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Convalescent Plasma vs Human Immunoglobulin to Treat COVID-19 Pneumonia

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: NCT04381858
Recruitment Status : Recruiting
First Posted : May 11, 2020
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Centenario Hospital Miguel Hidalgo

Brief Summary:

Background: On December 2019, a new human coronavirus infection (COVID-19) was detected in China. Its infectivity and virulence characteristics caused a rapid spread, being declared pandemic on March 2020. The mortality attributed to the infection ranges between 3 and 10%. Main risk factors are age, male sex, and chronic degenerative comorbidities. Due to the absence of therapeutic options, potential alternatives such as human immunoglobulin or plasma from convalescent patients have been administered. Due to the severity of the disease and the associated mortality, it is urgent to find therapeutic alternatives.

Objective: To assess the safety and efficacy of the administration of Convalescent plasma vs human immunoglobulin in critically ill patients with COVID-19 infection.

Material and methods: Randomized Controlled trial of patients diagnosed with respiratory infection by COVID-19, with severe respiratory failure without indication of mechanical ventilation, or those who due to their severity are intubated upon admission. Randomization will be performed 2:1 to receive plasma from convalescent patients or human immunoglobulin.

Outcomes: The primary outcome will be time to discharge from hospital for improvement. The safety outcomes will be: Kirby index (PaO2/FiO2) evolution and dead.


Condition or disease Intervention/treatment Phase
COVID-19 Pneumonia Drug: Plasma from COVID-19 convalescent patient Drug: Human immunoglobulin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Convalescent Plasma vs Human Immunoglobulin for the Treatment of COVID-19 Pneumonia: A Randomized Controlled Trial
Actual Study Start Date : May 6, 2020
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Severe pneumonia due to COVID-19

Patients who are admitted to Hospital Centers with a positive RT-qPCR SARS-CoV-2 test or a CT scan compatible with a diagnosis of COVID-19 pneumonia, in addition to one of the following two criteria:

  1. Severe respiratory failure [respiratory rate> 25 - <35 x minute, oxygen saturation ≤ 90% with reservoir mask (FiO2 = 100%)]
  2. Requiring invasive mechanical ventilation.
Drug: Plasma from COVID-19 convalescent patient

Infusion of 400 ml (2 units) of plasma.

Plasma donated from convalescent patients will be extracted in strict compliance with the following criteria:

  • History of a clinical event with symptoms attributed to COVID-19 and a positive PCR test for COVID-19
  • Further confirmation of a negative PCR test for COVID-19
  • In order to be eligible plasma donors must complete at least 14 days after the last negative PCR in the absence of any symptom attributable to COVID-19 infection
  • IgG antibodies for COVID-19 must be confirmed POSITIVE when a qualitative assay is being used
  • When quantification of IgG antibodies for COVID-19 is available a title > 1: 640 will be required for inclusion.
  • Apheresis will be used as the only method for plasma extraction.

Active Comparator: Severe pnemonia due to COVID-19

Patients who are admitted to Hospital Centers with a positive RT-qPCR SARS-CoV-2 test or a CT scan compatible with a diagnosis of COVID-19 pneumonia, in addition to one of the following two criteria:

  1. Severe respiratory failure [respiratory rate> 25 - <35 x minute, oxygen saturation ≤ 90% with reservoir mask (FiO2 = 100%)]
  2. Requiring invasive mechanical ventilation.
Drug: Human immunoglobulin
Human immunoglobulin 0.3 gr/kg/day (5 doses)




Primary Outcome Measures :
  1. Mean hospitalization time [ Time Frame: Through study completion, an average of 3 months ]
    Mean days from admission as a suspected case of COVID with hospitalization criteria until discharge

  2. Mean Oxigenation index evolution [ Time Frame: Through study completion, an average of 3 months ]
    Mean of delta of oxigenation index (PaO2/FiO2)

  3. Rate of severe ARDS [ Time Frame: Through study completion, an average of 3 months ]
    Rate of patients with evolution to severe ARDS (PaO2/FiO2 < 100)

  4. Rate and time to dead [ Time Frame: Through study completion, an average of 3 months ]
    Rate of Dead caused by COVID-19 related complications and time to dead caused by COVID-19 complication

  5. Mean time with invasive mechanical ventilation [ Time Frame: Through study completion, an average of 3 months ]
    Mean time with invasive mechanical ventilation


Secondary Outcome Measures :
  1. Time to Viral PCR Negativization [ Time Frame: Through study completion, an average of 3 months. ]
    Time to negativization of RT-qPCR SARS-CoV-2 test.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are admitted to Hospital Centers with a positive RT-qPCR SARS-CoV-2 test or a CT scan compatible with a diagnosis of COVID-19 pneumonia, in addition to one of the following two criteria:

    1. Severe respiratory failure [respiratory rate> 25 - <35 x minute, oxygen saturation ≤ 90% with reservoir mask (FiO2 = 100%)]
    2. Requiring invasive mechanical ventilation.

Exclusion Criteria:

  • Patients with a viral infection other than COVID-19

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): NCT04381858


Contacts
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Contact: Jose Manuel Arreola, MD,PhD 4494632049 dr.jmag@gmail.com

Locations
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Mexico
Centenario Hospital Miguel Hidalgo Recruiting
Aguascalientes, Mexico, 20259
Contact: Jose Manuel Arreola Guerra, MD, MSc, PhD    4494632049      
Contact: Mario Gonzalez Gamez, MD    5544911865    mariogzg@gmail.com   
Sub-Investigator: Lucila Martinez, MDPhD         
Sub-Investigator: Mario Gonzalez Gamez, MD         
Sub-Investigator: Victor Monroy, MD         
Sub-Investigator: Alejandro Castillo, MD         
Sponsors and Collaborators
Centenario Hospital Miguel Hidalgo
Additional Information:
Publications:

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Responsible Party: Centenario Hospital Miguel Hidalgo
ClinicalTrials.gov Identifier: NCT04381858    
Other Study ID Numbers: 2020-A-10
First Posted: May 11, 2020    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 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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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
Immunologic Factors
Physiological Effects of Drugs