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

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Fundacion Arturo Lopez Perez
Updated on 19 February 2024
diabetes
absolute neutrophil count
renal failure
interleukin-6
neutrophil count
hypertension
dyspnea
immunosuppression
chronic disease
chronic obstructive pulmonary disease
d-dimer
covid-19
interleukins
lung disease
lactate dehydrogenase
fraction of inspired oxygen (fio2)

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

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

Details
Condition General Population, COVID-19 Infection, Cancer Patients
Age 15-100 years
Treatment Convalescent Plasma from COVID-19 donors
Clinical Study IdentifierNCT04384588
SponsorFundacion Arturo Lopez Perez
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

For all patients
Patient must sign an informed consent to participate in this trial
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
50 years or older
any of the following comorbidities: Diabetes Mellitus, Hypertension, Chronic Obstructive Pulmonary Disease, Chronic Kidney Failure, non-oncological related chronic immunosuppression
Total bilirubin>1,2 mg/dl or Blood Urea Nitrogen> 20 mg/dl or Lactate Dehydrogenase>245 U/L
D-dimer > 1mg/L
Neutrophils 7.3 x 10 or greater and or Lymphocytes lesser than 0,8 x 10 l
C reactive protein >9,5 mg/dl and ferritin > 300 ug/ml
Interleukin-6 >7 pg/mL
antineoplastic treatment such as radiotherapy- cytotoxic chemotherapy- immunotherapymolecular 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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