Working…
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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04332835
Recruitment Status : Completed
First Posted : April 3, 2020
Last Update Posted : November 27, 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

Tracking Information
First Submitted Date  ICMJE March 31, 2020
First Posted Date  ICMJE April 3, 2020
Last Update Posted Date November 27, 2020
Actual Study Start Date  ICMJE August 8, 2020
Actual Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2020)
  • Change in Viral Load [ Time Frame: Days 0, 4, 7, 14 and 28 ]
    Copies of COVID-19 per ml
  • Change in Immunoglobulin G COVID-19 Titers [ Time Frame: Days 0, 4, 7, 14 and 28 ]
    Immunoglobulin G COVID-19 antibodies
Original Primary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
  • Change in Viral Load [ Time Frame: Days 0, 4, 7, 14 and 28 ]
    Copies of COVID-19 per ml
  • Change in Immunoglobulin M COVID-19 Titers [ Time Frame: Days 0, 4, 7, 14 and 28 ]
    Immunoglobulin M COVID-19 antibodies
  • Change in Immunoglobulin G COVID-19 Titers [ Time Frame: Days 0, 4, 7, 14 and 28 ]
    Immunoglobulin G COVID-19 antibodies
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
  • 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)
  • Length of Intensive Care Unit stay [ Time Frame: Days 7, 14 and 28 ]
    Days of Intensive Care Unit management (days 7, 14 and 28)
  • Length of hospital stay (days) [ Time Frame: Days 7, 14 and 28 ]
    Days of Hospitalization (days 7, 14 and 28)
  • Requirement of mechanical ventilation [ Time Frame: Days 7, 14 and 28 ]
    Proportion of patients with mechanical ventilation (days 7, 14 and 28)
  • Duration (days) of mechanical ventilation [ Time Frame: Days 7, 14 and 28 ]
    Days with mechanical ventilation (days 7, 14 and 28)
  • 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)
  • Mortality [ Time Frame: Days 7, 14 and 28 ]
    Proportion of death patients at days 7, 14 and 28
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical Study
Official Title  ICMJE Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical Study
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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Single Blinded
Primary Purpose: Treatment
Condition  ICMJE
  • Coronavirus
  • Coronavirus Infection
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Plasma
    • Drug: Standard Therapy
  • Active Comparator: Control Group
    Participants included in the control group will receive standard therapy defined by institutional protocol.
    Intervention: Drug: Standard Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 25, 2020)
92
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2020)
80
Actual Study Completion Date  ICMJE November 15, 2020
Actual Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04332835
Other Study ID Numbers  ICMJE ABN011-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Juan Manuel Anaya Cabrera, Universidad del Rosario
Study Sponsor  ICMJE Universidad del Rosario
Collaborators  ICMJE
  • Fundación Universitaria de Ciencias de la Salud
  • CES University
  • Instituto Distrital de Ciencia Biotecnología e Innovacion en Salud
Investigators  ICMJE
Study Director: Juan M Anaya Cabrera, MD, PhD Universidad del Rosario
PRS Account Universidad del Rosario
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP