COVID-19
Conditions
Interventions
ivermectin group Ivermectin approximately 200microgram per kg administered as a single oral dose on day 1 (fasting state)
placebo group placebo without ivermectin as an ingredient, single ora
Sponsors
Yamaoka Kunihiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 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. 2) A person with oxygen saturation (SpO2) in the room air of 95% or more. 3) A person who are 20 years or older at the time of obtaining consent. 4) A person who weigh 40 kg or more at the time of qualification test. 5) A person who understands the content of this clinical trial and can obtain written consent to participate in the clinical trial.
Exclusion criteria
Exclusion criteria: 1) 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. 2) 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). 3) A person with hypersensitivity to ivermectin. 4) A person with a history of severe drug allergies such as Stevens-Johnson syndrome, toxic epidermal necrolysis. 5) 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. 6) Those who are scheduled to receive SARS-CoV-2 vaccination from the date of consent to the end of the follow-up period. 7) A person who are currently participating in other clinical trials or who have participated in other clinical trials within 30 days before obtaining consent. 8) In addition, a person who is determined to be unsuitable as a subject of this clinical trial by the principal investigator."
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Period until the COVID-19 PCR test (SARS-CoV-2 nucleic acid detection) becomes negative | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Occurrence rate of cases in which the condition changed between Day1 and Day15 (evaluation by 7-point ordinal scale) Ordinal scale; 1 No pneumonia, no restrictions on activities of daily living (PS0) 2 No pneumonia, limited daily activities (PS1 or higher) 3 With pneumonia, no oxygen inhalation 4 With pneumonia and oxygen inhalation 5 With non-invasive assisted ventilation or high-flow oxygen inhalation therapy 6 With artificial respiration management (including ECMO use) 7 Death" Definition of change in medical condition; The following change in clinical condition is defined as change in medical condition. (1) Change from 1 by two or more steps (2) Change from 2 or 3 by one or more steps Definition of pneumonia: A chest X-ray film or chest CT shows a shadow, and there is no obvious cause other than pneumonia such as heart failure. Criteria for restricting activities of daily living; 0 is not restricted to activities of daily living and 1 or more is restricted to activities of daily living according to the following criteria." "Table 11.2 ECOG (Eastern Cooperative Oncology Group) Performance Status (PS) GRADE ECOG PERFORMANCE STATUS 0 Fully active, able to carry on all pre-disease performance without restriction 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair 5 Dead Source: Oken, M.M., et al., Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol, 1982. 5(6): p. 649-55. Evaluator: The Principle investigator or sub-inves | — |
Contacts
Public ContactMiwa Nonaka
Kitasato University Hospital
Outcome results
None listed