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Completed

NCT Number: NCT04405843

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

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

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Centro de Estudios en Infectología Pediátrica

Cali, Valle del Cauca Department, 12345, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ivermectin Oral Product

Drug

Ivermectin oral suspension, 6 mg/mL

Placebo

Drug

Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient

Primary outcomes

  1. Time to event

    Time frame: 21 days

    Time until resolution of symptoms

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Proportion of subjects who die

    Time frame: From randomization up to 21 days

    Proportion of subjects who die

  9. Duration of additional care

    Time frame: 21 days

    Duration of supplementary oxygen, hospitalization, ICU stay

  10. Adverse events

    Time frame: 21 days

    Proportion of subjects who develop solicited adverse events

  11. Proportion of subjects who discontinue intervention

    Time frame: 21 days

    Proportion of subjects who required discontinuation of the intervention due to adverse events

  12. Time to event

    Time frame: 21 days

    Time until deterioration of 2 or more points in an ordinal 7 points scale.

  13. Duration of fever

    Time frame: 21 days

    Number of days with fever since randomization

Sponsors and collaborators

Lead sponsor

Centro de Estudios en Infectogía Pediatrica

Other

Registry information

Official study 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

Acronym: EPIC

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 28, 2020
Registry last updated
Dec 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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