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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-31

Study Completion Date

2022-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Ivermectin in COVID-19

NCT05076253

Safety SARS-CoV2 Infection Ivermectin Poisoning +1 more

COMPLETED PHASE1/PHASE2

Ivermectin as a Novel Therapy in COVID-19 Treatment

NCT04403555

COVID

COMPLETED PHASE2/PHASE3

Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi

NCT01213576

Lymphatic Filariasis

TERMINATED NA

Effectiveness of Oral Albendazole in the Treatment of Severe Acute Malnutrition

NCT01395381

Kwashiorkor Marasmus

WITHDRAWN NA

Effectiveness of Ivermectin in SARS-CoV-2/COVID-19 Patients

NCT04739410

Covid19

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

SARS-CoV-2 Ivermectin

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Ivermectin

Intervention Type DRUG

Treatment of SARS Cov-2 patients with Ivermectin

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

Group Type EXPERIMENTAL

Prophylaxis

Intervention Type OTHER

Treatment of high risk population with Ivermectin as prophylaxis

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ivermectin

Treatment of SARS Cov-2 patients with Ivermectin

Intervention Type DRUG

Prophylaxis

Treatment of high risk population with Ivermectin as prophylaxis

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No