To Assess the Reduction in the Viral Load of SARS-CoV-2 in Patients Receiving Ivermectin Compared to Those Receiving Standard CarePhase 3IVERCoVNCT05040724
Evaluation of the Impact of the Administration of Single Dose of Ivermectin in the Early Phase of COVID-19
A Phase 3 study testing Ivermectin in people with To Assess the Reduction in the Viral Load of SARS-CoV-2 in Patients Receiving Ivermectin Compared to Those Receiving Standard Care, run by Raincy Montfermeil Hospital Group at 1 site in France.
Trial summary
The action of ivermectin in vitro on the viral replication of SARS-CoV-2 was demonstrated and published by an Australian team in June 2020. On the other hand, the doses to be administered in vivo to reach the concentrations described in vitro would lead to toxicities especially neurological, in treated patients, . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- To Assess the Reduction in the Viral Load of SARS-CoV-2 in Patients Receiving Ivermectin Compared to Those Receiving Standard Care
- 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
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 28 May 2021to Jun 2022
- 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
- patient ≥ 18 years old,
- symptomatic COVID-19 for less than 96 hours (see list of symptoms in appendix),
- tested positive for SARS-CoV-2 by RT-PCR on a nasopharyngeal sample within 48 hours of inclusion,
- following an effective method of contraception for women of childbearing age,
- affiliated to a social security scheme,
- informed and written consent from patient.
Who cannot join
- patient requiring normal hospitalization or intensive care
- oxygen-requiring patient,
- with a history of parasitosis, in particular filariasis,
- with a history of hypereosinophilia,
- notion of recent travel (less than 3 months) in poor hygienic conditions
- taking ivermectin in the last 12 months,
Show all 10Show fewer
- contraindications to ivermectin or one of the constituents of the drug (known history of allergies),
- pregnant or breastfeeding women,
- participation in another interventional study relating to COVID-19 concerning a drug during this research,
- patient under AME or without social security coverage.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of the Administration of Single Dose of Ivermectin in the Early Phase of COVID-19 on the Time to Negativation of the SARS-COV-2 Viral Load Determinated by RT-PCR
The action of ivermectin in vitro on the viral replication of SARS-CoV-2 was demonstrated and published by an Australian team in June 2020. On the other hand, the doses to be administered in vivo to reach the concentrations described in vitro would lead to toxicities especially neurological, in treated patients, . However, some trials and studies, such as the ICON3 study, demonstrate the clinical efficacy of ivermectin administered at lower doses (200 µg / kg) in hospitalized patients with COVID-19.
The use of ivermectin in the early stages of the disease has not yet been studied. The administration of the maximum authorized dose (MA) of ivermectin could at least slow down the replication of the virus in vivo before the inflammatory phase of COVID-19, and reduce the duration of symptoms as well as the risk of hospitalization of patients, especially in critical care.
Unlike other studies conducted so far on COVID-19, IVERCoV will target the "viral" phase of the disease by screening patients in the city. In addition, home visits (symptom recording +/- PCR) will make it easier to monitor patients during the study.
Read the detailed description
The action of ivermectin in vitro on viral replication of SARS-CoV-2 was demonstrated and published by an Australian team in June 2020. On the other hand, the doses to be administered in vivo making it possible to reach the concentrations described in vitro would result in toxicities in treated patients, especially neurological. However, some trials and studies, such as the ICON3 study, demonstrate the clinical efficacy of ivermectin administered at lower doses (200 µg / kg) in hospitalized patients with COVID-19.
The use of ivermectin in the early stages of the disease has not yet been studied. The administration of the maximum authorized dose (MA) of ivermectin could at least slow down the replication of the virus in vivo before the inflammatory phase of COVID-19, and reduce the duration of symptoms as well as the risk of hospitalization of patients, especially in critical care.
Unlike other studies conducted so far on COVID-19, IVERCoV will target the "viral" phase of the disease by screening patients in the city. In addition, home visits (symptom recording +/- PCR) will make it easier to monitor patients during the study.
Prospective, multicenter, double-blind, randomized trial in two parallel groups:
- a control group: with administration of a placebo in addition to the usual treatment
- an experimental group: treated with ivermectin 400 µg / kg in addition to the usual treatment.
The primary endpoint: negation of the RT-PCR test on nasopharyngeal samples of SARS-CoV-2 on D3 of taking Ivermectin compared to the control group (placebo).
The secondary endpoints are:
- Evolution of symptoms from D0 to D28,
- SARS-CoV-2 viral load negativation kinetics measured on D0, D3, D7, D14 after treatment by ivermectin,
- comparison of the number of RT-PCR amplification cycles (Ct: Cycle threshold) in each group,
- number of patients having recourse to home oxygen therapy,
- number of patients hospitalized and / or requiring oxygen therapy,
- number of patients admitted to intensive care,
- number of deaths. 200 patients will be enrolled: 100 patients for each randomization group.
- Being tested
- Ivermectin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvermectinDrug
Also called placebo
ivermectin placebo
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin | Experimental | Ivermectin 3mg, on tablet. As a single dose of 400 µg / kg orally (rounded down to the nearest unit). T+ usual care Receives: Drug: Ivermectin |
| control | Placebo comparator | placebo of ivermectin administered in the same manner as the active drug in experimental arm + usual care Receives: Drug: Ivermectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
negativation of the RT-PCR test on nasopharyngeal samples of SARS-CoV-2
negativation of the RT-PCR test on nasopharyngeal samples of SARS-CoV-2 on D3 of taking Ivermectin compared to the control group (placebo).
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start28 May 2021
- Primary completionMay 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Assess the Reduction in the Viral Load of SARS-CoV-2 in Patients Receiving Ivermectin Compared to Those Receiving Standard CareStudies 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
- Prospective, multicenter, double-blind, randomized trial in two parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Raincy Montfermeil Hospital Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040724
- Sponsor's protocol ID
- 2020-005423-37
- Acronym
- IVERCoV
- Status last verified
- Jun 2021
- First submitted
- 9 Sep 2021
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of the Administration of Single Dose of Ivermectin in the Early Phase of COVID-19 on the Time to Negativation of the SARS-COV-2 Viral Load Determinated by RT-PCR
- ClinicalTrials.gov ID
- NCT05040724
- Acronym / sponsor ID
- IVERCoV / 2020-005423-37
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Raincy Montfermeil Hospital GroupResearch network
- Study start
- 28 May 2021 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 10 Sep 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.
The action of ivermectin in vitro on the viral replication of SARS-CoV-2 was demonstrated and published by an Australian team in June 2020. On the other hand, the doses to be administered in vivo to reach the concentrations described in vitro would lead to toxicities especially neurological, in treated patients, . However, some trials and studies, such as the ICON3 study, demonstrate the clinical efficacy of ivermectin administered at lower doses (200 µg / kg) in hospitalized patients with COVID-19.
The use of ivermectin in the early stages of the disease has not yet been studied. The administration of the maximum authorized dose (MA) of ivermectin could at least slow down the replication of the virus in vivo before the inflammatory phase of COVID-19, and reduce the duration of symptoms as well as the risk of hospitalization of patients, especially in critical care.
Unlike other studies conducted so far on COVID-19, IVERCoV will target the "viral" phase of the disease by screening patients in the city. In addition, home visits (symptom recording +/- PCR) will make it easier to monitor patients during the study.
Detailed description
The action of ivermectin in vitro on viral replication of SARS-CoV-2 was demonstrated and published by an Australian team in June 2020. On the other hand, the doses to be administered in vivo making it possible to reach the concentrations described in vitro would result in toxicities in treated patients, especially neurological. However, some trials and studies, such as the ICON3 study, demonstrate the clinical efficacy of ivermectin administered at lower doses (200 µg / kg) in hospitalized patients with COVID-19.
The use of ivermectin in the early stages of the disease has not yet been studied. The administration of the maximum authorized dose (MA) of ivermectin could at least slow down the replication of the virus in vivo before the inflammatory phase of COVID-19, and reduce the duration of symptoms as well as the risk of hospitalization of patients, especially in critical care.
Unlike other studies conducted so far on COVID-19, IVERCoV will target the "viral" phase of the disease by screening patients in the city. In addition, home visits (symptom recording +/- PCR) will make it easier to monitor patients during the study.
Prospective, multicenter, double-blind, randomized trial in two parallel groups:
- a control group: with administration of a placebo in addition to the usual treatment
- an experimental group: treated with ivermectin 400 µg / kg in addition to the usual treatment.
The primary endpoint: negation of the RT-PCR test on nasopharyngeal samples of SARS-CoV-2 on D3 of taking Ivermectin compared to the control group (placebo).
The secondary endpoints are:
- Evolution of symptoms from D0 to D28,
- SARS-CoV-2 viral load negativation kinetics measured on D0, D3, D7, D14 after treatment by ivermectin,
- comparison of the number of RT-PCR amplification cycles (Ct: Cycle threshold) in each group,
- number of patients having recourse to home oxygen therapy,
- number of patients hospitalized and / or requiring oxygen therapy,
- number of patients admitted to intensive care,
- number of deaths. 200 patients will be enrolled: 100 patients for each randomization group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, multicenter, double-blind, randomized trial in two parallel groups
| Arm | Type | Receives |
|---|---|---|
| Ivermectin | Experimental | Drug: IvermectinIvermectin 3mg, on tablet. As a single dose of 400 µg / kg orally (rounded down to the nearest unit). T+ usual care |
| control | Placebo comparator | Drug: Ivermectinplacebo of ivermectin administered in the same manner as the active drug in experimental arm + usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patient ≥ 18 years old,
- symptomatic COVID-19 for less than 96 hours (see list of symptoms in appendix),
- tested positive for SARS-CoV-2 by RT-PCR on a nasopharyngeal sample within 48 hours of inclusion,
- following an effective method of contraception for women of childbearing age,
- affiliated to a social security scheme,
Key exclusion criteria (10 listed)
- patient requiring normal hospitalization or intensive care
- oxygen-requiring patient,
- with a history of parasitosis, in particular filariasis,
- with a history of hypereosinophilia,
- notion of recent travel (less than 3 months) in poor hygienic conditions
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: placeboivermectin placebo | Drug | Ivermectin, control |
Primary outcome
negativation of the RT-PCR test on nasopharyngeal samples of SARS-CoV-2
Time frame: Day 3
negativation of the RT-PCR test on nasopharyngeal samples of SARS-CoV-2 on D3 of taking Ivermectin compared to the control group (placebo).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
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.
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 in people with To Assess the Reduction in the Viral Load of SARS-CoV-2 in Patients Receiving Ivermectin Compared to Those Receiving Standard Care, run by Raincy Montfermeil Hospital Group at 1 site in France.
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 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: status not confirmed, as of the sponsor's last update on 10 Sep 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 France. 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?
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?
negativation of the RT-PCR test on nasopharyngeal samples of SARS-CoV-2 (time frame: Day 3). 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 10 Sep 2021.