Placebo-controlled randomized, double-blind (evaluator, patient) multicenter, parallel-group, controlled trial investigating the efficacy and safety of ivermectin in COVID-19 patients (Japan 2020-09-16) New trial!

[-] TrumpLyftAlles | 1 points | Oct 09 2020 00:08:40

This looks like a very solid design, it's only fault being the typical dose of 200mcg/kg. Why not go higher?

N = 240, with a placebo arm! Parallel assignment. Recruiting now.

Intervention:
Ivermectin group: Approximately 200 μg / kg of ivermectin administered daily 1 oral single dose (fasting)
Placebo group: Placebo containing no ivermectin as an ingredient Day1 oral single dose (fasting)

Subjects were tested on Day 1 (ivermectin 3 mg tablets) Alternatively, take a control drug (ivermectin placebo tablets) in the number of study drug doses per subject weight.

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

There are many secondary outcomes (15).

Inclusion criteria:
1) Those who have been diagnosed with COVID-19 (including asymptomatic) by COVID-19 PCR test (SARS-CoV-2 nucleic acid detection) within 3 days before the eligibility test.
2) Those who have an oxygen saturation (SpO2) of 95% or more in the room.
3) Those who are 20 years old or older at the time of obtaining consent.
4) Those who weigh 40 kg or more at the time of eligibility test.
5) Those who understand the content of this clinical trial and can obtain written consent to participate in the clinical trial.

Exclusion criteria:
1) Breast-feeding, pregnant or potentially pregnant women, or those who do not consent to contraception by medically appropriate means up to 7 days after administration of the study drug. Medically appropriate contraception means not having sexual intercourse, surgical infertility such as vasectomy, or using a combination of two or more of intrauterine contraceptive devices, oral contraceptives, and condoms.
2) Serious hepatic disorder (AST or ALT at the time of eligibility test is at least 3 times the upper limit of the facility standard value and total bilirubin is more than 2 times the upper limit of the facility standard value), renal disorder (eGFR of the eligibility test value is 30) Those who have mL / min / 1.73m2 or less). 3) Persons with hypersensitivity to ivermectin.
4) Persons with a history of serious drug allergies such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
5) Those who have received prohibited drugs within the past 1 month (within the past 6 months for biologics), or those who need to use prohibited drugs during the clinical trial period.
6) Those who are currently participating in other clinical trials, or those who participated in other clinical trials within 30 days before obtaining consent.
7) In addition, those who are judged by the investigator, etc. to be inappropriate as subjects for this clinical trial.

Ages 20+, no upper limit

Cancellation criteria:
1) stop by the subject of the convenience 1) When offered the withdrawal of the study participants if you no longer want to visit 2) for some reason
(2) investigator (sharing) discontinued due to the judgment of the practitioner
1) after the start of the trial "selection criteria"
2) When it is difficult to continue the clinical trial due to the occurrence of adverse events, etc.
* 3) In addition, the investigator (sharing) has determined that it is difficult to continue the clinical trial of the subject.

I didn't spot the time frame for the outcome measures, typically 14 days.