| Main |
| Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
| Register: |
CTRI |
| Last refreshed on: |
24 November 2021 |
| Main ID: |
CTRI/2020/05/025068 |
| Date of registration: |
07-05-2020 |
| Prospective Registration: |
Yes |
| Primary sponsor: |
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| Public title: |
Can a medicine help in curing viral infection |
| Scientific title: |
A Phase IIB open label randomized controlled trial to evaluate the efficacy and safety of Ivermectin in reducing viral loads in patients with hematological disorders who are admitted with COVID 19 infection - Not applicable |
| Date of first enrolment: |
27-05-2020 |
| Target sample size: |
50 |
| Recruitment status: |
Not Yet Recruiting |
| URL: |
http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43449 |
| Study type: |
Interventional |
| Study design: |
Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label |
| Phase: |
Phase 3 |
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| Countries of recruitment |
| India |
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| Contacts |
| Name: |
Biju George |
| Address: |
Department of Haematology, First Floor, Room no-3, Christian Medical College Department of Haematology, First Floor, Room no-3, Christian Medical College 632004 Khordha, TAMIL NADU India |
| Telephone: |
04162282352 |
| Email: |
biju@cmcvellore.ac.in |
| Affiliation: |
Christian Medical College Vellore |
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| Name: |
Biju George |
| Address: |
Department of Haematology, First Floor, Room no-3, Christian Medical College Department of Haematology, First Floor, Room no-3, Christian Medical College 632004 Khordha, TAMIL NADU India |
| Telephone: |
04162282352 |
| Email: |
biju@cmcvellore.ac.in |
| Affiliation: |
Christian Medical College Vellore |
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| Key inclusion & exclusion criteria |
Inclusion criteria: Confirmed diagnosis of COVID19 infection based on +ve RTPCR
Exclusion criteria: Patients with other viral infections
Age minimum:
Age maximum:
Gender: |
| Health Condition(s) or Problem(s) studied |
| Health Condition 1: B338- Other specified viral diseases |
| Intervention(s) |
Intervention1: Ivermectin: The doses are as follows (based on body weight)
15 - 24 kg: 3 mg PO once
25 - 35 kg: 6 mg PO once
36 - 50 kg: 9 mg PO once
51 - 65 kg: 12 mg PO once
66 - 79 kg: 15 mg PO once
80 kg and 15 kg: 200 ug/kg PO once
Control Intervention1: patients will receive the standard protocol for management of COVID 19 infection.: patients will receive the standard protocol for management of COVID 19 infection.
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| Primary Outcome(s) |
To study if Ivermectin can reduce the viral load in patients with hematological illnesses who are admitted with COVD19 infectionTimepoint: Day 7
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| Secondary Outcome(s) |
To study the factors that affect viral load reduction
To study if the reduction in viral load correlates with improvement in inflammatory parameters
To study the incidence of serious adverse events and safety of this drug when used in hematological illnessesTimepoint: Day 7
Day 20 |
| Secondary ID(s) |
| Not applicable |
| Source(s) of Monetary Support |
| Christian Medical College Vellore, Ida Scudder Road, Vellore, 632004, Tamil Nadu |
| Ethics review |
Status: Approved
Approval date: 15/04/2020
Contact:
Ethics Committee - Institution Review Board
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| Results |
| Results available: |
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| Date Posted: |
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| Date Completed: |
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| URL: |
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