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

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ClinicalTrials.gov Identifier: NCT04726098
Recruitment Status : Completed
First Posted : January 27, 2021
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
Manuel Taboada Muñiz, Hospital Clinico Universitario de Santiago

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.

Condition or disease Intervention/treatment Phase
Covid19 Corticosteroids Drug: Dexamethasone high dose Drug: Dexamethasone low dose Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Efficacy of Low or High Dose of Dexamethasone in Patients With Respiratory Failure by COVID-19
Actual Study Start Date : January 15, 2021
Actual Primary Completion Date : August 31, 2021
Actual Study Completion Date : August 31, 2021


Arm Intervention/treatment
Active Comparator: Low dose group
Dexamethasone 6mg/day for 10 days
Drug: Dexamethasone low dose
Low doses: dexamethasone 6 mg/day 10 days.

Active Comparator: High dose group
Dexamethasone 20mg/day for 5 days + Dexamethasone 10mg/day for 5 days (Total 10 days)
Drug: Dexamethasone high dose
High doses: dexamethasone 20 mg/day 5 days + 10 mg/day 5 days (total 10 days)




Primary Outcome Measures :
  1. Percentage of patients with treatment failure at day 11 [ Time Frame: Day 11 after randomization ]
    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 :
  1. Percentage of patients without the need for oxygen support at day 11. [ Time Frame: Day 11 after randomization ]
  2. 28-days mortality [ Time Frame: 28 days after randomization ]
  3. 90-days mortality [ Time Frame: 90 days after randomization ]
  4. Clinical status of patients using the World Health Organization 7-point Ordinal Scale for clinical improvement during 10 days of treatment [ Time Frame: 10 days after randomization ]
    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)

  5. Percentage of patients needing Intensive Care Unit admission [ Time Frame: 28 days after randomization ]
  6. Percentage of patients needing invasive mechanical ventilation or extracorporeal membrane oxygenation [ Time Frame: 28 days after randomization ]
  7. Percentage of patients needing non-invasive ventilation or nasal high-flow oxygen therapy [ Time Frame: 28 days after randomization ]
  8. Length of stay in the hospital [ Time Frame: 90 days after randomization ]
  9. Infectious complications during hospital admission [ Time Frame: 90 days after randomization ]
  10. Adverse drug reactions [ Time Frame: 11 days after randomization ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04726098


Locations
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Spain
University Clinical Hospital of Santiago de Compostela
Santiago de Compostela, A Coruña, Spain, 15866
Sponsors and Collaborators
Manuel Taboada Muñiz
Investigators
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Principal Investigator: Manuel Taboada Muñiz, Ph.D. University Clinical Hospital of Santiago de Compostela
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Responsible Party: Manuel Taboada Muñiz, Associate Proffesor, Hospital Clinico Universitario de Santiago
ClinicalTrials.gov Identifier: NCT04726098    
Other Study ID Numbers: HIGHLOWDEXA-COVID
2020-005702-25 ( EudraCT Number )
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Manuel Taboada Muñiz, Hospital Clinico Universitario de Santiago:
COVID19
respiratory failure
corticosteroids
Additional relevant MeSH terms:
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COVID-19
Respiratory Insufficiency
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors