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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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ClinicalTrials.gov |
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Last refreshed on:
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13 September 2021 |
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Main ID: |
NCT04891250 |
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Date of registration:
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11/05/2021 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Zambia Ivermectin Trial for the Treatment and Prevention of COVID-19
ZIT |
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Scientific title:
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The Zambia Ivermectin Trial for the Treatment and Prevention of COVID-19 |
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Date of first enrolment:
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October 2021 |
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Target sample size:
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800 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04891250 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Zambia
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Contacts
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Name:
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Wilbroad Mutala, PhD |
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Address:
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Telephone:
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+260967780284 |
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Email:
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wmutale@yahoo.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Individuals diagnosed positive for SARS-CoV-2 by real-time reverse transcription PCR
(rRT-PCR with presence of a fever, cough, and/or sore throat.
Exclusion Criteria:
- Patients will be excluded if they report to be allergic to ivermectin or if there is
potential for a drug-drug interaction with ivermectin;
- Have chronic illnesses (e.g., ischemic heart disease, heart failure, documented
cardiomyopathy, chronic kidney disease, chronic liver disease);
- Have received ivermectin in the last 7 days; are pregnant or lactating;
- Or have participated in any other clinical trial within the last month.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ivermectin
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SARS-CoV-2
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Intervention(s)
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Drug: Ivermectin
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Other: Prophylaxis
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Primary Outcome(s)
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All-cause COVID-19 related mortality
[Time Frame: within 28 days of enrollment]
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COVID-19 Infection
[Time Frame: Study duration]
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Secondary Outcome(s)
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Participant Infection Rate
[Time Frame: 90 days]
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Patient cure rate
[Time Frame: 14- 28 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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