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A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of Aerosolized JH509 in Hospitalized Adult Patients with Mild to Moderate COVID 19

A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of Aerosolized JH509 in Hospitalized Adult Patients with Mild to Moderate COVID 19 (JH509 for COVID-19 Treatment Trial (NCTT-005))

Shoji Hashimoto

Dept of infectious Diseases

3-7-1, Habikino, Habikino-shi, Osaka

hashisyo@ra.opho.jp

Shoji Hashimoto

Dept of infectious Diseases

3-7-1, Habikino, Habikino-shi, Osaka

+81-72-9572121

hashisyo@ra.opho.jp

Recruiting

Mar. 08, 2021

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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

Both

COVID-19 infections disease

JH509 or placebo is administered by inhalation for 15 minutes using a disposable nebulizer, twice daily (morning and evening) for 7 days. If symptoms consistently exist, the drug administration course can be extended up to 10 days. Adverse events will be observed up to 28 days after starting drug administration.

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

1. Rate of clinical improvement by at least 1point on a 7-point ordinal scale on Day1 to Day10, Day14, and Day28
2. Rate of clinical deterioration by at least 1 point on a 7-point ordinal scale on Day1 to Day10, Day14, and Day28
3.Time to negative RT-PCR testofSARS-CoV-2 in nasopharyngeal swap or in other samples from respiratory system after starting drug administration
4. Rate of negative RT-PCR testofSARS-CoV-2 in nasopharyngeal swap or in other samples from respiratory system on each test day after starting drug administration
5. Post-baseline changes of SARS-CoV-2viral loads in nasopharyngeal swap or in other samples from respiratory system on each test day after starting drug administration
6. Rate of mortality on Day 28 of starting drug administration
7. Duration of hospital stay for treatment of new coronavirus infection
8. Time to resolution of symptoms defined as a (National Early Warning Score 2) NEWS2 of 0 maintained for 24hours
9. Rate and duration of requiring supplemental oxygen
10. Rate and duration of requiring mechanical ventilator (invasive or non-invasive)
11. Rate of alive patients without using invasive ventilator or ECMO on Day 28 of starting drug administration
12. Adverse events

+81-72-957-2121

Feb. 24, 2021

No

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