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A multicenter, randomized, double-blind, placebo-controlled trial for hospitalized moderate COVID-19 patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Inhaled Novaferon, given 20 ug BID, daily for 7 days |
|
| Placebo | Placebo Comparator | Inhaled saline (placebo), given BID, daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novaferon | Biological | a novel recombinant antiviral protein drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to clinical improvement | Time to patient clinical improvement by 2 points on a 7-point ordinal scale | From enrollment up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of clinical improvement | Rate at which patients show a clinical improvement by 2 points on a 7-point ordinal scale | Day 1 to Day 10, 14 and 28 |
| Rate of clinical deterioration | Rate at which patients show a clinical deterioration by 2 points on a 7-point ordinal scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huimei Huang | Contact | +6582027938 | hhuang@genova.cn | |
| Haifeng Jin | Contact | kkin@genova.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiba Aoba Municipal Hospital | Recruiting | Chiba | Japan |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000605797 | recombinant interferon alpha 2b-like protein |
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| Placebo |
| Biological |
Saline |
|
| Day 1 to Day 10, 14 and 28 |
| Time to viral clearance | Time taken for patients to demonstrate negative RT-PCR test of SARS-CoV-2 in the samples taken from nasopharyngeal swabs | From enrollment up to Day 28 |
| Rate of viral clearance | The rate at which patients demonstrate negative RT-PCR test of SARS-CoV-2 in the samples taken from nasopharyngeal swabs | Each Day from Day 1 up to Day 28 |
| Change in viral load | Changes of SARS-CoV-2 viral loads in the samples of nasopharyngeal swabs | Each Day from Day 1 up to Day 28 |
| Mortality rate | Mortality rate | At Day 28 |
| Duration of hospital stay | Number of days the patient is in hospital | From enrollment up to Day 28 |
| Time to resolution of symptoms | Time taken for patients to demonstrate a resolution of symptoms defined as a (National Early Warning Score 2) NEWS 2 of 0 maintained for 24hours | From enrollment up to Day 28 |
| Requirement of supplemental oxygen | Rate at which patients require supplemental oxygen | From enrollment up to Day 28 |
| Requirement of mechanical ventilation | Rate at which patients require mechanical ventilation (invasive or non-invasive) | From enrollment up to Day 28 |
| Rate of alive patients | Rate of patients alive without having to use invasive ventilator or ECMO | At Day 28 |
| Adverse events | Adverse event incidence, type and severity | From enrollment up to Day 28 |
| Kamagaya General Hospital | Recruiting | Chiba | Japan |
|
| NHO Chiba Medical Center | Recruiting | Chiba | Japan |
|
| NHO Omuta National Hospital | Active, not recruiting | Fukuoka | Japan |
| NHO Kasumigaura Medical Center | Recruiting | Ibaraki | Japan |
|
| Tsukuba Medical Center Foundation Tsukuba Medical Center Hospital | Active, not recruiting | Ibaraki | Japan |
| Kokankai Nippon Kokan Hospital | Recruiting | Kanagawa | Japan |
|
| Rakuwakai Otowa Hospital | Recruiting | Kyoto | Japan |
|
| Okayama City General Medical Center Okayama City Hospital | Recruiting | Okayama | Japan |
|
| Osaka Habikino Medical Center | Recruiting | Osaka | Japan |
|
| Rinku General Medical Center | Recruiting | Osaka | Japan |
|
| Sakai City Medical Center | Recruiting | Osaka | Japan |
|
| Omi Medical Center | Recruiting | Shiga | Japan |
|
| NHO Utsunomiya Hospital | Active, not recruiting | Tochigi | Japan |
| Japanese Red Cross Medical Center | Active, not recruiting | Tokyo | Japan |
| Juntendo University Hospital | Active, not recruiting | Tokyo | Japan |
| Nihon University Itabashi Hospital | Active, not recruiting | Tokyo | Japan |
| Showa University East Hospital | Active, not recruiting | Tokyo | Japan |
| Showa University Hospital | Recruiting | Tokyo | Japan |
|
| Tokyo Medical University Hachioji Medical Center | Recruiting | Tokyo | Japan |
|
| Tokyo Shinagawa Hospital | Recruiting | Tokyo | Japan |
|
| NHO Iwakuni Clinical Center | Recruiting | Yamaguchi | Japan |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |