| Study characteristics |
| Methods |
Trial design: open‐label, single‐centre RCT
Type of publication: preprint
Setting: inpatient
Recruitment dates: 30 March‐18 May 2020 (only estimated dates from registry entry)
Country: Iran
Language: English
Number of centres: 1
Trial registration number: IRCT20200406046963N1
Date of trial registration: 22 April 2020 |
| Participants |
Age: 18‐90 years
Gender: no sexes excluded
Proportion of confirmed infections: PCR positivity inclusion criterion
Ethnicity: no ethnicities excluded
Number of participants (recruited/allocated/evaluated): 14 intervention group, 15 control group
Severity of condition according to study definition:
moderate to severe COVID‐19 admitted to ICU PaO2/FiO2 < 300 progression of disease severity and not responding to standard treatment prediction of intubation for next 24 h
Severity of condition according to WHO score: moderate‐severe 5‐6
Co‐morbidities: not reported
Inclusion criteria
Confirmed SARS CoV 2 infection Moderate‐severe COVID‐19 Admitted to ICU PaO2/FiO2, < 300 Progression of disease severity and not responding to standard treatment Prediction of intubation for next 24 h
Exclusion criteria
Uncontrolled diabetes mellitus Active GI bleeding History of corticosteroid hypersensitivity Severe electrolyte imbalances Procalcitonin > 0.5 active bacterial Viral (HIV, hepatitis) and fungal infection
Previous treatments: not specified |
| Interventions |
Treatment details of intervention group (e.g dose, route of administration, number of doses): 1000 mg methylprednisolone IV for 3 days followed by 1 mg/kg oral prednisolone with dose tapering for 7 days + standard care
Treatment details of control group (e.g dose, route of administration, number of doses): standard care
Concomitant therapy (e.g. description of standard care):
Kaletra (lopinavir/ritonavir) daily Hydroxychloroquine 400 mg daily Azithromycin 500 mg daily
Duration of follow‐up: not specified
Treatment cross‐overs: none reported
Compliance with assigned treatment: no deviations reported |
| Outcomes |
Primary study outcome: mortality rate, blood O2 saturation and need for further oxygen therapy
Review outcomes: inpatient setting
All‐cause mortality at day 21, or longest observation period: not reported -
Improvement of clinical status during observation period:
Liberation from IMV in participants i.e. transition to WHO ≤ 6 if ≥ 7 at baseline (see Figure 1). If liberation was not available directly, death was used as a proxy for assumed non‐liberation counted together with participants alive and ventilated: not reported Ventilator‐free days and alive: not reported
-
Worsening of clinical status during observation period:
Need for dialysis (at up to 28 days): not reported Quality of life, including fatigue and neurological status, assessed with standardised scales (e.g. WHOQOL‐100) at longest follow‐up available: not reported Viral clearance, assessed with RT‐PCR test for SARS‐CoV‐2 at baseline, up to 3, 7, and 15 days: not reported Serious adverse events: not reported Adverse events (any grade): not reported Hospital‐acquired infection: not reported
Additional study outcomes
Glasgow Coma Scale: daily for 10 days mean, although scale is not metric Means of SpO2, FiO2, blood pressure, PEEP, CPK, LDH for 10 days
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| Identification |
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| Notes |
Date of publication: 9 September 2020
Sponsor/funding: Artesh University of Medical Sciences |
