Convalescent Plasma as Potential Therapy for Severe COVID-19 Pneumonia

Sponsor

Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno (Other)

Overall Status

Completed

CT.gov ID

NCT04535063

Collaborator

(none)

200

Enrollment

Location

Arm

10.3

Actual Duration (Months)

19.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Covid19 Pneumonia	Biological: COVID19 convalescent plasma infusion	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

patients with severe COVID19 pneumonia will be recruited to a single arm therapy group with convalescent plasma from recovered patientspatients with severe COVID19 pneumonia will be recruited to a single arm therapy group with convalescent plasma from recovered patients

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Convalescent Plasma as Potential Therapy for Severe COVID-19 Pneumonia

Actual Study Start Date :

Apr 18, 2020

Actual Primary Completion Date :

Dec 30, 2020

Actual Study Completion Date :

Feb 25, 2021

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

28 days survival [28 days]
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 [28 days]
comparison of clinical efficacy according antibodies levels
clinical efficacy of plasma infusion according to frame time from symptoms onset and hospitalization [28 days]
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 [14 days]
WHO clinical scale is a measure of patient progression through the health-care system with 1 point asymptomatic patient and 10 patient dead

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro de Educación Médica e Investigaciones Clínicas	Buenos Aires		Argentina	1425

Sponsors and Collaborators

Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ricardo Valentini, Medical Doctor, Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

ClinicalTrials.gov Identifier:

NCT04535063

Other Study ID Numbers:

RValentini

First Posted:

Sep 1, 2020

Last Update Posted:

Jul 19, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Pneumonia

Study Results

No Results Posted as of Jul 19, 2022