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Convalescent Plasma of Covid-19 to Treat SARS-COV-2 a Randomized Doble Blind 2 Center Trial (CPC-SARS)

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ClinicalTrials.gov Identifier: NCT04405310
Recruitment Status : Recruiting
First Posted : May 28, 2020
Last Update Posted : September 29, 2020
Sponsor:
Collaborators:
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
National Institute of Pediatrics, Mexico
Instituto Nacional de Enfermedades Respiratorias
Information provided by (Responsible Party):
Angel Augusto Perez Calatayud, Grupo Mexicano para el Estudio de la Medicina Intensiva

Brief Summary:

The new SARS-CoV-2 coronavirus is an emerging virus originating in Wuhan, China that has spread rapidly throughout the world. As of March 24, 2020, China had reported 81,767 cases with 3,281 deaths, and the World Health Organization (WHO) declared coronavirus 19 (COVID-19) a pandemic. COVID-19 disease is currently a pandemic without specific therapeutic agents and substantial mortality. So it is of utmost importance to find new treatments. Various therapies, such as Remdesivir and Favipiravir, are being investigated but the antiviral efficacy of these drugs is not yet known. The use of convalescent plasma was used as an empirical treatment during the Ebola virus outbreaks in 2014 and in 2015 a protocol was established for the treatment of the Middle East respiratory syndrome coronavirus (MERS) with convalescent plasma. This approach with other viral infections such as SARS-CoV, H5N1 avian influenza and H1N1 influenza suggesting that plasma transfusion from convalescent donors was effective.

For this study, plasma from convalescent donors will be collected from those donors who have recovered from SARS-CoV-2 and are between 10 and 14 days after illness. Immunoassays will be carried out to detect total IgM and IgG antibodies against SARS-CoV-2. Patients will receive 1 to 3 convalescent plasma transfusions, depending on the response to treatment.

The expected results are: normal body temperature, decrease in viral load or negative between 10-12 days after transfusion of convalescent plasma, which does not progress to ARDS, extubation of mechanical ventilation within two weeks of treatment, recovery of patient.


Condition or disease Intervention/treatment Phase
SARS Pneumonia Biological: Convalescent Plasma of patients with COVID-19 Other: placebo (hartmann plus albumine) Phase 2

Detailed Description:

Currently, SARS-CoV-2 disease represents a Public Health emergency of international concern. The new coronavirus COVID-19 is estimated to have infected more than 1.8 million people worldwide. The WHO estimates that the contagion rate (R0) of the virus is 1.4 to 2.5, which affects its exponential replication. In the absence of an effective treatment for SARS-CoV-2 disease, there is an urgent need to evaluate therapeutic alternatives that reduce the mortality and morbidity of this virus. There is scientific evidence that supports the use of convalescent donor plasma for the treatment of emerging virus outbreaks and suggests that the transfusion of convalescent donor plasma is effective, and therefore the following question is established:

The use of plasma from convalescent donors by COVID-19 in patients with SARS-CoV-2 disease, stage II (moderate) and III (severe), is a treatment that reduces mortality?

Given that the mortality rate is a very relevant fact, which concerns the general population, the clinical treatments that can be used to reduce the mortality rate of critical cases are of great relevance. There are patients recovered from COVID-19 who are potential plasma donors, and in turn, many critical patients who need to receive it.

Currently, there are no effective treatments to address COVID-19 disease. A recent WHO report indicates that early results with the use of convalescent plasma suggest that it may be a potentially useful treatment modality for severe SARS-CoV-2 disease. The use of convalescent plasma from COVID-19 in acute infected patients is currently considered an experimental therapy. This implies the need to promote clinical trials in order to demonstrate their efficacy. It is recommended that the entire process from donor selection, processing, labeling, storage and distribution to be carried out in a specifically licensed institution. These institutions must have all the guarantees that prove the correct practice of the procedures.

The use of convalescent plasma has been used as rescue therapy in patients with SARS whose condition continues to deteriorate despite treatment with methylprednisolone pulses, in addition, different studies have shown a decrease in hospital stay, and lower mortality in patients treated with convalescent plasma compared to those in which this treatment was not used.

A multicenter randomized study by Hung showed that the use of convalescent plasma in patients with type A H1N1 influenza was associated with a lower viral load and a reduction in mortality 5 days after the onset of symptoms. A Mair-Jenkins meta-analysis showed that mortality was reduced after several doses of convalescent plasma, and another meta-analysis by Luke identified in 1703 patients with influenza pneumonia (1918-1925) that the use of convalescent plasma blood products an absolute reduction. 21% (95% CI 15-27; p = 0.001) in crude fatality with low risk of bias.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment, relationship 3.2.3
Masking: Double (Participant, Care Provider)
Masking Description: parallel design 3:2:3
Primary Purpose: Treatment
Official Title: Plasma From Covalescent Donors With Covid-19 for the Management of Patients With SARS-COV-2 Fase II and III, a Doble Center Randomized Doble Blind Trial
Actual Study Start Date : May 20, 2020
Estimated Primary Completion Date : November 20, 2020
Estimated Study Completion Date : December 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: EXP-PC-F2
Patients with Pneumonia due to SARS-COV-2 phase 2 with Hyperimmune Plasma from Convalescent patients and conventional Therapy (Azithromycin and Hydroxychloroquine)
Biological: Convalescent Plasma of patients with COVID-19
Convalescent Plasma from patients with covid-19 by Apheresis, the maximum plasma volume withdrawn per session should not exceed 600 mL, excluding the anticoagulant volume, or 16% of the total blood volume, in the absence of volumetric replacement.
Other Name: Hyperinmunne plasma

Placebo Comparator: EXP-NONPC-F2
20 Patients with Pneumonia due to SARS-COV-2 phase 2 with conventional Therapy (Azithromycin and Hydroxychloroquine) and 20% Albumin in Hartman Solution.
Other: placebo (hartmann plus albumine)
use of albumin 20% in 250cc of Hartmann solution

Experimental: EXP-PC-F3
20 Patients with Pneumonia due to SARS-VOC-2 phase 3 with Hyperimmune Plasma from Convalescent patients and conventional Therapy (Azithromycin and Hydroxychloroquine)
Biological: Convalescent Plasma of patients with COVID-19
Convalescent Plasma from patients with covid-19 by Apheresis, the maximum plasma volume withdrawn per session should not exceed 600 mL, excluding the anticoagulant volume, or 16% of the total blood volume, in the absence of volumetric replacement.
Other Name: Hyperinmunne plasma

Placebo Comparator: EXP-NONPC-F3
20 Patients with Pneumonia due to SARS-VOC-2 phase 3 with conventional Therapy (Azithromycin and Hydroxychloroquine) and 20% Albumin in Hartman Solution.
Other: placebo (hartmann plus albumine)
use of albumin 20% in 250cc of Hartmann solution




Primary Outcome Measures :
  1. Death [ Time Frame: 15 days ]
    any cause


Secondary Outcome Measures :
  1. Lenth of stay ICU [ Time Frame: 15 days ]
    Time for discharge from the ICU

  2. Days of Mechanical Ventilation [ Time Frame: 15 days ]
    Number of days with ventilatory support

  3. Suplemental Oxigen support [ Time Frame: 15 days ]
    Number of days with need of oxigen suport without Mechanical Ventilation

  4. Viral Load by RT-PCR [ Time Frame: 15 days ]
    changes in viral load

  5. Inflamatory biomarkers [ Time Frame: 15 days ]
    changes in pro- inflamatory and anti-inflamatory biomarkes (IL-6, PCR, Ferritine, D Dimer, IL-8 IL-10

  6. SOFA (sequencial Organ Failure Assesment) [ Time Frame: 15 days ]
    changes in SOFA scale



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 to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults 18 to 70 years of age.
  • Serious or critically ill patients confirmed for SARS-CoV-2 disease (RT-PCR).
  • Meet the criteria for Disease with SARS-CoV-2 disease, phase II (Moderate) and phase III (severe) .
  • Suspected Cytokine Release Syndrome with Hscore 169 points.
  • Presence of severe acute hypoxemia with SpO2 <90% in ambient air and / or PaO2 / FiO2 <300 mmHg.
  • Meet criteria (plain chest tomography or plain chest radiograph) for SARS-CoV-2 disease.
  • Supplemental oxygen requirement either through the facial store plus reservoir bag, high-flow nasal tips or advanced airway management and invasive mechanical ventilation support.

Exclusion Criteria:

  • patient has no interest in participating in the trial.
  • Bilateral pulmonary infiltrate related to heart failure or other cause of water overload.
  • Virus positive respiratory viral panel other than COVID-19
  • History of allergy to plasma, sodium citrate, or methylene blue.
  • Patients with a history of autoimmune diseases or selective IgA insufficiency.
  • Those patients who are participating in other protocols.

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): NCT04405310


Contacts
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Contact: ANGEL A PEREZ-CALATAYUD, MD +525542389377 gmemiinv@gmail.com
Contact: YANET VENTURA, MD +52554848965 yanereb@gmail.com

Locations
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Mexico
Hospital Nava de Alta Especialidad Recruiting
Mexico City, Mexico, 04470
Contact: YANET VENTURA-ENRIQUEZ, MD    +525548489695    yanereb@gmail.com   
Principal Investigator: YANET VENTURA-ENRIQUEZ, MD         
Sub-Investigator: CARLOS PEÑA-PEREZ, MD         
Sub-Investigator: VERONICA FERNANDEZ-SANCHEZ, PHD         
Sub-Investigator: CARLOS CABELLO-GUTIERREZ, PHD         
Sub-Investigator: BALTAZAR PECH-ALONSO, MD         
Sub-Investigator: SANDRA MURRIETA, MD         
Sub-Investigator: EVELYN CORTINA-DE LA ROSA, MS         
Hospital General de Mexico Dr Eduardo Liceaga Recruiting
Mexico City, Mexico, 06720
Contact: JOSE CARRILLO RUIZ, PhD    525527892000 ext 5642    registroyseguimiento.di@gmail.com   
Principal Investigator: ANGEL AUGUSTO PEREZ-CALATAYUD, MD         
Sub-Investigator: ORLANDO CARRILLO-TORRES, PHD         
Sub-Investigator: CATALINA CASILLAS-SUAREZ, PHD         
Sub-Investigator: KARLA MALDONADO-SILVA, MD         
Sub-Investigator: AMALIA BRAVO-LINDORO, MS         
Sub-Investigator: RAUL CARRILLO-ESPER, MD         
Sponsors and Collaborators
Grupo Mexicano para el Estudio de la Medicina Intensiva
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
National Institute of Pediatrics, Mexico
Instituto Nacional de Enfermedades Respiratorias
Investigators
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Study Chair: ORLANDO CARILLO-TORRES, PHD Hospital General de Mexico Dr. Eduardo Liceaga
Publications:
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Responsible Party: Angel Augusto Perez Calatayud, Grupo Mexicano para el Estudio de la Medicina Intensiva
ClinicalTrials.gov Identifier: NCT04405310    
Other Study ID Numbers: DI/20/201/04/19
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be shared by petition.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 3 months after completion up to five years
Access Criteria: proposal should be directed to gmemiinv@gmails.com, to gain access, requestor will need to sign a data access agreement

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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 Angel Augusto Perez Calatayud, Grupo Mexicano para el Estudio de la Medicina Intensiva:
SARS-COV-2, CONVALESCENT PLASMA
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections