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Trial - CTRI/2020/06/025960


Column Value
Trial registration number CTRI/2020/06/025960
Full text link
Last imported at : July 30, 2021, 1:30 p.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)

Dr Meenakshi Bhakare

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

asstprof.respiratorymedicine1@smcw.siu.edu.in

Registration date
Last imported at : July 30, 2021, 1:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2020-06-18

Recruitment status
Last imported at : July 30, 2021, 1:30 p.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 : July 30, 2021, 1:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Blind label

Center
Last imported at : July 30, 2021, 1:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

single-center

Study aim
Last imported at : July 30, 2021, 1:30 p.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)

Symptomatic patients infected with SARS-CoV-2 virus diagnosed on Real time PCR test, admitted to hospital.

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

1. Age less than 18 and more 70 years <br/ >2. Pregnant and lactating women <br/ >3. Patients not willing to give written informed consent <br/ >4. Seriously ill patients requiring intensive care <br/ >5. Known hypersensitivity to Ivermectin drug 6. Subjects who have participated in another investigational drug or research study within 30 days of screening. <br/ >7. Subjects who are using any medication or has any disease which in the judgment of the Investigator will interfere with the conduct or interpretation of the study.

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 : July 30, 2021, 1:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Dr Rajkumar Nikalje

Inclusion age min
Last imported at : July 30, 2021, 1:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : July 30, 2021, 1:30 p.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 : July 30, 2021, 1:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Mild/moderate disease at enrollment

Severity scale
Last imported at : July 30, 2021, 1:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : July 30, 2021, 1:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

100

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

Effect of Ivermectin on eradication of virus by testing for SARS-Co-V-2 by Real time PCR testTimepoint: day 7

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 : July 30, 2021, 1:30 p.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": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]