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Prophylactic Corticosteroid to Prevent COVID-19 Cytokine Storm

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: NCT04355247
Recruitment Status : Recruiting
First Posted : April 21, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Fernando Cabanillas, Auxilio Mutuo Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Covid-19 Drug: MethylPREDNISolone 80 Mg/mL Injectable Suspension Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

This is a pilot Phase II exploratory study. It is a non-randomized study which will be carried out at Auxilio Mutuo Hospital and possibly at other institutions to be recruited.

The investigator plans to enter a total of 20 patients in order to determine whether the risk of progressing to respiratory failure can be reduced by administering corticosteroids.

The investigator assume that virtually all patients who met the criteria for entry into this trial will develop respiratory insufficiency if left untreated.

If </= 50% of patients with high risk develop respiratory failure the investigator will consider the treatment as successful.

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prophylactic Corticosteroid to Prevent COVID-19 Cytokine Storm
Actual Study Start Date : April 14, 2020
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : April 30, 2021


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.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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.




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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:

  • 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

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): NCT04355247


Contacts
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Contact: Fernando Cabanillas, MD 787-758-2000 ext 3503 cabanillasmd@gmail.com
Contact: Idalia Liboy, MD 787-758-2000 ext 3569 iliboy@auxiliomutuo.com

Locations
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Puerto Rico
San Juan City Hospital / Puerto Rico Medical Center Recruiting
San Juan, Puerto Rico, 00917
Contact: Carmelo Santana-López, MD    787-480-2700      
Hospital Auxilio Mutuo Cancer Center Recruiting
San Juan, Puerto Rico, 00918
Contact: Fernando Cabanillas, MD    787-758-2000 ext 3513    cabanillasmd@gmail.com   
Contact: Idalia Liboy, MD    787-758-2000 ext 3569    iliboy@auxiliomutuo.com   
Principal Investigator: Fernando Cabanillas, MD         
Sub-Investigator: Carmelo Santana-López, MD         
Sub-Investigator: James Bryan, MD         
Sub-Investigator: Juan Arraut, MD         
Sub-Investigator: José Abreu-Arbelo, MD         
Sub-Investigator: Luis Cotto, MD         
Sub-Investigator: Mirelis Acosta-Rivera, MD         
Sub-Investigator: Margarita Bruno, MD         
Sub-Investigator: Idalia Liboy, MD         
Sponsors and Collaborators
Auxilio Mutuo Cancer Center
Investigators
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Principal Investigator: Fernando Cabanillas, MD Hospital Español Auxilio Mutuo
Additional Information:
Publications:

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Responsible Party: Fernando Cabanillas, Medicine Doctor/Medical Director, Auxilio Mutuo Cancer Center
ClinicalTrials.gov Identifier: NCT04355247    
Other Study ID Numbers: CCAM 20-01
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: April 21, 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
Keywords provided by Fernando Cabanillas, Auxilio Mutuo Cancer Center:
Severe Acute Respiratory Syndrome (SARS)-Cov-2 Virus
Additional relevant MeSH terms:
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Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents