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IRCT20200723048178N3 IRCT 2021-08-13 Pakistan Institute of Medical Sciences, Islamabad Solumedrol in Covid-19 infection High dose solumedrol in patients with severe Covid-19 infection 2021-05-03 anticipated 60 Complete https://irct.ir/trial/57938 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomized using a "simple" randomization method with "individuals" considered as a single unit. A table of random numbers will be generated using "https://www.randomizer.org/". One set of patients will be labeled as "controls" while the other group will be labeled as the "Interventional Group". Patients and caregivers (ICU nurse) will be blinded, Blinding description: Patients and caregivers will be blinded. Blinding is done by the primary investigator who will label the infusion sets according to the randomization table provided by "https://www.randomizer.org/". Both groups will receive 100 ml Saline infusion labeled according to the table provided by the randomization site. Control will receive Saline, while those receiving an active drug will be infused solumedrol added to the 100 ml saline. N/A COVID-19 infection. Intervention 1: Control group: Patients will receive 100 ml saline once daily in addition to the standard therapy for three days. Saline will contain 150 mmol/L sodium and 150 mmol/L chloride and an osmolality of 308 mOsm/L. Brand Name: UNISOL-NS (UNISA Pharamaceuticals Industries Ltd). Intervention 2: Intervention group: Patients will receive 1000 mg methylprednisolone (Solumedrol injection, manufactured by Pfizer Pharmaceuticals Ltd). The injection will be diluted in 90 ml Saline to make up a total of 100 ml solution. Patients will receive the injection of three consecutive days once daily infusion over 30 minutes. Yes - There is a plan to make this available What will be shared: All data regarding the patient's demographics, response to the treatment, and the outcome may be shared. When: Data will be available as soon as the study is ready to be published. To whom: All healthcare workers and researchers can access the data. Conditions: Data will be shared via email. Where to obtain: Data will be accessible on request via email. How to obtain: Data may be shared via email. Anyone who is a healthcare personal or a researcher can get a soft copy of the data via email. Comments:
public Ahmed Farhan
Jhelum Road
Islamabad Pakistan 44000 +92 51 9107679 drfarhan992@gmail.com Pakistan Institute of Medical Sciences scientific Ahmed Farhan
Jhelum Road
Islamabad Pakistan 44000 +92 51 9107679 drfarhan992@gmail.com Pakistan Institute of Medical Sciences Pakistan Provide written informed consent Subjects age > 18 years at the time of signing the Informed Consent Form. Male or Female Must have a clinical diagnosis of COVID-19, with at least one clinical symptom (e.g., fever ≥38°C, fatigue, cough) and a positive result by the reverse-transcription polymerase chain reaction (RT-PCR) testing or equivalent. Individuals with severe COVID-19 symptoms according to Berlin Criteria Hospitalized patients and on Mechanical Ventilation Patients requiring FiO2 of 0.5 or more and a PEEP of 5 mmHg or more Ability to provide informed consent or an authorized representative can sign the informed consent 18 years 60 years Both Pregnant females Patients with HIV infection. Patients with active tuberculosis or a history of treatment for pulmonary tuberculosis Patients with a CrCl of less than 30 ml/minute Patients with heart disease and an ejection fraction of 30% or less Patients with advanced liver disease Patients allergic to methylprednisolone U07.1 COVID-19, virus identified Placebo Treatment - Drugs Control group: Patients will receive 100 ml saline once daily in addition to the standard therapy for three days. Saline will contain 150 mmol/L sodium and 150 mmol/L chloride and an osmolality of 308 mOsm/L. Brand Name: UNISOL-NS (UNISA Pharamaceuticals Industries Ltd) Intervention group: Patients will receive 1000 mg methylprednisolone (Solumedrol injection, manufactured by Pfizer Pharmaceuticals Ltd). The injection will be diluted in 90 ml Saline to make up a total of 100 ml solution. Patients will receive the injection of three consecutive days once daily infusion over 30 minutes. In-hospital mortality. Timepoint: 28 days. Method of measurement: Pre-designed Performa. Duration of hospital stay. Timepoint: 28 days. Method of measurement: Predesigned performa. Improvement in lung mechanics. Timepoint: 28 days. Method of measurement: predesigned performa. Improvement in inflammatory markers. Timepoint: 28 days. Method of measurement: predesigned performa. Incidence of secondary infections. Timepoint: 28 days. Method of measurement: predesigned performa. Pakistan Institute of Medical Sciences, Islamabad Approved 2021-04-28 Ethics Committee of Shaheed Zulfiqar Ali Medical University G-8/3 Islamabad Punjab Pakistan