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Trial - CTRI/2020/11/028959


Column Value
Trial registration number CTRI/2020/11/028959
Full text link
Last imported at : Dec. 5, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

ashutosh kumar singh

Contact
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

anjantrikha@gmail.com

Registration date
Last imported at : Dec. 5, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2020-11-06

Recruitment status
Last imported at : Dec. 5, 2020, 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 : Dec. 5, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : Dec. 5, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

single-center

Study aim
Last imported at : Dec. 5, 2020, 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)

sars-cov-2 positive patients. <br/ >moderate to severe disease who require non-invasive or invasive ventilation.

Exclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

patients relative refusal. <br/ >terminal end-organ failure (renal, liver, cardiac, cns) <br/ >thrombocytosis. <br/ >concomitant potential serious infections.

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 : Dec. 5, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

All India Institute Of Medical Sciences New Delhi

Inclusion age min
Last imported at : Dec. 5, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : Dec. 5, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

90

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 : Dec. 5, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Moderate/severe/critical disease at enrollment

Severity scale
Last imported at : Dec. 5, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

5: Moderate/severe/critical disease at enrollment

Total sample size
Last imported at : Dec. 5, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

40

primary outcome
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Deescalation from mechanical ventilation and mortality benefit.Timepoint: 02 weeks

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 : Dec. 5, 2020, 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": 1076, "treatment_name": "Recombinant erythropoietin", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]