Convalescent Plasma as Potential Therapy for Severe COVID-19 Pneumonia

NCT04535063 | Completed Phase 3

• 1 other identifier: RValentini
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Covid19 Pneumonia

Outcome Measures

Primary Outcomes (1)

• 28 days survival

  number of subjects surviving at 28 days from plasma infusion

  28 days

Secondary Outcomes (3)

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

  28 days

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

  28 days

• change in clinical WHO ordinal scale from 1 to 10 points

  14 days

Study Arms (1)

severe pneumonia arm

OTHER

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

Biological: COVID19 convalescent plasma infusion

Interventions

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)

severe pneumonia arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• days from the onset of symptoms or ≤ 7 days on mechanical ventilation. -

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno: lead

Study Sites (1)

Centro de Educación Médica e Investigaciones Clínicas

Buenos Aires, 1425, Argentina

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: patients with severe COVID19 pneumonia will be recruited to a single arm therapy group with convalescent plasma from recovered patients

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: September 1, 2020
• Study Start: April 18, 2020
• Primary Completion: December 30, 2020
• Study Completion: February 25, 2021
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)