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Higher vs. Lower Doses of Dexamethasone for COVID-19 and Severe Hypoxia (COVIDSTEROID2)

Primary Purpose

Covid19, Hypoxia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
Scandinavian Critical Care Trials Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Randomised clinical trial, COVID-19, Hypoxia, Corticosteroids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All of the following must be fulfilled

  • Aged 18 years or above AND
  • Confirmed SARS-CoV-2 (COVID-19) requiring hospitalisation AND

  • Use of one of the following:

    • Invasive mechanical ventilation OR
    • Non-invasive ventilation or continuous use of continuous positive airway pressure (CPAP) for hypoxia OR
    • Oxygen supplementation with an oxygen flow of at least 10 L/min independent of delivery system

Exclusion Criteria: We will exclude patients who fulfil any of the following criteria:

  • Use of systemic corticosteroids for other indications than COVID-19 in doses higher than 6 mg dexamethasone equivalents
  • Use of systemic corticosteroids for COVID-19 for 5 days consecutive days or more
  • Invasive fungal infection
  • Active tuberculosis
  • Fertile woman (<60 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG
  • Known hypersensitivity to dexamethasone
  • Previously randomised into the COVID STEROID 2 trial
  • Informed consent not obtainable

Sites / Locations

  • Dept. of Anaesthesia and Intensive Care, Aalborg University Hospital, Denmark.
  • Dept. of Intensive care, Aarhus University Hospital
  • Dept. of Intensive Care, Copenhagen University Hospital, Rigshospitalet
  • Dept. of Neuroanaesthesiology
  • Dept. of Thoracic Anaesthesiology, Copenhagen University Hospital, Rigshospitalet
  • Dept of Infectious diseases, Copenhagen University Hospital, Rigshospitalet
  • Dept. of Intensive Care, Gentofte Hospital
  • Dept. of Anaesthesia and Intensive Care, Herlev Hospital
  • Dept. of Anaesthesia, Regional Hospital West Jutland, Herning
  • Dept. of Intensive Care, Nordsjællands Hospital - Hillerød, Denmark.
  • Hvidovre Hospital - Dept of Infectious diseases
  • Hvidovre Hospital - Dept of Intensive Care
  • Hvidovre Hospital - Dept of Pulmonary Medicine
  • Dept. of Anaesthesia and Intensive Care, Lillebaelt Hospital
  • Dept. of Intensive Care, Køge University Hospital
  • Dept of Intensive Care, Odense University Hospital
  • Dept. of Anaesthesia and Intensive Care, Zealand University Hospital Roskilde
  • Dept. of Anaesthesia, Slagelse Hospital
  • Dept. of Anaesthesia and Intensive Care, Viborg Hospital
  • Jawahar Lal Nehru Medical Collega, AMU
  • Apollo Hospital
  • Amrita Institute of Medical Sciences
  • Bombay Hospital & Medical Research Centre
  • K. J. Somaiya Super Specialty Hospital
  • P. D. Hinduja National Hospital & Medical Research Centre
  • S L Raheja Fortis Hospital
  • Tata Memorial Hospital
  • Wockhardt hospitals
  • Indraprastha Apollo Hospital
  • Max Super Specialty Hospital, Saket
  • Symbiosis University Hospital and Research Centre
  • Vishwaraj Hospital
  • Rajendra Institute of Medical Sciences
  • Gotri General Hospital
  • Christian Medical College Vellore
  • Dept. of Anaesthesia and Intensive Care, Sahlgranska Universitetssjukhuset
  • Dept. of Infectious Diseases, Sahlgranska Universitetssjukhuset
  • Dept. of Anaesthesia and Intensive Care, Universitetssjukhuset i Linköping
  • Dept. of Anaesthesia and Intensive Care, Skånes Universitetssjukhus (SUS) Malmö
  • Dept. of Infectious Diseases, Skånes Universitetssjukhus (SUS) Malmö
  • Dept. of Anaesthesia and Intensive Care, Vrinnevisjukhuset, Norrköping
  • Dept. of Anaesthesia and Intensive Care, Capio St Görans Sjukhus
  • Dept. of Anaesthesia and Intensive Care, Danderyds Sjukhuset
  • Dept. of Anaesthesia and Intensive Care, Karolinska Universitetssjukhuset, Huddinge
  • Dept. of Anaesthesia and Intensive Care, Karolinska Universitetssjukhuset, Solna
  • Dept. of Cardiology, Södersjukhuset
  • Dept. of Infectious Diseases, Danderyds Sjukhuset
  • Dept. of Infectious Diseases, Karolinska Universitetssjukhuset, Solna
  • Dept. of Infectious Diseases, Södersjukhuset
  • Dept. of Internal Medicine, Danderyds Sjukhuset
  • Dept. of Internal Medicine, Södersjukhuset
  • Södersjukhuset
  • Dept. of Intensive Care Medicine, Bern University Hospital (Inselspital)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dexamethasone 12 mg

Dexamethasone 6 mg

Arm Description

Intravenous bolus injection of dexamethasone 12 mg once daily in addition to standard care for up to 10 days. We will allow the use of betamethasone 12 mg at sites, where dexamethasone is not available.

Intravenous bolus injection of dexamethasone 6 mg once daily in addition to standard care for up to 10 days. We will allow the use of betamethasone 6 mg at sites, where dexamethasone is not available.

Outcomes

Primary Outcome Measures

Days alive without life support at day 28
Days alive without life support (i.e. invasive mechanical ventilation, circulatory support or renal replacement therapy) from randomisation to day 28

Secondary Outcome Measures

Number of participants with one or more serious adverse reactions
Serious adverse reactions defined as new episodes of septic shock, invasive fungal infection, clinically important gastrointestinal bleeding or anaphylactic reaction
All-cause mortality at day 28
Death from all causes
All-cause mortality at day 90
Death from all causes
Days alive without life support at day 90
Days alive without life support (i.e. invasive mechanical ventilation, circulatory support or renal replacement therapy) from randomisation to day 90
Days alive and out of hospital at day 90
Number of days alive and out of hospital not limited to the index admission
All-cause mortality at day 180
Death from all causes
Health-related quality of life at day 180
Assessed by EQ-5D-5L
Health-related quality of life at day 180
Assessed by EQ-VAS

Full Information

First Posted
August 11, 2020
Last Updated
February 22, 2022
Sponsor
Scandinavian Critical Care Trials Group
Collaborators
Copenhagen Trial Unit, Center for Clinical Intervention Research, Centre for Research in Intensive Care (CRIC), Aarhus University Hospital, Aalborg University Hospital, Rigshospitalet, Denmark, The George Institute for Global Health, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT04509973
Brief Title
Higher vs. Lower Doses of Dexamethasone for COVID-19 and Severe Hypoxia
Acronym
COVIDSTEROID2
Official Title
Higher vs. Lower Doses of Dexamethasone in Patients With COVID-19 and Severe Hypoxia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 27, 2020 (Actual)
Primary Completion Date
June 17, 2021 (Actual)
Study Completion Date
February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scandinavian Critical Care Trials Group
Collaborators
Copenhagen Trial Unit, Center for Clinical Intervention Research, Centre for Research in Intensive Care (CRIC), Aarhus University Hospital, Aalborg University Hospital, Rigshospitalet, Denmark, The George Institute for Global Health, Australia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
We aim to assess the benefits and harms of higher (12 mg) vs lower doses (6 mg) of dexamethasone on patient-centered outcomes in patients with COVID-19 and severe hypoxia.
Detailed Description
Background: Preliminary results from the Randomised Evaluation of COVid-19 thERapY (RECOVERY) trial have reported a reduction in 28-day mortality with low-dose dexamethasone (6 mg) once daily versus no intervention in hospitalised patients with COVID-19; an effect that may have been more pronounced in patients with increasing hypoxia. Yet, higher doses of dexamethasone may be beneficial in patients with non-COVID-19 acute respiratory distress syndrome. At present, it is unclear what dose of dexamethasone is most beneficial in patients with COVID-19 and severe hypoxia, and clinical equipoise exists. Objective: We aim to assess the effects of higher (12 mg) vs lower doses (6 mg) of intravenous dexamethasone on the number of days alive without life-support in adult patients with COVID-19 and severe hypoxia. Design: International, parallel-group, centrally randomised, stratified, blinded, clinical trial. Population: Adult patients with documented COVID-19 receiving at least 10 L/min of oxygen independent of delivery system OR mechanical ventilation. Experimental intervention: Dexamethasone 12 mg once daily for up to 10 days in addition to standard care. Control intervention: Dexamethasone 6 mg once daily for up to 10 days in addition to standard care. Outcomes: The primary outcome is days alive without life support (i.e. mechanical ventilation, circulatory support, or renal replacement therapy) at day 28. Secondary outcomes are serious adverse reactions (i.e. anaphylactic reaction to hydrocortisone, new episode of septic shock, invasive fungal infection or clinically important gastrointestinal bleeding) at day 28; days alive without life support at day 90; days alive and out of hospital at day 90; all-cause mortality at day 28, 90 and 180; and health-related quality of life at day 180. Sample size: A total of 1000 participants will be randomised in order to detect a 15% relative reduction in 28-day mortality combined with a 10% reduction in time on life support among the survivors with a power of 85%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Hypoxia
Keywords
Randomised clinical trial, COVID-19, Hypoxia, Corticosteroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone 12 mg
Arm Type
Experimental
Arm Description
Intravenous bolus injection of dexamethasone 12 mg once daily in addition to standard care for up to 10 days. We will allow the use of betamethasone 12 mg at sites, where dexamethasone is not available.
Arm Title
Dexamethasone 6 mg
Arm Type
Active Comparator
Arm Description
Intravenous bolus injection of dexamethasone 6 mg once daily in addition to standard care for up to 10 days. We will allow the use of betamethasone 6 mg at sites, where dexamethasone is not available.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Dexavit
Intervention Description
ATC code: H02AB02
Primary Outcome Measure Information:
Title
Days alive without life support at day 28
Description
Days alive without life support (i.e. invasive mechanical ventilation, circulatory support or renal replacement therapy) from randomisation to day 28
Time Frame
Day 28 after randomisation
Secondary Outcome Measure Information:
Title
Number of participants with one or more serious adverse reactions
Description
Serious adverse reactions defined as new episodes of septic shock, invasive fungal infection, clinically important gastrointestinal bleeding or anaphylactic reaction
Time Frame
Day 28 after randomisation
Title
All-cause mortality at day 28
Description
Death from all causes
Time Frame
Day 28 after randomisation
Title
All-cause mortality at day 90
Description
Death from all causes
Time Frame
Day 90 after randomisation
Title
Days alive without life support at day 90
Description
Days alive without life support (i.e. invasive mechanical ventilation, circulatory support or renal replacement therapy) from randomisation to day 90
Time Frame
Day 90 after randomisation
Title
Days alive and out of hospital at day 90
Description
Number of days alive and out of hospital not limited to the index admission
Time Frame
Day 90 after randomisation
Title
All-cause mortality at day 180
Description
Death from all causes
Time Frame
Day 180 after randomisation
Title
Health-related quality of life at day 180
Description
Assessed by EQ-5D-5L
Time Frame
Day 180 after randomisation
Title
Health-related quality of life at day 180
Description
Assessed by EQ-VAS
Time Frame
Day 180 after randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All of the following must be fulfilled Aged 18 years or above AND Confirmed SARS-CoV-2 (COVID-19) requiring hospitalisation AND Use of one of the following: Invasive mechanical ventilation OR Non-invasive ventilation or continuous use of continuous positive airway pressure (CPAP) for hypoxia OR Oxygen supplementation with an oxygen flow of at least 10 L/min independent of delivery system Exclusion Criteria: We will exclude patients who fulfil any of the following criteria: Use of systemic corticosteroids for other indications than COVID-19 in doses higher than 6 mg dexamethasone equivalents Use of systemic corticosteroids for COVID-19 for 5 days consecutive days or more Invasive fungal infection Active tuberculosis Fertile woman (<60 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG Known hypersensitivity to dexamethasone Previously randomised into the COVID STEROID 2 trial Informed consent not obtainable
Facility Information:
Facility Name
Dept. of Anaesthesia and Intensive Care, Aalborg University Hospital, Denmark.
City
Aalborg
Country
Denmark
Facility Name
Dept. of Intensive care, Aarhus University Hospital
City
Aarhus
Country
Denmark
Facility Name
Dept. of Intensive Care, Copenhagen University Hospital, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Dept. of Neuroanaesthesiology
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Dept. of Thoracic Anaesthesiology, Copenhagen University Hospital, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Dept of Infectious diseases, Copenhagen University Hospital, Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
Dept. of Intensive Care, Gentofte Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Dept. of Anaesthesia and Intensive Care, Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Dept. of Anaesthesia, Regional Hospital West Jutland, Herning
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Dept. of Intensive Care, Nordsjællands Hospital - Hillerød, Denmark.
City
Hillerød
Country
Denmark
Facility Name
Hvidovre Hospital - Dept of Infectious diseases
City
Hvidovre
Country
Denmark
Facility Name
Hvidovre Hospital - Dept of Intensive Care
City
Hvidovre
Country
Denmark
Facility Name
Hvidovre Hospital - Dept of Pulmonary Medicine
City
Hvidovre
Country
Denmark
Facility Name
Dept. of Anaesthesia and Intensive Care, Lillebaelt Hospital
City
Kolding
Country
Denmark
Facility Name
Dept. of Intensive Care, Køge University Hospital
City
Køge
ZIP/Postal Code
4600
Country
Denmark
Facility Name
Dept of Intensive Care, Odense University Hospital
City
Odense
Country
Denmark
Facility Name
Dept. of Anaesthesia and Intensive Care, Zealand University Hospital Roskilde
City
Roskilde
Country
Denmark
Facility Name
Dept. of Anaesthesia, Slagelse Hospital
City
Slagelse
ZIP/Postal Code
4200
Country
Denmark
Facility Name
Dept. of Anaesthesia and Intensive Care, Viborg Hospital
City
Viborg
Country
Denmark
Facility Name
Jawahar Lal Nehru Medical Collega, AMU
City
Aligarh
Country
India
Facility Name
Apollo Hospital
City
Chennai
Country
India
Facility Name
Amrita Institute of Medical Sciences
City
Kochi
Country
India
Facility Name
Bombay Hospital & Medical Research Centre
City
Mumbai
Country
India
Facility Name
K. J. Somaiya Super Specialty Hospital
City
Mumbai
Country
India
Facility Name
P. D. Hinduja National Hospital & Medical Research Centre
City
Mumbai
Country
India
Facility Name
S L Raheja Fortis Hospital
City
Mumbai
Country
India
Facility Name
Tata Memorial Hospital
City
Mumbai
Country
India
Facility Name
Wockhardt hospitals
City
Mumbai
Country
India
Facility Name
Indraprastha Apollo Hospital
City
New Delhi
Country
India
Facility Name
Max Super Specialty Hospital, Saket
City
New Delhi
Country
India
Facility Name
Symbiosis University Hospital and Research Centre
City
Pune
Country
India
Facility Name
Vishwaraj Hospital
City
Pune
Country
India
Facility Name
Rajendra Institute of Medical Sciences
City
Ranchi
Country
India
Facility Name
Gotri General Hospital
City
Vadodara
Country
India
Facility Name
Christian Medical College Vellore
City
Vellore
Country
India
Facility Name
Dept. of Anaesthesia and Intensive Care, Sahlgranska Universitetssjukhuset
City
Göteborg
Country
Sweden
Facility Name
Dept. of Infectious Diseases, Sahlgranska Universitetssjukhuset
City
Göteborg
Country
Sweden
Facility Name
Dept. of Anaesthesia and Intensive Care, Universitetssjukhuset i Linköping
City
Linköping
Country
Sweden
Facility Name
Dept. of Anaesthesia and Intensive Care, Skånes Universitetssjukhus (SUS) Malmö
City
Malmö
Country
Sweden
Facility Name
Dept. of Infectious Diseases, Skånes Universitetssjukhus (SUS) Malmö
City
Malmö
Country
Sweden
Facility Name
Dept. of Anaesthesia and Intensive Care, Vrinnevisjukhuset, Norrköping
City
Norrköping
Country
Sweden
Facility Name
Dept. of Anaesthesia and Intensive Care, Capio St Görans Sjukhus
City
Stockholm
Country
Sweden
Facility Name
Dept. of Anaesthesia and Intensive Care, Danderyds Sjukhuset
City
Stockholm
Country
Sweden
Facility Name
Dept. of Anaesthesia and Intensive Care, Karolinska Universitetssjukhuset, Huddinge
City
Stockholm
Country
Sweden
Facility Name
Dept. of Anaesthesia and Intensive Care, Karolinska Universitetssjukhuset, Solna
City
Stockholm
Country
Sweden
Facility Name
Dept. of Cardiology, Södersjukhuset
City
Stockholm
Country
Sweden
Facility Name
Dept. of Infectious Diseases, Danderyds Sjukhuset
City
Stockholm
Country
Sweden
Facility Name
Dept. of Infectious Diseases, Karolinska Universitetssjukhuset, Solna
City
Stockholm
Country
Sweden
Facility Name
Dept. of Infectious Diseases, Södersjukhuset
City
Stockholm
Country
Sweden
Facility Name
Dept. of Internal Medicine, Danderyds Sjukhuset
City
Stockholm
Country
Sweden
Facility Name
Dept. of Internal Medicine, Södersjukhuset
City
Stockholm
Country
Sweden
Facility Name
Södersjukhuset
City
Stockholm
Country
Sweden
Facility Name
Dept. of Intensive Care Medicine, Bern University Hospital (Inselspital)
City
Bern
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Fully de-identified IPD will be shared after the approval by the the trial management committee
IPD Sharing Time Frame
Immediate sharing of protocol, SAP and ICF. CSR will be shared no later than 6 months after last-patient-last-visit
IPD Sharing Access Criteria
Contact to the trial management committee
IPD Sharing URL
http://www.cric.nu/covid-steroid-2/
Citations:
PubMed Identifier
35359168
Citation
Granholm A, Kjaer MN, Munch MW, Myatra SN, Vijayaraghavan BKT, Cronhjort M, Wahlin RR, Jakob SM, Cioccari L, Vesterlund GK, Meyhoff TS, Helleberg M, Moller MH, Benfield T, Venkatesh B, Hammond NE, Micallef S, Bassi A, John O, Jha V, Kristiansen KT, Ulrik CS, Jorgensen VL, Smitt M, Bestle MH, Andreasen AS, Poulsen LM, Rasmussen BS, Brochner AC, Strom T, Moller A, Khan MS, Padmanaban A, Divatia JV, Saseedharan S, Borawake K, Kapadia F, Dixit S, Chawla R, Shukla U, Amin P, Chew MS, Wamberg CA, Bose N, Shah MS, Darfelt IS, Gluud C, Lange T, Perner A. Long-term outcomes of dexamethasone 12 mg versus 6 mg in patients with COVID-19 and severe hypoxaemia. Intensive Care Med. 2022 May;48(5):580-589. doi: 10.1007/s00134-022-06677-2. Epub 2022 Mar 31.
Results Reference
derived
PubMed Identifier
35349129
Citation
Durr KM, Hendin A, Perry JJ. Effect of 12 mg vs 6 mg of dexamethasone on the number of days alive without life support in adults with COVID-19 and severe hypoxemia: the COVID STEROID 2 randomized trial. CJEM. 2022 Apr;24(3):266-267. doi: 10.1007/s43678-022-00293-1. Epub 2022 Mar 29. No abstract available.
Results Reference
derived
PubMed Identifier
34757439
Citation
Granholm A, Munch MW, Myatra SN, Vijayaraghavan BKT, Cronhjort M, Wahlin RR, Jakob SM, Cioccari L, Kjaer MN, Vesterlund GK, Meyhoff TS, Helleberg M, Moller MH, Benfield T, Venkatesh B, Hammond NE, Micallef S, Bassi A, John O, Jha V, Kristiansen KT, Ulrik CS, Jorgensen VL, Smitt M, Bestle MH, Andreasen AS, Poulsen LM, Rasmussen BS, Brochner AC, Strom T, Moller A, Khan MS, Padmanaban A, Divatia JV, Saseedharan S, Borawake K, Kapadia F, Dixit S, Chawla R, Shukla U, Amin P, Chew MS, Wamberg CA, Gluud C, Lange T, Perner A. Dexamethasone 12 mg versus 6 mg for patients with COVID-19 and severe hypoxaemia: a pre-planned, secondary Bayesian analysis of the COVID STEROID 2 trial. Intensive Care Med. 2022 Jan;48(1):45-55. doi: 10.1007/s00134-021-06573-1. Epub 2021 Nov 10.
Results Reference
derived
PubMed Identifier
34673895
Citation
COVID STEROID 2 Trial Group; Munch MW, Myatra SN, Vijayaraghavan BKT, Saseedharan S, Benfield T, Wahlin RR, Rasmussen BS, Andreasen AS, Poulsen LM, Cioccari L, Khan MS, Kapadia F, Divatia JV, Brochner AC, Bestle MH, Helleberg M, Michelsen J, Padmanaban A, Bose N, Moller A, Borawake K, Kristiansen KT, Shukla U, Chew MS, Dixit S, Ulrik CS, Amin PR, Chawla R, Wamberg CA, Shah MS, Darfelt IS, Jorgensen VL, Smitt M, Granholm A, Kjaer MN, Moller MH, Meyhoff TS, Vesterlund GK, Hammond NE, Micallef S, Bassi A, John O, Jha A, Cronhjort M, Jakob SM, Gluud C, Lange T, Kadam V, Marcussen KV, Hollenberg J, Hedman A, Nielsen H, Schjorring OL, Jensen MQ, Leistner JW, Jonassen TB, Kristensen CM, Clapp EC, Hjortso CJS, Jensen TS, Halstad LS, Bak ERB, Zaabalawi R, Metcalf-Clausen M, Abdi S, Hatley EV, Aksnes TS, Gleipner-Andersen E, Alarcon AF, Yamin G, Heymowski A, Berggren A, La Cour K, Weihe S, Pind AH, Engstrom J, Jha V, Venkatesh B, Perner A. Effect of 12 mg vs 6 mg of Dexamethasone on the Number of Days Alive Without Life Support in Adults With COVID-19 and Severe Hypoxemia: The COVID STEROID 2 Randomized Trial. JAMA. 2021 Nov 9;326(18):1807-1817. doi: 10.1001/jama.2021.18295. Erratum In: JAMA. 2021 Dec 14;326(22):2333. JAMA. 2022 Jan 18;327(3):286.
Results Reference
derived
PubMed Identifier
33583027
Citation
Granholm A, Munch MW, Myatra SN, Vijayaraghavan BKT, Cronhjort M, Wahlin RR, Jakob SM, Cioccari L, Kjaer MN, Vesterlund GK, Meyhoff TS, Helleberg M, Moller MH, Benfield T, Venkatesh B, Hammond N, Micallef S, Bassi A, John O, Jha V, Kristiansen KT, Ulrik CS, Jorgensen VL, Smitt M, Bestle MH, Andreasen AS, Poulsen LM, Rasmussen BS, Brochner AC, Strom T, Moller A, Khan MS, Padmanaban A, Divatia JV, Saseedharan S, Borawake K, Kapadia F, Dixit S, Chawla R, Shukla U, Amin P, Chew MS, Gluud C, Lange T, Perner A. Higher vs Lower Doses of Dexamethasone in Patients with COVID-19 and Severe Hypoxia (COVID STEROID 2) trial: Protocol for a secondary Bayesian analysis. Acta Anaesthesiol Scand. 2021 May;65(5):702-710. doi: 10.1111/aas.13793. Epub 2021 Feb 25.
Results Reference
derived
Links:
URL
http://www.cric.nu/covid-steroid-2/
Description
Trial website

Learn more about this trial

Higher vs. Lower Doses of Dexamethasone for COVID-19 and Severe Hypoxia

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