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| Name | Class |
|---|---|
| Xi'an Jiaotong University | OTHER |
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A randomized clinical trial designed and intended to evaluate the efficacy of Dexamethasone and Methylprednisolone as a treatment for severe Acute Respiratory Distress Syndrome (ARDS) caused by coronavirus disease 19 (COVID-19). Our aim is to find the best option for the treatment and management of ARDS in COVID-19 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Dexamethasone | Active Comparator | Dexamethasone (20 mg/iv/daily/from Day 1 of randomization, followed by a tapering dose according to the patient's condition. |
|
| Group B: Methylprednisolone | Active Comparator | Methylprednisolone Sodium Succinate at a dose of 0.5mg/kg (Injectable solution) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Injectable solution |
| |
| Methylprednisolone |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate (In hospital) | Following randomization 30 days. | |
| Clinical improvement | The number of participants with "Clinical improvement" determined by the improvement of individual presenting symptoms of the COVID19; changes in radiological and laboratory values.Patient admitted in general bed requiring High Dependency Unit (HDU), and an HDU patient requiring Ventilator or Intensive care support. | Following randomization 30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator free days | Following randomization 30 days. | |
| Changes in Oxygen level | Oxygen saturation in the peripheral blood determined by pulse oximetry. | Following randomization 30 days. |
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Inclusion Criteria:
• Moderate to severe COVID-19 requires hospitalization. SARS-CoV-2 infection will be confirmed by RT PCR / CT Chest in every case.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD | Contact | 008801817711079 | dr_mohiuddinchy@yahoo.com | |
| Shubhashis Talukder, MBBS, DO | Contact | 008801911882232 | drshubhashis@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD | First Affiliated Hospital Xi'an Jiaotong University | Study Director |
| Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD | First Affiliated Hospital Xi'an Jiaotong University |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chattogram General Hospital | Recruiting | Chittagong | 4000 | Bangladesh |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Drug |
Injectable solution |
|
| M. Abdur Rahim Medical College Hospital | Recruiting | Dinajpur | Bangladesh |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D011239 | Prednisolone |