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NCT Number: NCT04726098

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Corticosteroids Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Clinical Hospital of Santiago de Compostela

Santiago de Compostela, A Coruña, 15866, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone high dose

Drug

High doses: dexamethasone 20 mg/day 5 days + 10 mg/day 5 days (total 10 days)

Dexamethasone low dose

Drug

Low doses: dexamethasone 6 mg/day 10 days.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Manuel Taboada Muñiz

Other

Registry information

Official study title

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

Acronym: HIGHLOWDEXA

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 27, 2021
Registry last updated
Oct 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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