Clinical trial NCT04395105: Dexamethasone for COVID-19 Related ARDS: a Multicenter, Randomized Clinical Trial
Official title: High Versus Low Dose Dexamethasone for the Treatment of COVID-19 Related ARDS: a Multicenter and Randomized Open-label Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Respiratory Distress Syndrome, Adult
Covid-19
Lead sponsor: Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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
* More than 5 days of treatment of low dose dexamethasone for COVID-19
* Abscence of informed consent
* Active participation in other randomized clinical trial

Primary outcomes:
measure: Ventilator-free days at 28 days
timeFrame: 28 days after randomization
measure: Time to successful discontinuation from mechanical ventilation
timeFrame: 28 days after randomization
Secondary outcomes:
measure: 28-days mortality
timeFrame: 28 days after randomization
measure: Rate of nosocomial infections
timeFrame: 28 days after randomization
measure: SOFA variation
timeFrame: 10 days after randomization
measure: Use of prone position
timeFrame: 10 days after randomization
measure: Delirium
timeFrame: 28 days after randomization
measure: Muscle weakness
timeFrame: 28 days after randomization
measure: 90-day mortality
timeFrame: 90 days after randomization
measure: Peak daily blood glucose
timeFrame: 10 days after randomization
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Hospital Universitario Sede Saaveda - IUC CEMIC
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Universitario Sede Pombo - IUC CEMIC
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Sanatorio Sagrado Corazon
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Clínica Bazterrica
Study officials:
affiliation: Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
name: Pablo O Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
name: Luis P Maskin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.