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

NCT04384588 | Unknown Phase 2 DMC

• 1 other identifier: FALP 001-2020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19 Infection; Cancer Patients; General Population

Keywords

convalescent plasma; COVID

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (31)

• Mortality at 30 days, 90 days, 6 months and 1 year

  1 year

• in-hospital Mortality COVID-19 related compared with non-treated population according to Chilean official reports

  through study completion, an average of 1 year

• 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

  1 year

• Number of days of mechanical ventilatory support in patients after convalescent plasma use

  1 year

Study Arms (4)

Cancer patients with COVID 19 infection and severity criteria

EXPERIMENTAL

All patients will be treated with 1 or more convalescent plasma units

Biological: Convalescent Plasma from COVID-19 donors

Cancer patients with COVID 19 infection and risk factors

EXPERIMENTAL

All patients will be treated with 1 or more convalescent plasma units

Biological: Convalescent Plasma from COVID-19 donors

Non-Cancer patients COVID 19 infection and severity criteria

EXPERIMENTAL

All patients will be treated with 1 or more convalescent plasma units

Biological: Convalescent Plasma from COVID-19 donors

Non-cancer patients COVID 19 (+) and risk factors

EXPERIMENTAL

All patients will be treated with 1 or more convalescent plasma units

Biological: Convalescent Plasma from COVID-19 donors

Interventions

Convalescent Plasma from COVID-19 donors BIOLOGICAL

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

Cancer patients with COVID 19 infection and risk factors; Cancer patients with COVID 19 infection and severity criteria; Non-Cancer patients COVID 19 infection and severity criteria; Non-cancer patients COVID 19 (+) and risk factors

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion Arturo Lopez Perez: lead
• Confederación de la Producción y del Comercio (CPC): collaborator
• Bolsa de Santiago: collaborator

Study Sites (1)

Fundacion Arturo Lopez Perez

Providencia, Santiago Metropolitan, 7500921, Chile

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Raimundo Gazitua, MD

  Fundacion Arturo Lopez Perez

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Caglevic, MD

CONTACT

56981369487; christian.caglevic@falp.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, non-randomized, 4 arms

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 12, 2020
• Study Start: April 7, 2020
• Primary Completion: April 6, 2021
• Study Completion: April 6, 2021
• Last Updated: May 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)