Convalescent Plasma as Potential Therapy for Severe COVID-19 Pneumonia

Covid19 Pneumonia Clinical Trial

Official title:

Convalescent Plasma as Potential Therapy for Severe COVID-19 Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04535063
• Other study ID #: RValentini
• Status: Completed
• Phase: Phase 3
• Start date: April 18, 2020
• Est. completion date: February 25, 2021

Study information

• Verified date: July 2022
• Source: Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determinate feasibility, safety and outcome with convalescent plasma in patients with severe COVID-19 penumonia

Description:

COVID-19 convalescent plasma will be infused to patients with severe COVID-19 pneumonia to determine feasibility, safety and clinical outcome efficacy by survival at-28 days. Data will be compared with match control arm patients without plasma infusion

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 25, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients =18, and non-pregnant women
• Severe or critical COVID-19 disease define by one or more of the following: blood oxygen saturation = 94% on supplemental oxygen by nasal cannula at least 3 L/min, non-rebreathing mask (NRO2-mask) or on noninvasive ventilation; and pulmonary infiltrates with >50% increase within 24 to 48 hours in chest-X-ray or chest CT. Life-threatening disease was defined as one or more of the following: respiratory failure on mechanical ventilation with PaO2 / FiO2 less than 300 mm Hg, septic shock, and/or multiple organ dysfunction.
• 10 days from the onset of symptoms or = 7 days on mechanical ventilation. -

Exclusion Criteria:

• More than 10 days from symptoms onset or more than 7 days on mechanical ventilation
• Pregnancy
• Contraindication for plasma infusion because anaphylaxis history
• Patients with high risk of circulatory overload
• Limitation of therapeutic efforts
• Refractory shock define by norepinephrine dose more than 1 ug/k/min
• SOFA score more than 15 points at the moment of the protocol inclusion i Coagulopathy with requirements of plasma infusion

Related Conditions & MeSH terms

• COVID-19
• Covid19 Pneumonia
• Pneumonia

Intervention

Biological:
• COVID19 convalescent plasma infusion
intravenous infusion of 300-600 mL of convalescent plasma with an antibody title more than 3 according to chemiluminescent microparticle immunoassay (Architect Plus Abbott)

Locations

Country	Name	City	State
Argentina	Centro de Educación Médica e Investigaciones Clínicas	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28 days survival	number of subjects surviving at 28 days from plasma infusion	28 days
Secondary	efficacy of plasma infusion according to antibodies levels in the infuse bags	comparison of clinical efficacy according antibodies levels	28 days
Secondary	clinical efficacy of plasma infusion according to frame time from symptoms onset and hospitalization	we will search if clinical efficacy is better when the earlier the infusion is decided	28 days
Secondary	change in clinical WHO ordinal scale from 1 to 10 points	WHO clinical scale is a measure of patient progression through the health-care system with 1 point asymptomatic patient and 10 patient dead	14 days