Clinical trial NCT04834375: Randomized Open Investigation Determining Steroid Dose
Official title: Randomized Open Investigation Determining Steroid Dose (ROIDS-Dose)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Covid19
Keywords: dexamethasone
COVID-19
COVID pneumonia
respiratory failure
steroids
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized in a parallel fashion into either the standard dexamethasone dose of 6 mg or weight-based dexamethasone of 0.2 mg/kg (maximum dose of 20 mg)
Primary purpose: TREATMENT

Brief summary: Dexamethasone has been approved for the treatment of severe COVID-19, but higher doses of steroids may be more effective. The purpose of this research study is to compare the current standard dose of dexamethasone 6 mg to a higher, weight-based dosing (0.2 mg/kg with maximum dose of 20 mg) to determine if it would be more effective against COVID-19 pneumonia.

Detailed description: Treatment for COVID-19 patients with respiratory failure has been vexing, but the use of steroids has shown promise. In a recent randomized control trial, dexamethasone 6 mg once daily showed a modest decrease in mortality among hospitalized COVID-19 patients who require oxygen supplementation or invasive mechanical ventilation. Other trials have shown that the inflammatory response to COVID-19 can be further attenuated at higher dosages of dexamethasone. These higher dosages have not been well studied and have not been directly compared to the current standard dose of dexamethasone 6 mg daily. We propose that a higher dexamethasone dose, equivalent to methylprednisolone 1 mg/kg/day which is routinely used to treat other inflammatory conditions of the lungs, may be more effective than the current standard dose in reducing mortality in COVID-19 patients with respiratory failure.

Eligibility criteria: Inclusion Criteria:

* Adults greater or equal than 18 years old
* COVID-19 infection confirmed by positive PCR test
* Hypoxemia defined by an oxygen saturation \< 94% or the need for supplemental oxygen

Exclusion Criteria:

* Corticosteroid use for \> 48h within the past 15 days prior to enrollment
* Use of steroids with doses higher than the equivalent to dexamethasone 6 mg
* Use of immunosuppressive drugs
* Pregnant women
* Chronic oxygen use
* Known history of dexamethasone allergy
* DNR / DNI
* Patient or proxy cannot consent

Primary outcomes:
measure: All Cause Mortality at 28 Days
timeFrame: 28 days
Secondary outcomes:
measure: Number of Participants Admitted to the ICU
timeFrame: 28 days
measure: Days of Stay in the Intensive Care Unit
timeFrame: 28 days
measure: Days of Hospitalization
timeFrame: 28 days
measure: Number of Participants That Required Higher Levels of Oxygen Supplementation
timeFrame: 28 days
measure: Number of Participants That Required Invasive Mechanical Ventilation
timeFrame: 28 days
measure: Duration of Invasive Mechanical Ventilation
timeFrame: 28 days
measure: Number of Participants That Required ECMO
timeFrame: 28 days
measure: Number of Participants That Required Tracheostomy
timeFrame: 28 days
measure: Number of Participants That Developed Secondary Bacterial or Fungal Infections
timeFrame: 28 days
measure: Number of Participants That Developed Clinically Significant Hyperglycemia
timeFrame: 28 days
measure: Number of Participants That Required Oxygen Supplementation a Discharge From the Hospital
timeFrame: Until hospital discharge
measure: Subjective Symptoms at 28 Days
timeFrame: 28 days
measure: Disposition Upon Discharge
timeFrame: At hospital discharge
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Northwell Health
state: New York
Study officials:
affiliation: Northwell Health
name: Mangala Narasimhan, DO
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Tomazini BM, Maia IS, Cavalcanti AB, Berwanger O, Rosa RG, Veiga VC, Avezum A, Lopes RD, Bueno FR, Silva MVAO, Baldassare FP, Costa ELV, Moura RAB, Honorato MO, Costa AN, Damiani LP, Lisboa T, Kawano-Dourado L, Zampieri FG, Olivato GB, Righy C, Amendola CP, Roepke RML, Freitas DHM, Forte DN, Freitas FGR, Fernandes CCF, Melro LMG, Junior GFS, Morais DC, Zung S, Machado FR, Azevedo LCP; COALITION COVID-19 Brazil III Investigators. Effect of Dexamethasone on Days Alive and Ventilator-Free in Patients With Moderate or Severe Acute Respiratory Distress Syndrome and COVID-19: The CoDEX Randomized Clinical Trial. JAMA. 2020 Oct 6;324(13):1307-1316. doi: 10.1001/jama.2020.17021.
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citation: Edalatifard M, Akhtari M, Salehi M, Naderi Z, Jamshidi A, Mostafaei S, Najafizadeh SR, Farhadi E, Jalili N, Esfahani M, Rahimi B, Kazemzadeh H, Mahmoodi Aliabadi M, Ghazanfari T, Sattarian M, Ebrahimi Louyeh H, Raeeskarami SR, Jamalimoghadamsiahkali S, Khajavirad N, Mahmoudi M, Rostamian A. Intravenous methylprednisolone pulse as a treatment for hospitalised severe COVID-19 patients: results from a randomised controlled clinical trial. Eur Respir J. 2020 Dec 24;56(6):2002808. doi: 10.1183/13993003.02808-2020. Print 2020 Dec.