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Completed

NCT Number: NCT04332380

Convalescent Plasma for Patients With COVID-19: A Pilot Study

Convalescent plasma (CP) has been used in recent years as an empirical treatment strategy when there is no vaccine or treatment available for infectious diseases. In the latest viral epidemics, such as the Ebola outbreak in West Africa in 2014, the World Health Organization issued a document outlining a protocol for the use of whole blood or plasma collected from patients who have recovered from the Ebola virus disease by transfusion to empirically treat local infectious outbreaks.

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Key information

Conditions

Coronavirus COVID-19 Coronaviridae Infections Coronavirus Infection 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–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universidad del Rosario

Bogota, Cundinamarca, 11100, Colombia

About this study

The process is based on obtaining plasma from patients recovered from COVID-19 in Colombia, and through a donation of plasma from the recovered, the subsequent transfusion of this to patients infected with coronavirus disease (COVID-19). Our group has reviewed the scientific evidence regarding the application of convalescent plasma for emergency viral outbreaks and has recommended the following protocol

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Fulfilling all the following criteria

  • Aged between 18 and 60 years, male or female.
  • Hospitalized participants with diagnosis for COVID 19 by Real Time - Polymerase Chain Reaction.
  • Without treatment.
  • Moderate cases according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)".
  • Confusion, Urea, Respiratory rate, Blood pressure-65 (CURB-65) >= 2.
  • Sequential Organ Failure Assessment score (SOFA) < 6.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

  • Female subjects who are pregnant or breastfeeding.
  • Patients with prior allergic reactions to transfusions.
  • Critical ill patients in intensive care units.
  • Patients with surgical procedures in the last 30 days.
  • Patients with active treatment for cancer (Radiotherapy or Chemotherapy).
  • HIV diagnosed patients with viral failure (detectable viral load> 1000 copies / ml persistent, two consecutive viral load measurements within a 3 month interval, with medication adherence between measurements after at least 6 months of starting a new regimen antiretrovirals).
  • Patients who have suspicion or evidence of coinfections.
  • End-stage chronic kidney disease (Glomerular Filtration Rate <15 ml / min / 1.73 m2).
  • Child Pugh C stage liver cirrhosis.
  • High cardiac output diseases.
  • Autoimmune diseases or Immunoglobulin A nephropathy.
  • Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.

Treatment and study plan

Plasma

Drug

Day 1: CP-COVID19, 250 milliliters. Day 2: CP-COVID19, 250 milliliters.

Other names: Convalescent Plasma COVID-19

Primary outcomes

  1. Change in Viral Load

    Time frame: Days 0, 4, 7, 14 and 28

    Copies of COVID-19 per ml

  2. Change in Immunoglobulin M COVID-19 antibodies Titers

    Time frame: Days 0, 4, 7, 14 and 28

    Immunoglobulin M COVID-19 antibodies

  3. Change in Immunoglobulin G COVID-19 antibodies Titers

    Time frame: Days 0, 4, 7, 14 and 28

    Immunoglobulin G COVID-19 antibodies

Secondary outcomes

  1. Intensive Care Unit Admission

    Time frame: Days 7, 14 and 28

    Proportion of patients with Intensive Care Unit Admission requirement (days 7, 14 and 28)

  2. Length of Intensive Care Unit stay

    Time frame: Days 7, 14 and 28

    Days of Intensive Care Unit management (days 7, 14 and 28)

  3. Length of hospital stay (days)

    Time frame: Days 7, 14 and 28

    Days of Hospitalization (days 7, 14 and 28)

  4. Requirement of mechanical ventilation

    Time frame: Days 7, 14 and 28

    Proportion of patients with mechanical ventilation (days 7, 14 and 28)

  5. Duration (days) of mechanical ventilation

    Time frame: Days 7, 14 and 28

    Days with mechanical ventilation (days 7, 14 and 28)

  6. Clinical status assessed according to the World Health Organization guideline

    Time frame: Days 7, 14 and 28

    • Hospital discharge; 2. Hospitalization, not requiring supplemental oxygen; 3. Hospitalization, requiring supplemental oxygen (but not Noninvasive Ventilation/ HFNC); 4. Intensive care unit/hospitalization, requiring Noninvasive Ventilation/ HFNC therapy; 5. Intensive care unit, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; 6. Death. (days 7, 14 and 28)

  7. Mortality

    Time frame: Days 7, 14 and 28

    Proportión of death patients at days 7, 14 and 28

Sponsors and collaborators

Lead sponsor

Universidad del Rosario

Other

Collaborators

  • CES University
  • Fundación Universitaria de Ciencias de la Salud
  • Instituto Distrital de Ciencia Biotecnologia e Innovacion en salud

Registry information

Acronym: CP-COVID-19

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 2, 2020
Registry last updated
Aug 17, 2020

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.

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