| Study name |
Pre‐emptive steroids to alter the disease course in COVID‐19 patients |
| Methods |
Trial design: open‐label, randomised controlled trial
Sample size: 500
Setting: outpatient
Language: English
Number of centres: 1
Type of intervention (treatment/prevention): treatment |
| Participants |
Inclusion criteria:
Male or non‐pregnant female adult ≥ 18 years of age at the time of enrolment Confirmed diagnosis of SARS‐CoV‐2 infection, defined as either: a) SARS‐CoV‐2 PCR positive within 72 h before randomisation or b) in patients without PCR‐confirmed diagnosis at inclusion, all efforts will be made to confirm definite SARS‐CoV‐2 infection (e.g. PCR on bronchial aspirate, PCR on BAL fluid or serologic testing), but patients who despite all efforts do not have a confirmed diagnosis of COVID‐19 will be excluded from the analysis Patients eligible for home isolation
Exclusion criteria:
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Moderate to severe type of disease, with at least one of the following criteria:
Frequency of breath > 24 per minute, which does not decrease after the body temperature drops to normal or subfebrile values Blood oxygen saturation (SpO2) < 94% at rest Chest involvement on HRCT Partial pressure of oxygen in arterial blood (PaO2) < 60 mm Hg Oxygenation index (RaO2/FiO2) ≤ 200 mm Hg Partial pressure of CO2 in arterial blood (PaCO2) < 60 mm Hg Septic shock
Patients treated with lopinavir/ritonavir, ribavirin, arbidol, chloroquine, hydroxychloroquine, mefloquine, favipiravir within 7 days prior to screening Severe cardiovascular diseases currently or 6 months prior to trial Uncontrolled arterial hypertension with systolic blood pressure > 180 mm Hg and diastolic blood pressure > 110 mm Hg, pulmonary embolism or deep vein thrombosis Severe chronic renal impairment (GFR < 30 mL/min) or continuous renal replacement therapy, haemodialysis or peritoneal dialysis A history of cirrhosis or an increase in alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 5 times × upper limit of normal (ULN) Significant uncontrolled concomitant disease, e.g. neurological, renal, hepatic, endocrinological or gastrointestinal disorder which according to the investigator, could prevent the patient from participating in the study Malignancies that require chemotherapy within 6 months prior to screening Known HIV infection Uncontrolled diabetes mellitus Participation in other clinical studies or taking other study drugs within 28 days prior to screening Pregnant or lactating women Patients not giving consent
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| Interventions |
Details of intervention: methylprednisolone plus standard care
Dose: given pre‐emptively at day 5 in addition to the standard care: administered for 14 days: 2 phases ‐ prevention phase for 1 week followed by maintenance and tapering phase for 1 week, Category 1: 4 mg to 8 mg per day if minimal initial symptoms (fever 100.5 °F, body ache, headache, sore throat, HRCT 5%), upgrade to Category 2 if symptoms persist beyond 3 days or increasing, Category 2: 12 mg to 32 mg per day if moderate symptoms (fever 100.5 °F to 103 °F, loss of smell/ taste, lethargy, cough) Route of administration: oral
Treatment details of control group (e.g. dose, route of administration): standard care
Concomitant therapy: not stated |
| Outcomes |
Primary study outcome: number of patients requiring hospitalisation, supplemental oxygen and/or ICU care as compared to standard of care protocol (time points: baseline, 7 days, 14 days and, if applicable, ICU status/hospitalisation time)
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| Starting date |
2 May 2022 |
| Contact information |
Prakhar Gupta, JK Hospital and LN Medical College, Department of Medicine, Third floor JK Hospital and LN Medical college, Bhopal MADHYA PRADESH 462042, India
Email: itsme.prakhar@gmail.com |
| Notes |
Recruitment status: not yet recruiting
Prospective completion date: not stated
Date last update was posted: 28 May 2021
Sponsor/funding: JK Hospital and LN Medical College |
