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. 2022 Nov 17;2022(11):CD014963. doi: 10.1002/14651858.CD014963.pub2

Gautam 2021.

Methods Trial design: randomised controlled trial
Type of publication: journal publication
Setting: inpatient
Recruitment dates: 15 April to 15 June 2021
Country: India
Language: English
Number of centres: 1
Trial registration number: not stated
Date first posted: not stated
Participants Age: mean age
  • 45.50 years in the methylprednisolone group

  • 45.34 years in the dexamethasone group


Gender:
  • 46 male (65.71%) and 24 (34.28%) in the methylprednisolone group

  • 50 male (71.42%) and 20 female (28.57%) in the dexamethasone group


Proportion of confirmed infections: PCR positivity inclusion criterion
Ethnicity: not stated
Number of participants (recruited/allocated/evaluated)
  • Recruited: 140

  • Allocated: 70 methylprednisolone group, 70 dexamethasone group

  • Evaluated: 70 methylprednisolone group, 70 dexamethasone group


Severity of condition according to study definition: moderate‐to‐severe COVID‐19 cases according to definition, patients having oxygen saturation < 93% on room air
Severity of condition according to WHO score: moderate to severe ≥ 5
Co‐morbidities: diabetes mellitus, chronic kidney disease, hypertension, chronic obstructive pulmonary disease, hypothyroidism, heart disease, obesity, malignancy
Inclusion criteria:
  • Age: 18 to 75 years

  • COVID‐19 RT‐PCR positive

  • Moderate‐to‐severe COVID‐19 cases according to definition

  • Patients having oxygen saturation < 93% on room air, regardless of chest X‐ray infiltrates

  • Patients given informed consent


Exclusion criteria:
  • Pregnant or lactating females

  • Immunocompromised conditions such as HIV or long‐term use of immunosuppressant for any chronic illness


Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): not stated
Interventions Treatment details of intervention group (e.g. dose, route of administration, number of doses)
  • Type of corticosteroid: methylprednisolone

  • Dose: 2.0 mg/kg bodyweight for 3 days followed by 1.0 mg/kg for 3 days in the divided dose

  • Route of administration: IV


Treatment details of control group (e.g. dose, route of administration, number of doses): dexamethasone, 8 mg/day intravenously daily in divided dose up to 10 days
Concomitant therapy (e.g. description of standard care): patients were given oxygen by nasal cannula, face mask, and non‐rebreathing mask
Duration of follow‐up: day 0, 5, 10
Treatment cross‐overs: no
Compliance with assigned treatment: yes
Outcomes Primary study outcome: not stated
Additional study outcomes: all‐cause mortality, hospital‐acquired infections, radiological improvement, transfer to intensive care unit, hyperglycaemic coma, clinical improvement
Notes Date of publication: 1 December 2021
Sponsor/funding: none