Number of days of hospitalization in intensive care unit after convalescent plasma use
timeFrame: 1 year
measure: Number of days of mechanical ventilatory support in patients after convalescent plasma use
timeFrame: 1 year
measure: Total number of days of mechanical ventilatory support
timeFrame: 1 year
measure: Total number of hospitalization days in patients treated with convalescent plasma
timeFrame: 1 year
measure: Number of hospitalization days in patients after treatment with convalescent plasma
timeFrame: 1 year
measure: Viral load measuring
timeFrame: 14 days
measure: Immunological response in treated patients (COVID19-Immunoglobulin M and Immunoglobulin G, neutralizing antibodies)
timeFrame: day 1 of hospitalization
measure: Negativization of COVID 19 load since convalescent plasma use
timeFrame: 14 days
measure: Negativization of COVID 19 load since hospitalization
timeFrame: 14 days
measure: Negativization of COVID 19 load since first reported symptoms COVID-19 related
timeFrame: 14 days
measure: Donor Interferon Gamma profile characterization
timeFrame: 1 day
measure: Donor Granulocyte Macrophage Colony Stimulating Factor characterization
timeFrame: 1 day
measure: Donor Tumor Necrosis Factor Alfa characterization
timeFrame: 1 day
measure: Donor Interleukin -1 beta characterization
timeFrame: 1 day
measure: Donor Interleukin-2 characterization
timeFrame: 1 day
measure: Donor Interleukin-4 characterization
timeFrame: 1 day
measure: Donor Interleukin-6 characterization
timeFrame: 1 day
measure: Donor Interleukin-8 characterization
timeFrame: 1 day
measure: Donor Interleukin-10 characterization
timeFrame: 1 day
measure: Receptor Interferon Gamma profile characterization
timeFrame: 1 day
measure: Receptor Granulocyte Macrophage Colony Stimulating Factor characterization
timeFrame: 1 day
measure: receptor Tumor Necrosis Factor Alfa characterization
timeFrame: 1 day
measure: receptor Interleukin -1 beta characterization
timeFrame: 1 day
measure: Receptor Interleukin-2 characterization
timeFrame: 1 day
measure: Receptor Interleukin-4 characterization
timeFrame: 1 day
measure: Receptor Interleukin-6 characterization
timeFrame: 1 day
measure: Receptor Interleukin-8 characterization
timeFrame: 1 day
measure: Receptor Interleukin-10 characterization
timeFrame: 1 day
Other outcomes:
Locations:
city: Providencia
country: Chile
facility: Fundacion Arturo Lopez Perez
state: Santiago
Study officials:
affiliation: Fundacion Arturo Lopez Perez
name: Raimundo Gazitua, MD
role: PRINCIPAL_INVESTIGATOR
References: