meta|Evidence - COVID-19
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methylprednisolone (n=44) vs. dexamethasone (n=42)
randomized controlled trial some concerns about risk of bias
Methylprednisolone
2mg/kg/day of methylprednisolone intravenously daily infused over 60 minutes, which was tapered to half dosage every five days.
Dexamethasone
6 mg of dexamethasone intravenously daily for ten days.
All patients received standard care. Methylprednisolone treatment was stopped in any patient who faced severe elevations in blood pressure or uncontrolled blood sugar.
COVID 19 hospitalized
Hospitalized patients above 18 years of age with SARS-CoV-2 infection confirmed by real-time PCR, with an O2 saturation of less than 92 in room air.
Triple-blind.
Faghihi hospital in Shiraz, Iran.
9-point scale (WHO), ranging from 0 as no clinical or virological evidence of infection (uninfected) to 8 assigned as death. The patient, assessor, and analyzer in the two groupsdid not have access to the randomization list and type of administered drug (Triple blind).
methylprednisolone (n=43) vs. placebo (n=43)
randomized controlled trial some concerns about risk of bias
Methylprednisolone
IV Methylprednisolone 1mg/kg/day dissolved in 100 mL 0.9% normal saline for 7 days.
Placebo
IV 100 mL 0.9% normal saline for 7 days.
All the participants received standard therapy of COVID-19 according to the Chinese Diagnosis and Treatment Plan for COVID-19.
COVID 19 hospitalized
Patients who were laboratory confirmed of SARS-CoV-2 infection and had pneumonia confirmed by chest computed tomography were diagnosed with COVID-19 pneumonia. Patients with COVID-19 pneumonia aged 18 years or older, admitted to the general wards for less than 72 h, and able to sign informed consent.
Single-blind.
7 tertiary hospitals in Beijing and Hubei, China.
Physicians were aware of the treatment assignment, but the participants were blinded. The clinical deterioration fulfilled at least one of the following criteria: the clinical symptoms and signs continue to deteriorate, new pulmonary or extrapulmonary lesions appear, the chest computed tomography indicates the progress, or the patient is transferred to the ICU or is dead.
Trial terminated early because of the COVID-19 decrease in late March.
methylprednisolone (n=209) vs. placebo (n=207)
randomized controlled trial some concerns about risk of bias
Methylprednisolone
IV 0.5 mg/kg sodium succinate MP (0.5 mg/kg), twice daily for 5 days
Placebo
Saline solution twice daily for 5 days.
As per hospital protocol, all patients meeting ARDS criteria used pre-emptively intravenous ceftriaxone (1g 2x for 7 days) plus azithromycin (500 mg 1x for 5 days) or clarithromycin (500 mg 2x for 7 days), starting on day 1.
COVID 19 hospitalized
Hospitalized patients were included if they had clinical and/or radiological suspicion of COVID-19 (history of fever and any respiratory symptom; eg, cough or dyspnea and/or ground glass opacity or pulmonary consolidation on computed tomography [CT] scan), were aged 18 years or older at the time of inclusion,and either had SpO2 ≤ 94% with room air, required supplementary oxygen, or required IMV.
Double-blind.
Single center, Manaus, Brazil.
Phase IIb.
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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