Convalescent Plasma as Potential Therapy for Severe COVID-19 Pneumonia

NCT ID: NCT04535063

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-18
• Study Completion Date: 2021-02-25

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

Conditions

Covid19 Pneumonia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

COVID19 convalescent plasma infusion

Intervention Type: BIOLOGICAL

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

Interventions

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)

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

OTHER

Sponsor Role: lead

Responsible Party

Ricardo Valentini

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro de Educación Médica e Investigaciones Clínicas

Buenos Aires, , Argentina

Countries

Argentina

Other Identifiers

RValentini

Identifier Type: -

Identifier Source: org_study_id