COVID-19Phase 3NCT05993143
Ivermectin to Prevent SARS-CoV-2 (COVID-19) Hospitalisation in Subjects Over 50
A Phase 3 study testing Ivermectin in people with COVID-19 and SARS-CoV-2, run by Insud Pharma at 20 sites in Spain.
Trial summary
The primary objective of this study is to assess the efficacy of early administration of ivermectin for three consecutive days to prevent SARS-CoV-2 hospitalisation in adults older than 50 years of age. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- COVID-19, SARS-CoV-2
- What is being tested?
- Ivermectin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 249 participants
- Where
- 20 sitesSpain
- Study dates
- 18 Jan 2021to 21 Jul 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female adult > 50 years of age
- SARS-CoV-2 infection diagnosed either through a rapid antigen-based test or an RNA based reverse-transcription polymerase chain reaction (RT-PCR) diagnostic test performed in nasopharyngeal sample
- Onset of COVID-19 symptoms < 120 hours (5 days) prior to screening
- Written informed consent
- For females of childbearing potential only: They must declare that they did not intend to become pregnant in the last month prior to screening and they do not intend to become pregnant for one month following the last IP administration. For males who have partners of childbearing potential: Willing to use condoms until 3 months after last IP intake.
- Negative result for urine pregnancy test (women of childbearing potential only)
Who cannot join
- Intake of Ivermectin within 30 days before screening
- Routine intake of antivirals, including antiretroviral treatment
- Allergy, hypersensitivity or contraindication to Ivermectin, metabolites or excipients
- Subjects with symptoms of disease severity (dyspnoea, SpO2 ≤ 94%)
- Subjects requiring hospitalisation for any reason.
- Epidemiological risk or suspicion of being infected by Loa loa or other filariases
Show all 23Show fewer
- Previous enrolment in this trial or participation in any other drug investigational trial within the past 30 days (or five half-lives of IP whichever is longer) prior to screening
- Weight < 50 kg
- Pregnancy or lactation
- Inability to take oral medications
- At least one of the following acute/chronic disease or deficiency:
- History of bone marrow transplant or haematopoietic systems diseases
- Moderate or severe liver disease (Child Pugh score ≥ B or ALT [alanine transaminase] or AST [aspartate transaminase] > 3 times upper limit as determined at screening visit), severe cholestasis, cirrhosis or severe hepatic failure
- Transplanted patient under immunosuppressive treatment, disease that may need immunosuppressive treatments or other medical conditions that under the judgement of investigator would not benefit the patient to be included (including but not limited to psoriasis, G6PD (glucose-6-phosphate dehydrogenase) deficiency, porphyria, history of diverticulosis, seizure disorder, concurrent malignancy requiring chemotherapy, ongoing skin infection (e.g. pyodermitis) or evidence of current tuberculosis including latent untreated tuberculosis)
- Ophthalmological or recent/ongoing neurological diseases
- Active cardiac disease or a history of cardiac dysfunction including any of the following:
- History of angina pectoris, symptomatic pericarditis, or myocardial infarction within 12 months prior to screening
- History of congestive heart failure (New York Heart Association functional classification III-IV)
- Concomitant use of barbiturates, sodium oxybate, valproic acid or warfarin
- Laboratory abnormalities relevant for the trial, including but not limited to: neutropenia < 500/mm3, thrombocytopenia < 100,000/mm3
- Any other significant disease, disorder or finding which, in the opinion of the investigator, may significantly increase the risk to the subject because of participation in the study, affect the ability of the subject to participate in the study or impair interpretation of the study data
- Employees of the investigator or clinical trial site, with direct involvement in the proposed trial or other studies under the direction of that investigator or clinical trial site, as well as family members of the employees or the principal investigator
- Persons committed to an institution by virtue of an order issued either by the judicial or other authorities
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Spain20 sites
Complejo Hospitalario Universitario A Coruña-CHUAC
A Coruña, 15006
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Centro de Atención Primaria Les Corts
Barcelona, 08028
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
HM Montepríncipe
Boadilla del Monte, Madrid, 28660
Hospital de Poniente
El Ejido, Almeria, 04700
Hospital General de Granollers
Granollers, Barcelona, 08402
Hospital San Pedro
Logroño, La Rioja, 26006
Hospital Universitario de la Princesa
Madrid, 28006
Clínica Universidad de Navarra - Madrid
Madrid, 28027
Hospital Clínico San Carlos
Madrid, 28040
HM Sanchinarro
Madrid, 28050
HM Puerta del Sur
Móstoles, Madrid, 28938
Clínica Universidad de Navarra
Pamplona, Navarre, 31008
Complejo Hospitalario de Navarra
Pamplona, 31008
Complejo Asistencial Universitario de Salamanca
Salamanca, 37007
Hospital Universitario Virgen de la Macarena
Seville, 41009
Hospital Universitari de Tarragona Joan XXIII
Tarragona, 43005
HM Torrelodones
Torrelodones, Madrid, 28250
About this study
Official title: A Multicentre, Phase III, Double-blind, Randomised, Parallel, Placebo-controlled Trial to Assess Efficacy and Safety of Early Administration of Ivermectin During 3 Consecutive Days to Prevent SARS CoV-2 (COVID-19) Hospitalisation in Adults Older Than 50 Years of Age
The primary objective of this study is to assess the efficacy of early administration of ivermectin for three consecutive days to prevent SARS-CoV-2 hospitalisation in adults older than 50 years of age. Secondary objectives include assessing the efficacy of an early administration of ivermectin for three consecutive days to prevent SARS-CoV-2 disease progression in adults older than 50 years of age and evaluating the safety and tolerability of ivermectin in SARS-CoV-2 infected adults older than 50 years of age.
Read the detailed description
This is a randomised, double-blind, placebo-controlled, multicentre trial in parallel groups. During the screening/enrollment phase (Visit 1.1 to Visit 1.3) informed consent will be obtained and the screening procedures will be performed. A rapid antigen-based test will be offered to all patients who do not have a polymerase chain reaction (PCR) or a rapid antigen-based test result at screening (each of these tests may be considered a part of the standard procedure of the site). Eligible subjects will be randomised 1:1 to receive ivermectin or placebo. The subjects will be dispensed investigational product (IP), based on their body weight, and will take the first dose of IP at site. The subjects will receive portable pulse oximeters for peripheral capillary oxygen saturation (SpO2) monitoring at home. The treatment phase will last 3 days and include an on-site Visit 1.3 and phone call Visits 2 and 3 which will be performed on the following 2 days. PCR test or rapid antigen test results will be communicated to subjects as soon as available. Subjects with negative COVID-19 PCR test or rapid antigen test results will be withdrawn from the trial unless they have a positive rapid antigen test or COVID-19 PCR test result a few days later. The subjects will be followed up until Day 28.
During the follow-up, the subjects will have phone call Visits 4 to 9 every other day, followed by Visit 10 after one week (Day 21). The subjects will be asked to measure oxygen saturation as well as body temperature during all phone call visits and report the respective results to the investigator. The on-site Visit 11 is the last visit (Day 28). The subjects will return IPs (including empty and partially empty containers) and pulse oximeters.
In addition, the subjects will be provided with a contact number available 24/7 to contact the investigator if their condition worsens. In case of health condition worsening (dyspnoea, fever [body temperature ≥ 37.8°C] lasting for more than 6 days, SpO2 ≤ 95% or any other worsening criteria based on the investigator's judgement) confirmed during the phone call visit, the subjects will have an unscheduled visit at the site.
The subjects will be hospitalised if they fulfill any of the following criteria: pneumonia confirmed by chest X-ray; SpO2 ≤ 94% or partial pressure of oxygen in blood (PO2) < 80 mmHg in gasometry; respiratory frequency > 20 rpm; fever (body temperature ≥ 37.8°C) for more than 6 days plus one of the following analytic parameters: C-reactive protein (CRP) > 5 mg/dL, ferritin > 500 ng/mL or D dimer > 700 ng/mL. If there is any other condition that requires hospitalisation as per investigator judgement, the condition has to be documented in detail in the subject's file including a description whether the hospitalisation was performed due to SARS-CoV-2 infection.
- Conditions
- COVID-19, SARS-CoV-2
- Being tested
- Ivermectin, Placebo
- Keywords
- ivermectin
- 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
Also called Ivermectin 9 mg and 18 mg
Round and white tablets
PlaceboDrug
Round and white tablets
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin (test product) | Experimental | Ivermectin 9 mg and 18 mg immediate-released tablets to be taken orally once daily during 3 days at 600 µg/kg/day ± 120 µg/kg/day depending on their body weight. Receives: Drug: Ivermectin |
| Placebo (reference product) | Placebo comparator | Placebo tablets to be taken orally once daily during 3 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalisation due to SARS-CoV-2
Percentage of subjects requiring SARS-CoV-2 hospitalisation during 28 days after first IP administration.
Measured: day 1 to day 28
Secondary outcomes (2)
Change in subjects' clinical status
Efficacy of an early administration of Ivermectin for three consecutive days to prevent SARS-CoV-2 disease progression in adults older than 50 years of age.
Measured: day 1, 2, 3, 4, 6, 8, 10, 12, 14, 21 and 28
Occurrence of any adverse event related to Ivermectin treatment
Evaluation of safety and tolerability of Ivermectin in SARS CoV 2 infected adults older than 50 years of age
Measured: day 1, 2, 3, 4, 6, 8, 10, 12, 14, 21 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start18 Jan 2021
- Primary completion21 Jul 2021
- Study completion21 Jul 2021
Why it stopped: Study was stopped because no statistically significant difference was observed in the interim analysis. With high vaccine rates in those over 50 and an expected low incidence, it would not be feasible to complete recruitment within a short period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insud Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993143
- Sponsor's protocol ID
- IVER-303
- Status last verified
- Aug 2023
- First submitted
- 8 Aug 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Phase III, Double-blind, Randomised, Parallel, Placebo-controlled Trial to Assess Efficacy and Safety of Early Administration of Ivermectin During 3 Consecutive Days to Prevent SARS CoV-2 (COVID-19) Hospitalisation in Adults Older Than 50 Years of Age
- ClinicalTrials.gov ID
- NCT05993143
- Acronym / sponsor ID
- IVER-303
- Conditions
- COVID-19, SARS-CoV-2
- Keywords
- ivermectin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped because no statistically significant difference was observed in the interim analysis. With high vaccine rates in those over 50 and an expected low incidence, it would not be feasible to complete recruitment within a short period.
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Insud PharmaIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 21 Jul 2021 (actual)
- First posted
- 15 Aug 2023 (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.
The primary objective of this study is to assess the efficacy of early administration of ivermectin for three consecutive days to prevent SARS-CoV-2 hospitalisation in adults older than 50 years of age. Secondary objectives include assessing the efficacy of an early administration of ivermectin for three consecutive days to prevent SARS-CoV-2 disease progression in adults older than 50 years of age and evaluating the safety and tolerability of ivermectin in SARS-CoV-2 infected adults older than 50 years of age.
Detailed description
This is a randomised, double-blind, placebo-controlled, multicentre trial in parallel groups. During the screening/enrollment phase (Visit 1.1 to Visit 1.3) informed consent will be obtained and the screening procedures will be performed. A rapid antigen-based test will be offered to all patients who do not have a polymerase chain reaction (PCR) or a rapid antigen-based test result at screening (each of these tests may be considered a part of the standard procedure of the site). Eligible subjects will be randomised 1:1 to receive ivermectin or placebo. The subjects will be dispensed investigational product (IP), based on their body weight, and will take the first dose of IP at site. The subjects will receive portable pulse oximeters for peripheral capillary oxygen saturation (SpO2) monitoring at home. The treatment phase will last 3 days and include an on-site Visit 1.3 and phone call Visits 2 and 3 which will be performed on the following 2 days. PCR test or rapid antigen test results will be communicated to subjects as soon as available. Subjects with negative COVID-19 PCR test or rapid antigen test results will be withdrawn from the trial unless they have a positive rapid antigen test or COVID-19 PCR test result a few days later. The subjects will be followed up until Day 28.
During the follow-up, the subjects will have phone call Visits 4 to 9 every other day, followed by Visit 10 after one week (Day 21). The subjects will be asked to measure oxygen saturation as well as body temperature during all phone call visits and report the respective results to the investigator. The on-site Visit 11 is the last visit (Day 28). The subjects will return IPs (including empty and partially empty containers) and pulse oximeters.
In addition, the subjects will be provided with a contact number available 24/7 to contact the investigator if their condition worsens. In case of health condition worsening (dyspnoea, fever [body temperature ≥ 37.8°C] lasting for more than 6 days, SpO2 ≤ 95% or any other worsening criteria based on the investigator's judgement) confirmed during the phone call visit, the subjects will have an unscheduled visit at the site.
The subjects will be hospitalised if they fulfill any of the following criteria: pneumonia confirmed by chest X-ray; SpO2 ≤ 94% or partial pressure of oxygen in blood (PO2) < 80 mmHg in gasometry; respiratory frequency > 20 rpm; fever (body temperature ≥ 37.8°C) for more than 6 days plus one of the following analytic parameters: C-reactive protein (CRP) > 5 mg/dL, ferritin > 500 ng/mL or D dimer > 700 ng/mL. If there is any other condition that requires hospitalisation as per investigator judgement, the condition has to be documented in detail in the subject's file including a description whether the hospitalisation was performed due to SARS-CoV-2 infection.
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 (test product) | Experimental | Drug: IvermectinIvermectin 9 mg and 18 mg immediate-released tablets to be taken orally once daily during 3 days at 600 µg/kg/day ± 120 µg/kg/day depending on their body weight. |
| Placebo (reference product) | Placebo comparator | Drug: PlaceboPlacebo tablets to be taken orally once daily during 3 days. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female adult > 50 years of age
- SARS-CoV-2 infection diagnosed either through a rapid antigen-based test or an RNA based reverse-transcription polymerase chain reaction (RT-PCR) diagnostic test performed in nasopharyngeal sample
- Onset of COVID-19 symptoms < 120 hours (5 days) prior to screening
- Written informed consent
- For females of childbearing potential only: They must declare that they did not intend to become pregnant in the last month prior to screening and they do not intend to become pregnant for one month following the last IP administration. For males who have partners of childbearing potential: Willing to use condoms until 3 months after last IP intake.
Key exclusion criteria (23 listed)
- Intake of Ivermectin within 30 days before screening
- Routine intake of antivirals, including antiretroviral treatment
- Allergy, hypersensitivity or contraindication to Ivermectin, metabolites or excipients
- Subjects with symptoms of disease severity (dyspnoea, SpO2 ≤ 94%)
- Subjects requiring hospitalisation for any reason.
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 |
|---|---|---|
| IvermectinAlso: Ivermectin 9 mg and 18 mgRound and white tablets | Drug | Ivermectin (test product) |
| PlaceboRound and white tablets | Drug | Placebo (reference product) |
Primary outcome
Hospitalisation due to SARS-CoV-2
Time frame: day 1 to day 28
Percentage of subjects requiring SARS-CoV-2 hospitalisation during 28 days after first IP administration.
2 secondary outcomes
Change in subjects' clinical status
Time frame: day 1, 2, 3, 4, 6, 8, 10, 12, 14, 21 and 28
Occurrence of any adverse event related to Ivermectin treatment
Time frame: day 1, 2, 3, 4, 6, 8, 10, 12, 14, 21 and 28
Results and safety
The study was stopped early (reason given: Study was stopped because no statistically significant difference was observed in the interim analysis. With high vaccine rates in those over 50 and an expected low incidence, it would not be feasible to complete recruitment within a short period.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
20 sites 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 in people with COVID-19 and SARS-CoV-2, run by Insud Pharma at 20 sites in Spain.
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 6 inclusion and 23 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: stopped early, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain. 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?
The study was stopped early (reason given: Study was stopped because no statistically significant difference was observed in the interim analysis. With high vaccine rates in those over 50 and an expected low incidence, it would not be feasible to complete recruitment within a short period.). Results are not available in the source record.
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?
Hospitalisation due to SARS-CoV-2 (time frame: day 1 to day 28). 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 15 Aug 2023.