| Trial registration number
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CTRI/2020/12/029894 |
Full text link
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49273
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First author
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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DR R Nivetha
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Contact
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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tavidya@gmail.com
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Registration date
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2020-12-18
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Recruitment status
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Treatment
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Inclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Hospitalized patients with moderate SARS-COV-2 infection laboratory confirmed by RT-PCR <br/ >(Moderate COVID 19- SPO2 <94% Under room air and requiring supplemental oxygen for hypoxemia <br/ >Respiratory rate 24-30/min <br/ >NLR >5 <br/ >CRP 50-100 mg/l <br/ >Serum ferritin 600-1500 ng/ml <br/ >Serum LDH 300-500 IU/l <br/ >D Dimer 0.5-1.0 mic/ml <br/ >IL-6 20-100 pg/ml <br/ >CT chest showing 25-75% infiltrates) <br/ >
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Exclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
1.Patients with mild and severe covid pneumonia <br/ >2.Patients who are already on steroid treatment for any underlying condition <br/ >3.Patients already started on antivirals <br/ >4.Pregnant or lactating women <br/ >5.Any known contraindication to short term corticosteroid like severe immunosuppression, HIV infection or any other immunosuppressant usage <br/ >Â <br/ >
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Number of arms
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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SRM Medical College Hospital and Research Centre
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Inclusion age min
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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80
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Countries
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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India
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Type of patients
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Severe disease at enrollment
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Severity scale
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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6: Severe disease at enrollment
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Total sample size
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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50
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primary outcome
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Mortality during hospital stayTimepoint: Day 1 - Day 7
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Notes
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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| Declared number of arm (2.0)
differs from found arms (3.0)
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Phase
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Arms
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 798, "treatment_name": "Methylprednisolone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}]
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