meta|Evidence - COVID-19
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methylprednisolone (n=14) vs. control (n=15)
randomized controlled trial risk of bias NA
Methylprednisolone pulse
Methylprednisolone (1000 mg/day for three days, IV), and oral prednisolone 1 mg/kg with tapering of dose within ten days
Standard of care only
Kaletra (lopinavir/ritonavir) daily, Hydroxychloroquine 400 mg daily, Azithromycin 500 mg daily.
Standard of care in both groups: Kaletra (lopinavir/ritonavir) daily, Hydroxychloroquine 400 mg daily, Azithromycin 500 mg daily, oxygen therapy, nutritional support.
COVID-19 severe or critically
Double-blind
Phase 2
methylprednisolone (n=24) vs. standard of care (n=23)
randomized controlled trial some concerns about risk of bias
Methylprednisolone (high dose)
Methylprednisolone 40 mg IV every 12h for 5 days plus standard of care.
Standard of care
Standard of care only.
COVID-19 severe or critically
Adult patients with PCR confirmed COVID-19 infection, symptoms developed more than 7 days, PaO2/FiO2 < 200 mmHg, positive pressure ventilation (non-invasive or invasive) or high flow nasal cannula (HFNC) higher than 45 L/min for less than 48 hours, and requiring ICU admission.
Open-label.
Medical ICU,peking union medical college hospital, China.
Data and results come from Sterne J et al. meta-analysis and study registry. Planned sample size: 80 patients.
methylprednisolone (n=34) vs. standard of care (n=34)
randomized controlled trial high risk of bias
Methylprednisolone pulse
Methylprednisolone pulse (intravenous injection, 250 mg/day for 3 days) plus standard care.
Standard care
Hydroxychloroquine sulfate, lopinavir, and naproxen. Patients did not receive methylprednisolone or other glucocorticoids.
All patients received standard care (Hydroxychloroquine sulfate, Lopinavir, and Naproxen) for COVID-19 according to the protocol for diagnosis and treatment of COVID-19 in Iran. In the standard care group, six patients received corticosteroids by the attending physician during treatment and excluded from the ITT population.
COVID-19 severe or critically
Aged 18 years or older, confirmed COVID-19 with blood oxygen saturation <90%, elevated C-reactive protein (CRP >10), and interleukin (IL)-6 (>6) at the early pulmonary phase of disease before connecting to the ventilator and intubation and agreed to give informed consent. The diagnosis of COVID-19 in subjects was performed based on the following criteria: 1. Identification of SARS-CoV-2 via reverse transcription-polymerase chain reaction (RT-PCR) in nasopharyngeal swab or sputum samples and 2. Abnormal computed tomography (CT) scan finding (bilateral, subpleural, peripheral ground-glass opacities) with oxygen saturation <90% at rest.
Single-blind.
2 centers: Imam Khomeini Hospital and Khorshid Hospital, Iran.
Improvement was defined as BORG score>3, improved dyspnea, stopped fever for 72 hours,SO2> 93%, tolerated oral regimen (PO), normal urinary output and reduced CRP levelwithout any treatment side effects.
Phase II.
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