Evaluate the Efficacy and Safety of "Formosa 1-Breath Free (NRICM101) " in Subjects With the Symptoms of COVID-19 or Influenza-like Disease

China Medical University

Status and phase: Not yet enrolling; Phase 3

Conditions: COVID-19; Influenza Viral Infections

Treatments: Drug: Formosa 1-Breath Free (NRICM101); Drug: Placebo control drug

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06175468

CMUH112-REC2-154

Details and patient eligibility

About

"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 scientific, standardized, and comparable clinical results, the study will be implemented to evaluate the efficacy of safety of "Formosa 1-Breath Free (NRICM101) ".

The objective of the study was used the product which be provided by Tian-I Pharmaceutical Co. Ltd. to evaluate the efficacy and safety of the subjects with the symptoms of COVID-19 or Influenza-like after taking "Formosa 1-Breath Free (NRICM101) ".

This study is a randomized, double-blind, parallel controlled clinical trial. The study consisted of 3 cycles: screening period, treatment period (5 days) and follow-up period. The treatment of this study is divided into two groups: The test drug is Formosa 1-Breath Free (NRICM101) granule 5g/bag, 3 times a day；The control drug is the placebo (dummy) 5g/bag, 3 times a day. The sample size in the study is at least 150 people who can be evaluated, and the dropout rate of the test is 10-15%. The estimated sample size is around 170 people. After signing the ICF, vital signs (sitting blood pressure, pulse rate, SpO2, respiratory rate and body temperature), physical examination, chest X-ray, and laboratory test will be checked in screening period. Only subjects with clinically acceptable and following the inclusion and exclusion criteria will eligible to enroll in this study. Compliance will be assured by administration of the study drug under the supervision of the investigator or his deputy. Subjects will be free to withdraw at any time without stating any reason. Data will be analyzed from those subjects who complete the entire study; however, the case report forms and the final study report should include reasons for withdrawals and any necessary treatment.

Enrollment: 170 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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170 participants in 2 patient groups, including a placebo group

Placebo control group

Placebo Comparator group

Description:

take the placebo drug 5g/bag、three times a day, treatment for 5 days

Treatment:

Drug: Placebo control drug

Treatment group

Active Comparator group

Description:

take the Formosa 1-Breath Free (NRICM101) 5g/bag、three times a day, treatment for 5 days

Treatment:

Drug: Formosa 1-Breath Free (NRICM101)