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CompletedNCT04834375ROIDS-DoseUpdated Jul 20, 2023Results posted

Randomized Open Investigation Determining Steroid Dose

A Phase 3 interventional study of Weight-based dexamethasone dose in Covid19, sponsored by Northwell Health. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-20.

Sponsored by Northwell Health · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
142
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Covid19

Keywords

  • dexamethasone
  • COVID-19
  • COVID pneumonia
  • respiratory failure
  • steroids
03

In context

COVID-19

7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's enrollment of 142 is above the median of 100 across 4,175 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Northwell Health is the lead sponsor of 473 studies on the registry; 106 are open to participants now.

Of its 43 completed or terminated interventional studies of FDA-regulated products, 22 (51%) have results posted.

Browse Northwell Health studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
142 participants (actual)

Study arms

  • No intervention
    Standard dexamethasone dose

    Dexamethasone 6 mg IV daily for 10 days

  • Experimental
    Weight-based dexamethasone dose

    Dexamethasone 0.2 mg/kg/day IV (maximum 20 mg daily) for 10 days

    Drug: Weight-based dexamethasone dose

Interventions

  • DrugWeight-based dexamethasone dose

    Weight-based dexamethasone dose in COVID-19 patients with hypoxic respiratory failure

    Also known as: Higher dexamethasone dose

06

What researchers measure

Primary outcomes

  1. All Cause Mortality at 28 Days

    All cause mortality at 28 days. Comment: Primary outcome was all cause mortality at 28 days but the patients were followed until end of admission for the final disposition (death or discharge) which accounts for the differences in the primary outcome of mortality at 28 days and the total number of deaths at discharge

    Time frame: 28 days

Secondary outcomes

  1. Number of Participants Admitted to the ICU

    Number of participants that required admission to the ICU

    Time frame: 28 days

  2. Days of Stay in the Intensive Care Unit

    ICU length of stay

    Time frame: 28 days

  3. Days of Hospitalization

    Duration of hospitalization

    Time frame: 28 days

  4. Number of Participants That Required Higher Levels of Oxygen Supplementation

    Venturi mask, Non-rebreather mask, High-flow nasal cannula, Non-invasive ventilation

    Time frame: 28 days

  5. Number of Participants That Required Invasive Mechanical Ventilation

    Escalation to invasive mechanical ventilation

    Time frame: 28 days

  6. Duration of Invasive Mechanical Ventilation

    Total days requiring invasive mechanical ventilation

    Time frame: 28 days

  7. Number of Participants That Required ECMO

    Refractory hypoxemia requiring ECMO

    Time frame: 28 days

  8. Number of Participants That Required Tracheostomy

    Need for tracheostomy

    Time frame: 28 days

  9. Number of Participants That Developed Secondary Bacterial or Fungal Infections

    Culture positive evidence of secondary bacterial or fungal infections

    Time frame: 28 days

  10. Number of Participants That Developed Clinically Significant Hyperglycemia

    Defined as need for insulin drip or ICU admission to control hyperglycemia

    Time frame: 28 days

  11. Number of Participants That Required Oxygen Supplementation a Discharge From the Hospital

    Need for oxygen supplementation at hospital discharge Comment: Corrected total number of discharged patients alive to 55 in the "Standard Dexamethasone Dose" Arm.

    Time frame: Until hospital discharge

  12. Subjective Symptoms at 28 Days

    Subjective symptoms questionnaire at 28 days

    Time frame: 28 days

  13. Disposition Upon Discharge

    Home, home with physical therapy, other (skilled nursing facility, long-term acute care facility, long-term care facility / nursing home, acute rehabilitation facility, hospice care), expired

    Time frame: At hospital discharge

07

Results

Posted Jul 20, 2023
Limitations and caveats
Study was not blinded. Small sample size may have reduced the ability to detect statistically significant differences among some of the secondary outcomes. Selecting a maximum dose of 20 mg in the weight-based dexamethasone group may have affected the results. As the standard of care for the treatment of COVID-19 changed over time, those changes may have affected patient care in undetectable ways, affecting the results of the trial.

Participant flow

Patients underwent screening and randomization between March 19, 2021 and December 28, 2021 at seven hospitals in Northwell Health in New York. Randomization was performed using a computer-generated allocation sequence via the Research Electronic Data Capture (REDCap) system. Eligible patients were randomized in a 1:1 ratio stratified by the trial site to either the standard dose group or the intervention group.

Participant flow — Overall Study
MilestoneStandard Dexamethasone DoseWeight-based Dexamethasone Dose
Started7270
Completed7270
Not completed00

Outcome measures

PrimaryAll Cause Mortality at 28 Days

All cause mortality at 28 days. Comment: Primary outcome was all cause mortality at 28 days but the patients were followed until end of admission for the final disposition (death or discharge) which accounts for the differences in the primary outcome of mortality at 28 days and the total number of deaths at discharge

Time frame:
28 days
Reported as:
Count of participants · Participants
All Cause Mortality at 28 Days
ParticipantsStandard Dexamethasone DoseWeight-based Dexamethasone Dose
All Cause Mortality at 28 Days1512
SecondaryNumber of Participants Admitted to the ICU

Number of participants that required admission to the ICU

Time frame:
28 days
Reported as:
Count of participants · Participants
Number of Participants Admitted to the ICU
ParticipantsStandard Dexamethasone DoseWeight-based Dexamethasone Dose
Number of Participants Admitted to the ICU2712
SecondaryDays of Stay in the Intensive Care Unit

ICU length of stay

Time frame:
28 days
Reported as:
Mean · days
Days of Stay in the Intensive Care Unit
daysStandard Dexamethasone DoseWeight-based Dexamethasone Dose
Days of Stay in the Intensive Care Unit15.33 ± 11.2811.33 ± 8.85
SecondaryDays of Hospitalization

Duration of hospitalization

Time frame:
28 days
Reported as:
Mean · days
Days of Hospitalization
daysStandard Dexamethasone DoseWeight-based Dexamethasone Dose
Days of Hospitalization14.83 ± 1711.56 ± 8.88
SecondaryNumber of Participants That Required Higher Levels of Oxygen Supplementation

Venturi mask, Non-rebreather mask, High-flow nasal cannula, Non-invasive ventilation

Time frame:
28 days
Reported as:
Count of participants · Participants
Number of Participants That Required Higher Levels of Oxygen Supplementation
ParticipantsStandard Dexamethasone DoseWeight-based Dexamethasone Dose
Number of Participants That Required Higher Levels of Oxygen Supplementation3231
SecondaryNumber of Participants That Required Invasive Mechanical Ventilation

Escalation to invasive mechanical ventilation

Time frame:
28 days
Reported as:
Count of participants · Participants
Number of Participants That Required Invasive Mechanical Ventilation
ParticipantsStandard Dexamethasone DoseWeight-based Dexamethasone Dose
Number of Participants That Required Invasive Mechanical Ventilation1910
SecondaryDuration of Invasive Mechanical Ventilation

Total days requiring invasive mechanical ventilation

Time frame:
28 days
Reported as:
Mean · days
Duration of Invasive Mechanical Ventilation
daysStandard Dexamethasone DoseWeight-based Dexamethasone Dose
Duration of Invasive Mechanical Ventilation19.95 ± 16.1410.90 ± 8.88
SecondaryNumber of Participants That Required ECMO

Refractory hypoxemia requiring ECMO

Time frame:
28 days
Reported as:
Count of participants · Participants
Number of Participants That Required ECMO
ParticipantsStandard Dexamethasone DoseWeight-based Dexamethasone Dose
Number of Participants That Required ECMO32
SecondaryNumber of Participants That Required Tracheostomy

Need for tracheostomy

Time frame:
28 days
Reported as:
Count of participants · Participants
Number of Participants That Required Tracheostomy
ParticipantsStandard Dexamethasone DoseWeight-based Dexamethasone Dose
Number of Participants That Required Tracheostomy51
SecondaryNumber of Participants That Developed Secondary Bacterial or Fungal Infections

Culture positive evidence of secondary bacterial or fungal infections

Time frame:
28 days
Reported as:
Count of participants · Participants
Number of Participants That Developed Secondary Bacterial or Fungal Infections
ParticipantsStandard Dexamethasone DoseWeight-based Dexamethasone Dose
Number of Participants That Developed Secondary Bacterial or Fungal Infections199
SecondaryNumber of Participants That Developed Clinically Significant Hyperglycemia

Defined as need for insulin drip or ICU admission to control hyperglycemia

Time frame:
28 days
Reported as:
Count of participants · Participants
Number of Participants That Developed Clinically Significant Hyperglycemia
ParticipantsStandard Dexamethasone DoseWeight-based Dexamethasone Dose
Number of Participants That Developed Clinically Significant Hyperglycemia54
SecondaryNumber of Participants That Required Oxygen Supplementation a Discharge From the Hospital

Need for oxygen supplementation at hospital discharge Comment: Corrected total number of discharged patients alive to 55 in the "Standard Dexamethasone Dose" Arm.

Time frame:
Until hospital discharge
Reported as:
Count of participants · Participants
Number of Participants That Required Oxygen Supplementation a Discharge From the Hospital
ParticipantsStandard Dexamethasone DoseWeight-based Dexamethasone Dose
Number of Participants That Required Oxygen Supplementation a Discharge From the Hospital2527
SecondarySubjective Symptoms at 28 Days

Subjective symptoms questionnaire at 28 days

Time frame:
28 days
Reported as:
Count of participants · Participants
Subjective Symptoms at 28 Days
ParticipantsStandard Dexamethasone DoseWeight-based Dexamethasone Dose
Better3344
Same/worse32
SecondaryDisposition Upon Discharge

Home, home with physical therapy, other (skilled nursing facility, long-term acute care facility, long-term care facility / nursing home, acute rehabilitation facility, hospice care), expired

Time frame:
At hospital discharge
Reported as:
Count of participants · Participants
Disposition Upon Discharge
ParticipantsStandard Dexamethasone DoseWeight-based Dexamethasone Dose
Home4042
Home with physical therapy1011
Other55
Expired1712

Adverse events

Collected over Adverse events were assessed up to 28 days. Mortality was assessed through 28 days for the primary outcome but final disposition was assessed at end of hospitalization (e.g. death or discharge).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Standard Dexamethasone Dose17/72 (23.6%)0/72 (0%)24/72 (33.3%)
Weight-based Dexamethasone Dose12/70 (17.1%)0/70 (0%)13/70 (18.6%)
Most frequent other events
Most frequent other events
EventStandard Dexamethasone DoseWeight-based Dexamethasone Dose
Secondary bacterial or fungal infectionsInfections and infestations19/729/70
Clinically significant hyperglycemiaEndocrine disorders5/724/70

Baseline characteristics

Age, Continuous
Age, Continuous(years)Standard Dexamethasone DoseWeight-based Dexamethasone DoseTotal
Mean57.22 ± 15.1855.46 ± 15.1156.35 ± 15.12
Sex: Female, Male
Sex: Female, Male(Participants)Standard Dexamethasone DoseWeight-based Dexamethasone DoseTotal
Female232043
Male495099
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Standard Dexamethasone DoseWeight-based Dexamethasone DoseTotal
Hispanic or Latino151429
Not Hispanic or Latino5655111
Unknown or Not Reported112
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Standard Dexamethasone DoseWeight-based Dexamethasone DoseTotal
American Indian or Alaska Native101
Asian9918
Native Hawaiian or Other Pacific Islander000
Black or African American252651
White272552
More than one race101020
Unknown or Not Reported000
Steroid initiation prior to the study
Steroid initiation prior to the study(Participants)Standard Dexamethasone DoseWeight-based Dexamethasone DoseTotal
Count of participants6866134
BMI
BMI(kg/m^2)Standard Dexamethasone DoseWeight-based Dexamethasone DoseTotal
Mean31.72 ± 8.9933.57 ± 9.8432.62 ± 9.43
Dexamethasone dose
Dexamethasone dose(mg)Standard Dexamethasone DoseWeight-based Dexamethasone DoseTotal
Mean6 ± 017.49 ± 2.6611.66 ± 6.06
Pre-enrollment nadir oxygen saturation
Pre-enrollment nadir oxygen saturation(% of oxygen saturation)Standard Dexamethasone DoseWeight-based Dexamethasone DoseTotal
Mean83.92 ± 10.7284.43 ± 7.9684.17 ± 9.43

5 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Northwell Health
    New Hyde Park, New York 11042, United States
09

References and documents

Publications

  • RECOVERY Collaborative Group; Horby P, Lim WS, Emberson JR, Mafham M, Bell JL, Linsell L, Staplin N, Brightling C, Ustianowski A, Elmahi E, Prudon B, Green C, Felton T, Chadwick D, Rege K, Fegan C, Chappell LC, Faust SN, Jaki T, Jeffery K, Montgomery A, Rowan K, Juszczak E, Baillie JK, Haynes R, Landray MJ. Dexamethasone in Hospitalized Patients with Covid-19. N Engl J Med. 2021 Feb 25;384(8):693-704. doi: 10.1056/NEJMoa2021436. Epub 2020 Jul 17. PubMed 32678530 ↗
  • WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group; Sterne JAC, Murthy S, Diaz JV, Slutsky AS, Villar J, Angus DC, Annane D, Azevedo LCP, Berwanger O, Cavalcanti AB, Dequin PF, Du B, Emberson J, Fisher D, Giraudeau B, Gordon AC, Granholm A, Green C, Haynes R, Heming N, Higgins JPT, Horby P, Juni P, Landray MJ, Le Gouge A, Leclerc M, Lim WS, Machado FR, McArthur C, Meziani F, Moller MH, Perner A, Petersen MW, Savovic J, Tomazini B, Veiga VC, Webb S, Marshall JC. Association Between Administration of Systemic Corticosteroids and Mortality Among Critically Ill Patients With COVID-19: A Meta-analysis. JAMA. 2020 Oct 6;324(13):1330-1341. doi: 10.1001/jama.2020.17023. PubMed 32876694 ↗
  • 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. PubMed 32876695 ↗
  • Villar J, Ferrando C, Martinez D, Ambros A, Munoz T, Soler JA, Aguilar G, Alba F, Gonzalez-Higueras E, Conesa LA, Martin-Rodriguez C, Diaz-Dominguez FJ, Serna-Grande P, Rivas R, Ferreres J, Belda J, Capilla L, Tallet A, Anon JM, Fernandez RL, Gonzalez-Martin JM; dexamethasone in ARDS network. Dexamethasone treatment for the acute respiratory distress syndrome: a multicentre, randomised controlled trial. Lancet Respir Med. 2020 Mar;8(3):267-276. doi: 10.1016/S2213-2600(19)30417-5. Epub 2020 Feb 7. PubMed 32043986 ↗
  • 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. PubMed 32943404 ↗
  • Rabascall CX, Lou BX, Dhar S, Hasan Z, Fryman C, Izard S, Makaryus M, Acharya S, Mastroianni F, Kamper M, Duenas S, Gong J, Shah D, Khanijo S, Ying D, Habibullah J, Kim DH, Butzko R, Oks M, Birnbaum B, Moore J, Singh AK, Quintero L, Lau M, Honigman J, Hilewitz A, Shah K, Simonson J, Agrawal A, Frank M, Tsegaye A, Narasimhan M, Greenberg H, Hahn SS. Randomized Open Investigation Determining Steroid Dose in Severe COVID-19: The ROIDS-Dose Clinical Trial. Cureus. 2022 Nov 4;14(11):e31086. doi: 10.7759/cureus.31086. eCollection 2022 Nov. PubMed 36475114 ↗

Study documents

  • Protocol and statistical analysis plan · Nov 3, 2021
  • Informed consent form · Nov 4, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2021 to primary completion in Jan 2022, 10 months.

Results were first posted in Jul 2023, 1 year 5 months after primary completion.

Of 279 non-industry phase 3 interventional studies under COVID-19, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 18. This study's 10 months is above that.

Counting every sponsor, half of 436 studies reached it within 9 months; a quarter within 5 and three quarters within 17.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 31, 2021
First posted
Apr 8, 2021
StartActual
Mar 19, 2021
Primary completionActual
Jan 25, 2022
CompletionActual
Mar 29, 2022
Results first posted
Jul 20, 2023
Last update
Jul 20, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04834375
Lead sponsor
Northwell Health
Responsible party
Stella S Hahn, MD (Associate Medical Director, Northwell Sleep Disorders Center, Northwell Health) — Principal investigator
First posted
Apr 8, 2021
Start date
Mar 19, 2021
Primary completion
Jan 25, 2022
Completion
Mar 29, 2022
Results posted
Jul 20, 2023
Last update
Jul 20, 2023

Study contacts

Mangala Narasimhan, DO
principal investigator · Northwell Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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