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Main
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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. |
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Register:
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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR202108891693522 |
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Date of registration:
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08/07/2021 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Does the addition of Hydroxychloroquine HCQ and Azithromycin enhance the effect of Ivermectin against Covid 19 infection?
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Scientific title:
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A COMPARATIVE RANDOMIZED CLINICAL TRIAL OF IVERMECTIN VERSUS HYDROXYCHLOROQUINE, IVERMECTIN, AND AZITHROMYCIN(HIA TRIPLE THERAPY) IN COVID- 19 IN NIGERIA. |
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Date of first enrolment:
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01/05/2021 |
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Target sample size:
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60 |
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Recruitment status: |
Complete |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=15995 |
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Study type:
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Interventional |
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Study design:
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Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously,Randomised,Simple randomization using a randomization table from a statistics book,Numbered containers
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Phase:
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Phase-2
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Countries of recruitment
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Nigeria
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Contacts
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Name:
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Yahaya Abdullahi
Ndanusa |
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Address:
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B43 CBN Executive Estate, Karu Abuja.Karu Abuja
Abuja
Nigeria |
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Telephone:
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+2348170440500 |
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Email:
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yndanusa@gmail.com |
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Affiliation:
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Medical Director |
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Name:
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Olufemi
Babalola |
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Address:
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23 Onitsha crescent Garki II
BOX 4108
Abuja
Nigeria |
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Telephone:
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+2348098603395 |
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Email:
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bablo57@gmail.com |
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Affiliation:
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ProfessorEpidemiologist |
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Key inclusion & exclusion criteria
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Inclusion criteria: Newly diagnosed cases of Covid 19 virologically confirmed
Exclusion criteria: Pregnant
Breastfeeding
Allergy to drugs
Age minimum:
19 Year(s)
Age maximum:
44 Year(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Covid 19
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Covid 19
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Intervention(s)
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Ivermectin IVM Hydroxychloroquine HCQ Azithromycin AZT
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Drugs Ivermectin IVM
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Primary Outcome(s)
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Proportion virologically negative by days 2, 5, 14 and 21 in each arm, other virology outcomes
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Secondary Outcome(s)
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Effect on Platelet count and inflammatory markers
Time to discharge from care.
Time to resolution of symptoms.
Serious adverse events.
SPO2 changes over time
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Source(s) of Monetary Support
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Central Bank of Nigeria HSRDIS
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Ethics review
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Status: Approved
Approval date: 28/10/2020
Contact:
info@uath.gov.ng
University of Abuja Teaching Hospiral HREC
+2347040045614
info@uath.gov.ng
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