NCT04391101

Brief Summary

Convalescent plasma has been used for over 100 years in the treatment of severe acute respiratory infections of viral origin. There are not pharmacological treatments for the actual outbreak for SARS-Cov-2 and it is necessary to evaluate the efficacy of treatment options, including convalescent plasma transfusion. The hypothesis is that convalescent plasma is efficacious and safe for reducing mortality in patients with COVID-19 treated in ICU

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
231

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 18, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

May 20, 2020

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

May 8, 2020

Last Update Submit

May 19, 2020

Conditions

SARS-Cov-2

Keywords

CoronavirusCovid-19Convalescent plasmaIntensive Care Unit

Outcome Measures

Primary Outcomes (1)

  • Intrahospital mortality from any cause

    Proportion of patients who die while being hospitalized

    Up to 28 days

Secondary Outcomes (4)

  • Length of hospital stay

    Up to 60 days

  • Free time for ventilatory support on day 60

    Day 60

  • Overall survival at day 60 since hospitalization

    Day 60

  • Cumulative incidence of adverse events: transfusion reactions (fever, flare), TRALI (transfusion-associated lung injury), TACO (transfusion-related circulatory overload), transfusion- related infections

    Up to 28 days

Study Arms (2)

Intervention group

EXPERIMENTAL

Administration of two units of fresh frozen plasma (between 400 and 500 ml) obtained from convalescent patients from infection by SARS-CoV-2. Convalescent plasma is defined as the plasma of patients who had PCR confirmed SARS-CoV-2 infection, who have recovered clinically, and who have positive antibodies against SARS-CoV-2.

Drug: Convalescent plasma

Control group

NO INTERVENTION

Subjects assigned to the control group will receive support treatment in the intensive care unit based on institutional management guidelines. The use of antiviral, antimalarial or anti-inflammatory drugs is allowed in both groups according to the ICU protocols.

Interventions

Convalescent plasmaDRUG

400-500ml convalescent plasma

Also known as: Plasma
Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For plasma donors:
  • Over 18 years of age
  • Men or nulliparous women with no history of recent abortions or transfusions SARS-CoV-2 infection by PCR in any sample or serological test with a maximum of 60 days from resolution of symptoms.
  • If donation is done within 14 to 28 days after resolution of symptoms, the patient must have a negative PCR test for SARS-CoV-2. If donation is done after 28 days of resolving symptoms, no negative control test will be required.
  • For plasma recipients:
  • Over 18 years of age
  • SARS-CoV-2 infection confirmed by PCR in any sample
  • Hospitalized in the ICU due to shock or respiratory failure, with less than 24 hours after entering the ICU.

You may not qualify if:

  • For plasma donors:
  • Severe SARS-CoV-2 infections with an ICU requirement or those with asymptomatic infections will not be accepted as donors.
  • Nor will a person who has received convalescent plasma as part of the COVID-19 treatment.
  • For plasma receivers:
  • Serious volume overload or other condition that contraindicates plasma transfusion.
  • History of anaphylaxis or serious adverse reaction to plasma.
  • Previous diagnosis of immunoglobulin A deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital San Vicente Fundacion

Medellín, Antioquia, Colombia

Location

MeSH Terms

Conditions

Coronavirus InfectionsCOVID-19

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Oliver Perilla Suarez, Hematologist

    Hospital San Vicente Fundación

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oliver G Perilla Suarez, Hematologist

CONTACT

+573136395608gerardoperilla@gmail.com

Fabian A Jaimes Barragan, Epidemiol

CONTACT

+5742192420fabian.jaimes@udea.edu.co

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Open label, parallel, randomized clinical trial with stratified (center and age) patient allocation in a 2 :1 ratio (plasma: standard management) for a superiority hypothesis
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2020

First Posted

May 18, 2020

Study Start

June 1, 2020

Primary Completion

June 1, 2021

Study Completion

December 1, 2021

Last Updated

May 20, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)