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Covid19Phase 2NCT04703205

Study in COvid-19 Patients With iveRmectin (CORVETTE-01)

A Phase 2 study testing Ivermectin 3 MG in people with Covid19, run by Kitasato University at 1 site in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Treatment of mild COVID-19 is basically performed at an outpatient clinic, then when the symptom and clinical findings exacerbate to a moderate level, patients are admitted. There is no standard treatment for mild cases. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Covid19
What is being tested?
Ivermectin 3 MG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
214 participants
Where
1 siteJapan
Study dates
16 Sep 2020to 31 May 2022
Phase
Phase 2
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 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • A person who has been diagnosed with COVID-19 (including asymptomatic) by the COVID-19 PCR test (SARS-CoV-2 nucleic acid detection) within 3 days before the qualification test.
  • A person with oxygen saturation (SpO2) in the room air of 95% or more.
  • A person who are 20 years or older at the time of obtaining consent.
  • A person who weigh 40 kg or more at the time of qualification test.
  • A person who understands the content of this clinical trial and can obtain written consent to participate in the clinical trial.

Who cannot join

  • A woman who is in lactation period or who may be pregnant, or those who do not agree to prevent pregnancy by medically appropriate means for up to 7 days after study drug administration.
  • Medically appropriate contraception means that using a combination of two or more of the following: not having sexual intercourse, taking surgical sterilization such as vasectomy or intrauterine device, taking oral contraceptive, using condom.
  • A person who has severe liver damage (AST or ALT at the time of qualification test is more than 3 times the upper limit of institutional standard and total bilirubin is more than twice the upper limit of institutional standard value), renal disorder (eGFR of eligibility test value 30 mL/min/1.73m2 or less).
  • A person with hypersensitivity to ivermectin.
  • A person with a history of severe drug allergies such as Stevens-Johnson syndrome, toxic epidermal necrolysis.
  • A person who has received the prohibited medication within the past month (within the past 6 months for biologics), or those who need to use the prohibited medication during the clinical trial period.
Show all 9Show fewer
  • Those who are scheduled to receive SARS-CoV-2 vaccination from the date of consent to the end of the follow-up period.
  • A person who are currently participating in other clinical trials or who have participated in other clinical trials within 30 days before obtaining consent.
  • In addition, a person who is determined to be unsuitable as a subject of this clinical trial by the principal investigator."

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Kitasato University

    Sagamihara, Kanagawa, COVID-19

Other trials in Japan

About this study

Official title: A Placebo-controlled, Randomized, Double-blind Study in COvid-19 Patients With iveRmectin; An inVEstigator iniTiaTEd Trial

Treatment of mild COVID-19 is basically performed at an outpatient clinic, then when the symptom and clinical findings exacerbate to a moderate level, patients are admitted. There is no standard treatment for mild cases. This study will investigate whether ivermectin administration suppresses the replication of SARS-CoV-2 in mild to moderate COVID-19 by investigating the negative rate of SARS-CoV-2 PCR by a randomized controlled trial. Subjects are assigned to two groups, the placebo group, and the ivermectin group. The target number of each treatment arm is 120, a total of 240 cases. A single oral administration of 200 ㎍/kg of ivermectin or an ivermectin-free placebo will be administered on an empty stomach. Time to negativization of SARS-CoV-2 PCR as the primary endpoint with additional efficacy and safety of the process will be investigated.

Conditions
Covid19
Being tested
Ivermectin 3 MG, 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 3 MGDrug

    Ivermectin approximately 200 μg/kg administered as a single oral dose on Day 1 (fasting state)

  • PlaceboDrug

    Placebo group: Placebo without ivermectin as an ingredient, single oral administration on Day 1 (fasting state)

Study groups in NCT04703205
Study groupRoleWhat they receive
ivermectinExperimentalIvermectin group: Ivermectin approximately 200 μg/kg administered as a single oral dose on Day 1 (fasting state) subjects take the study drug (3 mg tablet of ivermectin) at the dose of the study drug taken once per body weight of the subject.
Receives: Drug: Ivermectin 3 MG
placeboPlacebo comparatorPlacebo group: Placebo without ivermectin as an ingredient, single oral administration on Day 1 (fasting state) the control drug (ivermectin placebo tablet) at the dose of the study drug taken once per body weight of the subject.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. COVID-19 PCR test (SARS-CoV-2 nucleic acid detection) Period until the COVID-19 PCR test (SARS-CoV-2 nucleic acid detection) becomes negative

    Period until the COVID-19 PCR test (SARS-CoV-2 nucleic acid detection) becomes negative

    Measured: 15days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2021
  2. Study start16 Sep 2020
  3. Primary completion22 Oct 2021
  4. Study completion31 May 2022 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
214 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04703205
Sponsor's protocol ID
CORVETTE-01
Status last verified
Jan 2022
First submitted
1 Dec 2020
Last updated
20 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Nicolas P, Maia MF, Bassat Q, Kobylinski KC, Monteiro W, Rabinovich NR, Menendez C, Bardaji A, Chaccour C. Safety of oral ivermectin during pregnancy: a systematic review and meta-analysis. Lancet Glob Health. 2020 Jan;8(1):e92-e100. doi: 10.1016/S2214-109X(19)30453-X.

    PubMed 31839144

  • Lv C, Liu W, Wang B, Dang R, Qiu L, Ren J, Yan C, Yang Z, Wang X. Ivermectin inhibits DNA polymerase UL42 of pseudorabies virus entrance into the nucleus and proliferation of the virus in vitro and vivo. Antiviral Res. 2018 Nov;159:55-62. doi: 10.1016/j.antiviral.2018.09.010. Epub 2018 Sep 26.

    PubMed 30266338

  • Caly 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 32251768

  • Rajter JC, Sherman MS, Fatteh N, Vogel F, Sacks J, Rajter JJ. Use of Ivermectin Is Associated With Lower Mortality in Hospitalized Patients With Coronavirus Disease 2019: The Ivermectin in COVID Nineteen Study. Chest. 2021 Jan;159(1):85-92. doi: 10.1016/j.chest.2020.10.009. Epub 2020 Oct 13.

    PubMed 33065103

  • Wada T, Hibino M, Aono H, Kyoda S, Iwadate Y, Shishido E, Ikeda K, Kinoshita N, Matsuda Y, Otani S, Kameda R, Matoba K, Nonaka M, Maeda M, Kumagai Y, Ako J, Shichiri M, Naoki K, Katagiri M, Takaso M, Iwamura M, Katayama K, Miyatsuka T, Orihashi Y, Yamaoka K; CORVETTE-01 Study Group. Efficacy and safety of single-dose ivermectin in mild-to-moderate COVID-19: the double-blind, randomized, placebo-controlled CORVETTE-01 trial. Front Med (Lausanne). 2023 May 22;10:1139046. doi: 10.3389/fmed.2023.1139046. eCollection 2023.

    PubMed 37283627

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ivermectin 3 MG in people with Covid19, run by Kitasato University at 1 site in Japan.

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 9 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 20 Jan 2022. 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 Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

COVID-19 PCR test (SARS-CoV-2 nucleic acid detection) Period until the COVID-19 PCR test (SARS-CoV-2 nucleic acid detection) becomes negative (time frame: 15days). 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 NCT04703205, which also lists 5 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 20 Jan 2022.

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