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

Covid19 Clinical Trial

— HIGHLOWDEXA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04726098
• Other study ID #: HIGHLOWDEXA-COVID
• Secondary ID: 2020-005702-25
• Status: Completed
• Phase: Phase 4
• Start date: January 15, 2021
• Est. completion date: August 31, 2021

Study information

• Verified date: October 2021
• Source: Hospital Clinico Universitario de Santiago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Corticosteroids
• COVID-19
• Covid19
• Respiratory Insufficiency

Intervention

Drug:
• Dexamethasone high dose
High doses: dexamethasone 20 mg/day 5 days + 10 mg/day 5 days (total 10 days)
• Dexamethasone low dose
Low doses: dexamethasone 6 mg/day 10 days.

Locations

Country	Name	City	State
Spain	University Clinical Hospital of Santiago de Compostela	Santiago de Compostela	A Coruña

Sponsors (1)

Lead Sponsor	Collaborator
Manuel Taboada Muñiz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Day 11 after randomization
Secondary	Percentage of patients without the need for oxygen support at day 11.		Day 11 after randomization
Secondary	28-days mortality		28 days after randomization
Secondary	90-days mortality		90 days after randomization
Secondary	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)	10 days after randomization
Secondary	Percentage of patients needing Intensive Care Unit admission		28 days after randomization
Secondary	Percentage of patients needing invasive mechanical ventilation or extracorporeal membrane oxygenation		28 days after randomization
Secondary	Percentage of patients needing non-invasive ventilation or nasal high-flow oxygen therapy		28 days after randomization
Secondary	Length of stay in the hospital		90 days after randomization
Secondary	Infectious complications during hospital admission		90 days after randomization
Secondary	Adverse drug reactions		11 days after randomization