search
Back to results

Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical Study (CP-COVID-19)

Primary Purpose

Coronavirus, Coronavirus Infection

Status
Completed
Phase
Phase 2
Locations
Colombia
Study Type
Interventional
Intervention
Plasma
Standard Therapy
Sponsored by
Universidad del Rosario
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus focused on measuring COVID-19, Coronavirus Disease 2019

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidad del Rosario

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control Group

Arm Description

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.

Participants included in the control group will receive standard therapy defined by institutional protocol.

Outcomes

Primary Outcome Measures

Change in Viral Load
Copies of COVID-19 per ml
Change in Immunoglobulin G COVID-19 Titers
Immunoglobulin G COVID-19 antibodies

Secondary Outcome Measures

Intensive Care Unit Admission
Proportion of patients with Intensive Care Unit Admission requirement (days 7, 14 and 28)
Length of Intensive Care Unit stay
Days of Intensive Care Unit management (days 7, 14 and 28)
Length of hospital stay (days)
Days of Hospitalization (days 7, 14 and 28)
Requirement of mechanical ventilation
Proportion of patients with mechanical ventilation (days 7, 14 and 28)
Duration (days) of mechanical ventilation
Days with mechanical ventilation (days 7, 14 and 28)
Clinical status assessed according to the World Health Organization guideline
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
Proportion of death patients at days 7, 14 and 28

Full Information

First Posted
March 31, 2020
Last Updated
November 25, 2020
Sponsor
Universidad del Rosario
Collaborators
Fundación Universitaria de Ciencias de la Salud, CES University, Instituto Distrital de Ciencia Biotecnología e Innovacion en Salud
search

1. Study Identification

Unique Protocol Identification Number
NCT04332835
Brief Title
Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical Study
Acronym
CP-COVID-19
Official Title
Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 8, 2020 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
November 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad del Rosario
Collaborators
Fundación Universitaria de Ciencias de la Salud, CES University, Instituto Distrital de Ciencia Biotecnología e Innovacion en Salud

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus, Coronavirus Infection
Keywords
COVID-19, Coronavirus Disease 2019

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Single Blinded
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participants included in the control group will receive standard therapy defined by institutional protocol.
Intervention Type
Drug
Intervention Name(s)
Plasma
Other Intervention Name(s)
Convalescent Plasma COVID-19
Intervention Description
Day 1: CP-COVID19, 250 milliliters. Day 2: CP-COVID19, 250 milliliters.
Intervention Type
Drug
Intervention Name(s)
Standard Therapy
Intervention Description
Standard therapy defined by institutional protocol.
Primary Outcome Measure Information:
Title
Change in Viral Load
Description
Copies of COVID-19 per ml
Time Frame
Days 0, 4, 7, 14 and 28
Title
Change in Immunoglobulin G COVID-19 Titers
Description
Immunoglobulin G COVID-19 antibodies
Time Frame
Days 0, 4, 7, 14 and 28
Secondary Outcome Measure Information:
Title
Intensive Care Unit Admission
Description
Proportion of patients with Intensive Care Unit Admission requirement (days 7, 14 and 28)
Time Frame
Days 7, 14 and 28
Title
Length of Intensive Care Unit stay
Description
Days of Intensive Care Unit management (days 7, 14 and 28)
Time Frame
Days 7, 14 and 28
Title
Length of hospital stay (days)
Description
Days of Hospitalization (days 7, 14 and 28)
Time Frame
Days 7, 14 and 28
Title
Requirement of mechanical ventilation
Description
Proportion of patients with mechanical ventilation (days 7, 14 and 28)
Time Frame
Days 7, 14 and 28
Title
Duration (days) of mechanical ventilation
Description
Days with mechanical ventilation (days 7, 14 and 28)
Time Frame
Days 7, 14 and 28
Title
Clinical status assessed according to the World Health Organization guideline
Description
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)
Time Frame
Days 7, 14 and 28
Title
Mortality
Description
Proportion of death patients at days 7, 14 and 28
Time Frame
Days 7, 14 and 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Fulfilling all the following criteria Olerder than 18. Hospitalized participants with diagnosis of COVID 19 by Real Time - Polymerase Chain Reaction. Severe cases according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 7)". 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 with requierment of Invasive Mechanical Venitlation. 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). Demonstrated coinfection that explains the patient's symptoms 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan M Anaya Cabrera, MD, PhD
Organizational Affiliation
Universidad del Rosario
Official's Role
Study Director
Facility Information:
Facility Name
Universidad del Rosario
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
11100
Country
Colombia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31986264
Citation
Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum In: Lancet. 2020 Jan 30;:
Results Reference
background
PubMed Identifier
32134116
Citation
Wang Y, Wang Y, Chen Y, Qin Q. Unique epidemiological and clinical features of the emerging 2019 novel coronavirus pneumonia (COVID-19) implicate special control measures. J Med Virol. 2020 Jun;92(6):568-576. doi: 10.1002/jmv.25748. Epub 2020 Mar 29.
Results Reference
background
PubMed Identifier
32125362
Citation
Young BE, Ong SWX, Kalimuddin S, Low JG, Tan SY, Loh J, Ng OT, Marimuthu K, Ang LW, Mak TM, Lau SK, Anderson DE, Chan KS, Tan TY, Ng TY, Cui L, Said Z, Kurupatham L, Chen MI, Chan M, Vasoo S, Wang LF, Tan BH, Lin RTP, Lee VJM, Leo YS, Lye DC; Singapore 2019 Novel Coronavirus Outbreak Research Team. Epidemiologic Features and Clinical Course of Patients Infected With SARS-CoV-2 in Singapore. JAMA. 2020 Apr 21;323(15):1488-1494. doi: 10.1001/jama.2020.3204. Erratum In: JAMA. 2020 Apr 21;323(15):1510.
Results Reference
background
Citation
Infectious, D. & Outbreaks, D. Maintaining a safe and adequate blood supply during the pandemic outbreak of coronavirus disease ( COVID-19 ). OMS 1-5 (2020)
Results Reference
background
PubMed Identifier
35761219
Citation
Rojas M, Rodriguez Y, Hernandez JC, Diaz-Coronado JC, Vergara JAD, Velez VP, Mancilla JP, Araujo I, Yepes JT, Ricaurte OB, Pardo-Oviedo JM, Monsalve DM, Acosta-Ampudia Y, Ramirez-Santana C, Garcia PG, Landinez LA, Correales LD, Grass JS, Perez CR, Lopez GS, Mateus N, Mancera L, Devia RR, Orjuela JE, Parra-Moreno CR, Buitrago AA, Ordonez IE, Osorio CF, Ballesteros N, Patino LH, Castaneda S, Munoz M, Ramirez JD, Bastard P, Gervais A, Bizien L, Casanova JL, Camacho B, Gallo JE, Gomez O, Rojas-Villarraga A, Perez CE, Manrique R, Mantilla RD, Anaya JM. Safety and efficacy of convalescent plasma for severe COVID-19: a randomized, single blinded, parallel, controlled clinical study. BMC Infect Dis. 2022 Jun 27;22(1):575. doi: 10.1186/s12879-022-07560-7.
Results Reference
derived
Links:
URL
https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds
Description
FDA recommendations for convalescent plasma clinical research

Learn more about this trial

Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical Study

We'll reach out to this number within 24 hrs