Prophylactic Corticosteroid to Prevent COVID-19 Cytokine Storm

April 17, 2020 updated by: Fernando Cabanillas, Auxilio Mutuo Cancer Center
This is a Phase II pilot exploratory study designed to investigate if prophylactic treatment with short term steroids administered to high risk Covid-19 patient might prevent cytokine storm and progression to respiratory failure. High risk is defined based on serologic markers of inflammation that include abnormalities of Interleukin 6 (IL-6), Ferritin , D-dimer, Lactate Dehydrogenase (LDH), as well as lymphopenia and impaired O2 saturation prior to or on the 7th day of first symptom of Covid-19.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To decrease the rate of progression to hypoxemic respiratory failure in high risk patients with Covid-19, treated with prophylactic steroids during the first phase of the disease.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00918
        • Recruiting
        • Hospital Auxilio Mutuo Cancer Center
        • Contact:
        • Sub-Investigator:
          • Carmelo Santana-López, MD
        • Sub-Investigator:
          • James Bryan, MD
        • Sub-Investigator:
          • Juan Arraut, MD
        • Sub-Investigator:
          • José Abreu-Arbelo, MD
        • Sub-Investigator:
          • Idalia Liboy, MD
      • San Juan, Puerto Rico, 00917
        • Recruiting
        • San Juan City Hospital / Puerto Rico Medical Center
        • Contact:
          • Carmelo Santana-López, MD
          • Phone Number: 787-480-2700

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients diagnosed with Covid-19 will be registered on the study regardless pf their severity, but only those who meet high risk criteria will be treated with steroids. Those who don't meet the criteria will only be registered with no need to collect further data except baseline labs and CT Chest. They should sign the consent form and the data manager can collect the rest of the information.
  • Patients older than 18 years diagnosed with Covid-19 by Polymerase Chain Reaction (PCR) or by rapid serological test will be eligible. Cases who are Immunoglobulin G (IgG) positive but Immunoglobulin M (IgM) negative, will not be considered eligible unless they are positive for molecular PCR test. Eligible patients will be registered on study on or before 7 days from first onset of symptoms.

Exclusion Criteria:

  • Any patient with life expectancy < 1 month
  • Any patient who is oxygen dependent
  • Any patient with long standing history of severe Chronic Obstructive Pulmonary Disease (COPD)
  • Any patient who is chronically oxygen dependent because of previous existing lung disease
  • Anyone with severely uncontrolled diabetes despite adequate management
  • Anyone with active serious bacterial infection such as septicemia or pneumonia
  • Anyone receiving Tocilizumab (anti IL-6 therapy) or plasma therapy
  • Any patient already receiving steroids from another pre-existing illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Single Arm
  • Patients will be admitted to a regular room in the hospital (not ICU)
  • They will be monitored closely with vital signs every 4 hours to ensure their respiratory and cardiovascular status do not deteriorate.
  • Methylprednisolone 80 mg IV bolus injection will be given daily x 5 days starting upon day 1 of admission to hospital.
Drug: MethylPREDNISolone 80 Mg/mL Injectable Suspension
  • Patients will be admitted to a regular room in the hospital (not ICU)
  • They will be monitored closely with vital signs every 4 hours to ensure their respiratory and cardiovascular status do not deteriorate.
  • Methylprednisolone 80 mg IV bolus injection will be given daily x 5 days starting upon day 1 of admission to hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical complete response criteria
Time Frame: 14 days

Clinical complete response criteria requires all the following:

  • No need for ventilatory support at any point
  • O2 Saturation of >/= 93% by day 14 of therapy
  • Alive by day 28 from registration
  • CT chest with minimal or no evidence of disease by day 28 from registration
14 days
Clinical Partial Response criteria
Time Frame: 14 days

Clinical Partial Response criteria require that 2 of the following be present by day 14 of therapy:

  • No need for ventilatory support at any point O2 saturation > 93% bay day 14 from registration
  • CT chest stable to improve over baseline by day 28 from registration
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary response criteria
Time Frame: 14 days

Decrease of at least 25% in anyone of the following markers: IL-6, Ferritin, D-dimer, C reactive protein (CRP) or LDH by day 14

- Improvement of absolute lymphocyte count in those presenting with lymphopenia. Improvement is defined as increase by 25% or more by day 14.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Auxilio Mutuo Cancer Center

Investigators

  • Principal Investigator: Fernando Cabanillas, MD, Hospital Español Auxilio Mutuo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 14, 2020

Primary Completion (ANTICIPATED)

July 31, 2020

Study Completion (ANTICIPATED)

April 30, 2021

Study Registration Dates

First Submitted

April 17, 2020

First Submitted That Met QC Criteria

April 17, 2020

First Posted (ACTUAL)

April 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 21, 2020

Last Update Submitted That Met QC Criteria

April 17, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCAM 20-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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