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

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: 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

Tracking Information
First Submitted Date  ICMJE June 29, 2020
First Posted Date  ICMJE June 30, 2020
Last Update Posted Date July 7, 2020
Estimated Study Start Date  ICMJE July 6, 2020
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2020)
  • All-cause mortality [ Time Frame: 30 days ]
    Any cause mortality during the first 30 days of treatment
  • Side effects [ Time Frame: 30 days ]
    Side effects associated with the administration of convalescent plasma
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2020)
  • Length of stay in Intensive Care Unit (ICU) [ Time Frame: 14 days ]
    Time to discharge from the ICU
  • Length of stay in hospitalization [ Time Frame: 21 days ]
    Time for discharge from hospital
  • Days of mechanical ventilation [ Time Frame: 14 days ]
    Number of days with ventilatory support
  • Inflammatory biomarkers (d-dimer) [ Time Frame: 21 days ]
    change in D-dimer (micrograms/L)
  • Inflammatory biomarkers (c-reactive protein) [ Time Frame: 21 days ]
    change in C-reactive protein (milligrams/dL)
  • Inflammatory biomarkers (lactate dehydrogenase) [ Time Frame: 21 days ]
    Change in LDH (UI/L)
  • Inflammatory biomarkers (ferritin) [ Time Frame: 21 days ]
    Change in ferritin (nanograms/mL)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2020)
  • Length of stay in Intensive Care Unit (ICU) [ Time Frame: 14 days ]
    Time to discharge from the ICU
  • Length of stay in hospitalization [ Time Frame: 21 days ]
    Time for discharge from hospital
  • Days of mechanical ventilation [ Time Frame: 14 days ]
    Number of days with ventilatory support
  • Inflammatory biomarkers [ Time Frame: 21 days ]
    change in pro-inflammatory biomarkers (D dimer, ferritin, PCR and LDH)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Statistical and Epidemiological Study Based on the Use of Convalescent Plasma for the Management of Patients With COVID-19
Official Title  ICMJE Pilot Clinical, Statistical and Epidemiological Study on Efficacy and Safety of Convalescent Plasma for the Management of Patients With COVID-19
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Pilot, experimental, randomized, prospective, longitudinal, clinical study
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID-19 Pneumonia
  • Convalescent Plasma
Intervention  ICMJE 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.

Study Arms  ICMJE
  • 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.

    Intervention: Biological: Convalescent plasma
  • 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.

    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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 29, 2020)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2021
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
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: Julio César Martínez Gallegos, MD, MMSc 8113852249 juliomartinez.18@hotmail.com
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04452812
Other Study ID Numbers  ICMJE HUS-001/2020
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: Yes
Supporting Materials: Study Protocol
Responsible Party Universidad Autonoma de Coahuila
Study Sponsor  ICMJE Universidad Autonoma de Coahuila
Collaborators  ICMJE National Council of Science and Technology, Mexico
Investigators  ICMJE Not Provided
PRS Account Universidad Autonoma de Coahuila
Verification Date June 2020

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