Convalescent Plasma as Potential Therapy for Severe COVID-19 Pneumonia

C

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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