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Statistical and Epidemiological Study Based on the Use of Convalescent Plasma for the Management of Patients With COVID-19 (PROMETEO)

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ClinicalTrials.gov Identifier: NCT04452812
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
National Council of Science and Technology, Mexico
Information provided by (Responsible Party):
Universidad Autonoma de Coahuila

Study Description
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Brief Summary:

The health contingency established against the Severe Acute Respiratory Syndrome associated type 2 Coronavirus (SARS-CoV-2) has promoted a race against the clock for the search on treatment against the disease related with coronavirus (COVID-19). There are no current approved therapeutic options against the virus, although there is a rush for the development of drugs, vaccines and even the passive immunization through plasma from convalescent patients. This passive immunization is made with the administration of antibodies from patients that went through the infectious state of the disease and progress to clinical remission.

SARS-CoV-2, and its predecessor SARS-CoV-1, have great similarities between their genes and proteins; tis allow to hypothesize that the antibodies developed against SARS-CoV1 can recognize the antigens of SARS-CoV-2. In this manner, the transfusion of convalescent plasma to patients with the infection brings the probability on eliminating the infection, in this case SARS-CoV-2. There are evidence of this phenomenon observed in previous pandemics caused by SARS-CoV-1, Influenza AH1N1 and Ebola virus.

The objective of the study is to develop a therapeutic strategy based on the administration of plasma from patients with COVID-19 with clinical remission to patients that are coursing with the infection. The expected results hopes to establish an effective treatment and satisfactory recovery of patients with COVID-19. Also, we expect to describe the respective antibodies related against the SARS-CoV-2 infection.


Condition or disease Intervention/treatment Phase
COVID-19 Pneumonia Convalescent Plasma Biological: Convalescent plasma Phase 1 Phase 2

Detailed Description:

The health contingency established against the Severe Acute Respiratory Syndrome associated type 2 Coronavirus (SARS-CoV-2) has promoted a race against the clock for the search on treatment against the disease related with coronavirus (COVID-19). There are no current approved therapeutic options against the virus, although there is a rush for the development of drugs, vaccines and even the passive immunization through plasma from convalescent patients. This passive immunization is made with the administration of antibodies from patients that went through the infectious state of the disease and progress to clinical remission.

SARS-CoV-2, and its predecessor SARS-CoV-1, have great similarities between their genes and proteins; tis allow to hypothesize that the antibodies developed against SARS-CoV1 can recognize the antigens of SARS-CoV-2. In this manner, the transfusion of convalescent plasma to patients with the infection brings the probability on eliminating the infection, in this case SARS-CoV-2. There are evidence of this phenomenon observed in previous pandemics caused by SARS-CoV-1, Influenza AH1N1 and Ebola virus.

The objective of the study is to develop a therapeutic strategy based on the administration of plasma from patients with COVID-19 with clinical remission to patients that are coursing with the infection. The expected results hopes to establish an effective treatment and satisfactory recovery of patients with COVID-19. Also, we expect to describe the respective antibodies related against the SARS-CoV-2 infection.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pilot, experimental, randomized, prospective, longitudinal, clinical study
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Pilot Clinical, Statistical and Epidemiological Study on Efficacy and Safety of Convalescent Plasma for the Management of Patients With COVID-19
Estimated Study Start Date : July 6, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : April 1, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Convalescent plasma

Best available treatment + convalescent plasma

Best available treatment: hemodynamic support, oxygen supplementation, antibiotic therapy (if required), and individualized treatment judged by the attending physician.

Plasma will be split by aliquots of 200 ml for its storage on -60 celsius degrees until it's used. After defrosting, it will be administered on 2 200 ml separated doses on a 12 hours interval.

 Biological: Convalescent plasma

Best available treatment + convalescent plasma

Best available treatment: hemodynamic support, oxygen supplementation, antibiotic therapy (if required), and individualized treatment judged by the attending physician.

Plasma will be split by aliquots of 200 ml for its storage on -60 celsius degrees until it's used. After defrosting, it will be administered on 2 200 ml separated doses on a 12 hours interval.
Placebo Comparator: Best available treatment

Best available treatment + Placebo (0.9% saline solution)

Best available treatment: hemodynamic support, oxygen supplementation, antibiotic therapy (if required), and individualized treatment judged by the attending physician.

Placebo will consist on 2 doses of 200 ml of 0.9% saline solution separated on a 12 hour interval.

 Biological: Convalescent plasma

Best available treatment + convalescent plasma

Best available treatment: hemodynamic support, oxygen supplementation, antibiotic therapy (if required), and individualized treatment judged by the attending physician.

Plasma will be split by aliquots of 200 ml for its storage on -60 celsius degrees until it's used. After defrosting, it will be administered on 2 200 ml separated doses on a 12 hours interval.


Outcome Measures
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Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 30 days ]
    Any cause mortality during the first 30 days of treatment

  2. Side effects [ Time Frame: 30 days ]
    Side effects associated with the administration of convalescent plasma


Secondary Outcome Measures :
  1. Length of stay in Intensive Care Unit (ICU) [ Time Frame: 14 days ]
    Time to discharge from the ICU

  2. Length of stay in hospitalization [ Time Frame: 21 days ]
    Time for discharge from hospital

  3. Days of mechanical ventilation [ Time Frame: 14 days ]
    Number of days with ventilatory support

  4. Inflammatory biomarkers (d-dimer) [ Time Frame: 21 days ]
    change in D-dimer (micrograms/L)

  5. Inflammatory biomarkers (c-reactive protein) [ Time Frame: 21 days ]
    change in C-reactive protein (milligrams/dL)

  6. Inflammatory biomarkers (lactate dehydrogenase) [ Time Frame: 21 days ]
    Change in LDH (UI/L)

  7. Inflammatory biomarkers (ferritin) [ Time Frame: 21 days ]
    Change in ferritin (nanograms/mL)


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 (Donors):

  • Signed informed consent
  • At least positive for 1 q-PCR test for SARS-CoV-2
  • 14 days of COVID-19 clinical remission
  • Positive serologic test for SARS-CoV-2
  • Requirements to donate according to NOM-253-SSA1-2012
  • To accept sample storing for future study

Inclusion Criteria (Receptors):

  • Signed informed consent provided by the patient, legal guardian or the health provider if not available
  • Patients hospitalized in an ICU dedicated to the treatment of COVID-19 patients
  • At least positive for 1 q-PCR test for SARS-CoV-2
  • Patients with COVID-19 defined as severe or critically ill:

Severe: RF > 30 bpm, oxygen saturation <94%, Pa/FiO2 <301, bilateral lung infiltrates that extends in >50% (by chest radiograph or CT scan) in 24-48 hours Critically ill: Respiratory failure (PaO2 <60 mmHg or SatO2 <90% with FiO2 >60%) and septic shock (MAP <65 mmHg with vasoactive requirement, lactate > 2 mmol/L and SOFA score >1)

Exclusion Criteria:

  • Positive pregnancy test
  • Patients in lactation
  • Informed consent not signed
  • Patients involved in other treatment protocols
  • Patients on immunomodulatory drugs (DMARDs, monoclonal antibodies or smal molecule drugs)
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): NCT04452812


Contacts
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Contact: Julio César Martínez Gallegos, MD, MMSc 8113852249 juliomartinez.18@hotmail.com

Locations
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Mexico
Hospital Universitario "Dr. Gonzalo Valdés Valdés"
Saltillo, Coahuila, Mexico, 25000
Contact: Julio César Martínez Gallegos, MD, MSc    8113852249    juliomartinez.18@hotmail.com   
Sponsors and Collaborators
Universidad Autonoma de Coahuila
National Council of Science and Technology, Mexico
More Information
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Responsible Party: Universidad Autonoma de Coahuila
ClinicalTrials.gov Identifier: NCT04452812    
Other Study ID Numbers: HUS-001/2020
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidad Autonoma de Coahuila:
COVID-19
Convalescent plasma
plasmapheresis
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections