COVID-19 PneumoniaPhase 2/3IVERCOLNCT04886362
Ivermectina Colombia (IVERCOL)
A Phase 2/3 study testing Ivermectin in people with COVID-19 Pneumonia, run by Ayudas Diagnosticas Sura S.A.S.
Trial summary
A parallel, prospective, double-blind, placebo-controlled clinical trial will be conducted in the population affiliated to EPS SURAMERICANA S.A. with positive test for antigen and PCR for SARS-CoV-2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Ivermectin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 966 participants
- Where
- No sites listed yet
- Study dates
- Jul 2021to Dec 2021
- 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
- Age equal to or greater than 18 years.
- Patients with positive antigen test or RT-PCR for SARS-CoV-2.
- Patients with less than 7 days from symptoms onset.
- Patients with indication for outpatient management.
- Patients with mild disease according to the official guide "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 8)": Subjects with mild symptoms, with or without radiological signs of pneumonia, with oxygen saturation>90% . - Able to provided consent to participate.
Who cannot join
- Patients who at the time of admission require hospitalization and / or supplemental oxygen.
- Known history of allergy to ivermectin.
- Known medical history of liver disease.
- Belong to another clinical trial evaluating the efficacy of an investigational drug against COVID-19.
- The following comorbidities:
- Immunosuppression or HIV.
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- Acute or chronic kidney failure.
- Current neoplasia.
- Currently use of warfarin, erdafitinib, or quinidine.
- Have received vaccination for SARS-CoV-2.
- Ivermectin consumption prior to inclusion in the research protocol.
- The patient does not accept the conditions of home care and monitoring.
- The patient desists from participating in the study.
- Women in pregnancy or breastfeeding.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Safety and Efficacy and of Ivermectin for the Prevention of Severe Disease in Patients With COVID-19: A Randomized, Controlled, Double-Blind Clinical Study.
A parallel, prospective, double-blind, placebo-controlled clinical trial will be conducted in the population affiliated to EPS SURAMERICANA S.A. with positive test for antigen and PCR for SARS-CoV-2. Participants will be randomly assigned in a 1: 1 ratio to the intervention group or the control group using a sequence of random numbers. The patients included will be those with less than 7 days from the onset of symptoms, and without evidence of serious disease.
One group will be assigned oral ivermectin therapy at a dose of 600 mcg/kg every 12 hours for 5 consecutive days, and the other group will received placebo. A minimum sample size of 483 patients for each arm was calculated to observe differences. All randomized patients will be included in the analysis according to the randomization arm (intention-to-treat analysis).
The primary objective is to evaluate the efficacy of ivermectin in the prevention of severe disease, reduction in the rate of hospitalization, reduction of ICU stay, and mortality. This evaluation will be carried out up to 28 days after the intervention begins. Given the public health emergency, the study is expected to be completed in a period of 6 months from the INVIMA approval.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Ivermectin, Placebo
- Keywords
- Ivermectin, COVID-19, Ambulatory
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvermectinDrug
Treatment with Ivermectin in the first 7 days from symptoms onset.
PlaceboDrug
Treatment with Placebo in the first 7 days from symptoms onset.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Ivermectin 600 mcg/kg every 12 hours for 5 days. Receives: Drug: Ivermectin |
| Control Group | Placebo comparator | Same volume like ivermectin Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Outcome
Proportion of patients progressing to severe COVID-19. Progression to severe disease will be considered when at least one of the following clinical situations occurs (composite outcome) the first thing that occurs in each patient during the 28 days after the intervention begins:
- Hypoxemia (oxygen saturation ≤90%) and need for supplemental oxygen in home care program; or
- Need for hospitalization includes general bed, ICU or ICU; or
- Death from any cause.
Measured: 28 days
Secondary outcomes (9)
Hypoxemia (oxygen saturation ≤90%) and need for supplemental oxygen in home care program.
Measured: 28 days
Need for hospitalization including general bed, ICU or ICU.
Measured: 28 days
Death from any cause.
Measured: 28 days
Proportion of patients with 4 or more points on the WHO scale (8-point ordinal scale).
Measured: 28 days
Number of days with supplemental oxygen requirement.
Measured: 28 days
Number of days on ICU management.
Measured: 28 days
Number of days on endotracheal intubation (IOT).
Measured: 28 days
Number of days of hospitalization.
Measured: 28 days
Number and type of serious and non-serious adverse events.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study startJul 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies 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
- 966 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ayudas Diagnosticas Sura S.A.S
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Carlos Chacón Jimenez, MD, Study director, Emergencies Department Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886362
- Sponsor's protocol ID
- IVERCOL01
- Acronym
- IVERCOL
- Status last verified
- May 2021
- First submitted
- 10 May 2021
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available on request and the proper approval from ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy and of Ivermectin for the Prevention of Severe Disease in Patients With COVID-19: A Randomized, Controlled, Double-Blind Clinical Study.
- ClinicalTrials.gov ID
- NCT04886362
- Acronym / sponsor ID
- IVERCOL / IVERCOL01
- Conditions
- COVID-19 Pneumonia
- Keywords
- Ivermectin, COVID-19, Ambulatory
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 966 participants (estimated)
- Lead sponsor
- Ayudas Diagnosticas Sura S.A.SUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 14 May 2021 (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.
A parallel, prospective, double-blind, placebo-controlled clinical trial will be conducted in the population affiliated to EPS SURAMERICANA S.A. with positive test for antigen and PCR for SARS-CoV-2. Participants will be randomly assigned in a 1: 1 ratio to the intervention group or the control group using a sequence of random numbers. The patients included will be those with less than 7 days from the onset of symptoms, and without evidence of serious disease.
One group will be assigned oral ivermectin therapy at a dose of 600 mcg/kg every 12 hours for 5 consecutive days, and the other group will received placebo. A minimum sample size of 483 patients for each arm was calculated to observe differences. All randomized patients will be included in the analysis according to the randomization arm (intention-to-treat analysis).
The primary objective is to evaluate the efficacy of ivermectin in the prevention of severe disease, reduction in the rate of hospitalization, reduction of ICU stay, and mortality. This evaluation will be carried out up to 28 days after the intervention begins. Given the public health emergency, the study is expected to be completed in a period of 6 months from the INVIMA approval.
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 |
|---|---|---|
| Intervention Group | Experimental | Drug: IvermectinIvermectin 600 mcg/kg every 12 hours for 5 days. |
| Control Group | Placebo comparator | Drug: PlaceboSame volume like ivermectin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age equal to or greater than 18 years.
- Patients with positive antigen test or RT-PCR for SARS-CoV-2.
- Patients with less than 7 days from symptoms onset.
- Patients with indication for outpatient management.
- Patients with mild disease according to the official guide "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 8)": Subjects with mild symptoms, with or without radiological signs of pneumonia, with oxygen saturation>90% . - Able to provided consent to participate.
Key exclusion criteria (14 listed)
- Patients who at the time of admission require hospitalization and / or supplemental oxygen.
- Known history of allergy to ivermectin.
- Known medical history of liver disease.
- Belong to another clinical trial evaluating the efficacy of an investigational drug against COVID-19.
- The following comorbidities:
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 |
|---|---|---|
| IvermectinTreatment with Ivermectin in the first 7 days from symptoms onset. | Drug | Intervention Group |
| PlaceboTreatment with Placebo in the first 7 days from symptoms onset. | Drug | Control Group |
Primary outcome
Composite Outcome
Time frame: 28 days
Proportion of patients progressing to severe COVID-19. Progression to severe disease will be considered when at least one of the following clinical situations occurs (composite outcome) the first thing that occurs in each patient during the 28 days after the intervention begins: 1. Hypoxemia (oxygen saturation ≤90%) and need for supplemental oxygen in home care program; or 2. Need for hospitalization includes general bed, ICU or ICU; or 3. Death from any cause.
9 secondary outcomes
Hypoxemia (oxygen saturation ≤90%) and need for supplemental oxygen in home care program.
Time frame: 28 days
Need for hospitalization including general bed, ICU or ICU.
Time frame: 28 days
Death from any cause.
Time frame: 28 days
Proportion of patients with 4 or more points on the WHO scale (8-point ordinal scale).
Time frame: 28 days
Number of days with supplemental oxygen requirement.
Time frame: 28 days
Number of days on ICU management.
Time frame: 28 days
Number of days on endotracheal intubation (IOT).
Time frame: 28 days
Number of days of hospitalization.
Time frame: 28 days
Number and type of serious and non-serious adverse events.
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Individual participant dataSharing planned: No. Data will be available on request and the proper approval from ethics committee.
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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.
Juan Carlos Chacón Jimenez, MD study director
Emergencies Department Director
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ivermectin in people with COVID-19 Pneumonia, run by Ayudas Diagnosticas Sura S.A.S.
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 14 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: status not confirmed, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Carlos Chacón Jimenez, MD (+57 301 5465296, ceivercol@suramericana.com.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Outcome (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2021.