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ZIT: The Zambia Ivermectin Trial for the Treatment and Prevention of COVID-19

Sponsor
Centre for Infectious Disease Research in Zambia (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04891250
Collaborator
Ministry of Health, Zambia (Other), University of Zambia (Other)
0
Enrollment
1
Location
2
Arms
8
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aims to test whether Ivermectin would decrease mortality and reduces chances of getting infected with corona virus, improve management of clinical symptoms and reduce length of stay in ICU and transition probabilities to ICU (ventilator).

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

With the onset of global pandemic of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and the sharp rise in infection and mortality rates, efficient management of the current medical emergency has become an absolute priority. A lot of resources have been directed to developing a comprehensive therapeutic approach to preventing and curing this disease, and this has mostly been in western countries. However, lack of definite treatment, high number of infected people, limited capacity and the impact of COVID-19 on existing health infrastructure has left biomedical researchers and clinicians faced with the mammoth task of providing appropriate clinical care solutions and strategies with favorable cost-benefit outcomes, which can help in both curbing the disease and treating patients. To meet this challenge, repurposing of available drugs has become vital. Evidence from several recent clinical trials on the effects of available therapeutic clinical drugs and vitamin supplements on mortality rate and other clinical outcomes associated with COVID-19 are promising, however, the efficacy, safety, and appropriate dosing of therapeutic clinical drugs such as ivermectin, remain largely unevaluated in Sub-Saharan Africa. The investigators propose to evaluate and compare the efficacy of ivermectin in the management of Covid-19.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients with moderate to severe COVID-19 disease will be randomized to either Ivermectin (Intervention) or Standard of Care (Control arm) in a 1:1 ratio.Patients with moderate to severe COVID-19 disease will be randomized to either Ivermectin (Intervention) or Standard of Care (Control arm) in a 1:1 ratio.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Zambia Ivermectin Trial for the Treatment and Prevention of COVID-19
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Patients with moderate to severe COVID-19 disease will be randomized to either Ivermectin (Intervention) or Standard of Care (Control arm) in a 1:1 ratio

Drug: Ivermectin
Treatment of SARS Cov-2 patients with Ivermectin
Experimental: Prophylaxis

An additional group of patients will be recruited will be randomized to either Ivermectin as prophylaxis (Intervention) or Standard of Care with no ivermectin (Control arm) in a 1:1 ratio

Other: Prophylaxis
Treatment of high risk population with Ivermectin as prophylaxis

Outcome Measures

Primary Outcome Measures

  1. All-cause COVID-19 related mortality [within 28 days of enrollment]

    All-cause COVID-19 related mortality

  2. COVID-19 Infection [Study duration]

    the proportion of patients on Ivermectin prophylaxis who test positive for COVID 19 using PCR after initially testing negative at enrolment

Secondary Outcome Measures

  1. Patient cure rate [14- 28 days]

    The percentage of cured patients, defined as symptoms free to be discharged from the hospital and the percentage Changes of WHO's OSCI scale for COVID-19 between baseline and day 14 and between baseline and day 28. The study will will also evaluate the time to cure in both groups by measuring time from admission of the patient to the hospital till discharge.

  2. Participant Infection Rate [90 days]

    determine proportion who will develop severe disease and needing admission in addition to the above outcomes.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Zambia Lusaka Zambia 10101

Sponsors and Collaborators

  • Centre for Infectious Disease Research in Zambia
  • Ministry of Health, Zambia
  • University of Zambia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Centre for Infectious Disease Research in Zambia
ClinicalTrials.gov Identifier:
NCT04891250
Other Study ID Numbers:
  • ZIT
First Posted:
May 18, 2021
Last Update Posted:
Feb 3, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Ivermectin

Study Results

No Results Posted as of Feb 3, 2022