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

NCT04726098 | Completed Phase 4 DMC

• 2 other identifiers: HIGHLOWDEXA-COVID2020-005702-25
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Corticosteroids

Keywords

COVID19; respiratory failure; corticosteroids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Percentage of patients without the need for oxygen support at day 11.

  Day 11 after randomization

• 28-days mortality

  28 days after randomization

• 90-days mortality

  90 days after randomization

• Clinical status of patients using the World Health Organization 7-point Ordinal Scale for clinical improvement during 10 days of treatment

  10 days after randomization

• Percentage of patients needing Intensive Care Unit admission

  28 days after randomization

Study Arms (2)

Low dose group

ACTIVE COMPARATOR

Dexamethasone 6mg/day for 10 days

Drug: Dexamethasone low dose

High dose group

ACTIVE COMPARATOR

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

Drug: Dexamethasone high dose

Interventions

Dexamethasone high dose DRUG

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

High dose group

Dexamethasone low dose DRUG

Low doses: dexamethasone 6 mg/day 10 days.

Low dose group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manuel Taboada Muñiz: lead

Study Sites (1)

University Clinical Hospital of Santiago de Compostela

Santiago de Compostela, A Coruña, 15866, Spain

Location

Related Publications (1)

• 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.

  PMID: 34916266 DERIVED

MeSH Terms

Conditions

COVID-19; Respiratory Insufficiency

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Manuel Taboada Muñiz, Ph.D.

  University Clinical Hospital of Santiago de Compostela

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Proffesor

Model Details: Randomized, controlled, open-label trial involving hospitalized adult patients with respiratory failure needing oxygen therapy, caused by COVID-19.

Study Record Dates

• First Submitted: January 23, 2021
• First Posted: January 27, 2021
• Study Start: January 15, 2021
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: October 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)