NCT04726098: HIGHLOWDEXA

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

Completed Phase 4 Last updated 20 October 2021

What this trial tests

Phase 4 trial testing Dexamethasone high dose in Covid19 in 198 participants. Completed in 31 August 2021.

Timeline

15 January 2021

Primary endpoint
31 August 2021

31 August 2021

Quick facts

Lead sponsor	Manuel Taboada Muñiz
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	198
Start date	15 January 2021
Primary completion	31 August 2021
Estimated completion	31 August 2021
Sites	1 location across Spain

Drugs / interventions tested

• Dexamethasone high dose — full drug profile →
• Dexamethasone low dose — full drug profile →

Conditions studied

• Covid19 — all drugs for Covid19 →
• Corticosteroids — all drugs for Corticosteroids →

Sponsor

Manuel Taboada Muñiz — full company profile →

Who can join

18 and older, any sex, with Covid19 or Corticosteroids. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

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

1. An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
   Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
2. 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
3. Corticosteroids for COVID-19 Therapy: Potential Implications on Tuberculosis.
   Gopalaswamy R, Subbian S. · · 2021 · cited 52× · PMID 33917321 · DOI 10.3390/ijms22073773
4. 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
5. 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
6. Existing Drugs Considered as Promising in COVID-19 Therapy.
   Janik E, Niemcewicz M, Podogrocki M, Saluk-Bijak J, et al · · 2021 · cited 19× · PMID 34063964 · DOI 10.3390/ijms22115434
7. Higher- versus Lower-Dose Corticosteroids for Severe to Critical COVID-19: A Systematic Review and Dose-Response Meta-analysis.
   Pitre T, Su J, Mah J, Helmeczi W, et al · · 2023 · cited 9× · PMID 36449393 · DOI 10.1513/annalsats.202208-720oc
8. A patient-tailored approach for corticosteroid treatment in COVID-19: still not there yet.
   Nigro M, Chalmers JD, Aliberti S. · · 2023 · cited 4× · PMID 36858444 · DOI 10.1183/13993003.00270-2023