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

ABSTRACT

ConditionCOVID-19 infections disease

InterventionJH509 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.

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

CriteriaInclusion criteria 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

Exclusion criteria 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