Convalescent Plasma as Potential Therapy for Severe COVID-19 Pneumonia

Phase 3

Completed

• Conditions: Covid19 Pneumonia
• Interventions: Biological: COVID19 convalescent plasma infusion

• Registration Number: NCT04535063
• Lead Sponsor: Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

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

Study Timeline

• Study Start: 2020-04-18
• Study First Submitted: 2020-08-29
• Study First Submitted QC: 2020-08-29
• Study First Posted: 2020-09-01
• Primary Completion: 2020-12-30
• Study Completion: 2021-02-25
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
severe pneumonia arm	COVID19 convalescent plasma infusion	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

Primary Outcome Measures

Name	Time	Method
28 days survival	28 days	number of subjects surviving at 28 days from plasma infusion

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Centro de Educación Médica e Investigaciones Clínicas; 🇦🇷 Buenos Aires, Argentina