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Convalescent Plasma as Potential Therapy for Severe COVID-19 Pneumonia

Primary Purpose

Covid19 Pneumonia

Status
Completed
Phase
Phase 3
Locations
Argentina
Study Type
Interventional
Intervention
COVID19 convalescent plasma infusion
Sponsored by
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro de Educación Médica e Investigaciones Clínicas

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

severe pneumonia arm

Arm Description

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

Outcomes

Primary Outcome Measures

28 days survival
number of subjects surviving at 28 days from plasma infusion

Secondary Outcome Measures

efficacy of plasma infusion according to antibodies levels in the infuse bags
comparison of clinical efficacy according antibodies levels
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
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

Full Information

First Posted
August 29, 2020
Last Updated
July 18, 2022
Sponsor
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
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1. Study Identification

Unique Protocol Identification Number
NCT04535063
Brief Title
Convalescent Plasma as Potential Therapy for Severe COVID-19 Pneumonia
Official Title
Convalescent Plasma as Potential Therapy for Severe COVID-19 Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 18, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
February 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19 Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
patients with severe COVID19 pneumonia will be recruited to a single arm therapy group with convalescent plasma from recovered patients
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
severe pneumonia arm
Arm Type
Other
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
COVID19 convalescent plasma infusion
Intervention Description
intravenous infusion of 300-600 mL of convalescent plasma with an antibody title more than 3 according to chemiluminescent microparticle immunoassay (Architect Plus Abbott)
Primary Outcome Measure Information:
Title
28 days survival
Description
number of subjects surviving at 28 days from plasma infusion
Time Frame
28 days
Secondary Outcome Measure Information:
Title
efficacy of plasma infusion according to antibodies levels in the infuse bags
Description
comparison of clinical efficacy according antibodies levels
Time Frame
28 days
Title
clinical efficacy of plasma infusion according to frame time from symptoms onset and hospitalization
Description
we will search if clinical efficacy is better when the earlier the infusion is decided
Time Frame
28 days
Title
change in clinical WHO ordinal scale from 1 to 10 points
Description
WHO clinical scale is a measure of patient progression through the health-care system with 1 point asymptomatic patient and 10 patient dead
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centro de Educación Médica e Investigaciones Clínicas
City
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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

Learn more about this trial

Convalescent Plasma as Potential Therapy for Severe COVID-19 Pneumonia

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