Covid19Phase 3NCT04834115
Efficacy of Ivermectin in Outpatients With Non-severe COVID-19
A Phase 3 study testing Ivermectin Tablets in people with Covid19 and Coronavirus Infection, run by Universidad Nacional de Asunción at 1 site in Paraguay.
Trial summary
This is a randomized controlled trial to evaluate the efficacy of ivermectin in reducing the risk of progression to severe disease and hospitalizations in COVID-19 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Coronavirus Infection
- What is being tested?
- Ivermectin Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteParaguay
- Study dates
- 17 Nov 2020to 30 May 2021
- Phase
- Phase 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
- Positive diagnostic RT-qPCR or antigen test for SARS-CoV-2
- Symptomatic patients with up to 8 days from the onset of symptoms, and asymptomatic cases with up to 5 days of positive test for SARS-CoV-2.
- Patients who agree to participate in the study by signing the informed consent.
Who cannot join
- Patients with severity criteria defined in the Coronavirus Disease Epidemiological and Laboratory Surveillance Guide (Version 3/11/2020)
- Pregnant or breastfeeding women
- Women of childbearing age and without commitment to use contraceptive methods during the study time.
- Inability to complete the study
- Current treatment with drugs known to interact with ivermectin
- Known intolerance to ivermectin, its derivate or any of its excipients.
- Patients with known Child-Pugh C liver disease
- Patients with prior ivermectin consumption in the 10 days prior to study entry.
Trial locations and contacts
1 site in 1 country.
Paraguay1 site, 1 recruiting
- Recruiting
Facultad de Ciencias Médicas - Universidad Nacional de Asunción
Asunción, 111421
Gabriela Avila, MD, MSc, PhD, +59521683930, mavila@med.una.py
About this study
Official title: Efficacy of Ivermectin in Outpatients With Non-severe COVID-19: A Randomized Controlled Trial
This is a randomized controlled trial to evaluate the efficacy of ivermectin in reducing the risk of progression to severe disease and hospitalizations in COVID-19 patients.
Read the detailed description
This is a randomized controlled trial to evaluate the efficacy of ivermectin in COVID-19 outpatients reducing the risk of progression to severe disease.
Patients with COVID-19 infection are randomized to receive a single dose of 200mcg/kg of ivermectin or a placebo.
The randomization code is generated by the trial statistician. The allocation is made after fulfilment of both inclusion and exclusion criteria.
- Conditions
- Covid19, Coronavirus Infection
- Being tested
- Ivermectin Tablets, Placebo
- Keywords
- Ivermectin, Communicable Diseases, Respiratory Tract Infections
- Medical subject headings
- COVID-19, Coronavirus Infections, Communicable Diseases, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivermectin TabletsDrug
Oral ivermectin at a one time dose
PlaceboOther
Oral placebo at a one time dose
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin | Experimental | Ivermectin 200mcg/kg single dose, maximum dose 18mg Receives: Drug: Ivermectin Tablets |
| Placebo | Placebo comparator | Inactive medication tablets indistinguishable from ivermectin tablets Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with hospitalization criteria
Proportion of patients with hospitalization criteria at day 30
Measured: 30 days
Secondary outcomes (4)
Proportion of patients with COVID-19 signs and symptoms
Proportion of patients with COVID-19 signs and symptoms up to day 14
Measured: 14 days
Proportion of cohabitants who had COVID-19 after the index case
Proportion of cohabitants who had COVID-19 after the index case up to day 30
Measured: 30 days
Drug-related adverse events
Proportion of patients with ivermectin adverse events up to day 30
Measured: 30 days
Levels of IgG for SARS-CoV-2
Quantitative levels of IgG for SARS-CoV-2 measured by ELISA immunoassay
Measured: 30-60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start17 Nov 2020
- Primary completion30 Apr 2021 (estimated)
- Study completion30 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double blind, randomized controlled trial with two parallel groups that evaluates the efficacy of ivermectin in reducing hospitalization in outpatients with COVID-19.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Asunción
- Sponsor type
- University, hospital or other
- Collaborators
- Consejo Nacional de Ciencias y Tecnologia, Paraguay, Ministerio de Salud Pública y Bienestar Social, Paraguay, Centro de información y recursos para el desarrollo, Paraguay, Centro para el Desarrollo de la Investigación Científica, CEDIC, Paraguay, Instituto Desarrollo, Paraguay
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834115
- Sponsor's protocol ID
- PINV20-387
- Status last verified
- Apr 2021
- First submitted
- 28 Mar 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will publish the results to compare data with other studies with ivermectin and SARS-CoV-2 infection.
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 33662102Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3.
PubMed 32251768Chaccour C, Ruiz-Castillo P, Richardson MA, Moncunill G, Casellas A, Carmona-Torre F, Giraldez M, Mota JS, Yuste JR, Azanza JR, Fernandez M, Reina G, Dobano C, Brew J, Sadaba B, Hammann F, Rabinovich R. The SARS-CoV-2 Ivermectin Navarra-ISGlobal Trial (SAINT) to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission in low risk, non-severe COVID-19 patients in the first 48 hours after symptoms onset: A structured summary of a study protocol for a randomized control pilot trial. Trials. 2020 Jun 8;21(1):498. doi: 10.1186/s13063-020-04421-z.
PubMed 32513289
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ivermectin in Outpatients With Non-severe COVID-19: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04834115
- Acronym / sponsor ID
- PINV20-387
- Conditions
- Covid19, Coronavirus Infection
- Keywords
- Ivermectin, Communicable Diseases, Respiratory Tract Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Universidad Nacional de AsunciónUniversity, hospital or other
- Collaborators
- Consejo Nacional de Ciencias y Tecnologia, Paraguay, Ministerio de Salud Pública y Bienestar Social, Paraguay, Centro de información y recursos para el desarrollo, Paraguay, Centro para el Desarrollo de la Investigación Científica, CEDIC, Paraguay, Instituto Desarrollo, Paraguay
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 May 2021 (estimated)
- First posted
- 6 Apr 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.
This is a randomized controlled trial to evaluate the efficacy of ivermectin in reducing the risk of progression to severe disease and hospitalizations in COVID-19 patients.
Detailed description
This is a randomized controlled trial to evaluate the efficacy of ivermectin in COVID-19 outpatients reducing the risk of progression to severe disease.
Patients with COVID-19 infection are randomized to receive a single dose of 200mcg/kg of ivermectin or a placebo.
The randomization code is generated by the trial statistician. The allocation is made after fulfilment of both inclusion and exclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a double blind, randomized controlled trial with two parallel groups that evaluates the efficacy of ivermectin in reducing hospitalization in outpatients with COVID-19.
| Arm | Type | Receives |
|---|---|---|
| Ivermectin | Experimental | Drug: Ivermectin TabletsIvermectin 200mcg/kg single dose, maximum dose 18mg |
| Placebo | Placebo comparator | Other: PlaceboInactive medication tablets indistinguishable from ivermectin tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Positive diagnostic RT-qPCR or antigen test for SARS-CoV-2
- Symptomatic patients with up to 8 days from the onset of symptoms, and asymptomatic cases with up to 5 days of positive test for SARS-CoV-2.
- Patients who agree to participate in the study by signing the informed consent.
Key exclusion criteria (8 listed)
- Patients with severity criteria defined in the Coronavirus Disease Epidemiological and Laboratory Surveillance Guide (Version 3/11/2020)
- Pregnant or breastfeeding women
- Women of childbearing age and without commitment to use contraceptive methods during the study time.
- Inability to complete the study
- Current treatment with drugs known to interact with ivermectin
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 TabletsOral ivermectin at a one time dose | Drug | Ivermectin |
| PlaceboOral placebo at a one time dose | Other | Placebo |
Primary outcome
Proportion of patients with hospitalization criteria
Time frame: 30 days
Proportion of patients with hospitalization criteria at day 30
4 secondary outcomes
Proportion of patients with COVID-19 signs and symptoms
Time frame: 14 days
Proportion of cohabitants who had COVID-19 after the index case
Time frame: 30 days
Drug-related adverse events
Time frame: 30 days
Levels of IgG for SARS-CoV-2
Time frame: 30-60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Background: 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.
- Background: PubMed 32251768Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3.
- Background: PubMed 32513289Chaccour C, Ruiz-Castillo P, Richardson MA, Moncunill G, Casellas A, Carmona-Torre F, Giraldez M, Mota JS, Yuste JR, Azanza JR, Fernandez M, Reina G, Dobano C, Brew J, Sadaba B, Hammann F, Rabinovich R. The SARS-CoV-2 Ivermectin Navarra-ISGlobal Trial (SAINT) to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission in low risk, non-severe COVID-19 patients in the first 48 hours after symptoms onset: A structured summary of a study protocol for a randomized control pilot trial. Trials. 2020 Jun 8;21(1):498. doi: 10.1186/s13063-020-04421-z.
- National Council of Science and Technology, ParaguayLink provided by the sponsor.
- Individual participant dataSharing planned: No. The investigators will publish the results to compare data with other studies with ivermectin and SARS-CoV-2 infection.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ivermectin Tablets in people with Covid19 and Coronavirus Infection, run by Universidad Nacional de Asunción at 1 site in Paraguay.
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 3 inclusion and 8 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 6 Apr 2021. 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 Paraguay. 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 phase mean?
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 Gabriela Avila, MD, MSc, PhD (+59521683930 ext. 324, mavila@med.una.py), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with hospitalization criteria (time frame: 30 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 NCT04834115, which also lists 3 linked publications.
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 6 Apr 2021.