NCT04545242 (DEXA-REFINE) is a Phase 4 clinical trial of Dexamethasone in Acute Hypoxemic Respiratory Failure, sponsored by Dr. Negrin University Hospital.

Who is sponsoring NCT04545242?

NCT04545242 is sponsored by Dr. Negrin University Hospital.

What drugs are being tested in NCT04545242?

Interventions in NCT04545242: Dexamethasone.

What condition does NCT04545242 study?

NCT04545242 studies Acute Hypoxemic Respiratory Failure.

Is NCT04545242 still recruiting?

NCT04545242 is currently recruiting now. Last updated 26 August 2025.

Last reviewed 2025-08-26 · How we verify

NCT04545242: DEXA-REFINE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy of DEXamethasone in Patients With Acute Hypoxemic REspiratory Failure Caused by INfEctions

Recruiting now Phase 4 Last updated 26 August 2025

What this trial tests

Phase 4 trial testing Dexamethasone in Acute Hypoxemic Respiratory Failure in 980 participants. Currently enrolling.

Timeline

6 July 2021

Primary endpoint
30 December 2026

30 December 2026

Quick facts

Lead sponsor	Dr. Negrin University Hospital
Phase	Phase 4
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	980
Start date	6 July 2021
Primary completion	30 December 2026
Estimated completion	30 December 2026
Sites	40 locations across Spain

Drugs / interventions tested

Dexamethasone (dexamethasone) — full drug profile →

Conditions studied

Acute Hypoxemic Respiratory Failure — all drugs for Acute Hypoxemic Respiratory Failure →

Sponsor

Dr. Negrin University Hospital

Who can join

18 and older, any sex, with Acute Hypoxemic Respiratory Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: There are no proven therapies specific for pulmonary dysfunction in patients with acute hypoxemic respiratory failure (AHRF) caused by infections (including Covid-19). The full spectrum of AHRF ranges from mild respiratory tract illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multiorgan failure, and death. The efficacy of corticosteroids in AHRF and ARDS caused by infections remains controversial. Methods: This is a multicenter, randomized, controlled, open-label clinical trial testing dexamethasone in mechanically ventilated adult patients with established AHRF (including ARDS) caused by confirmed pulmonary or systemic infections, admitted in a network of Spanish ICUs. Eligible patients will be randomly assigned to receive dexamethasone: either 6 mg/d x 10 days or 20 mg/d x 5 days followed by 10 mg/d x 5 days. The primary outcome is 60-day mortality. The secondary outcome is the number of ventilator-free days at 28 days. All analyses will be done according to the intention-to-treat principle.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Systemic corticosteroids for the treatment of COVID-19.
Wagner C, Griesel M, Mikolajewska A, Mueller A, et al · · 2021 · cited 151× · PMID 34396514 · DOI 10.1002/14651858.cd014963
Mitochondrial network dynamics in pulmonary disease: Bridging the gap between inflammation, oxidative stress, and bioenergetics.
Pokharel MD, Garcia-Flores A, Marciano D, Franco MC, et al · · 2024 · cited 73× · PMID 38295575 · DOI 10.1016/j.redox.2024.103049
Effect of high <i>versus</i> low dose of dexamethasone on clinical worsening in patients hospitalised with moderate or severe COVID-19 pneumonia: an open-label, randomised clinical trial.
Taboada M, Rodríguez N, Varela PM, Rodríguez MT, et al · · 2022 · cited 48× · PMID 34916266 · DOI 10.1183/13993003.02518-2021
Systemic corticosteroids for the treatment of COVID-19: Equity-related analyses and update on evidence.
Wagner C, Griesel M, Mikolajewska A, Metzendorf MI, et al · · 2022 · cited 44× · PMID 36385229 · DOI 10.1002/14651858.cd014963.pub2
The Role of Cyclodextrins in COVID-19 Therapy-A Literature Review.
Almeida B, Domingues C, Mascarenhas-Melo F, Silva I, et al · · 2023 · cited 17× · PMID 36769299 · DOI 10.3390/ijms24032974
Mechanisms of alveolar type II epithelial cells' mitochondrial quality control during acute lung injury/acute respiratory distress syndrome: bridging the gap between oxidative stress, inflammation, and fibrosis.
Zeng L, Yan J. · · 2025 · cited 1× · PMID 41178984 · DOI 10.3389/fphys.2025.1684729

Verify or expand the search:

Other trials of Dexamethasone

Trials testing the same drug.

NCT07543458 — Therapeutics for Moderate and Severe Dengue · Phase 3 · not yet recruiting
NCT07175415 — HEM-iSMART E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological · Phase 1, PHASE2 · not yet recruiting
NCT07513129 — A Phase 1 Study Of Venetoclax, Dexamethasone, Bortezomib, And Daratumumab (VDBD) For Adolescent And Young Adult Patients · Phase 1 · not yet recruiting
NCT07444710 — Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) · Phase 1 · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Other recruiting trials for Acute Hypoxemic Respiratory Failure

Currently open trials in the same condition.

NCT07334379 — Interleukin-6 Guided Treatment With Dexamethasone or Tocilizumab in Patients Hospitalized With Acute Respiratory Symptom · Phase 2 · recruiting
NCT06921655 — Targeting prEssure-Muscle-index to Avoid Ventilatory Over-Assistance During Pressure Support Ventilation · NA · recruiting
NCT06931938 — Awake Prone Positioning in Spontaneous Breathing Patients With Acute Hypoxic Respiratory Failure Due to Pneumonia · NA · recruiting
NCT07178483 — Evaluation of Physical Capacity and Energy Requirements in Patients With Hypoxemic Acute Respiratory Failure · active not recruiting
NCT06815523 — Prediction of Duration of Mechanical Ventilation in Acute Hypoxemic Respiratoty Failure · active not recruiting

Other Dr. Negrin University Hospital trials

Trials by the same sponsor.

NCT07131228 — Changes in Portal Vein Pulsatility Variability During a Tidal Volume Challenge Can Predict Fluid Tolerance · not yet recruiting
NCT06857513 — Post-ICU Syndrome Over Time in Patients With Respiratory Failure · not yet recruiting
NCT06785389 — Influence of Preoperative Fear on Pain and Postoperative Outcomes · recruiting
NCT06635915 — Ultrasound to Check the Position of the Nasogastric Tube · NA · recruiting
NCT06386354 — Residual Neuromuscular Block in the Post-Anesthetic Unit and Postoperative Complications · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04545242 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dr. Negrin University Hospital
Last refreshed: 26 August 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04545242.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing