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

Fundacion Arturo Lopez Perez

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Cancer Patients; General Population; COVID-19 Infection

Treatments: Biological: Convalescent Plasma from COVID-19 donors

Study type: Interventional

Funder types: Other

Identifiers

NCT04384588

FALP 001-2020

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 4 patient groups

Cancer patients with COVID 19 infection and severity criteria

Experimental group

Description:

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

Treatment:

Biological: Convalescent Plasma from COVID-19 donors

Cancer patients with COVID 19 infection and risk factors

Experimental group

Description:

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

Treatment:

Biological: Convalescent Plasma from COVID-19 donors

Non-Cancer patients COVID 19 infection and severity criteria

Experimental group

Description:

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

Treatment:

Biological: Convalescent Plasma from COVID-19 donors

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

Experimental group

Description:

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

Treatment:

Biological: Convalescent Plasma from COVID-19 donors