Covid19Phase 3ROIDS-DoseNCT04834375

Randomized Open Investigation Determining Steroid Dose

A Phase 3 study testing Weight-based dexamethasone dose in people with Covid19, run by Northwell Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Covid19
What is being tested?: Weight-based dexamethasone dose
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 142 participants
Where: 1 siteUnited States
Study dates: 19 Mar 2021to 29 Mar 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwell Health
New Hyde Park, New York, 11042

Other trials in United States

About this study

Official title: Randomized Open Investigation Determining Steroid Dose (ROIDS-Dose)

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.

Conditions: Covid19
Being tested: Weight-based dexamethasone dose
Keywords: dexamethasone, COVID-19, COVID pneumonia, respiratory failure, steroids
Medical subject headings: COVID-19, Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Weight-based dexamethasone doseDrug
Also called Higher dexamethasone dose
Weight-based dexamethasone dose in COVID-19 patients with hypoxic respiratory failure

Study groups in NCT04834375
Study group	Role	What they receive
Standard dexamethasone dose	No intervention	Dexamethasone 6 mg IV daily for 10 days
Weight-based dexamethasone dose	Experimental	Dexamethasone 0.2 mg/kg/day IV (maximum 20 mg daily) for 10 days Receives: Drug: Weight-based dexamethasone dose

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 28 days

Secondary outcomes (13)

Number of Participants Admitted to the ICU
Number of participants that required admission to the ICU
Measured: 28 days
Days of Stay in the Intensive Care Unit
ICU length of stay
Measured: 28 days
Days of Hospitalization
Duration of hospitalization
Measured: 28 days
Number of Participants That Required Higher Levels of Oxygen Supplementation
Venturi mask, Non-rebreather mask, High-flow nasal cannula, Non-invasive ventilation
Measured: 28 days
Number of Participants That Required Invasive Mechanical Ventilation
Escalation to invasive mechanical ventilation
Measured: 28 days
Duration of Invasive Mechanical Ventilation
Total days requiring invasive mechanical ventilation
Measured: 28 days
Number of Participants That Required ECMO
Refractory hypoxemia requiring ECMO
Measured: 28 days
Number of Participants That Required Tracheostomy
Need for tracheostomy
Measured: 28 days
Number of Participants That Developed Secondary Bacterial or Fungal Infections
Culture positive evidence of secondary bacterial or fungal infections
Measured: 28 days
Number of Participants That Developed Clinically Significant Hyperglycemia
Defined as need for insulin drip or ICU admission to control hyperglycemia
Measured: 28 days
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.
Measured: Until hospital discharge
Subjective Symptoms at 28 Days
Subjective symptoms questionnaire at 28 days
Measured: 28 days
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
Measured: At hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Mar 202129 Mar 2022

First posted8 Apr 2021
Study start19 Mar 2021
Primary completion25 Jan 2022
Study completion29 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Covid19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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)
Masking: None (open label)
Enrolment: 142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04834375
Sponsor's protocol ID: 21-0171
Acronym: ROIDS-Dose
Status last verified: Jul 2023
First submitted: 31 Mar 2021
Last updated: 20 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Covid19 trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Open Investigation Determining Steroid Dose (ROIDS-Dose)
ClinicalTrials.gov ID: NCT04834375
Acronym / sponsor ID: ROIDS-Dose / 21-0171
Conditions: Covid19
Keywords: dexamethasone, COVID-19, COVID pneumonia, respiratory failure, steroids
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 142 participants (actual)
Lead sponsor: Northwell HealthUniversity, hospital or other
Study start: 19 Mar 2021 (actual)
Primary completion: 25 Jan 2022 (actual)
Study completion: 29 Mar 2022 (actual)
First posted: 8 Apr 2021 (actual)
Results: Posted 20 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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)

Arm	Type	Receives
Standard dexamethasone dose	No intervention	–Dexamethasone 6 mg IV daily for 10 days
Weight-based dexamethasone dose	Experimental	Drug: Weight-based dexamethasone doseDexamethasone 0.2 mg/kg/day IV (maximum 20 mg daily) for 10 days

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Weight-based dexamethasone doseAlso: Higher dexamethasone doseWeight-based dexamethasone dose in COVID-19 patients with hypoxic respiratory failure	Drug	Weight-based dexamethasone dose

Primary outcome

All Cause Mortality at 28 Days
Time frame: 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

13 secondary outcomes

Number of Participants Admitted to the ICU
Time frame: 28 days
Days of Stay in the Intensive Care Unit
Time frame: 28 days
Days of Hospitalization
Time frame: 28 days
Number of Participants That Required Higher Levels of Oxygen Supplementation
Time frame: 28 days
Number of Participants That Required Invasive Mechanical Ventilation
Time frame: 28 days
Duration of Invasive Mechanical Ventilation
Time frame: 28 days
Number of Participants That Required ECMO
Time frame: 28 days
Number of Participants That Required Tracheostomy
Time frame: 28 days
Number of Participants That Developed Secondary Bacterial or Fungal Infections
Time frame: 28 days
Number of Participants That Developed Clinically Significant Hyperglycemia
Time frame: 28 days
Number of Participants That Required Oxygen Supplementation a Discharge From the Hospital
Time frame: Until hospital discharge
Subjective Symptoms at 28 Days
Time frame: 28 days
Disposition Upon Discharge
Time frame: At hospital discharge

Results and safety

Results posted to the registry on 20 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Dexamethasone Dose	72	72
Weight-based Dexamethasone Dose	70	70

Primary outcome: All Cause Mortality at 28 Days

Time frame: 28 days. Count of participants. Unit: Participants

Measure	Standard Dexamethasone Dose n = 72	Weight-based Dexamethasone Dose n = 70
Value	15	12

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Dexamethasone Dose	0 of 72 (0%)	24 of 72 (33.3%)	17 of 72
Weight-based Dexamethasone Dose	0 of 70 (0%)	13 of 70 (18.6%)	12 of 70

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32678530RECOVERY 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.
Background: PubMed 32876694WHO 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.
Background: PubMed 32876695Tomazini 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.
Background: PubMed 32043986Villar 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.
Background: PubMed 32943404Edalatifard 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.
Derived from this study: PubMed 36475114Rabascall 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mangala Narasimhan, DO principal investigator

Northwell Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Weight-based dexamethasone dose in people with Covid19, run by Northwell Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All Cause Mortality at 28 Days (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04834375, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.