Trial registration number
|
CTRI/2020/12/030143 |
Full text link
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50886
|
First author
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Dr Sukhyanti Kerai
|
Contact
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
drsukhi25@gmail.com
|
Registration date
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
2020-12-31
|
Recruitment status
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Not recruiting
|
Study design
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
RCT
|
Allocation
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Randomized
|
Design
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Parallel
|
Masking
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Not reported
|
Center
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
single-center
|
Study aim
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Treatment
|
Inclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
1.Confirmed COVID-19 infection with pulmonary involvement <br/ >2.Admitted to ICU within 14 days of onset of symptoms <br/ >3.Receiving Invasive or non -invasive positive pressure ventilation or respiratory support through HFNC
|
Exclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Septicemia <br/ >2. Active malignancy or patient on immunosuppressive therapy within last 3 months <br/ >2.Uncontrolled hyperglycaemia <br/ >3.Clinically important gastrointestinal bleed <br/ >4.Pregnancy <br/ >5.History of hypersensitivity to steroid preparations <br/ >
|
Number of arms
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
2
|
Funding
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Maulana Azad Medical College and associated Lok Nayak Hospital
|
Inclusion age min
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
18
|
Inclusion age max
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
70
|
Countries
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
India
|
Type of patients
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Critical disease at enrollment
|
Severity scale
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
8: Critical disease at enrollment
|
Total sample size
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
500
|
primary outcome
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
28 day Mortality of patientsTimepoint: 28 days
|
Notes
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
| Declared number of arm (2.0)
differs from found arms (3.0)
|
Phase
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Not reported
|
Arms
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
[{"arm_notes": "", "treatment_id": 798, "treatment_name": "Methylprednisolone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}]
|