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

NCT ID: NCT04726098

Last Updated: 2021-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2021-08-31

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.

Conditions

Covid19; Corticosteroids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low dose group

Dexamethasone 6mg/day for 10 days

Group Type: ACTIVE_COMPARATOR

Dexamethasone low dose

Intervention Type: DRUG

Low doses: dexamethasone 6 mg/day 10 days.

High dose group

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

Group Type: ACTIVE_COMPARATOR

Dexamethasone high dose

Intervention Type: DRUG

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

Interventions

Dexamethasone high dose

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

Intervention Type: DRUG

Dexamethasone low dose

Low doses: dexamethasone 6 mg/day 10 days.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Manuel Taboada Muñiz

OTHER

Sponsor Role: lead

Responsible Party

Manuel Taboada Muñiz

Associate Proffesor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Manuel Taboada Muñiz, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University Clinical Hospital of Santiago de Compostela

Locations

University Clinical Hospital of Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 34916266 (View on PubMed)

Other Identifiers

2020-005702-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

HIGHLOWDEXA-COVID

Identifier Type: -

Identifier Source: org_study_id