Convalescent Plasma as Potential Therapy for Severe COVID-19 Pneumonia

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

Study Overview

• Status: Completed
• Conditions: Covid19 Pneumonia
• Intervention / Treatment: Biological: COVID19 convalescent plasma infusion

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1425
    • Centro de Educación Médica e Investigaciones Clínicas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: severe pneumonia arm; patients with severe COVID19 pneumonia defined by: spontaneous breathing patients with respiratory failure requiring O2 nasal cannula more than 3 L/min or reservoir oxygen mask and SaO2 less than 95% or patients with critical pneumonia define by mechanical ventilation with less than 300 mmHg PaO2/FiO2 or shock or multi-organic dysfunction	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28 days survival	number of subjects surviving at 28 days from plasma infusion	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy of plasma infusion according to antibodies levels in the infuse bags	comparison of clinical efficacy according antibodies levels	28 days
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
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

Collaborators and Investigators

• Sponsor: Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2020
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): February 25, 2021

Study Registration Dates

• First Submitted: August 29, 2020
• First Submitted That Met QC Criteria: August 29, 2020
• First Posted (Actual): September 1, 2020

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; COVID-19; Pneumonia
• Other Study ID Numbers: RValentini

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: we will to share results to compare data with other studies with convalescent plasma infusion in COVID 19 patients after finishing our study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No