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Low or High Dose of Dexamethasone in Patients With Respiratory Failure by COVID-19 (HIGHLOWDEXA)

Primary Purpose

Covid19, Corticosteroids

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Dexamethasone high dose
Dexamethasone low dose
Sponsored by
Manuel Taboada Muñiz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID19, respiratory failure, corticosteroids

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18 years or older.
  • Hospitalized COVID-19 patients admitted to the Hospital.
  • Patients requiring supplemental oxygen. Level 4 using the World Health Organization 7-point Ordinal Scale for clinical improvement
  • Patients requiring corticosteroids (dexamethasone) according to Hospital protocol.

Exclusion Criteria:

  • Pregnancy or active lactation.
  • Patient is expected to die in the next 48 hours.
  • Known history of dexamethasone allergy or known contraindication to the use of corticosteroids.
  • Daily use of corticosteroids in the past 15 days.
  • Indication for corticosteroids use for other clinical conditions (e.g. refractory septic shock).
  • Consent refusal for participating in the trial.
  • Different level of 4 in Level 4 using the World Health Organization 7-point Ordinal Scale for clinical improvement.

Sites / Locations

  • University Clinical Hospital of Santiago de Compostela

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Low dose group

High dose group

Arm Description

Dexamethasone 6mg/day for 10 days

Dexamethasone 20mg/day for 5 days + Dexamethasone 10mg/day for 5 days (Total 10 days)

Outcomes

Primary Outcome Measures

Percentage of patients with treatment failure at day 11
defined as death, need of ICU and extracorporeal membrane oxygenation, need of non-invasive ventilation or nasal high-flow oxygen therapy, or worsening of the condition clinic of the patient during treatment (two of these: need to increase Fraction of inspired oxygen inspired>20%, need for fraction inspired oxygenation>50%, increase in respiratory rate>25, increase in inflammatory markers).

Secondary Outcome Measures

Percentage of patients without the need for oxygen support at day 11.
28-days mortality
90-days mortality
Clinical status of patients using the World Health Organization 7-point Ordinal Scale for clinical improvement during 10 days of treatment
1:Not hospitalized, 2:Hospitalized and not treatment, 3: Hospitalized with treatment, not requiring supplemental oxygen, 4:Hospitalized requiring supplemental oxygen, 5:Hospitalized, requiring non-invasive ventilation or nasal high-flow oxygen therapy, 6: Hospitalized requiring invasive ventilation or Extracorporeal (ECMO)
Percentage of patients needing Intensive Care Unit admission
Percentage of patients needing invasive mechanical ventilation or extracorporeal membrane oxygenation
Percentage of patients needing non-invasive ventilation or nasal high-flow oxygen therapy
Length of stay in the hospital
Infectious complications during hospital admission
Adverse drug reactions

Full Information

First Posted
January 23, 2021
Last Updated
October 19, 2021
Sponsor
Manuel Taboada Muñiz
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1. Study Identification

Unique Protocol Identification Number
NCT04726098
Brief Title
Low or High Dose of Dexamethasone in Patients With Respiratory Failure by COVID-19
Acronym
HIGHLOWDEXA
Official Title
Efficacy of Low or High Dose of Dexamethasone in Patients With Respiratory Failure by COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Manuel Taboada Muñiz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
After RECOVERY trial publication, low dose (6 mg dexamethasone for 10 days) was recommended as the usual care treatment in hospitalized patients with respiratory failure by COVID-19 needing oxygen therapy. RECOVERY trial showed how the use of dexamethasone 6 mg / day for ten days compared to standard treatment without the use of corticosteroids in hospitalized patients reduced mortality at 28 days (22.9% with dexamethasone vs 25.7% without dexamethasone). In the dexamethasone group, the incidence of mortality was lower than standard treatment in patients with hypoxia and the need for mechanical ventilation (29.3% with dexamethasone vs 41.4% without dexamethasone), in patients admitted to the hospital ward with a need for oxygen therapy (23.3% with dexamethasone vs 26.2% without dexamethasone), but they did not find differences between those admitted patients who did not need oxygen therapy. There are two other studies (DEXA-COVID-19 and CoDEX) where they observed benefits of the use of dexamethasone 20 mg / day 5 days, and 10 mg / day 5 days (total 10 days) in patients admitted for respiratory distress syndrome (ARDS) and COVID-19. At present, it is unclear what dose of dexamethasone is most beneficial in patients with COVID-19 and respiratory failure.
Detailed Description
Objective: The investigators aim to assess the efficacy of high dose of dexamethasone (20 mg / day 5 days, and 10 mg/day 5 days) versus low dose of dexamethasone (6 mg/day 10 days) in patients with respiratory failure by COVID-19.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Corticosteroids
Keywords
COVID19, respiratory failure, corticosteroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled, open-label trial involving hospitalized adult patients with respiratory failure needing oxygen therapy, caused by COVID-19.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose group
Arm Type
Active Comparator
Arm Description
Dexamethasone 6mg/day for 10 days
Arm Title
High dose group
Arm Type
Active Comparator
Arm Description
Dexamethasone 20mg/day for 5 days + Dexamethasone 10mg/day for 5 days (Total 10 days)
Intervention Type
Drug
Intervention Name(s)
Dexamethasone high dose
Intervention Description
High doses: dexamethasone 20 mg/day 5 days + 10 mg/day 5 days (total 10 days)
Intervention Type
Drug
Intervention Name(s)
Dexamethasone low dose
Intervention Description
Low doses: dexamethasone 6 mg/day 10 days.
Primary Outcome Measure Information:
Title
Percentage of patients with treatment failure at day 11
Description
defined as death, need of ICU and extracorporeal membrane oxygenation, need of non-invasive ventilation or nasal high-flow oxygen therapy, or worsening of the condition clinic of the patient during treatment (two of these: need to increase Fraction of inspired oxygen inspired>20%, need for fraction inspired oxygenation>50%, increase in respiratory rate>25, increase in inflammatory markers).
Time Frame
Day 11 after randomization
Secondary Outcome Measure Information:
Title
Percentage of patients without the need for oxygen support at day 11.
Time Frame
Day 11 after randomization
Title
28-days mortality
Time Frame
28 days after randomization
Title
90-days mortality
Time Frame
90 days after randomization
Title
Clinical status of patients using the World Health Organization 7-point Ordinal Scale for clinical improvement during 10 days of treatment
Description
1:Not hospitalized, 2:Hospitalized and not treatment, 3: Hospitalized with treatment, not requiring supplemental oxygen, 4:Hospitalized requiring supplemental oxygen, 5:Hospitalized, requiring non-invasive ventilation or nasal high-flow oxygen therapy, 6: Hospitalized requiring invasive ventilation or Extracorporeal (ECMO)
Time Frame
10 days after randomization
Title
Percentage of patients needing Intensive Care Unit admission
Time Frame
28 days after randomization
Title
Percentage of patients needing invasive mechanical ventilation or extracorporeal membrane oxygenation
Time Frame
28 days after randomization
Title
Percentage of patients needing non-invasive ventilation or nasal high-flow oxygen therapy
Time Frame
28 days after randomization
Title
Length of stay in the hospital
Time Frame
90 days after randomization
Title
Infectious complications during hospital admission
Time Frame
90 days after randomization
Title
Adverse drug reactions
Time Frame
11 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or older. Hospitalized COVID-19 patients admitted to the Hospital. Patients requiring supplemental oxygen. Level 4 using the World Health Organization 7-point Ordinal Scale for clinical improvement Patients requiring corticosteroids (dexamethasone) according to Hospital protocol. Exclusion Criteria: Pregnancy or active lactation. Patient is expected to die in the next 48 hours. Known history of dexamethasone allergy or known contraindication to the use of corticosteroids. Daily use of corticosteroids in the past 15 days. Indication for corticosteroids use for other clinical conditions (e.g. refractory septic shock). Consent refusal for participating in the trial. Different level of 4 in Level 4 using the World Health Organization 7-point Ordinal Scale for clinical improvement.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel Taboada Muñiz, Ph.D.
Organizational Affiliation
University Clinical Hospital of Santiago de Compostela
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinical Hospital of Santiago de Compostela
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15866
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34916266
Citation
Taboada M, Rodriguez N, Varela PM, Rodriguez MT, Abelleira R, Gonzalez A, Casal A, Diaz Peromingo JA, Lama A, Dominguez MJ, Rabade C, Paez EM, Riveiro V, Pernas H, Beceiro MDC, Caruezo V, Naveira A, Carinena A, Cabaleiro T, Estany-Gestal A, Zarra I, Pose A, Valdes L, Alvarez-Escudero J. Effect of high versus low dose of dexamethasone on clinical worsening in patients hospitalised with moderate or severe COVID-19 pneumonia: an open-label, randomised clinical trial. Eur Respir J. 2022 Aug 4;60(2):2102518. doi: 10.1183/13993003.02518-2021. Print 2022 Aug.
Results Reference
derived

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Low or High Dose of Dexamethasone in Patients With Respiratory Failure by COVID-19

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