Status:
UNKNOWN
Study in COvid-19 Patients With iveRmectin (CORVETTE-01)
Lead Sponsor:
Kitasato University
Conditions:
Covid19
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief 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 treat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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."
Key Trial Info
Start Date :
September 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT04703205
Start Date
September 16 2020
End Date
May 31 2022
Last Update
January 20 2022
Active Locations (1)
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1
Kitasato University
Sagamihara, Kanagawa, Japan, COVID-19