Efficacy of Ivermectin in Adult Patients With Early Stages of COVID-19 (EPIC Trial)
- Registration Number
- NCT04405843
- Lead Sponsor
- Centro de Estudios en Infectogía Pediatrica
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 476
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient Ivermectin Ivermectin Oral Product Ivermectin, 300 micrograms / kg, once daily for 5 days
- Primary Outcome Measures
Name Time Method Time to event 21 days Time until resolution of symptoms
- Secondary Outcome Measures
Name Time Method Clinical condition on day 5 On day 5 (± 1 day) after randomization Clinical condition in an ordinal scale of 7 points, on day 5. Higher scores indicate worse outcomes
Proportion of subjects who discontinue intervention 21 days Proportion of subjects who required discontinuation of the intervention due to adverse events
Time to event 21 days Time until deterioration of 2 or more points in an ordinal 7 points scale.
Duration of fever 21 days Number of days with fever since randomization
Clinical condition on day 2 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 15 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 8 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 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 21 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 21 days Proportion of subjects who require hospitalization, use of supplementary oxygen for \>24 hours or ICU admission
Proportion of subjects who die From randomization up to 21 days Proportion of subjects who die
Duration of additional care 21 days Duration of supplementary oxygen, hospitalization, ICU stay
Adverse events 21 days Proportion of subjects who develop solicited adverse events
Trial Locations
- Locations (1)
Centro de Estudios en Infectología Pediátrica
🇨🇴Cali, Valle, Colombia