Covid19Phase 4HIGHLOWDEXANCT04726098
Low or High Dose of Dexamethasone in Patients With Respiratory Failure by COVID-19
A Phase 4 study testing Dexamethasone high dose and Dexamethasone low dose in people with Covid19 and Corticosteroids, run by Manuel Taboada Muñiz at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Corticosteroids
- What is being tested?
- Dexamethasone high dose and Dexamethasone low dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2021to 31 Aug 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
University Clinical Hospital of Santiago de Compostela
Santiago de Compostela, A Coruña, 15866
About this study
Official title: Efficacy of Low or High Dose of Dexamethasone in Patients With Respiratory Failure by COVID-19
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.
Read the 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
- Being tested
- Dexamethasone high dose, Dexamethasone low dose
- Keywords
- COVID19, respiratory failure, corticosteroids
- Medical subject headings
- COVID-19, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone high doseDrug
High doses: dexamethasone 20 mg/day 5 days + 10 mg/day 5 days (total 10 days)
Dexamethasone low doseDrug
Low doses: dexamethasone 6 mg/day 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Low dose group | Active comparator | Dexamethasone 6mg/day for 10 days Receives: Drug: Dexamethasone low dose |
| High dose group | Active comparator | Dexamethasone 20mg/day for 5 days + Dexamethasone 10mg/day for 5 days (Total 10 days) Receives: Drug: Dexamethasone high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 11 after randomization
Secondary outcomes (10)
Percentage of patients without the need for oxygen support at day 11.
Measured: Day 11 after randomization
28-days mortality
Measured: 28 days after randomization
90-days mortality
Measured: 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
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)
Measured: 10 days after randomization
Percentage of patients needing Intensive Care Unit admission
Measured: 28 days after randomization
Percentage of patients needing invasive mechanical ventilation or extracorporeal membrane oxygenation
Measured: 28 days after randomization
Percentage of patients needing non-invasive ventilation or nasal high-flow oxygen therapy
Measured: 28 days after randomization
Length of stay in the hospital
Measured: 90 days after randomization
Infectious complications during hospital admission
Measured: 90 days after randomization
Adverse drug reactions
Measured: 11 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start15 Jan 2021
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, open-label trial involving hospitalized adult patients with respiratory failure needing oxygen therapy, caused by COVID-19.
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manuel Taboada Muñiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Manuel Taboada Muñiz, Hospital Clinico Universitario de Santiago
- Investigators
- Manuel Taboada Muñiz, Ph.D., Principal investigator, University Clinical Hospital of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726098
- Sponsor's protocol ID
- HIGHLOWDEXA-COVID
- Other IDs
- 2020-005702-25
- Acronym
- HIGHLOWDEXA
- Status last verified
- Oct 2021
- First submitted
- 23 Jan 2021
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34916266
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Low or High Dose of Dexamethasone in Patients With Respiratory Failure by COVID-19
- ClinicalTrials.gov ID
- NCT04726098
- Acronym / sponsor ID
- HIGHLOWDEXA / HIGHLOWDEXA-COVID
- Conditions
- Covid19, Corticosteroids
- Keywords
- COVID19, respiratory failure, corticosteroids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Manuel Taboada MuñizUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled, open-label trial involving hospitalized adult patients with respiratory failure needing oxygen therapy, caused by COVID-19.
| Arm | Type | Receives |
|---|---|---|
| Low dose group | Active comparator | Drug: Dexamethasone low doseDexamethasone 6mg/day for 10 days |
| High dose group | Active comparator | Drug: Dexamethasone high doseDexamethasone 20mg/day for 5 days + Dexamethasone 10mg/day for 5 days (Total 10 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone high doseHigh doses: dexamethasone 20 mg/day 5 days + 10 mg/day 5 days (total 10 days) | Drug | High dose group |
| Dexamethasone low doseLow doses: dexamethasone 6 mg/day 10 days. | Drug | Low dose group |
Primary outcome
Percentage of patients with treatment failure at day 11
Time frame: Day 11 after randomization
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).
10 secondary outcomes
Percentage of patients without the need for oxygen support at day 11.
Time frame: Day 11 after randomization
28-days mortality
Time frame: 28 days after randomization
90-days mortality
Time frame: 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
Time frame: 10 days after randomization
Percentage of patients needing Intensive Care Unit admission
Time frame: 28 days after randomization
Percentage of patients needing invasive mechanical ventilation or extracorporeal membrane oxygenation
Time frame: 28 days after randomization
Percentage of patients needing non-invasive ventilation or nasal high-flow oxygen therapy
Time frame: 28 days after randomization
Length of stay in the hospital
Time frame: 90 days after randomization
Infectious complications during hospital admission
Time frame: 90 days after randomization
Adverse drug reactions
Time frame: 11 days after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Derived from this study: PubMed 34916266Taboada 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.
- Individual participant dataSharing planned: No
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Taboada Muñiz, Ph.D. principal investigator
University Clinical Hospital of Santiago de Compostela
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone high dose and Dexamethasone low dose in people with Covid19 and Corticosteroids, run by Manuel Taboada Muñiz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with treatment failure at day 11 (time frame: Day 11 after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04726098, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.