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

Phase 3

Terminated

• Conditions: Respiratory Distress Syndrome, Adult; Covid-19
• Interventions: Drug: High-Dose Dexamethasone

• Registration Number: NCT04395105
• Lead Sponsor: Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-16
• Study First Submitted QC: 2020-05-18
• Study First Posted: 2020-05-20
• Study Start: 2020-05-21
• Primary Completion: 2021-04-05
• Status Verified: 2021-05
• Study Completion: 2021-05-21
• Last Update Submitted: 2021-05-28
• Last Update Posted: 2021-06-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose Dexamethasone	High-Dose Dexamethasone	Intravenous Dexamethasone 16 mg qd from day 1 to 5 followed by 8 mg qd from day 6 to 10

Primary Outcome Measures

Name	Time	Method
Time to successful discontinuation from mechanical ventilation	28 days after randomization	Time to event (successful discontinuation from mechanical ventilation)
Ventilator-free days at 28 days	28 days after randomization	Days without ventilator support in the first 28 days following randomization

Secondary Outcome Measures

Name	Time	Method
SOFA variation	10 days after randomization	Variation in SOFA over the first 10 days after randomization
Use of prone position	10 days after randomization	Cumulative hours spent on prone position
28-days mortality	28 days after randomization	Dead rate within 28 days of randomization
Muscle weakness	28 days after randomization	mMRC score at ICU discharge
Peak daily blood glucose	10 days after randomization	Interaction between treatment and daily change in glucose
Delirium	28 days after randomization	Frequency of delirium at ICU discharge
Rate of nosocomial infections	28 days after randomization	Rate of ventilator associated pneumonia, blood stream infection, urinary tract infection or candidemia in the first 28 days following randomization
90-day mortality	90 days after randomization	Death rate within 90 days of randomization

Trial Locations

Locations (4)

Clínica Bazterrica; 🇦🇷 Ciudad Autónoma de Buenos Aires, Argentina

Hospital Universitario Sede Saaveda - IUC CEMIC; 🇦🇷 Caba, Argentina

Sanatorio Sagrado Corazon; 🇦🇷 Ciudad Autonoma de Buenos Aires, Argentina

Hospital Universitario Sede Pombo - IUC CEMIC; 🇦🇷 Ciudad Autonoma de Buenos Aires, Argentina