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| Column | Value |
|---|---|
| Trial registration number | NCT05172037 |
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Full text link
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
shikai050169@gmail.com |
|
Registration date
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
2021-12-29 |
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Recruitment status
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
Adaptive |
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Masking
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
inclusion criteria: written informed consent has been obtained from the participants with an age of over 20 years at the time of signing the informed consent. sars-cov-2 infection is diagnosed by rt-pcr within 72 hours before starting drug administration. less than six days from onset of covid-19-related symptoms below to starting the administration of the investigational drug with at least one of the following symptoms observed at the time of enrollment : fever (37.5c or higher), respiratory symptoms (cough, shortness of breath, sore throat, runny nose, etc.), headache, myalgia, malaise, abdominal pain, diarrhea, nausea/vomiting, dysosmia, dysgeusia, or other covid-19 symptoms defined by investigators or coinvestigators investigators. oxygen saturation (spo2) measured by pulse oximeter is more than 95%. require no supplemental oxygen. women (less than 12 months after the last menstrual period) who have a negative pregnancy test (urine hcg qualification) and agree to use highly effective contraceptive methods (taking oral contraceptives or use of condom by male partner) during the study period. investigators or coinvestigators investigators will provide guidance on contraceptive methods. women who are not breast-feeding. |
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Exclusion criteria
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
history of hypersensitivity to interferon or jh509 or any excipients of interferon or jh509. have received antiviral treatments and drugs expected to have antiviral effects (favipiravir, remdesivir, interferon, nafamostat mesilate, and basiliximab/imdevimab, including drugs that are being newly developed and that have been approved) in the past or having had it considered necessary to receive these treatments during the study period. having had it considered necessary to receive treatments, such as drugs containing corticosteroids (excluding topical drugs), antimicrobial agents, and inhalants other than the investigational drug during the study period. taking "shosaikoto," an herbal medicine. neuropsychiatric disorder and autoimmune disorder. 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. having the complication of malignant tumor or a history of malignant tumor within 1 year before consent acquisition. inappropriate for inclusion in the clinical trial as determined by investigators or coinvestigators investigators. |
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Number of arms
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
Genova Inc. |
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Inclusion age min
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
20 |
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Inclusion age max
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
Japan |
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Type of patients
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
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Severity scale
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
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Total sample size
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
222 |
|
primary outcome
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
Rate of severe conditions with Score 3 or more serious on a seven-point ordinal scale from the start date of investigational drug administration (Day 1) to Day 28. |
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Notes
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
Phase 3 |
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Arms
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 911, "treatment_name": "Novaferon", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |