Clinical trial NCT04664049: The Outcomes of NRICM101 on SARS-COV-2 (COVID-19) Infection
Official title: The Outcomes of NRICM101 on SARS-COV-2 (COVID-19) Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV-2
Covid 19
Keywords: NRICM101
Covid 19
SARS-CoV-2
Lead sponsor: National Research Institute of Chinese Medicine, Ministry of Health and Welfare
Sponsor class: OTHER_GOV
First posted: 2020-12-11
Enrollment: 51000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who confirmed, suspected or prevented infected of COVID 19 disease and take dietary supplement NRICM101

Brief summary: Traditional Chinese medicine is regarded as a dietary supplement in many countries around the world. Dietary supplement, NRICM101, has been available for people who diagnosed, suspected or prevented for coronavirus disease 2019 (COVID-19) in September 2020. It is expected to help people not to progress to severe illness, and reduce lung damage and mortality. The investigators gather the effects of people who taking NRICM101 using the Real-World Big Data Study and the network feedback information collection model. This study can be used as a reference for global prevention and control of coronavirus disease 2019 (COVID-19).

Detailed description: The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is raging around the world. Because of its strong spread, variability, survivability, and invisibility, the number of infected people rise rapidly. On March 11, 2020, the WHO officially declared COVID-19 as a pandemic disease. As of October 3, 2020, the number of confirmed cases has exceeded 34 million, and the cumulative deaths have exceeded 1 million. There are still no drugs to treatment the coronavirus disease 2019 (COVID-19). Due to the mutation of virus rapidly, vaccine development cannot be completed in a short period of time. At the beginning of the infection outbreak, the governments of China and South Korea, adopted a cooperative of Chinese and Western medicine to treatment the coronavirus disease 2019 (COVID-19). In addition to the reported good clinical effects, Chinese medicine prescriptions have included in diagnosis and treatment guideline of these two countries.

Traditional Chinese medicine is regarded as a dietary supplement in many countries around the world. Dietary supplement, NRICM101, has been available for people who diagnosed, suspected or prevented for coronavirus disease 2019 (COVID-19) in September 2020. It is expected to help people not to progress to severe illness, and reduce lung damage and mortality. The investigators gather the effects of people who taking NRICM101 using the Real-World Big Data Study and the network feedback information collection model. This study can be used as a reference for global prevention and control of coronavirus disease 2019 (COVID-19).

Eligibility criteria: Inclusion Criteria:

* Subjects who confirmed, suspected or prevented infected of COVID 19 disease and take dietary supplement NRICM101

Exclusion Criteria:

* Those who refuse to participate in observational research.

Primary outcomes:
measure: negative of COVID-19 test
timeFrame: 1 day to 2 months
measure: free of COVID 19 disease symptoms and signs
timeFrame: 1 day to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Research Institute of Chinese Medicine, Ministry of Health and Welfare
Study officials:
affiliation: National Research Institute of Chinese Medicine, Ministry of Health and Welfare
name: Yi-Chang Su, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: