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COPLA Study: Treatment of Severe Forms of COronavirus Infection With Convalescent PLAsma (COPLA)

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: NCT04357106
Recruitment Status : Recruiting
First Posted : April 22, 2020
Last Update Posted : April 22, 2020
Sponsor:
Collaborator:
Laboratorios Clínicos de Puebla (Laboratorios Ruiz)
Information provided by (Responsible Party):
Guillermo J. RUIZ-ARGÜELLES, Centro de Hematología y Medicina Interna

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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Convalescent plasma Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: COPLA Study: Treatment of Severe Forms of COronavirus Infection With Convalescent PLAsma
Actual Study Start Date : April 13, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Convalescent Plasma
200 ml of convalescent plasma, single dose.
Biological: Convalescent plasma
Convalescent plasma obtained by aphaeresis from recovered patients.




Primary Outcome Measures :
  1. Lung injury [ Time Frame: 7 days ]
    PaO2/FiO2 relation

  2. Overall survival [ Time Frame: 15-30 days ]
    Patients survival after therapy


Secondary Outcome Measures :
  1. Adverse reactions to plasma [ Time Frame: 7 days ]
    Determine the incidence of side effects from plasma administration



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT04357106


Contacts
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Contact: Juan Carlos Olivares-Gazca, MD, MPH 2222438100 jolivares@hsctmexico.com
Contact: José Manuel Priesca-Marin, MD 2222438100 mpriesca@hsctmexico.com

Locations
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Mexico
Centro de Hematología y Medicina Interna Recruiting
Puebla, Mexico, 72530
Contact: Juan Carlos Olivares-Gazca, MD,MPH    2222438100    jolivares@hsctmexico.com   
Principal Investigator: Guillermo J Ruiz-Arguelles, MD, FRCP, MACP, DSc         
Sponsors and Collaborators
Centro de Hematología y Medicina Interna
Laboratorios Clínicos de Puebla (Laboratorios Ruiz)
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Responsible Party: Guillermo J. RUIZ-ARGÜELLES, Dr. Guillermo J. Ruiz-Argüelles, Centro de Hematología y Medicina Interna
ClinicalTrials.gov Identifier: NCT04357106    
Other Study ID Numbers: CHMI-030420-01
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 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
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