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Low rate of recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose Dexamethasone | Experimental | Intravenous Dexamethasone 16 mg qd from day 1 to 5 followed by 8 mg qd from day 6 to 10 |
|
| Usual care - low dose Dexamethasone | No Intervention | Intravenous Dexamethasone 6 mg qd for 10 days based on RECOVERY trial |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Dose Dexamethasone | Drug | IV Dexamethasone administered once daily: 16 mg from day 1 to 5 and 8 mg from day 6 to 10 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator-free days at 28 days | Days without ventilator support in the first 28 days following randomization | 28 days after randomization |
| Time to successful discontinuation from mechanical ventilation | Time to event (successful discontinuation from mechanical ventilation) | 28 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 28-days mortality | Dead rate within 28 days of randomization | 28 days after randomization |
| Rate of nosocomial infections | Rate of ventilator associated pneumonia, blood stream infection, urinary tract infection or candidemia in the first 28 days following randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo O Rodriguez, MD | Centro de Educación Medica e Investigaciones ClÃnicas Norberto Quirno | Principal Investigator |
| Luis P Maskin, MD | Centro de Educación Medica e Investigaciones ClÃnicas Norberto Quirno | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClÃnica Bazterrica | Buenos Aires | 1425 | Argentina | |||
| Hospital Universitario Sede Pombo - IUC CEMIC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32843098 | Derived | 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. |
| Label | URL |
|---|---|
| Protocol publication | View source |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D011024 | Pneumonia, Viral |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| 28 days after randomization |
| SOFA variation | Variation in SOFA over the first 10 days after randomization | 10 days after randomization |
| Use of prone position | Cumulative hours spent on prone position | 10 days after randomization |
| Delirium | Frequency of delirium at ICU discharge | 28 days after randomization |
| Muscle weakness | mMRC score at ICU discharge | 28 days after randomization |
| 90-day mortality | Death rate within 90 days of randomization | 90 days after randomization |
| Peak daily blood glucose | Interaction between treatment and daily change in glucose | 10 days after randomization |
| Buenos Aires |
| 1425 |
| Argentina |
| Sanatorio Sagrado Corazon | Buenos Aires | Argentina |
| Hospital Universitario Sede Saaveda - IUC CEMIC | CABA | 1431 | Argentina |
| D011014 |
| Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |