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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04332380
Recruitment Status : Completed
First Posted : April 2, 2020
Last Update Posted : August 17, 2020
Sponsor:
Collaborators:
CES University
Instituto Distrital de Ciencia Biotecnologia e Innovacion en salud
Fundación Universitaria de Ciencias de la Salud
Information provided by (Responsible Party):
Juan Manuel Anaya Cabrera, Universidad del Rosario

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronavirus Coronavirus Infection Drug: Plasma Phase 2

Detailed Description:
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Convalescent Plasma for Patients With COVID-19: A Pilot Study
Actual Study Start Date : May 1, 2020
Actual Primary Completion Date : July 28, 2020
Actual Study Completion Date : July 28, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group
Participants included in the experimental group will receive 500 milliliters of convalescent plasma, distributed in two 250 milliliters transfusions on the first and second day after starting the protocol.
Drug: Plasma
Day 1: CP-COVID19, 250 milliliters. Day 2: CP-COVID19, 250 milliliters.
Other Name: Convalescent Plasma COVID-19




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]
    1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Fulfilling all the following criteria

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

Exclusion Criteria:

  1. Female subjects who are pregnant or breastfeeding.
  2. Patients with prior allergic reactions to transfusions.
  3. Critical ill patients in intensive care units.
  4. Patients with surgical procedures in the last 30 days.
  5. Patients with active treatment for cancer (Radiotherapy or Chemotherapy).
  6. 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).
  7. Patients who have suspicion or evidence of coinfections.
  8. End-stage chronic kidney disease (Glomerular Filtration Rate <15 ml / min / 1.73 m2).
  9. Child Pugh C stage liver cirrhosis.
  10. High cardiac output diseases.
  11. Autoimmune diseases or Immunoglobulin A nephropathy.
  12. Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04332380


Locations
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Colombia
Universidad del Rosario
Bogota, Cundinamarca, Colombia, 11100
Sponsors and Collaborators
Universidad del Rosario
CES University
Instituto Distrital de Ciencia Biotecnologia e Innovacion en salud
Fundación Universitaria de Ciencias de la Salud
Investigators
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Principal Investigator: Juan M Anaya Cabrera, MD, PhD Universidad del Rosario
Additional Information:
Publications:
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Responsible Party: Juan Manuel Anaya Cabrera, MD, PhD, Principal Investigator, Universidad del Rosario
ClinicalTrials.gov Identifier: NCT04332380    
Other Study ID Numbers: ABN011-1
First Posted: April 2, 2020    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juan Manuel Anaya Cabrera, Universidad del Rosario:
COVID-19
Coronavirus Disease 2019
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases