Efficacy of Ivermectin in Adult Patients With Early Stages of COVID-19 (EPIC Trial)

Study Overview
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Brief Summary
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Double blind, placebo controlled, randomized clinical trial to evaluate the efficacy of ivermectin in preventing progression of disease in adult patients with early stages of COVID-19

Official Title
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Randomized, Placebo Controlled, Double Blind Clinical Trial to Evaluate the Efficacy of Molecule D11AX22 in Adults Patients From Valle Del Cauca, Colombia With Early Stages of SARS COV2 / COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Ivermectin Oral Product
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age Confirmed SARS-CoV-2 by RT-PCR or antigen detection in a Colombian NIH-approved laboratory Beginning of symptoms in the past 7 days Mild disease Informed consent Exclusion Criteria: Preexisting liver disease Hypersensitivity to ivermectin Participants in other clinical trials for therapies against COVID-19 Severe pneumonia Pregnant or breastfeeding women Concomitant use of warfarin, erdafitinib or quinidine Use of ivermectin in the 5 days prior to randomization Inability to obtain a blood sample needed to assess liver transaminases Elevation of transaminases >1.5 times the normal level Participant whose first contact with the study personnel occurs between days 5 and 7 and at that time manifests significant and progressive resolution of COVID-19 related signs and symptoms

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ivermectin<br>Ivermectin, 300 micrograms / kg, once daily for 5 days | Drug: Ivermectin Oral Product<br>* Ivermectin oral suspension, 6 mg/mL<br>|
| Placebo Comparator: Placebo<br>Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient | Drug: Placebo<br>* Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to event | Time until resolution of symptoms | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical condition on day 2 | Clinical condition in an ordinal scale of 7 points, on day 2. Higher scores indicate worse outcomes | On day 2 (± 1 day) after randomization | 
| Clinical condition on day 5 | Clinical condition in an ordinal scale of 7 points, on day 5. Higher scores indicate worse outcomes | On day 5 (± 1 day) after randomization | 
| Clinical condition on day 8 | Clinical condition in an ordinal scale of 7 points, on day 8. Higher scores indicate worse outcomes | On day 8 (± 1 day) after randomization | 
| Clinical condition on day 11 | Clinical condition in an ordinal scale of 7 points, on day 11. Higher scores indicate worse outcomes | On day 11 (± 1 day) after randomization | 
| Clinical condition on day 15 | Clinical condition in an ordinal scale of 7 points, on day 15. Higher scores indicate worse outcomes | On day 15 (± 1 day) after randomization | 
| Clinical condition on day 21 | Clinical condition in an ordinal scale of 7 points, on day 21. Higher scores indicate worse outcomes | On day 21 (± 1 day) after randomization | 
| Proportion of subjects with additional care | Proportion of subjects who require hospitalization, use of supplementary oxygen for >24 hours or ICU admission | 21 days | 
| Proportion of subjects who die | Proportion of subjects who die | From randomization up to 21 days | 
| Duration of additional care | Duration of supplementary oxygen, hospitalization, ICU stay | 21 days | 
| Adverse events | Proportion of subjects who develop solicited adverse events | 21 days | 
| Proportion of subjects who discontinue intervention | Proportion of subjects who required discontinuation of the intervention due to adverse events | 21 days | 
| Time to event | Time until deterioration of 2 or more points in an ordinal 7 points scale. | 21 days | 
| Duration of fever | Number of days with fever since randomization | 21 days |