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Respiratory Distress Syndrome, AdultPhase 3NCT04395105

Dexamethasone for COVID-19 Related ARDS: a Multicenter, Randomized Clinical Trial

A Phase 3 study testing High-Dose Dexamethasone in people with Respiratory Distress Syndrome, Adult and Covid-19, run by Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno at 4 sites in Argentina.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

There is compelling data indicating that there is an excessive inflammatory response in some patients with COVID-19 leading them to develop ARDS that can be severe with a very poor prognosis. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
High-Dose Dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
4 sitesArgentina
Study dates
21 May 2020to 21 May 2021
Phase
Phase 3
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

  • ARDS according to Berlin's definition
  • PCR confirmed COVID-19
  • Length of mechanical ventilation less or equal to 72 hours

Who cannot join

  • Pregnancy or breast-feeding women
  • Terminal illness with very poor prognosis according to the investigator judgement
  • Therapeutic limitation
  • Known immunocompromised condition
  • Chronic use of systemic corticosteroids
  • Participation in another randomized crinical trial
Show all 9Show fewer
  • More than 5 days of treatment of low dose dexamethasone for COVID-19
  • Abscence of informed consent
  • Active participation in other randomized clinical trial

Trial locations and contacts

4 sites in 1 country.

Argentina4 sites

  • Clínica Bazterrica

    Buenos Aires, 1425

  • Hospital Universitario Sede Pombo - IUC CEMIC

    Buenos Aires, 1425

  • Sanatorio Sagrado Corazon

    Buenos Aires

  • Hospital Universitario Sede Saaveda - IUC CEMIC

    CABA, 1431

Other trials in Argentina

About this study

Official title: High Versus Low Dose Dexamethasone for the Treatment of COVID-19 Related ARDS: a Multicenter and Randomized Open-label Clinical Trial

There is compelling data indicating that there is an excessive inflammatory response in some patients with COVID-19 leading them to develop ARDS that can be severe with a very poor prognosis. Many of these patients require very long mechanical ventilation times to survive, which have led to the collapse of the health system in some regions of the world. The current evidence for the treatment of these severe forms is inconsistent and most scientific societies and governmental or international organizations recommend evaluating treatments with randomized clinical trials. Corticosteroids, being non-specific anti-inflammatory drugs, could shorten the duration of respiratory failure and improve the prognosis. Due to the lack of solid data available regarding this serious disease, our objective is to randomly evaluate the efficacy and safety of the use of dexamethasone, a parenteral corticosteroid approved in Argentina, in patients with ARDS with confirmed respiratory infection due to SARS-CoV-2 (COVID-19).

After RECOVERY trial prepublication, low dose (6 mg QD for 10 days) dexamethasone was recommended as the usual care treatment for severe COVID-19. At this time only 3 patients had been included in the trial. Thus, we updated our recommendations for centers and decided to compare two different doses of this glucocorticoid for the treatment of ADRS due to COVID-19.

Being tested
High-Dose Dexamethasone
Medical subject headings
Respiratory Distress Syndrome, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-Dose DexamethasoneDrug

    Also called Corticosteroid

    IV Dexamethasone administered once daily: 16 mg from day 1 to 5 and 8 mg from day 6 to 10

Study groups in NCT04395105
Study groupRoleWhat they receive
High dose DexamethasoneExperimentalIntravenous Dexamethasone 16 mg qd from day 1 to 5 followed by 8 mg qd from day 6 to 10
Receives: Drug: High-Dose Dexamethasone
Usual care - low dose DexamethasoneNo interventionIntravenous Dexamethasone 6 mg qd for 10 days based on RECOVERY trial

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ventilator-free days at 28 days

    Days without ventilator support in the first 28 days following randomization

    Measured: 28 days after randomization

  2. Time to successful discontinuation from mechanical ventilation

    Time to event (successful discontinuation from mechanical ventilation)

    Measured: 28 days after randomization

Secondary outcomes (8)

  1. 28-days mortality

    Dead rate within 28 days of randomization

    Measured: 28 days after randomization

  2. Rate of nosocomial infections

    Rate of ventilator associated pneumonia, blood stream infection, urinary tract infection or candidemia in the first 28 days following randomization

    Measured: 28 days after randomization

  3. SOFA variation

    Variation in SOFA over the first 10 days after randomization

    Measured: 10 days after randomization

  4. Use of prone position

    Cumulative hours spent on prone position

    Measured: 10 days after randomization

  5. Delirium

    Frequency of delirium at ICU discharge

    Measured: 28 days after randomization

  6. Muscle weakness

    mMRC score at ICU discharge

    Measured: 28 days after randomization

  7. 90-day mortality

    Death rate within 90 days of randomization

    Measured: 90 days after randomization

  8. Peak daily blood glucose

    Interaction between treatment and daily change in glucose

    Measured: 10 days after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2020
  2. Study start21 May 2020
  3. Primary completion5 Apr 2021
  4. Study completion21 May 2021

Why it stopped: Low rate of recruitment

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04395105
Sponsor's protocol ID
1264
Status last verified
May 2021
First submitted
16 May 2020
Last updated
2 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Maskin LP, Olarte GL, Palizas F Jr, Velo AE, Lurbet MF, Bonelli I, Baredes ND, Rodriguez PO. High dose dexamethasone treatment for Acute Respiratory Distress Syndrome secondary to COVID-19: a structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Aug 26;21(1):743. doi: 10.1186/s13063-020-04646-y.

    PubMed 32843098

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing High-Dose Dexamethasone in people with Respiratory Distress Syndrome, Adult and Covid-19, run by Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno at 4 sites in Argentina.

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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Argentina. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was stopped early (reason given: Low rate of recruitment). Results are not available in the source record.

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?

Ventilator-free days at 28 days (time frame: 28 days after randomization). The study lists 2 primary outcomes in all. 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 NCT04395105, 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 2 Jun 2021.

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