Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04332835
Recruitment Status : Recruiting
First Posted : April 3, 2020
Last Update Posted : September 2, 2020
Sponsor:
Collaborators:
Fundación Universitaria de Ciencias de la Salud
CES University
Instituto Distrital de Ciencia Biotecnología e Innovacion en 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 Drug: Standard Therapy Phase 2 Phase 3

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Single Blinded
Primary Purpose: Treatment
Official Title: Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical Study
Actual Study Start Date : August 8, 2020
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 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. Simultaneously, they will receive the standard therapy defined by institutional protocol.
Drug: Plasma
Day 1: CP-COVID19, 250 milliliters. Day 2: CP-COVID19, 250 milliliters.
Other Name: Convalescent Plasma COVID-19

Drug: Standard Therapy
Standard therapy defined by institutional protocol.

Active Comparator: Control Group
Participants included in the control group will receive standard therapy defined by institutional protocol.
Drug: Standard Therapy
Standard therapy defined by institutional protocol.




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 G COVID-19 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 ]
    Proportion of death patients at days 7, 14 and 28



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Fulfilling all the following criteria

  1. Olerder than 18.
  2. Hospitalized participants with diagnosis of COVID 19 by Real Time - Polymerase Chain Reaction.
  3. Severe cases according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 7)".
  4. Sequential Organ Failure Assessment score (SOFA) < 6.
  5. 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 with requierment of Invasive Mechanical Venitlation.
  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. Demonstrated coinfection that explains the patient's symptoms
  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): NCT04332835


Contacts
Layout table for location contacts
Contact: Juan M Anaya Cabrera, MD, PhD +57 321 233 9828 anayajm@gmail.com
Contact: Manuel E Rojas Quintana, MD, MSc +57 315 459 9951 manuel_9316@hotmail.com

Locations
Layout table for location information
Colombia
Universidad del Rosario Recruiting
Bogota, Cundinamarca, Colombia, 11100
Contact: Gustavo Quintero, MD, MSc    +57 318 3606458    gustavo.quintero@urosario.edu.co   
Principal Investigator: Juan M Anaya Cabrera, MD, PhD         
Sub-Investigator: Manuel E Rojas Quintana, MD, MSc         
Sub-Investigator: Sara Velez Gomez         
Sub-Investigator: Juan C Diaz Coronado, MD, MSc         
Sub-Investigator: Anha M Robledo Moreno         
Sub-Investigator: Juan E Gallo Bonilla, MSc, PhD         
Sub-Investigator: Ruben D Manrique Hernández, MSc, PhD         
Sub-Investigator: Oscar M Gómez Guzmán, MSc, PhD         
Sub-Investigator: Isaura P Torres Gómez, MSc, PhD         
Sub-Investigator: Paula A Pedroza Rodríguez         
Sub-Investigator: Bernardo Camacho Rodríguez, MD, MSc         
Sub-Investigator: Jeser S Grass Guaqueta, MSc         
Sub-Investigator: Gustavo A Salguero López, MD, PhD         
Sub-Investigator: Luisa P Duarte Correales         
Sub-Investigator: Cristian A Ricaurte Perez, MSc         
Sub-Investigator: Adriana Rojas Villarraga, MD         
Sub-Investigator: Heily C Ramírez Santana, MSc, PhD         
Sub-Investigator: Diana M Monsalve Carmona, PhD         
Sub-Investigator: Yhojan A Rodríguez Velandia, MD         
Sub-Investigator: Yeny Y Acosta Ampudia, PhD         
Sub-Investigator: Carlos E Perez, MD         
Sub-Investigator: Ruben D Mantilla, MD         
Sub-Investigator: Paula Gaviria, MSc         
Sponsors and Collaborators
Universidad del Rosario
Fundación Universitaria de Ciencias de la Salud
CES University
Instituto Distrital de Ciencia Biotecnología e Innovacion en Salud
Investigators
Layout table for investigator information
Study Director: Juan M Anaya Cabrera, MD, PhD Universidad del Rosario
Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Juan Manuel Anaya Cabrera, MD, PhD, Principal Investigator, Universidad del Rosario
ClinicalTrials.gov Identifier: NCT04332835    
Other Study ID Numbers: ABN011-2
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases