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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ivermectin | Experimental | Ivermectin 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. |
|
| placebo | Placebo Comparator | Placebo 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin 3 MG | Drug | Ivermectin approximately 200 μg/kg administered as a single oral dose on Day 1 (fasting state) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 15days |
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Inclusion Criteria:
Exclusion Criteria:
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.
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."
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| Name | Affiliation | Role |
|---|---|---|
| Kunihiro K.Y Yamaoka, Ph.D | Kitasato University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kitasato University | Sagamihara | Kanagawa | COVID-19 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31839144 | Background | 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. | |
| 30266338 | Background | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Placebo group: Placebo without ivermectin as an ingredient, single oral administration on Day 1 (fasting state) |
|
| 32251768 | Background | 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. |
| 33065103 | Background | 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. |
| 37283627 | Derived | 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |