SARS-CoV InfectionMethyl19LGHNCT04559113
Methylprednisolone in COVID-19 Patients (Methyl19LGH)
A study testing Methylprednisolone Injectable Product in people with SARS-CoV Infection and SARS (Severe Acute Respiratory Syndrome), run by Lahore General Hospital at 1 site in Pakistan.
Trial summary
In COVID-19 deep airway and alveolar destruction occurred due to inflammatory reaction resulting into severe pneumonia. In COVID-19, lung injury is not only due to viral damage to tissue, but it is also due to immune response that leads to activation of inflammatory cells and release of cytokines. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- SARS-CoV Infection, SARS (Severe Acute Respiratory Syndrome)
- What is being tested?
- Methylprednisolone Injectable Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2020to 30 Dec 2020
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients of all ages, males, and females who will be diagnosed COVID-19 positive by RT-PCR with moderate illness.
- Patients having classical radiological lesions of COVID-19 on X-ray chest or HRCT chest.
- Respiratory rate > 22/ min and >50% of radiological involvement of lung with typical lesions.
- FiO2 remain static or improving, along with > 30% deranged ≥ 2 biochemical markers CRP > 20 mg/l, LDH > 600 U/L, D.Dimer > 0.5mg/l or 500 ng/ml, Serum Ferritin < 500 ng/ml or mcg/l will be included in clinical trial.
Who cannot join
- Heart failure,
- Cardiac arrest
- Decompensated liver cirrhosis,
- Decompensated psychiatric disorder
- Contraindication for corticosteroids
- Leukopenia <1000/mm or neutropenia <500/mm
- Recent or history of bone marrow or solid organ transplantation
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Muhammad Irfan Malik
Lahore, Punjab Province, 54500
Muhammad Irfan malik, FCPS, 03334367220, drmirfanmalik@hotmail.com
About this study
Official title: Perks of Methylprednisolone for Hospitalized COVID-19 Patients: A Clinical Trial
In COVID-19 deep airway and alveolar destruction occurred due to inflammatory reaction resulting into severe pneumonia. In COVID-19, lung injury is not only due to viral damage to tissue, but it is also due to immune response that leads to activation of inflammatory cells and release of cytokines. In COVID-19 acute respiratory distress syndrome ARDS is produced due to mucinous or cellular fibromyxoid exudates, desquamation of pneumocytes and alveolar damage and hyaline membrane development and within 5-7 days disease become more aggressive due to pneumonia and respiratory failure. It is important to start the prompt and strengthen treatment for suppression of inflammatory response and cytokine storm. Methylprednisolone are the traditional immunosuppressive drugs. They are important and effective to delay the pneumonia progression and treating the ARDS.
Corticosteroids are broadly used as treatment for ARDS and there was an evidence for its efficacy for treating SARS and decreasing mortality of SARS in the past. However for COVID-19 corticosteroids efficacy and safety usage is still under clinical trials
Read the detailed description
All new decision and new interventions that are made for decreasing dependency of ventilator in patients and decreasing patients mortality would have played a great role on global public health. The aim of the study is to address the efficacy of methlyprednisolone for the treatment of COVID-19 patients and its clinical outcome at a tertriary care hospital.
- Being tested
- Methylprednisolone Injectable Product
- Keywords
- COVID-19, Methylprednisolone, Clinical outcome
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone Injectable ProductDrug
Also called solu madrol
- 0.5mg to 1mg/Kg methylprednisolone or equivalent dexamethasone dose (to a maximum of 20mg) given daily x 5 to 7-days or
- Methylprednisolone 1 mg/kg daily IV for 5 days followed by 40 mg daily x 3 days, followed by 10 mg daily x 2 day.
| Study group | Role | What they receive |
|---|---|---|
| Group intervene with Methylprednisolone | Experimental | Review effect of Methylprednisolone as clinical trial among hospitalized patients with COVID-19 infection.
Anyone of the following Corticosteroids dose will be given to moderate disease patients of COVID-19
1. 0.5mg to 1mg/Kg methylprednisolone or equivalent dexamethasone dose (to a maximum of 20mg) given daily x 5 to 7-days or
2. Methylprednisolone 1 mg/kg daily IV for 5 days followed by 40 mg daily x 3 days, followed by 10 mg daily x 2 day. *Note: in Diabetic patients' dose of methyl prednisolone should be divided in doses preferably 40mg BD. Receives: Drug: Methylprednisolone Injectable Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response after administration
Clinical improvement of COVID-19 patients by methylprednisolone.
Measured: 10 days
Secondary outcomes (2)
Clinical response to treatment
Overall survival of COVID-19 patients after drug administration.
Measured: 28 days
Duration of hospitalization
Number of days of hospital admission either in ICU or HDUs till date of discharge
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start1 May 2020
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV InfectionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- quasi-experimental
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lahore General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. M.Irfan Malik, Lahore General Hospital
- Investigators
- Sardar Al-Fareed Zafar, FCPS, Study director, Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559113
- Sponsor's protocol ID
- LGH005
- Acronym
- Methyl19LGH
- Status last verified
- Dec 2020
- First submitted
- 15 Sep 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang Y, Jiang W, He Q, Wang C, Wang B, Zhou P, Dong N, Tong Q. A retrospective cohort study of methylprednisolone therapy in severe patients with COVID-19 pneumonia. Signal Transduct Target Ther. 2020 Apr 28;5(1):57. doi: 10.1038/s41392-020-0158-2. No abstract available.
PubMed 32341331Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available.
PubMed 32085846Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PubMed 31986264
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perks of Methylprednisolone for Hospitalized COVID-19 Patients: A Clinical Trial
- ClinicalTrials.gov ID
- NCT04559113
- Acronym / sponsor ID
- Methyl19LGH / LGH005
- Keywords
- COVID-19, Methylprednisolone, Clinical outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Lahore General HospitalOther government
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 22 Sep 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.
In COVID-19 deep airway and alveolar destruction occurred due to inflammatory reaction resulting into severe pneumonia. In COVID-19, lung injury is not only due to viral damage to tissue, but it is also due to immune response that leads to activation of inflammatory cells and release of cytokines. In COVID-19 acute respiratory distress syndrome ARDS is produced due to mucinous or cellular fibromyxoid exudates, desquamation of pneumocytes and alveolar damage and hyaline membrane development and within 5-7 days disease become more aggressive due to pneumonia and respiratory failure. It is important to start the prompt and strengthen treatment for suppression of inflammatory response and cytokine storm. Methylprednisolone are the traditional immunosuppressive drugs. They are important and effective to delay the pneumonia progression and treating the ARDS.
Corticosteroids are broadly used as treatment for ARDS and there was an evidence for its efficacy for treating SARS and decreasing mortality of SARS in the past. However for COVID-19 corticosteroids efficacy and safety usage is still under clinical trials
Detailed description
All new decision and new interventions that are made for decreasing dependency of ventilator in patients and decreasing patients mortality would have played a great role on global public health. The aim of the study is to address the efficacy of methlyprednisolone for the treatment of COVID-19 patients and its clinical outcome at a tertriary care hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- quasi-experimental
| Arm | Type | Receives |
|---|---|---|
| Group intervene with Methylprednisolone | Experimental | Drug: Methylprednisolone Injectable ProductReview effect of Methylprednisolone as clinical trial among hospitalized patients with COVID-19 infection. Anyone of the following Corticosteroids dose will be given to moderate disease patients of COVID-19 1. 0.5mg to 1mg/Kg methylprednisolone or equivalent dexamethasone dose (to a maximum of 20mg) given daily x 5 to 7-days or 2. Methylprednisolone 1 mg/kg daily IV for 5 days followed by 40 mg daily x 3 days, followed by 10 mg daily x 2 day. *Note: in Diabetic patients' dose of methyl prednisolone should be divided in doses preferably 40mg BD. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients of all ages, males, and females who will be diagnosed COVID-19 positive by RT-PCR with moderate illness.
- Patients having classical radiological lesions of COVID-19 on X-ray chest or HRCT chest.
- Respiratory rate > 22/ min and >50% of radiological involvement of lung with typical lesions.
- FiO2 remain static or improving, along with > 30% deranged ≥ 2 biochemical markers CRP > 20 mg/l, LDH > 600 U/L, D.Dimer > 0.5mg/l or 500 ng/ml, Serum Ferritin < 500 ng/ml or mcg/l will be included in clinical trial.
Key exclusion criteria (7 listed)
- Heart failure,
- Cardiac arrest
- Decompensated liver cirrhosis,
- Decompensated psychiatric disorder
- Contraindication for corticosteroids
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 |
|---|---|---|
| Methylprednisolone Injectable ProductAlso: solu madrol1. 0.5mg to 1mg/Kg methylprednisolone or equivalent dexamethasone dose (to a maximum of 20mg) given daily x 5 to 7-days or 2. Methylprednisolone 1 mg/kg daily IV for 5 days followed by 40 mg daily x 3 days, followed by 10 mg daily x 2 day. | Drug | Group intervene with Methylprednisolone |
Primary outcome
Clinical response after administration
Time frame: 10 days
Clinical improvement of COVID-19 patients by methylprednisolone.
2 secondary outcomes
Clinical response to treatment
Time frame: 28 days
Duration of hospitalization
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Background: PubMed 32341331Wang Y, Jiang W, He Q, Wang C, Wang B, Zhou P, Dong N, Tong Q. A retrospective cohort study of methylprednisolone therapy in severe patients with COVID-19 pneumonia. Signal Transduct Target Ther. 2020 Apr 28;5(1):57. doi: 10.1038/s41392-020-0158-2. No abstract available.
- Background: PubMed 32085846Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available.
- Background: PubMed 31986264Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
- 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.
Sardar Al-Fareed Zafar, FCPS study director
Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylprednisolone Injectable Product in people with SARS-CoV Infection and SARS (Severe Acute Respiratory Syndrome), run by Lahore General 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 4 inclusion and 7 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 8 Dec 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.
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 Muhammad Irfan Malik, FCPS (03334367220, drmirfanmalik@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response after administration (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04559113, which also lists 3 linked publications.
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 8 Dec 2020.