COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCT2051200159

Hashimoto Shoji

hashisyo@ra.opho.jp

2021-03-19

Recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

1.Written informed consent has been obtained from the participants with the age of over 20 years at the time of signing the informed consent.2.SARS-CoV-2 infection is diagnosed by RT-PCR within 72 hours before starting drug administration.3.Less than 6 days from onset of COVID-19 symptoms to starting the administration of the investigational drug. The symptoms are defined as one or more of the following: fever (37.5 or higher), respiratory symptoms (cough, shortness of breath, chest pain, sore throat, running nose, nasal congestion, etc.), headache, malaise, abdominal pain, diarrhea, nausea, vomiting, loss of smell, loss of taste, or other COVID-19 symptoms defined by investigators or physicians. 4.Have at least one of the following findings.Oxygen saturation (SpO2) measured by pulse oximeter is less than 96% but more than 93%.Chest X-ray or CT scan shows pneumonia findings suggestive of COVID-19 infection

1.History of hypersensitivity to interferon or Novaferon or any excipients of interferon or Novaferon.2.Having received other antiviral treatments (Favipiravir, Remdesivir, interferon, etc.)3.CTCAE Grade 3 or higher liver dysfunction (ALT / AST> 5ULN) or renal dysfunction (eGFR <30 mL / min / 1.73 m2)4.Active infections or other medical conditions that contraindicate inhalation therapy

2

Shoji Hashimoto

20

100

Japan

Moderate disease at enrollment

3: Moderate disease at enrollment

385

Time to clinical improvement by two points on a 7-point ordinal scale

Phase 3

[{"arm_notes": "", "treatment_id": 698, "treatment_name": "Jh509", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]