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

Genova Inc.0 个研究点目标入组 385 人开始时间: 2021年3月25日最近更新: 2022年1月25日

试验速览

暂无简介。

•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

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

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

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

发起方