Status:
UNKNOWN
COVID19-Convalescent Plasma for Treating Patients With Active Symptomatic COVID 19 Infection (FALP-COVID)
Lead Sponsor:
Fundacion Arturo Lopez Perez
Collaborating Sponsors:
Confederación de la Producción y del Comercio (CPC)
Bolsa de Santiago
Conditions:
COVID-19 Infection
Cancer Patients
Eligibility:
All Genders
15+ years
Phase:
PHASE2
PHASE3
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 c...
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 curr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 6 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04384588
Start Date
April 7 2020
End Date
April 6 2021
Last Update
May 12 2020
Active Locations (1)
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1
Fundacion Arturo Lopez Perez
Providencia, Santiago Metropolitan, Chile, 7500921