Efficacy of Ivermectin in Adult Patients With Early Stages of COVID-19 (EPIC Trial) (EPIC)
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ClinicalTrials.gov Identifier: NCT04405843 |
Recruitment Status :
Completed
First Posted : May 28, 2020
Last Update Posted : December 28, 2020
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 | Drug: Ivermectin Oral Product Drug: Placebo | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 476 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | July 14, 2020 |
Actual Primary Completion Date : | December 21, 2020 |
Actual Study Completion Date : | December 21, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Ivermectin
Ivermectin, 300 micrograms / kg, once daily for 5 days
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Drug: Ivermectin Oral Product
Ivermectin oral suspension, 6 mg/mL |
Placebo Comparator: Placebo
Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient
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Drug: Placebo
Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient |
- Time to event [ Time Frame: 21 days ]Time until resolution of symptoms
- Clinical condition on day 2 [ Time Frame: On day 2 (± 1 day) after randomization ]Clinical condition in an ordinal scale of 7 points, on day 2. Higher scores indicate worse outcomes
- Clinical condition on day 5 [ Time Frame: On day 5 (± 1 day) after randomization ]Clinical condition in an ordinal scale of 7 points, on day 5. Higher scores indicate worse outcomes
- Clinical condition on day 8 [ Time Frame: On day 8 (± 1 day) after randomization ]Clinical condition in an ordinal scale of 7 points, on day 8. Higher scores indicate worse outcomes
- Clinical condition on day 11 [ Time Frame: On day 11 (± 1 day) after randomization ]Clinical condition in an ordinal scale of 7 points, on day 11. Higher scores indicate worse outcomes
- Clinical condition on day 15 [ Time Frame: On day 15 (± 1 day) after randomization ]Clinical condition in an ordinal scale of 7 points, on day 15. Higher scores indicate worse outcomes
- Clinical condition on day 21 [ Time Frame: On day 21 (± 1 day) after randomization ]Clinical condition in an ordinal scale of 7 points, on day 21. Higher scores indicate worse outcomes
- Proportion of subjects with additional care [ Time Frame: 21 days ]Proportion of subjects who require hospitalization, use of supplementary oxygen for >24 hours or ICU admission
- Proportion of subjects who die [ Time Frame: From randomization up to 21 days ]Proportion of subjects who die
- Duration of additional care [ Time Frame: 21 days ]Duration of supplementary oxygen, hospitalization, ICU stay
- Adverse events [ Time Frame: 21 days ]Proportion of subjects who develop solicited adverse events
- Proportion of subjects who discontinue intervention [ Time Frame: 21 days ]Proportion of subjects who required discontinuation of the intervention due to adverse events
- Time to event [ Time Frame: 21 days ]Time until deterioration of 2 or more points in an ordinal 7 points scale.
- Duration of fever [ Time Frame: 21 days ]Number of days with fever since randomization

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04405843
Colombia | |
Centro de Estudios en Infectología Pediátrica | |
Cali, Valle, Colombia, 12345 |
Principal Investigator: | Eduardo López-Medina, MD MSc | Scientific Director of Centro de Estudios en Infectología Pediátrica --CEIP-- |
Responsible Party: | Centro de Estudios en Infectogía Pediatrica |
ClinicalTrials.gov Identifier: | NCT04405843 |
Other Study ID Numbers: |
ScDi823 IVE-PA ( Other Identifier: INVIMA (Colombian Regulatory Agency) ) |
First Posted: | May 28, 2020 Key Record Dates |
Last Update Posted: | December 28, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Ivermectin Antiparasitic Agents Anti-Infective Agents |