Regencell Bioscience Announces Additional EARTH Efficacy Trial Results Corroborating Effectiveness of its Investigational Liquid-Formula RGC-COV19TM in Eliminating Mild to Moderate COVID-19 Symptoms within the 6-Day Treatment Period
Regencell Bioscience Holdings Limited (NASDAQ: RGC) announced the results of the EARTH-B Trial, demonstrating the efficacy of its oral COVID-19 treatment, RGC-COV19TM. Conducted on 51 patients in Malaysia, the trial showed that 94.1% of participants experienced complete symptom elimination within six days. Notably, 90.2% reported symptom improvement after one dose. No severe adverse effects were noted, and treatment did not lead to hospitalizations or deaths. These findings reinforce the potential of RGC-COV19TM as a promising alternative treatment for COVID-19.
- 94.1% of patients achieved complete symptom elimination within 6 days.
- 90.2% of patients experienced symptom improvement after one dose.
- No adverse side effects reported during or after the treatment.
- No hospitalizations or deaths occurred among trial participants.
- None.
Results of EARTH efficacy trial
|
EARTH Efficacy Trials |
||
Period of trial |
|
|
|
Number of patients |
51 |
37 |
88 |
Complete symptoms elimination in 6 days (% of patients) |
94.1 |
97.3 |
95.5 |
Elimination of one or more symptoms after 1 full dose of RGC-COV19TM (% of patients) |
90.2 |
83.8 |
87.5 |
Testing negative in 6 days (% of patients) |
23.5 |
43.5 |
29.7 |
Recovery period for patients who took RGC-COV19TM within 3 days of symptoms onset (days) |
3.7 |
3.2 |
3.5 |
Recovery period for patients who took RGC-COV19TM between 4-5 days of symptoms onset (days) |
2.3 |
3.6 |
3.4 |
No longer experienced difficulty breathing and/or persistent chest pain after 1 full dose of RGC-COV19TM (% of patients) |
57.1 |
66.7 |
66.7 |
“Regencell is committed to delivering alternative treatments that are safe and effective through the use of Traditional Chinese Medicine (“TCM”). Rigorous trials have been conducted and results have shown noticeable improvement in COVID-19 symptoms among our trial participants following the administration of RGC-COV19TM. Following the EARTH-B Trial’s results corroborating the effectiveness of RGC-COV19TM, we believe RGC-COV19TM can be a potential treatment that helps rehabilitate COVID-19 patients,” said
While emerging new COVID-19 variants continue to remain a threat to the public health, Regencell will continue to work in tandem with its R&D units to develop new breakthroughs designed to transform the way COVID-19 is being managed globally and provide safe and effective treatment for everyone.
About EARTH
The primary objective of EARTH is to evaluate and assess the efficacy of Regencell’s TCM – RGC-COV19TM (
The EARTH B Trial was conducted in
Based on the above-mentioned criteria, patients who were asymptomatic were rejected and a larger cohort of 51 random individuals qualified and were enrolled for the EARTH-B Trial, as compared to 37 random individuals in EARTH-A Trial. The enrolled patients were between the ages of 11 to 75 and of different races, ethnic backgrounds and socioeconomic backgrounds. All 51 individuals were based in
Regencell Asia set a maximum of 6 days of treatment per patient. Enrolled patients were required to report their COVID-19 symptoms every day according to 3 severity categories (mild, moderate and severe) and the list contained symptoms such as fever, fatigue, cough, sore throat, runny nose, headache, nausea, feeling hot, chills, drowsy, shortness of breath, persistent chest pain or pressure, muscle ache and abdominal discomfort. Patients were also asked to identify any other symptoms they were experiencing. Each patient received 2 days of treatment progressively while a reverse transcription polymerase chain reaction (RT-PCR) test was conducted every 2 days.
Whenever a patient’s RT-PCR test result turned negative or patients no longer had any COVID-19 symptoms (save for Sensory Dysfunction or occasional cough) within the 6-day treatment period, the treatment ended. While receiving the TCM treatment, 50 individuals were fully vaccinated and 1 child below 12 years old was not vaccinated. At the end of the treatment, the total number of patients whose symptoms were completely eliminated within the 6-day treatment period, save for Sensory Dysfunction and occasional cough, were recorded to determine the efficacy.
About the EARTH-B Trial’s Results
Efficacy of complete symptoms elimination within the 6-day treatment period
Results from this analysis of 51 trial participants build upon and corroborate previously released data and demonstrate the effectiveness of RGC-COV19TM in eliminating COVID-19 symptoms within 6 days.
Of the 51 patients, 48 patients (representing
Out of the 48 patients, the number of days it took for all symptoms to be eliminated, save for Sensory Dysfunction and occasional cough, within the 6-day treatment period, was 1 day = 3 patients, 2 days = 14 patients, 3 days = 9 patients, 4 days = 13 patients, 5 days = 4 patients, and 6 days = 5 patients.
Symptoms elimination after 1 full dose of RGC-COV19TM
In this analysis, a higher percentage of COVID-19 patients (
Treatment leading to negative RT-PCR
12 patients (representing approximately
Taking the treatment within 3 days from symptoms onset vs within 4 to 5 days from symptoms onset
The recent analysis showed that 48 out of the 51 patients started taking RGC-COV19TM within 3 days from symptoms onset and they took an average of approximately 3.7 days for the elimination of all symptoms, save for Sensory Dysfunction and occasional cough, whereby the maximum number of different symptoms reported by any one individual was 16 and the average number of different symptoms reported was 8.
The remaining 3 patients who started taking RGC-COV19TM between 4 to 5 days from symptoms onset took an average of approximately 2.3 days for the elimination of all symptoms, save for Sensory Dysfunction and occasional cough, whereby the maximum number of different symptoms reported by any one individual was 8 and the average number of symptoms reported was 5.
Vaccination status
50 individuals were fully vaccinated and 1 child below 12 years old was not vaccinated. All 12 patients who tested negative RT-PCR in 4 days were fully vaccinated prior to taking the RGC-COV19TM treatment. All patients who were vaccinated received vaccine from either Pfizer-BioNTech, AstraZeneca or Sinovac-CoronaVac, which are the top 3 vaccines distributed in
High-risk patients
Out of the 51 patients, 15 patients experienced a combination of dyspnea (difficulty breathing) and/or persistent chest pain. 10 of these 15 patients no longer experienced difficulty breathing and/or persistent chest pain after 1 full dose of RGC-COV19TM.
No adverse side effects
Based on the patients’ self-reported data, there were no worsening of symptoms during and after consuming RGC-COV19TM and none of the patients experienced any unknown adverse side effects.
No treatment emergent adverse events
Among the patients with chronic conditions such as chronic migraine, eczema, asthma, thyroid disease, high blood pressure and high cholesterol, there were no treatment emergent adverse events and no discontinuation of RGC-COV19TM due to adverse results.
Death/Hospitalization
At the end of the EARTH-B Trial, none of the patients was hospitalized and there was no death. The efficacy of RGC-COV19TM was not affected by timing of symptom onset or underlying risk factors. Results were consistent across all ages, gender, races and ethnicity demographic among the enrolled patients.
More about EARTH
There are hundreds of millions of individuals who have been diagnosed with COVID-19 around the world, and some experience post-COVID symptoms such as extreme tiredness (fatigue), shortness of breath, problems with memory and concentration (brain fog), heart palpitations, dizziness, chest pain or tightness, joint pain which are now being classified as long-COVID symptoms.
As long-COVID symptoms have substantial effects on individuals’ quality of life and work capability, Regencell Asia is in the midst of conducting its studies for long-COVID patients using a natural and holistic formula - RGC-COV19TM (RGCA-LCV01).
About RGC-COV19TM
RGC-COV19TM (RGCA-CV01) is an investigational, natural, orally administered liquid formula which aims to reduce and eliminate COVID-19 symptoms.
RGC-COV19TM is a natural formula designed by the TCM Practitioner according to the TCM Practitioner’s brain theory known as “Sik-Kee Au TCM Brain Theory®” and can be taken safely for two to three weeks. In conducting EARTH, the treatment was limited to 6 days in order to evaluate its efficacy in reducing and eliminating COVID-19 symptoms. The “TCM Practitioner” refers to our strategic TCM research partner,
According to the brain theory, brain functions depend on the oxygen level required for the brain to perform normal cognitive functions. For optimal brain performance, the heart needs to function normally to deliver sufficient oxygen to the brain. When the heart is weakened, the heart’s ability to deliver enough blood to circulate oxygen throughout the body is impaired. When this happens, brain functions are suppressed, resulting in a person experiencing fatigue, nausea, disorientation and reduced immune response.
RGC-COV19TM is designed to strengthen the heart’s functions. According to the brain theory, when the heart is strengthened, it increases blood flow and delivers more oxygen to the brain, resulting in reduced blood clots and restored brain functions. Regardless of the COVID-19 variant, the lungs and heart are where the coronavirus does much of its damage by setting off an inflammatory immune response that ravages infected and uninfected cells alike, leading to tissue scarring and oxygen deprivation which in turn suppress brain functions. RGC-COV19TM is formulated to generate more responsive cognitive functions which in turn stimulate the body’s own healing mechanism.
Regencell began its investigational approach towards COVID-19 treatment when a friend of Regencell contracted COVID-19 in
Study results showed that the treatment was effective. As Regencell has a mission to save lives, improve patients’ well-being and address unmet needs in the market, Regencell aims to make its natural and holistic treatment available to everyone in need.
From
RGC-COV19TM is designed to reduce COVID-19 symptoms such as fever, fatigue, cough, sore throat, runny nose, headache, nausea, chills, drowsiness, shortness of breath, persistent chest pain and muscle ache as the medicine works to (i) reduce and clear the mucus and phlegm from the upper respiratory system; (ii) dispel exterior viral pathogen via heavy sweats, urine and excrement; (iii) clear endogenous and liver heat; (iv) detox the liver; and (v) improve body circulation. By applying the TCM Practitioner’s “Sik-Kee Au TCM Brain Theory®”, RGC-COV19TM is also designed to remove blood clots from the brain and restore the patient's brain functions.
RGC-COV19TM (RGCA-CV01) is administered at 1 dose of RGCA-CV01-1Na (approximately 230ml) and 1 dose of RGCA-CV01-2Da (approximately 230ml) each time, with 1 dose of RGCA-CV01-1Na to be taken starting from the night of the first day of treatment and 1 dose of RGCA-CV01-2Da to be taken after lunch the next day, until symptoms are eliminated.
About
For more than 30 years, the TCM Practitioner whom Regencell partners with has treated patients with neurological disorders and infectious diseases. The TCM Practitioner’s TCM formulae candidates are derived from a TCM base formula and an adjustable formula which is developed based on his TCM brain theory, known as the “Sik-Kee Au TCM Brain Theory®”.
Both Regencell and the TCM Practitioner are committed in giving back to the society and demonstrates its
Since its listing, Regencell through a joint venture with
Forward-looking Statements
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