COPLA Study: Treatment of Severe Forms of COronavirus Infection With Convalescent PLAsma (COPLA)
Primary Purpose
COVID-19
Status
Unknown status
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Convalescent plasma
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Patients with SARS-CoV2 infection who have had a serious evolution and are in an ICU
- With or without ventilatory assistance
- Treated or not with hydroxychloroquine 200 mg. every 12 hours
- Indistinct sex
- Older than 18 years
- Signed informed consent
Exclusion Criteria:
- Patients treated with the following medications: azithromycin, ritonavir / lopinavir, remdesivir, interferons, ruxolinitib, tocilizumab.
- Patients with severe kidney failure who require replacement therapy.
Sites / Locations
- Centro de Hematología y Medicina InternaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Convalescent Plasma
Arm Description
200 ml of convalescent plasma, single dose.
Outcomes
Primary Outcome Measures
Lung injury
PaO2/FiO2 relation
Overall survival
Patients survival after therapy
Secondary Outcome Measures
Adverse reactions to plasma
Determine the incidence of side effects from plasma administration
Full Information
NCT ID
NCT04357106
First Posted
April 14, 2020
Last Updated
April 21, 2020
Sponsor
Centro de Hematología y Medicina Interna
Collaborators
Laboratorios Clínicos de Puebla (Laboratorios Ruiz)
1. Study Identification
Unique Protocol Identification Number
NCT04357106
Brief Title
COPLA Study: Treatment of Severe Forms of COronavirus Infection With Convalescent PLAsma
Acronym
COPLA
Official Title
COPLA Study: Treatment of Severe Forms of COronavirus Infection With Convalescent PLAsma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 13, 2020 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro de Hematología y Medicina Interna
Collaborators
Laboratorios Clínicos de Puebla (Laboratorios Ruiz)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
COVID-19 disease has become a very serious global health problem. Treatments for severe forms are urgently needed to lower mortality. Any procedure that improves these forms should be considered, especially those devoid of serious side effects.There is not enough published information on the use of allogeneic convalescent plasma (ACP) in the treatment of severe forms of COVID-19. The use of ACP can be combined with other treatments and has very few adverse effects. It takes 10-14 days for SARS-CoV2-infected patients to produce virus-neutralizing antibodies: within that time they can develop serious complications and die. Injecting PAC into patients with severe forms of COVID-19 shortens the period of risk while the patient produces the antibodies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Convalescent Plasma
Arm Type
Experimental
Arm Description
200 ml of convalescent plasma, single dose.
Intervention Type
Biological
Intervention Name(s)
Convalescent plasma
Intervention Description
Convalescent plasma obtained by aphaeresis from recovered patients.
Primary Outcome Measure Information:
Title
Lung injury
Description
PaO2/FiO2 relation
Time Frame
7 days
Title
Overall survival
Description
Patients survival after therapy
Time Frame
15-30 days
Secondary Outcome Measure Information:
Title
Adverse reactions to plasma
Description
Determine the incidence of side effects from plasma administration
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with SARS-CoV2 infection who have had a serious evolution and are in an ICU
With or without ventilatory assistance
Treated or not with hydroxychloroquine 200 mg. every 12 hours
Indistinct sex
Older than 18 years
Signed informed consent
Exclusion Criteria:
Patients treated with the following medications: azithromycin, ritonavir / lopinavir, remdesivir, interferons, ruxolinitib, tocilizumab.
Patients with severe kidney failure who require replacement therapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Carlos Olivares-Gazca, MD, MPH
Phone
2222438100
Email
jolivares@hsctmexico.com
First Name & Middle Initial & Last Name or Official Title & Degree
José Manuel Priesca-Marin, MD
Phone
2222438100
Email
mpriesca@hsctmexico.com
Facility Information:
Facility Name
Centro de Hematología y Medicina Interna
City
Puebla
ZIP/Postal Code
72530
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Carlos Olivares-Gazca, MD,MPH
Phone
2222438100
Email
jolivares@hsctmexico.com
First Name & Middle Initial & Last Name & Degree
Guillermo J Ruiz-Arguelles, MD, FRCP, MACP, DSc
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34013969
Citation
Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.
Results Reference
derived
PubMed Identifier
33044747
Citation
Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3.
Results Reference
derived
Learn more about this trial
COPLA Study: Treatment of Severe Forms of COronavirus Infection With Convalescent PLAsma
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