Skip to main content
OpenTrials
Completed

NCT Number: NCT04747158

COVID-19 Convalescent Plasma Therapy

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sars-CoV-2 Infection COVID-19 COVID-19 Infection Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Facultad de Ciencias Médicas - Universidad Nacional de Asunción

Asunción, 111421, Paraguay

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Convalescent Plasma

Biological

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Median length of hospital stay

    Time frame: 30 days

    To describe the median length of hospital stay in days

  2. 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.

  3. 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

  4. 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

  5. Change in inflammatory marker: leukocytes

    Time frame: 0, 7 and 14 days

    To measure leukocytes (/mm3) changes at 0, 7 and 14 days

  6. Serum Antibody Titers

    Time frame: 0, 3 and 7 days

    To measure immunoglobulin G (IgG) SARS-CoV 2 titles

  7. Transfer to ICU

    Time frame: 30 days

    To asses the frequency of patients admitted to ICU

  8. Transfusion related events

    Time frame: 4 hours

    To asses the frequency of adverse events to convalescent plasma

Sponsors and collaborators

Lead sponsor

Universidad Nacional de Asunción

Other

Collaborators

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

Registry information

Acronym: TPCC

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Feb 10, 2021
Registry last updated
Mar 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.