Status:
UNKNOWN
Evaluate the Efficacy and Safety of "Formosa 1-Breath Free (NRICM101) " in Subjects With the Symptoms of COVID-19 or Influenza-like Disease
Lead Sponsor:
China Medical University Hospital
Collaborating Sponsors:
Tian-I Pharmaceutical,. Co. Ltd.
China Medical University, China
Conditions:
Influenza Viral Infections
COVID-19
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
"Formosa 1-Breath Free (NRICM101) " has been widely known in Taiwan to treat COVID-19. However, there is no phase III pivotal clinical trial of "Formosa 1-Breath Free (NRICM101) " . In order to obtain...
Eligibility Criteria
Inclusion
- Subjects who meet the criteria guideline in the "Seasonal Influenza Prevention and Control Manual" recommended by the Taiwan Centers for Disease Control, or are determined by the investigator to have mild symptoms of COVID-19, including fever, sore throat, cough, and fatigue.
- Subjects who have had a fever (body temperature ≥37.5°C and ≤39°C) before their initial dose.
- Throat pain intensity score \>30 points during the screening period.
- Cough severity score \>3 points during the screening period.
- Fatigue level score \>30 points during the screening period.
- Able to perform activities of daily living and aged 20 weeks or older.
- Duration of illness ≤24 hours.
- Obtained informed consent from the subject and signed the informed consent form.
Exclusion
- Subject has used other medications for this condition (including cold medicine, antibiotics, antiviral drugs, and similar traditional Chinese medicines) within the 24 hours prior to screening, or is determined by the investigator to require the use of antibiotics or COVID-19 anti-virus drugs.
- Subject has used corticosteroids or NSAIDs for an extended period within the four weeks prior to screening.
- Subject has had poorly controlled chronic diseases in the past five years, including cardiovascular, respiratory, gastrointestinal, immune-related conditions, or mental health disorders (as determined by the investigator).
- Subject has had chronic bronchitis, streptococcal pharyngitis, herpetic pharyngitis, or pneumonia within the past two years or at the time of screening (as determined by the investigator).
- Subject is allergic to the investigational drug or its components.
- Women who are pregnant, breastfeeding, or planning to become pregnant.
- Subject has participated in other drug clinical trials within the 90 days prior to screening.
- The investigator evaluates the subject unsuitable for inclusion in the study.
Key Trial Info
Start Date :
December 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT06175468
Start Date
December 15 2023
End Date
August 1 2024
Last Update
December 19 2023
Active Locations (1)
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1
China Medical University Hospital
Taichung, Taiwan