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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

Tracking Information
First Submitted Date  ICMJE April 14, 2020
First Posted Date  ICMJE April 22, 2020
Last Update Posted Date April 22, 2020
Actual Study Start Date  ICMJE April 13, 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2020)
  • Lung injury [ Time Frame: 7 days ]
    PaO2/FiO2 relation
  • Overall survival [ Time Frame: 15-30 days ]
    Patients survival after therapy
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2020)
Adverse reactions to plasma [ Time Frame: 7 days ]
Determine the incidence of side effects from plasma administration
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 COPLA Study: Treatment of Severe Forms of COronavirus Infection With Convalescent PLAsma
Official Title  ICMJE COPLA Study: Treatment of Severe Forms of COronavirus Infection With Convalescent PLAsma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE Biological: Convalescent plasma
Convalescent plasma obtained by aphaeresis from recovered patients.
Study Arms  ICMJE Experimental: Convalescent Plasma
200 ml of convalescent plasma, single dose.
Intervention: Biological: Convalescent plasma
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 21, 2020)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Juan Carlos Olivares-Gazca, MD, MPH 2222438100 jolivares@hsctmexico.com
Contact: José Manuel Priesca-Marin, MD 2222438100 mpriesca@hsctmexico.com
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04357106
Other Study ID Numbers  ICMJE CHMI-030420-01
Has Data Monitoring Committee No
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 Guillermo J. RUIZ-ARGÜELLES, Centro de Hematología y Medicina Interna
Study Sponsor  ICMJE Centro de Hematología y Medicina Interna
Collaborators  ICMJE Laboratorios Clínicos de Puebla (Laboratorios Ruiz)
Investigators  ICMJE Not Provided
PRS Account Centro de Hematología y Medicina Interna
Verification Date April 2020

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