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Convalescent Plasma Compared to the Best Available Therapy for the Treatment of SARS-CoV-2 Pneumonia (COP-COVID-19)

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ClinicalTrials.gov Identifier: NCT04358783
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Adrian Camacho-Ortiz, Hospital Universitario Dr. Jose E. Gonzalez

Study Description
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Brief Summary:

In early December 2019, cases of pneumonia of unknown origin were identified in Wuhan, China. The causative virus was called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The World Health Organization (WHO) has recently declared coronavirus disease 2019 (COVID-19) a public health emergency of international concern.

According to the World Health Organization (WHO), the management of COVID-19 has focused primarily on infection prevention, detection and patient monitoring. However, there is no vaccine or specific treatment for SARS-CoV-2 due to the lack of evidence. Treatment options currently include broad-spectrum antiviral drugs but the efficacy and safety of these drugs is still unknown.

Convalescent plasma has previously been used to treat various outbreaks of other respiratory infections; however, it has not been shown to be effective in all the diseases studied. Therefore, clinical trials are required to demonstrate its safety and efficacy in patients with VIDOC-19.

The present work seeks to determine the mortality from any cause up to 14 days after plasma randomization of patients cured of COVID-19 compared to the Best Available Therapy in subjects with SARS-CoV-2 pneumonia. This is a 2:1 randomized, double-blind, single-center, phase 2, controlled clinical trial (plasma: best available therapy) for the treatment of SARS-CoV-2 pneumonia.


Condition or disease Intervention/treatment Phase
Coronavirus Infection Biological: Plasma Other: Best Available Therapy Phase 2

Detailed Description:
Randomized clinical trial comparing convalescent plasma to best available therapy (BAT) for the treatment of severely ill and critically ill patient with COVID-19: Patients will be electronically randomized 2:1 (plasma vs BAT) in a double blind fashion. Patients with SARS-CoV-2 PCR confirmed infection with pulmonary infiltrates and hypoxemia will be screened and invited to participate. Primary outcomes will be early all-cause mortality, and secondary outcomes will include all cause in hospital mortality, length of mechanical ventilation and hospital stay, time to PAO2 >200, progression of pulmonary infiltrates, antibody titers and time to negative PCR detection
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RCT double blind comparative study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double blind
Primary Purpose: Treatment
Official Title: Phase II, Randomized, Double-blind, Controlled Clinical Trial Evaluating the Efficacy and Safety of Plasma From Patients Cured of COVID-19 Compared to the Best Available Therapy in Subjects With SARS-CoV-2 Pneumonia
Actual Study Start Date : April 27, 2020
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Plasma
Convalescent plasma from cured COVID-19 patients y Supportive management depending on individual needs
 Biological: Plasma
The plasma unit will be fractionated in 200 mL aliquots for storage at -80°C until use. After thawing, it shall be administered in a single 200 mL dose to subjects who are randomized to that arm.
Experimental: Best Available Therapy
Will receive supportive management depending on individual needs including.
 Other: Best Available Therapy
It shall include, but not be limited to, oxygen therapy by means of a nasal cannula; high-flow nasal cannula; invasive or non-invasive mechanical ventilation; intravenous hydration; antibiotic therapy; thrombus prophylaxis; pain and fever management.


Outcome Measures
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Primary Outcome Measures :
  1. Early all-cause mortality [ Time Frame: 14 days ]
    any cause mortality during the first 14 days of treatment


Secondary Outcome Measures :
  1. Time in days for SARS-CoV-2 RT-PCR negatives [ Time Frame: 90 days ]
    (48-hour sampling interval from day 3 of hospitalization to two consecutive negatives).

  2. The serum anti-SARS-CoV-2 antibody titres [ Time Frame: 90 days ]
    In subjects of both arms at day 0, 3, 7, 14 and 90.

  3. Detection of serum antibodies [ Time Frame: days 0, 3, 7, 14 and 90. ]
    Comparison of anti-SARS-CoV-2 antibody titers


Eligibility Criteria
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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:

  1. Men or women ≥18 years. If you are a woman of childbearing age, you must agree to practice abstinence or to use an effective method of contraception during the study period.
  2. Vascular access suitable for administration of hemocomponents.
  3. SARS-CoV-2 positive RT-PCR.
  4. Negative pregnancy test in case of a woman of reproductive age
  5. Signing of evidentiary document of informed consent.
  6. Hospital admission for SARS-CoV-2 pneumonia with supplemental oxygen requirements.
  7. Subjects who access the storage of biological samples for future examination.

Exclusion Criteria:

  1. Respiratory rate >30 RPM, SO2 <93%, PaO2/FiO2 <200 despite intervention with oxygen therapy after 60 minutes of hospitalization.
  2. New alteration of the state of alert that does not revert after interventions 60 minutes after admission to hospital.
  3. PAM ≤ 65mmHg despite initial resuscitation on arrival at the centre.
  4. Pregnant or breastfeeding patients.
  5. Patients that the investigators consider inappropriate to participate in the clinical trial
  6. Contraindication to transfusion or history of previous severe reaction to blood products.
  7. Have received any blood products in the last 120 days.
Contacts and Locations
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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): NCT04358783


Contacts
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Contact: Eduardo Pérez Alba, MD +52 8117998705 md.eduardo.perez@gmail.com
Contact: Laura Marina Nuzzolo Shihadeh, MD +52 8112773423 laura.nuzzolo@gmail.com

Locations
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Mexico
Hospital Universitario José E. Gonzalez Recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Contact: Adrian Camacho, PHD    044 81 1263 5696    acamacho_md@yahoo.com   
Sub-Investigator: Eduardo Pérez Alba, MD         
Sub-Investigator: Laura Marina Nuzzolo Shihadeh, MD         
Sub-Investigator: David Gómez Almaguer, MD         
Sub-Investigator: Dalila M. Alvarado Navarro, MD         
Sub-Investigator: Andrés Gómez de León, MD         
Sub-Investigator: Elvira Garza González, MD         
Sub-Investigator: Jorge Llaca Diaz, MD         
Sub-Investigator: María del Rosario Salazar Riojas., MD         
Principal Investigator: Adrian Camacho, PHD         
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
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Principal Investigator: Adrian Camacho-Ortiz, MD Hospital Universitario "Dr. Jose Eleuterio Gonzalez, UANL
More Information
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Publications:
Numbers SIN. Coronavirus Disease 2019 ( COVID-19 ) Situation Report-71. Vol 2019.; 2020.
Disease C. Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease ( COVID-19 ). CDC. 2020;2019:4-6.
Yang Y, Yang M, Shen C, Wang F, Yuan J. Evaluating the accuracy of different respiratory specimens in the laboratory diagnosis and monitoring the viral shedding of 2019-nCoV infections ABSTRACT : medRxiv. 2020.
Guidance I. Clinical management of severe acute respiratory infection ( SARI ) when COVID-19 disease is suspected . World Heal Organ. 2020:1-21.
Brunk D. FDA OKs Emergency Use of Convalescent Plasma for Seriously Ill COVID-19 Patients. medscape. 2020:28-29. doi:10.1001/jama.2020.4783
NORMA Oficial Mexicana NOM-253-SSA1-2012, Para la disposición de sangre humana y sus componentes con fines terapéuticos. D Of. 2012;Tercera Se.

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Responsible Party: Dr. Adrian Camacho-Ortiz, Head of the Infectious Disease Department, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT04358783    
Other Study ID Numbers: IF20-00002
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dr. Adrian Camacho-Ortiz, Hospital Universitario Dr. Jose E. Gonzalez:
COVID-19
Plasma from patients cured
SARS-CoV-2 pneumonia
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Pneumonia
Lung Diseases
Respiratory Tract Diseases
 Respiratory Tract Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases