COVID-19Phase 2/3EPICNCT04405843
Efficacy of Ivermectin in Adult Patients With Early Stages of COVID-19 (EPIC Trial)
A Phase 2/3 study testing Ivermectin Oral Product in people with COVID-19, run by Centro de Estudios en Infectogía Pediatrica at 1 site in Colombia.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Ivermectin Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 476 participants
- Where
- 1 siteColombia
- Study dates
- 14 Jul 2020to 21 Dec 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Centro de Estudios en Infectología Pediátrica
Cali, Valle del Cauca Department, 12345
About this study
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
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
- Conditions
- COVID-19
- Being tested
- Ivermectin Oral Product, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivermectin Oral ProductDrug
Ivermectin oral suspension, 6 mg/mL
PlaceboDrug
Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin | Experimental | Ivermectin, 300 micrograms / kg, once daily for 5 days Receives: Drug: Ivermectin Oral Product |
| Placebo | Placebo comparator | Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to event
Time until resolution of symptoms
Measured: 21 days
Secondary outcomes (13)
Clinical condition on day 2
Clinical condition in an ordinal scale of 7 points, on day 2. Higher scores indicate worse outcomes
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 21 days
Proportion of subjects who die
Proportion of subjects who die
Measured: From randomization up to 21 days
Duration of additional care
Duration of supplementary oxygen, hospitalization, ICU stay
Measured: 21 days
Adverse events
Proportion of subjects who develop solicited adverse events
Measured: 21 days
Proportion of subjects who discontinue intervention
Proportion of subjects who required discontinuation of the intervention due to adverse events
Measured: 21 days
Time to event
Time until deterioration of 2 or more points in an ordinal 7 points scale.
Measured: 21 days
Duration of fever
Number of days with fever since randomization
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start14 Jul 2020
- Primary completion21 Dec 2020
- Study completion21 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 476 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Estudios en Infectogía Pediatrica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduardo López-Medina, MD MSc, Principal investigator, Scientific Director of Centro de Estudios en Infectología Pediátrica --CEIP--
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405843
- Sponsor's protocol ID
- ScDi823
- Other IDs
- IVE-PA
- Acronym
- EPIC
- Status last verified
- Dec 2020
- First submitted
- 23 May 2020
- Last updated
- 28 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Lopez-Medina E, Lopez P, Hurtado IC, Davalos DM, Ramirez O, Martinez E, Diazgranados JA, Onate JM, Chavarriaga H, Herrera S, Parra B, Libreros G, Jaramillo R, Avendano AC, Toro DF, Torres M, Lesmes MC, Rios CA, Caicedo I. Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19: A Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1426-1435. doi: 10.1001/jama.2021.3071.
PubMed 33662102
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04405843
- Acronym / sponsor ID
- EPIC / ScDi823
- Conditions
- COVID-19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 476 participants (actual)
- Lead sponsor
- Centro de Estudios en Infectogía PediatricaUniversity, hospital or other
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivermectin | Experimental | Drug: Ivermectin Oral ProductIvermectin, 300 micrograms / kg, once daily for 5 days |
| Placebo | Placebo comparator | Drug: PlaceboSubstance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- Preexisting liver disease
- Hypersensitivity to ivermectin
- Participants in other clinical trials for therapies against COVID-19
- Severe pneumonia
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ivermectin Oral ProductIvermectin oral suspension, 6 mg/mL | Drug | Ivermectin |
| PlaceboSubstance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient | Drug | Placebo |
Primary outcome
Time to event
Time frame: 21 days
Time until resolution of symptoms
13 secondary outcomes
Clinical condition on day 2
Time frame: On day 2 (± 1 day) after randomization
Clinical condition on day 5
Time frame: On day 5 (± 1 day) after randomization
Clinical condition on day 8
Time frame: On day 8 (± 1 day) after randomization
Clinical condition on day 11
Time frame: On day 11 (± 1 day) after randomization
Clinical condition on day 15
Time frame: On day 15 (± 1 day) after randomization
Clinical condition on day 21
Time frame: On day 21 (± 1 day) after randomization
Proportion of subjects with additional care
Time frame: 21 days
Proportion of subjects who die
Time frame: From randomization up to 21 days
Duration of additional care
Time frame: 21 days
Adverse events
Time frame: 21 days
Proportion of subjects who discontinue intervention
Time frame: 21 days
Time to event
Time frame: 21 days
Duration of fever
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
- Derived from this study: PubMed 33662102Lopez-Medina E, Lopez P, Hurtado IC, Davalos DM, Ramirez O, Martinez E, Diazgranados JA, Onate JM, Chavarriaga H, Herrera S, Parra B, Libreros G, Jaramillo R, Avendano AC, Toro DF, Torres M, Lesmes MC, Rios CA, Caicedo I. Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19: A Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1426-1435. doi: 10.1001/jama.2021.3071.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo López-Medina, MD MSc principal investigator
Scientific Director of Centro de Estudios en Infectología Pediátrica --CEIP--
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ivermectin Oral Product in people with COVID-19, run by Centro de Estudios en Infectogía Pediatrica at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to event (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04405843, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2020.