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COVID-19 Convalescent Plasma Therapy (TPCC)

Primary Purpose

SARS-CoV-2 Infection, COVID-19 Infection

Status
Completed
Phase
Phase 2
Locations
Paraguay
Study Type
Interventional
Intervention
Convalescent plasma
Sponsored by
Universidad Nacional de Asunción
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS-CoV-2 Infection focused on measuring SARS-CoV-2 infection, Convalescent plasma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Facultad de Ciencias Médicas - Universidad Nacional de Asunción

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Convalescent plasma

Arm Description

COVID-19 convalescent plasma

Outcomes

Primary Outcome Measures

Overall survival (30-day mortality)
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.

Secondary Outcome Measures

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

Full Information

First Posted
January 27, 2021
Last Updated
February 25, 2021
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
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1. Study Identification

Unique Protocol Identification Number
NCT04747158
Brief Title
COVID-19 Convalescent Plasma Therapy
Acronym
TPCC
Official Title
COVID-19 Convalescent Plasma Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
August 10, 2020 (Actual)
Primary Completion Date
December 10, 2020 (Actual)
Study Completion Date
January 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 Infection, COVID-19 Infection
Keywords
SARS-CoV-2 infection, Convalescent plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Convalescent plasma
Arm Type
Experimental
Arm Description
COVID-19 convalescent plasma
Intervention Type
Biological
Intervention Name(s)
Convalescent plasma
Intervention Description
COVID-19 convalescent plasma at admission, after confirmation of eligibility, 200 ml on day 1 and 2
Primary Outcome Measure Information:
Title
Overall survival (30-day mortality)
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Median length of hospital stay
Description
To describe the median length of hospital stay in days
Time Frame
30 days
Title
Change in clinical status
Description
To asses the changes of disease severity, according to the COVID-19 disease severity from the World Health Organization (WHO) Interim guidance.
Time Frame
0, 3, 7 and 14 days
Title
Change in inflammatory marker: ferritin
Description
To measure changes in ferritin (μg/L) at 0, 7 and 14 days
Time Frame
0, 7 and 14 days
Title
Change in inflammatory marker: D dimer
Description
To measure changes in D dimer (mg/L) at 0, 7 and 14 days
Time Frame
0, 7 and 14 days
Title
Change in inflammatory marker: leukocytes
Description
To measure leukocytes (/mm3) changes at 0, 7 and 14 days
Time Frame
0, 7 and 14 days
Title
Serum Antibody Titers
Description
To measure immunoglobulin G (IgG) SARS-CoV 2 titles
Time Frame
0, 3 and 7 days
Title
Transfer to ICU
Description
To asses the frequency of patients admitted to ICU
Time Frame
30 days
Title
Transfusion related events
Description
To asses the frequency of adverse events to convalescent plasma
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelica Jimenez de Samudio, MD,MSc
Organizational Affiliation
Facultad de Ciencias Médicas - Universidad Nacional de Asunción
Official's Role
Principal Investigator
Facility Information:
Facility Name
Facultad de Ciencias Médicas - Universidad Nacional de Asunción
City
Asunción
ZIP/Postal Code
111421
Country
Paraguay

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The investigators will publish the results to compare data with other studies with COVID-19 convalescent plasma patients
Citations:
PubMed Identifier
33300012
Citation
Yoon HA, Bartash R, Gendlina I, Rivera J, Nakouzi A, Bortz RH 3rd, Wirchnianski AS, Paroder M, Fehn K, Serrano-Rahman L, Babb R, Sarwar UN, Haslwanter D, Laudermilch E, Florez C, Dieterle ME, Jangra RK, Fels JM, Tong K, Mariano MC, Vergnolle O, Georgiev GI, Herrera NG, Malonis RJ, Quiroz JA, Morano NC, Krause GJ, Sweeney JM, Cowman K, Allen S, Annam J, Applebaum A, Barboto D, Khokhar A, Lally BJ, Lee A, Lee M, Malaviya A, Sample R, Yang XA, Li Y, Ruiz R, Thota R, Barnhill J, Goldstein DY, Uehlinger J, Garforth SJ, Almo SC, Lai JR, Gil MR, Fox AS, Chandran K, Wang T, Daily JP, Pirofski LA. Treatment of Severe COVID-19 with Convalescent Plasma in the Bronx, NYC. medRxiv. 2020 Dec 4:2020.12.02.20242909. doi: 10.1101/2020.12.02.20242909. Preprint.
Results Reference
background
PubMed Identifier
32861333
Citation
Joyner MJ, Bruno KA, Klassen SA, Kunze KL, Johnson PW, Lesser ER, Wiggins CC, Senefeld JW, Klompas AM, Hodge DO, Shepherd JRA, Rea RF, Whelan ER, Clayburn AJ, Spiegel MR, Baker SE, Larson KF, Ripoll JG, Andersen KJ, Buras MR, Vogt MNP, Herasevich V, Dennis JJ, Regimbal RJ, Bauer PR, Blair JE, van Buskirk CM, Winters JL, Stubbs JR, van Helmond N, Butterfield BP, Sexton MA, Diaz Soto JC, Paneth NS, Verdun NC, Marks P, Casadevall A, Fairweather D, Carter RE, Wright RS. Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients. Mayo Clin Proc. 2020 Sep;95(9):1888-1897. doi: 10.1016/j.mayocp.2020.06.028. Epub 2020 Jul 19.
Results Reference
background
Citation
Clinical Management of COVID-19 - Interim guidance 27 May 2020. WHO reference number: WHO/2019-nCoV/clinical/2020.5
Results Reference
background
Links:
URL
https://datos.conacyt.gov.py/proyectos/pdf/3449
Description
Open data' page of projects funded by CONACYT, Paraguay

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COVID-19 Convalescent Plasma Therapy

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