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OpenTrials
Completed

NCT Number: NCT04535063

Convalescent Plasma as Potential Therapy for Severe COVID-19 Pneumonia

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro de Educación Médica e Investigaciones Clínicas

Buenos Aires, 1425, Argentina

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COVID19 convalescent plasma infusion

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)

Primary outcomes

  1. 28 days survival

    Time frame: 28 days

    number of subjects surviving at 28 days from plasma infusion

Secondary outcomes

  1. efficacy of plasma infusion according to antibodies levels in the infuse bags

    Time frame: 28 days

    comparison of clinical efficacy according antibodies levels

  2. clinical efficacy of plasma infusion according to frame time from symptoms onset and hospitalization

    Time frame: 28 days

    we will search if clinical efficacy is better when the earlier the infusion is decided

  3. change in clinical WHO ordinal scale from 1 to 10 points

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Sep 1, 2020
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.