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Trial - CTRI/2021/11/037872


Column Value
Trial registration number CTRI/2021/11/037872
Full text link
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Amitabha Sengupta

Contact
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

drasengupta@gmail.com

Registration date
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

2021-11-08

Recruitment status
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Not recruiting

Study design
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

single-center

Study aim
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Treatment

Inclusion criteria
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

RT-PCR confirmed case of COVID 19 infection. <br/ > Patients with confirmed case of COVID 19 with persistence of lung lesion on HRCT after 6weeks of infection <br/ > Normal hepatic and renal function <br/ > Participants can understand the study and sign informed consent for the study. <br/ >

Exclusion criteria
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Previous or concurrent malignancies <br/ > Any previous immunosuppressive therapy/ radiotherapy/ or HIV <br/ > Medical or psychiatric conditions that compromise the patients ability to give informed consent. <br/ >

Number of arms
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

2

Funding
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Institute of Postgraduate Medical Education and Research

Inclusion age min
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

99

Countries
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

India

Type of patients
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

No restriction on type of patients

Severity scale
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

0: No restriction on type of patients

Total sample size
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

60

primary outcome
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Change in 6 minutesâ?? walk test at 3; 6 and 12 months after therapy. <br/ >Change in FVC at 3;6 and 12 months after therapy. <br/ >Radiological resolution at 6th and 12 months of therapy <br/ >Timepoint: Baseline; 3; 6 and 12 months

Notes
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

| Declared number of arm (2.0) differs from found arms (3.0)

Phase
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Phase 2/Phase 3

Arms
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "", "treatment_id": 2169, "treatment_name": "Mycophenolate mofetil", "treatment_type": "Immunosuppressants", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]