COVID-19 Convalescent Plasma Therapy (TPCC)

February 25, 2021 updated by: Universidad Nacional de Asunción
This study is an open-label trial in which hospitalized patients with risk factors of severe coronavirus disease 2019 [COVID-19] will be receive treatment with convalescent plasma (≤ 15 days from symptoms start).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Paraguay
      • Asunción, Paraguay, 111421
        • Facultad de Ciencias Médicas - Universidad Nacional de Asunción

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 Years and older
  • Presence of risk factors of severe COVID 19 diagnosed by quantitative polymerase chain reaction by reverse transcription (RT-qPCR)
  • Patients with no more than 15 days from the onset of symptoms
  • Signed informed consent

Exclusion Criteria:

  • Severely ill patients admitted directly to the ICU.
  • Need for mechanical ventilation at the time of hospital admission, regardless of the time of clinical evolution.
  • History of previous hypersensitivity to plasma transfusions.
  • History of immunoglobulin A (IgA) deficiency
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Convalescent plasma
COVID-19 convalescent plasma
Biological: Convalescent plasma
COVID-19 convalescent plasma at admission, after confirmation of eligibility, 200 ml on day 1 and 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (30-day mortality)
Time Frame: 30 days
To evaluate the effectiveness of convalescent plasma therapy COVID-19, to decrease mortality in hospitalized patients with COVID-19 and who present some risk factor for clinical deterioration.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median length of hospital stay
Time Frame: 30 days
To describe the median length of hospital stay in days
30 days
Change in clinical status
Time Frame: 0, 3, 7 and 14 days
To asses the changes of disease severity, according to the COVID-19 disease severity from the World Health Organization (WHO) Interim guidance.
0, 3, 7 and 14 days
Change in inflammatory marker: ferritin
Time Frame: 0, 7 and 14 days
To measure changes in ferritin (μg/L) at 0, 7 and 14 days
0, 7 and 14 days
Change in inflammatory marker: D dimer
Time Frame: 0, 7 and 14 days
To measure changes in D dimer (mg/L) at 0, 7 and 14 days
0, 7 and 14 days
Change in inflammatory marker: leukocytes
Time Frame: 0, 7 and 14 days
To measure leukocytes (/mm3) changes at 0, 7 and 14 days
0, 7 and 14 days
Serum Antibody Titers
Time Frame: 0, 3 and 7 days
To measure immunoglobulin G (IgG) SARS-CoV 2 titles
0, 3 and 7 days
Transfer to ICU
Time Frame: 30 days
To asses the frequency of patients admitted to ICU
30 days
Transfusion related events
Time Frame: 4 hours
To asses the frequency of adverse events to convalescent plasma
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Nacional de Asunción

Collaborators

Consejo Nacional de Ciencias y Tecnología, Paraguay
Ministerio de Salud Pública y Bienestar Social, Paraguay
Centro de información y recursos para el desarrollo, Paraguay

Investigators

  • Principal Investigator: Angelica Jimenez de Samudio, MD,MSc, Facultad de Ciencias Médicas - Universidad Nacional de Asunción

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2020

Primary Completion (Actual)

December 10, 2020

Study Completion (Actual)

January 10, 2021

Study Registration Dates

First Submitted

January 27, 2021

First Submitted That Met QC Criteria

February 8, 2021

First Posted (Actual)

February 10, 2021

Study Record Updates

Last Update Posted (Actual)

March 2, 2021

Last Update Submitted That Met QC Criteria

February 25, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PINV20-388

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators will publish the results to compare data with other studies with COVID-19 convalescent plasma patients

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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