COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCT2071200023

Naoki Hosogaya

nhosogaya@nagasaki-u.ac.jp

2020-07-21

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

(1) Japanese male or female patients aged 20 or above at the time of obtaining informed consent(2) Patients in which SARS-CoV-2 was detected from the upper and lower respiratory tract specimens using polymerase chain reaction (PCR) or loop-mediated isothermal amplification, or those who were positive for the antigen at least 3 days before obtaining the informed consent.(3) Patients who have been provided with complete information about the contents of the informed consent form and other study-related details, and who voluntarily sign the informed consent form to participate in the study after having understood the study content.

(1) Patients who develop symptoms 8 or more days prior to enrollment(2) Patients with an SpO2 < 96 % (room air)(3) Patients who meet any of the following screening criteria:a) Alanine aminotransferase or aspartate aminotransferase levels five times higher than the upper limit of the reference range.b) Child Pugh class B or C.c) Serum creatinine levels two times higher than the upper limit of the reference range, and creatinine clearance is < 30 mL/min (Estimated Creatinine clearance using the Cockcroft Gault formula. However, actually measured values will be used if available).(4) Patients with poorly controlled diabetes (random blood glucose >= 200 mg/dL or HbA1c >= 7.0 % despite treatment).(5) Patients with serious complications who are deemed unsuitable for inclusion in the study based on the assessment by either the principal investigator or the sub-investigator.(6) Hemophilic patients or patients with a marked hemorrhagic tendency(7) Patients with severe diarrhea(8) Patients with a history of hypersensitivity to the ingredients of the investigational drug.(9) Female patients who are breastfeeding, pregnant, or of childbearing potential.(10) Patients who refused to adopt contraceptive methods during the study period from the initial administration of the investigational drug (male patients, and female patients of childbearing potential).(11) Patients who were receiving rifampicin within 2 weeks prior to obtaining informed consent.(12) Patients who participated in other clinical trials and received drugs within 12 weeks prior to obtaining informed consent.(13) Patients undergoing treatment for HIV infection(14) Patients who have been vaccinated against COVID-19, or wish to be vaccinated against COVID-19 while participating in the clinical trial(15) Other patients who are deemed inappropriate (miscellaneous reasons) for inclusion in the clinical trial based on the assessment by either the principal investigator or the sub investigator.

2

Miyazaki Taiga

20

100

Japan

Mild disease at enrollment

1: Mild disease at enrollment

120

Time to negative conversion of SARS-CoV-2

Phase 1/Phase 2

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