Methylprednisolone in COVID-19 Patients (Methyl19LGH) (Methyl19LGH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04559113|
Recruitment Status : Recruiting
First Posted : September 22, 2020
Last Update Posted : December 8, 2020
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
|Condition or disease||Intervention/treatment||Phase|
|SARS-CoV Infection SARS (Severe Acute Respiratory Syndrome)||Drug: Methylprednisolone Injectable Product||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||quasi-experimental|
|Masking:||None (Open Label)|
|Official Title:||Perks of Methylprednisolone for Hospitalized COVID-19 Patients: A Clinical Trial|
|Actual Study Start Date :||May 1, 2020|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||December 30, 2020|
Experimental: Group intervene with Methylprednisolone
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
Drug: Methylprednisolone Injectable Product
Other Name: solu madrol
- Clinical response after administration [ Time Frame: 10 days ]Clinical improvement of COVID-19 patients by methylprednisolone.
- Clinical response to treatment [ Time Frame: 28 days ]Overall survival of COVID-19 patients after drug administration.
- Duration of hospitalization [ Time Frame: 28 days ]Number of days of hospital admission either in ICU or HDUs till date of discharge
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): NCT04559113
|Contact: Muhammad Irfan Malik, FCPSfirstname.lastname@example.org|
|Contact: Sardar Al-Fareed Zafar, FCPSemail@example.com|
|Muhammad Irfan Malik||Recruiting|
|Lahore, Punjab, Pakistan, 54500|
|Contact: Muhammad Irfan malik, FCPS 03334367220 firstname.lastname@example.org|
|Study Director:||Sardar Al-Fareed Zafar, FCPS||Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan|