Prophylactic Corticosteroid to Prevent COVID-19 Cytokine Storm

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prophylactic Corticosteroid to Prevent COVID-19 Cytokine Storm

Conditions
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Covid-19

Intervention / Treatment
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* Drug: MethylPREDNISolone 80 Mg/mL Injectable Suspension


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical complete response criteria | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe Acute Respiratory Syndrome (SARS)-Cov-2 Virus