Efficacy of Dexamethasone Treatment for Patients With ARDS Caused by COVID-19 (DEXA-COVID19)
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| ClinicalTrials.gov Identifier: NCT04325061 |
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Recruitment Status :
Terminated
(Lack of enrollment)
First Posted : March 27, 2020
Last Update Posted : February 3, 2021
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Background: There are no proven therapies specific for Covid-19. The full spectrum of Covid-19 ranges from asymptomatic disease to mild respiratory tract illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multiorgan failure, and death. The efficacy of corticosteroids in viral ARDS remains controversial.
Methods: This is an internationally (Spain, Canada, China, USA) designed multicenter, randomized, controlled, open-label clinical trial testing dexamethasone in mechanically ventilated adult patients with established moderate-to-severe ARDS caused by confirmed Covid-19 infection, admitted in a network of Spanish ICUs. Eligible patients will be randomly assigned to receive either dexamethasone plus standard intensive care, or standard intensive care alone. Patients in the dexamethasone group will receive an intravenous dose of 20 mg once daily from day 1 to day 5, followed by 10 mg once daily from day 6 to day 10. The primary outcome is 60-day mortality. The secondary outcome is the number of ventilator-free days at 28 days. All analyses will be done according to the intention-to-treat principle.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Respiratory Distress Syndrome Caused by COVID-19 | Drug: Dexamethasone | Phase 4 |
The acute respiratory distress syndrome (ARDS) is a catastrophic illness of multifactorial etiology characterized by a diffuse, severe inflammatory process of the lung leading to acute hypoxemic respiratory failure requiring mechanical ventilation (MV). Pulmonary infections are the leading causes of ARDS. Clinical and experimental research has established a strong association between dysregulated systemic and pulmonary inflammation and progression or delayed resolution of ARDS.
The COVID-19 pandemic is a critical moment for the world. Severe pneumonia is the main condition leading to ARDS requiring weeks of MV with high mortality (40-60%) in COVID-19 patients. There is no specific therapy for Covid-19, although patients are receiving drugs that are already approved for treating other diseases. There has been great interest in the role of corticosteroids to attenuate the pulmonary and systemic damage in ARDS patients because of their potent anti-inflammatory and antifibrotic properties. However, the efficacy of corticosteroids in viral ARDS remains controversial.
We justify the need of this study based on the positive results of a recent clinical trial by our group, showing that dexamethasone for 10 days was able to reduce the duration of mechanical ventilation (MV) and increase hospital survival in patients with ARDS from multiple causes (Villar J et al. Lancet Respir Med 2020). Dexamethasone has never been evaluated in viral ARDS in a randomized controlled fashion. Our goal in this study is to examine the effects of dexamethasone on hospital mortality and on ventilator-free days in patients with moderate-to-severe ARDS due to confirmed COVID-19 infection admitted into a network of Spanish intensive care units (ICUs).
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 19 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Multicenter, randomized, controlled, open-label trial involving mechanically ventilated adult patients with ARDS caused by confirmed COVID-19 infection |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Efficacy of Dexamethasone Treatment for Patients With ARDS Caused by COVID-19 |
| Actual Study Start Date : | April 3, 2020 |
| Actual Primary Completion Date : | June 19, 2020 |
| Actual Study Completion Date : | June 19, 2020 |
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Control group
Patients will be treated with standard intensive care
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Active Comparator: Dexamethasone
Standard intensive care plus dexamethasone
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Drug: Dexamethasone
Dexamethasone (20 mg/iv/daily/from Day 1 of randomization during 5 days, followed by 10 mg/iv/daily from Day 6 to 10 of randomization
Other Name: dexamethasone Indukern |
- 60-day mortality [ Time Frame: 60 days ]All-cause mortality at 60 days after enrollment
- Ventilator-free days [ Time Frame: 28 days ]Number of ventilator-free days (VFDs) at Day 28 (defined as days being alive and free from mechanical ventilation at day 28 after enrollment, For patients ventilated 28 days or longer and for subjects who die, VFD is 0.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age 18 years or older;
- positive reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay for COVID-19 in a respiratory tract sample;
- intubated and mechanically ventilated;
- acute onset of ARDS, as defined by Berlin criteria as moderate-to-severe ARDS,3 which includes: (i) having pneumonia or worsening respiratory symptoms, (ii) bilateral pulmonary infiltrates on chest imaging (x-ray or CT scan), (iii) absence of left atrial hypertension, pulmonary capillary wedge pressure <18 mmHg, or no clinical signs of left heart failure, and (iv) hypoxemia, as defined by a PaO2/FiO2 ratio of ≤200 mmHg on positive end-expiratory pressure (PEEP) of ≥5 cmH2O, regardless of FiO2.
Exclusion Criteria:
- Routine treatment with corticosteroids during the previous week irrespective of dose;
- Corticosteroid use within the previous 24 h of more than 20 mg of dexamethasone or equivalent;
- Patients with a known contraindication to corticosteroids;
- Decision by a physician that involvement in the trial is not in the patient's best interest;
- Pregnancy and breast-feeding;
- Participation in another therapeutic trial.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04325061
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| Principal Investigator: | Jesús Villar, MD | Hospital Universitario Dr. Negrin |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jesus Villar, Senior scientist, Dr. Negrin University Hospital |
| ClinicalTrials.gov Identifier: | NCT04325061 |
| Other Study ID Numbers: |
2020-001278-31 |
| First Posted: | March 27, 2020 Key Record Dates |
| Last Update Posted: | February 3, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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ARDS COVID-19 multiple system organ failure |
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COVID-19 Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Acute Lung Injury Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |
Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Lung Injury Dexamethasone Dexamethasone acetate BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones |