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

COVID-19 Clinical Trial

— EPIC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04405843
• Other study ID #: ScDi823
• Secondary ID: IVE-PA
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 14, 2020
• Est. completion date: December 21, 2020

Study information

• Verified date: December 2020
• Source: Centro de Estudios en Infectogía Pediatrica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 476
• Est. completion date: December 21, 2020
• Est. primary completion date: December 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Ivermectin Oral Product
Ivermectin oral suspension, 6 mg/mL
• Placebo
Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient

Locations

Country	Name	City	State
Colombia	Centro de Estudios en Infectología Pediátrica	Cali	Valle

Sponsors (1)

Lead Sponsor	Collaborator
Centro de Estudios en Infectogía Pediatrica

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to event	Time until resolution of symptoms	21 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Proportion of subjects with additional care	Proportion of subjects who require hospitalization, use of supplementary oxygen for >24 hours or ICU admission	21 days
Secondary	Proportion of subjects who die	Proportion of subjects who die	From randomization up to 21 days
Secondary	Duration of additional care	Duration of supplementary oxygen, hospitalization, ICU stay	21 days
Secondary	Adverse events	Proportion of subjects who develop solicited adverse events	21 days
Secondary	Proportion of subjects who discontinue intervention	Proportion of subjects who required discontinuation of the intervention due to adverse events	21 days
Secondary	Time to event	Time until deterioration of 2 or more points in an ordinal 7 points scale.	21 days
Secondary	Duration of fever	Number of days with fever since randomization	21 days