Convalescent Plasma as Potential Therapy for Severe COVID-19 Pneumonia

Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

Status and phase: Completed; Phase 3

Conditions: Covid19 Pneumonia

Treatments: Biological: COVID19 convalescent plasma infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT04535063

RValentini

Details and patient eligibility

About

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

Full 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

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

severe pneumonia arm

Other group

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

Treatment:

Biological: COVID19 convalescent plasma infusion