COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCT2031190264

Ayako Mikami

amikami@hosp.ncgm.go.jp

2020-03-24

Not recruiting

RCT

Randomized

Adaptive

Blind label

multi-center

Treatment

1.Admitted to a hospital with symptoms suggestive of COVID-19 infection.2.Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.3.Understands and agrees to comply with planned study procedures.4.Agrees to the collection of oropharyngeal (OP) swabs.5.Male or non-pregnant female adult =>18 years of age at time of enrollment.6.Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay in any specimen collected < 72 hours prior to randomization. Note - 72 hours is not necessarily time from initial diagnosis. If => 72 hours since positive PCR, the PCR may be repeated to assess eligibility. 7.Illness of any duration, and at least one of the following:-Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR-Clinical assessment (evidence of rales/crackles on exam) AND SpO2 <= 94% on room air, OR-Requiring supplemental oxygen, OR-Requiring mechanical ventilation.8.Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 29. 9.Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2.

1.ALT/AST > 5 times the upper limit of normal.2.Estimated glomerular filtration rate (eGFR) < 50 or requiring dialysis.3.Pregnancy or breast feeding.4.Anticipated transfer to another hospital which is not a study site within 72 hours.5.Allergy to any study medication.

2

Ohmagari Norio

20

None

Japan;Republic of Korea;United States

Severe disease at enrollment

6: Severe disease at enrollment

100

The overall objective of the study is to evaluate the clinical efficacy of different investigational therapeutics relative to the control arm in adults hospitalized with COVID-19.-The primary objective will be determined by a pilot study of the first 100 subjects.-Subject clinical status (8-point ordinal scale) at Day 15 is the default primary endpoint.

Phase 3

[{"arm_notes": "", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]