Covid19Phase 3NCT04499313
Dexamethasone Vs Methylprednisolone for the Treatment of Patients With ARDS Caused by COVID-19
A Phase 3 study testing Dexamethasone and Methylprednisolone in people with Covid19 and ARDS, run by Chattogram General Hospital at 2 sites in Bangladesh.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- What is being tested?
- Dexamethasone and Methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesBangladesh
- Study dates
- 2 Aug 2020to 30 Nov 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe COVID-19 requires hospitalization. SARS-CoV-2 infection will be confirmed by RT PCR / CT Chest in every case.
Who cannot join
- Participants with uncontrolled clinical status who were hospitalized from the before.
- Contraindication / possible drug interaction.
- Participants who have any severe and/or uncontrolled medical conditions like, Severe ischemic heart disease, epilepsy, malignancy, Pulmonary/renal/hepatic disease, pregnancy, Corpulmonale, etc.
Trial locations and contacts
2 sites in 1 country.
Bangladesh2 sites, 2 recruiting
- Recruiting
Chattogram General Hospital
Chittagong, 4000
Shubhashis Talukder, 008801911882232, drshubhashis@gmail.com
Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD
- Recruiting
M. Abdur Rahim Medical College Hospital
Dinajpur
Akter Kamal, MBBS, MD, PhD, 008801817233991, kamalaktar@yahoo.com
Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD
About this study
Official title: The Outcome of Dexamethasone and Methylprednisolone Treatment for Patients With ARDS Caused by COVID-19
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.
- Being tested
- Dexamethasone, Methylprednisolone
- Keywords
- COVID 19, Dexamethasone, Methylprednisolone, ARDS
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Injectable solution
Injectable solution
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dexamethasone |
| Group B: Methylprednisolone | Active comparator | Methylprednisolone Sodium Succinate at a dose of 0.5mg/kg (Injectable solution) Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate (In hospital)
Measured: 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.
Measured: Following randomization 30 days.
Secondary outcomes (2)
Ventilator free days
Measured: Following randomization 30 days.
Changes in Oxygen level
Oxygen saturation in the peripheral blood determined by pulse oximetry.
Measured: Following randomization 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start2 Aug 2020
- Primary completion15 Nov 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chattogram General Hospital
- Sponsor type
- Other government
- Collaborators
- Xi'an Jiaotong University
- Responsible party
- Sponsor
- Investigators
- Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD, Study director, First Affiliated Hospital Xi'an Jiaotong UniversityAbu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499313
- Sponsor's protocol ID
- 10000753
- Status last verified
- Aug 2020
- First submitted
- 27 Jul 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcome of Dexamethasone and Methylprednisolone Treatment for Patients With ARDS Caused by COVID-19
- ClinicalTrials.gov ID
- NCT04499313
- Acronym / sponsor ID
- 10000753
- Keywords
- COVID 19, Dexamethasone, Methylprednisolone, ARDS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chattogram General HospitalOther government
- Collaborators
- Xi'an Jiaotong University
- Study start
- 2 Aug 2020 (actual)
- Primary completion
- 15 Nov 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Dexamethasone | Active comparator | Drug: DexamethasoneDexamethasone (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 | Drug: MethylprednisoloneMethylprednisolone Sodium Succinate at a dose of 0.5mg/kg (Injectable solution) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Moderate to severe COVID-19 requires hospitalization. SARS-CoV-2 infection will be confirmed by RT PCR / CT Chest in every case.
Key exclusion criteria (3 listed)
- Participants with uncontrolled clinical status who were hospitalized from the before.
- Contraindication / possible drug interaction.
- Participants who have any severe and/or uncontrolled medical conditions like, Severe ischemic heart disease, epilepsy, malignancy, Pulmonary/renal/hepatic disease, pregnancy, Corpulmonale, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneInjectable solution | Drug | Group A: Dexamethasone |
| MethylprednisoloneInjectable solution | Drug | Group B: Methylprednisolone |
Primary outcome
Mortality rate (In hospital)
Time frame: Following randomization 30 days.
Clinical improvement
Time frame: Following randomization 30 days.
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.
2 secondary outcomes
Ventilator free days
Time frame: Following randomization 30 days.
Changes in Oxygen level
Time frame: Following randomization 30 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD study director
First Affiliated Hospital Xi'an Jiaotong University
Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone and Methylprednisolone in people with Covid19 and ARDS, run by Chattogram General Hospital at 2 sites in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD (008801817711079, dr_mohiuddinchy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate (In hospital) (time frame: Following randomization 30 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.