NCT04747158

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 10, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2021

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

January 27, 2021

Last Update Submit

February 25, 2021

Conditions

SARS-CoV-2 InfectionCOVID-19 Infection

Keywords

SARS-CoV-2 infectionConvalescent plasma

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 days

Secondary Outcomes (8)

  • Median length of hospital stay

    30 days

  • Change in clinical status

    0, 3, 7 and 14 days

  • Change in inflammatory marker: ferritin

    0, 7 and 14 days

  • Change in inflammatory marker: D dimer

    0, 7 and 14 days

  • Change in inflammatory marker: leukocytes

    0, 7 and 14 days

  • +3 more secondary outcomes

Study Arms (1)

Convalescent plasma

EXPERIMENTAL

COVID-19 convalescent plasma

Biological: Convalescent plasma

Interventions

Convalescent plasmaBIOLOGICAL

COVID-19 convalescent plasma at admission, after confirmation of eligibility, 200 ml on day 1 and 2

Convalescent plasma

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facultad de Ciencias Médicas - Universidad Nacional de Asunción

Asunción, 111421, Paraguay

Location

Related Publications (3)

  • 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 [Preprint]. 2020 Dec 4:2020.12.02.20242909. doi: 10.1101/2020.12.02.20242909.

    PMID: 33300012BACKGROUND

  • 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.

    PMID: 32861333BACKGROUND

  • Clinical Management of COVID-19 - Interim guidance 27 May 2020. WHO reference number: WHO/2019-nCoV/clinical/2020.5

    BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Angelica Jimenez de Samudio, MD,MSc

    Facultad de Ciencias Médicas - Universidad Nacional de Asunción

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2021

First Posted

February 10, 2021

Study Start

August 10, 2020

Primary Completion

December 10, 2020

Study Completion

January 10, 2021

Last Updated

March 2, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

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

Locations

PA(1)