Trial registration number
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CTRI/2021/03/031665 |
Full text link
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53325
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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 Manisha Bisht
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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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manishabisht@yahoo.co.in
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Registration date
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-03-02
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Recruitment status
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Blind label
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Center
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Health care personnel (HCP) >18 years age <br/ >2. HCP identified as primary contact and have High Risk defined as per ICMR guidelines for contracting COVID-19 infection <br/ >3. HCP who have not presented with general symptoms such as general discomfort, fever, cough, dyspnoea or muscle pain in the last week. <br/ >4. HCP who are willing to give written informed consent <br/ >
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Exclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Already infected with SARS-cov-2/ previous COVID-19 within the last 6 months <br/ >2. HCW who have taken any medication as possible prophylaxis for COVID-19 <br/ >3. Pregnancy <br/ >4. Prior enrolment into this or other COVID-19 prevention or treatment trials. <br/ >5. HCW with known allergy to ivermectin <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 : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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AIIMS Rishikesh
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Inclusion age min
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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65
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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 : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Health workers
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Severity scale
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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N/A
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Total sample size
Last imported at : March 26, 2021, 2:21 p.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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RT- Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection [ Day 10]- As per State covid management guidelinesTimepoint: Day 10
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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 : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 4
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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": "200 mcg / kg two doses - 72 hours apart [ 40-60 kg : 12 mg; 60 -80 kg :18 mg; 80 kg : 24 mg", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1369, "treatment_name": "Vitamin c", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}]
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