Covid 19 DiseasePhase 3covid19NCT04603729
Comparison of Efficacy of Dexamethasone and Methylprednisolone in Moderate to Severe Covid 19 Disease
A Phase 3 study testing Dexamethasone 2 MG/ML and Methylprednisolone Injection in people with Covid 19 Disease, run by Fatima Memorial Hospital at 1 site in Pakistan.
Trial summary
The investigator will select participants with moderate to severe covid 19 disease admitted in Fatima memorial hospital. The investigator will divide them in two groups according to convenience sampling. Group 1 will be given dexamethasone 8mg/day and group 2 will be given methylprednisolone 1mg/kg/day IV for 5 days. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid 19 Disease
- What is being tested?
- Dexamethasone 2 MG/ML and Methylprednisolone Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2020to 1 Jul 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years
- Covid PCR positive
- Patient having oxygen saturation < 94% on room air, regardless of chest x-ray findings
- Moderate or severe covid 19 disease according to operational definition.
- Patients who sign informed consent.
Who cannot join
- Severe immunosuppression like HIV( Human immunodeficiency Virus) or long term use of immunosuppressant for any other chronic illness
- Patients who need corticosteroids for any other disease like asthma, rheumatoid arthritis.
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
About this study
The investigator will select participants with moderate to severe covid 19 disease admitted in Fatima memorial hospital. The investigator will divide them in two groups according to convenience sampling. Group 1 will be given dexamethasone 8mg/day and group 2 will be given methylprednisolone 1mg/kg/day IV for 5 days. The investigator will compare the improvement in temperature, oxygen requirement and CRP level at day zero and day 5 in both the groups.
Read the detailed description
The investigators enrolled first 100 participants admitted in covid unit of Fatima memorial hospital who fulfilled the inclusion criteria and signed informed consent. Baseline oxygen saturation and clinical findings were noted. Chest x-ray was done on admission. Baseline labs were sent, initial level of CRP (C-reactive protein) was noted down.
Patients with oxygen saturation < 94% on room air with normal chest x-ray and CRP between 30 - 50, were labelled as having moderate covid 19 disease. Patients with CRP> 50 and having infiltrates on chest x-ray at the time of admission were considered having severe covid 19 disease. Intravenous methylprednisolone in a dose of 1 mg/kg/day in 2 divided doses or dexamethasone 8 mg/day IV was given to alternate patients for 5 days. After 5 days, the investigator again recorded the oxygen saturation, CRP level and repeat chest x-ray findings.
Patients were given tocilizumab and convalescent plasma as and when indicated. Oxygen was given by nasal cannula and face mask. Patient was shifted to ICU if clinical condition deteriorated and/or mechanical ventilation is needed.
The investigator noted the improvement in clinical, radiological and biochemical parameters of the patient on day 0 that is admission day and later on day 5 after giving steroids (methylprednisolone or dexamethasone) for 5 days.
Data was analyzed using SPSS version 25.0. Descriptive statistics like frequency and means were calculated. Paired sample t-test was applied for comparison of the two groups.
- Conditions
- Covid 19 Disease
- Being tested
- Dexamethasone 2 MG/ML, Methylprednisolone Injection
- Keywords
- covid19, dexamethasone, methlprednisolone, corticosteroids
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 2 MG/MLDrug
Also called decadron
Dexamethasone 8mg/day will be given intravenous for 5 days to group 1 participants
Methylprednisolone InjectionDrug
Also called solumedrol
methylprednisolone 1mg/kg/day will be given intravenous for 5 days to group 2 participants
| Study group | Role | What they receive |
|---|---|---|
| group 1 dexamethasone | Active comparator | participants will receive dexamethasone 8mg/day Intravenous for 5 days Receives: Drug: Dexamethasone 2 MG/ML |
| group 2 methylprednisolone | Active comparator | participants will receive methylprednisolone 1mg/kg/day intravenous for 5 days Receives: Drug: Methylprednisolone Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
temperature (F)
reduction in temperature in degree farrenheit
Measured: 5 days
oxygen saturation(%)
reduction in oxygen requirement in lit/min
Measured: 5 days
CRP (mg/dl)
mean reduction in CRP mg/dl in 5 days
Measured: 5 days
mortality
number of patients died
Measured: 5 days
ICU transfer
number of patients shifted to ICU
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start30 May 2020
- Primary completion30 Jun 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid 19 DiseaseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatima Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syeda Arzinda Fatima, Fatima Memorial Hospital
- Investigators
- Khurshid A Khan, MBBS, FACM, Study chair, Fatima Memorial HospitalArzinda F Syeda, MBBS, FCPS, Principal investigator, Fatima Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603729
- Sponsor's protocol ID
- FMH-06-2020-IRB-763-M
- Acronym
- covid19
- Status last verified
- Oct 2020
- First submitted
- 21 Oct 2020
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: patient name and medical record will be confidential, onle the principal investigator will have access to data. Results of study will be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Dexamethasone and Methylprednisolone in Moderate to Severe Covid 19 Disease
- ClinicalTrials.gov ID
- NCT04603729
- Acronym / sponsor ID
- covid19 / FMH-06-2020-IRB-763-M
- Conditions
- Covid 19 Disease
- Keywords
- covid19, dexamethasone, methlprednisolone, corticosteroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fatima Memorial HospitalUniversity, hospital or other
- Study start
- 30 May 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 27 Oct 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.
The investigator will select participants with moderate to severe covid 19 disease admitted in Fatima memorial hospital. The investigator will divide them in two groups according to convenience sampling. Group 1 will be given dexamethasone 8mg/day and group 2 will be given methylprednisolone 1mg/kg/day IV for 5 days. The investigator will compare the improvement in temperature, oxygen requirement and CRP level at day zero and day 5 in both the groups.
Detailed description
The investigators enrolled first 100 participants admitted in covid unit of Fatima memorial hospital who fulfilled the inclusion criteria and signed informed consent. Baseline oxygen saturation and clinical findings were noted. Chest x-ray was done on admission. Baseline labs were sent, initial level of CRP (C-reactive protein) was noted down.
Patients with oxygen saturation < 94% on room air with normal chest x-ray and CRP between 30 - 50, were labelled as having moderate covid 19 disease. Patients with CRP> 50 and having infiltrates on chest x-ray at the time of admission were considered having severe covid 19 disease. Intravenous methylprednisolone in a dose of 1 mg/kg/day in 2 divided doses or dexamethasone 8 mg/day IV was given to alternate patients for 5 days. After 5 days, the investigator again recorded the oxygen saturation, CRP level and repeat chest x-ray findings.
Patients were given tocilizumab and convalescent plasma as and when indicated. Oxygen was given by nasal cannula and face mask. Patient was shifted to ICU if clinical condition deteriorated and/or mechanical ventilation is needed.
The investigator noted the improvement in clinical, radiological and biochemical parameters of the patient on day 0 that is admission day and later on day 5 after giving steroids (methylprednisolone or dexamethasone) for 5 days.
Data was analyzed using SPSS version 25.0. Descriptive statistics like frequency and means were calculated. Paired sample t-test was applied for comparison of the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 dexamethasone | Active comparator | Drug: Dexamethasone 2 MG/MLparticipants will receive dexamethasone 8mg/day Intravenous for 5 days |
| group 2 methylprednisolone | Active comparator | Drug: Methylprednisolone Injectionparticipants will receive methylprednisolone 1mg/kg/day intravenous for 5 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 75 years
- Covid PCR positive
- Patient having oxygen saturation < 94% on room air, regardless of chest x-ray findings
- Moderate or severe covid 19 disease according to operational definition.
- Patients who sign informed consent.
Key exclusion criteria (3 listed)
- Severe immunosuppression like HIV( Human immunodeficiency Virus) or long term use of immunosuppressant for any other chronic illness
- Patients who need corticosteroids for any other disease like asthma, rheumatoid arthritis.
- Pregnant or lactating females
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 |
|---|---|---|
| Dexamethasone 2 MG/MLAlso: decadronDexamethasone 8mg/day will be given intravenous for 5 days to group 1 participants | Drug | group 1 dexamethasone |
| Methylprednisolone InjectionAlso: solumedrolmethylprednisolone 1mg/kg/day will be given intravenous for 5 days to group 2 participants | Drug | group 2 methylprednisolone |
Primary outcome
temperature (F)
Time frame: 5 days
reduction in temperature in degree farrenheit
oxygen saturation(%)
Time frame: 5 days
reduction in oxygen requirement in lit/min
CRP (mg/dl)
Time frame: 5 days
mean reduction in CRP mg/dl in 5 days
mortality
Time frame: 5 days
number of patients died
ICU transfer
Time frame: 5 days
number of patients shifted to ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Individual participant dataSharing planned: No. patient name and medical record will be confidential, onle the principal investigator will have access to data. Results of study will be shared with other researchers
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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.
Khurshid A Khan, MBBS, FACM study chair
Fatima Memorial Hospital
Arzinda F Syeda, MBBS, FCPS principal investigator
Fatima Memorial Hospital
1 site 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 2 MG/ML and Methylprednisolone Injection in people with Covid 19 Disease, run by Fatima Memorial Hospital at 1 site in Pakistan.
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 5 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: finished, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
temperature (F) (time frame: 5 days). The study lists 5 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 27 Oct 2020.