RGC: The results of the second investigational research of RGC-COV19TM in removing COVID-19 symptoms are consistent with those of the first study.
Founded in 2014, Hong Kong-based Regencell Bioscience (NASDAQ:RGC) is an early clinical stage bioscience company using Traditional Chinese Medicine (TCM) approach to develop standardized TCM formulas to holistically treat autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) in children, and infectious diseases such as the coronavirus disease (COVID-19).
In March 2020, Regencell’s strategic partner and TCM practitioner, Mr. Sik-Kee Au, modified his proprietary cold and flu TCM formula for use in COVID-19 patients. The TCM practitioner subsequently treated 9 voluntary COVID-19 patients in the United States and patients showed improvements after an average of five days. Based on these promising results, Regencell formed a joint venture with Honor Epic Enterprises Limited in September 2021 to conduct further tests and commercialize Regencell’s COVID-19 treatment in ASEAN countries.
EARTH Efficacy Trials (EARTH-A Trial and EARTH-B Trial)
From March 2020 to August 2021, Regencell set up protocols and procedures to conduct the Evaluation and Assessment of RGC-COV19TM TCM through a Holistic approach (EARTH) efficacy trial in Malaysia and the United States. The first EARTH efficacy trial (EARTH-A Trial), was a non-blinded trial of 37 subjects to study the efficacy of Regencell’s TCM formula for COVID-19 (RCG-COV19TM) over a six-day treatment period. In the EARTH-A Trial, of the 37 subjects, 36 patients (97.3%) had all mild-to-moderate symptoms eliminated (except for Sensory Dysfunction or occasional cough) within six days.
An additional efficacy trial (EARTH-B Trial) was conducted from January 30 to March 31, 2022 to corroborate EARTH-A’s results. The EARTH-B Trial followed the same design as the EARTH-A Trial, on a larger group of subjects. During the EARTH-B Trial, the Omicron variant accounted for 80% of COVID-19 cases in Malaysia. The EARTH-A Trial was conducted when Delta was the dominant variant.
51 subjects in Malaysia, aged 11 to 75, were enrolled for the EARTH-B Trial. They were of different races, ethnicity and socioeconomic background. All subjects showed onset of symptoms within five days of treatment initiation and laboratory-confirmed diagnosis of COVID-19 within three days to the start of treatment. Subjects with a confirmed diagnosis of COVID-19 but who were asymptomatic, were excluded from the study.
In the EARTH-B Trial, 50 subjects were fully-vaccinated and the one unvaccinated subject was 11 years old. Subjects who were vaccinated either received Pfizer-BioNTech, AstraZeneca or Sinovac-CoronaVac, the top three vaccines distributed in Malaysia.
Each subject was first given two doses of Regencell’s formula (two days of treatment) and were followed for a maximum of six days. Subjects took a reverse transcription-polymerase chain reaction test (RT-PCR test) for COVID-19 every two days. The COVID-19 treatment ended upon patients receiving a negative RT-PCR test or when their symptoms were gone (except for loss or reduce of sense of smell and/or taste (Sensory Dysfunction) or occasional cough), at the end of the six-day study period.
To assess the efficacy and time to symptom improvement/resolution, patients recorded their symptoms daily on a three-point scale ranging from mild to severe. Patients were asked to log specific symptoms such as fever (including hot flashes or chills), upper respiratory issues (cough, sore throat, runny nose), lower respiratory issues (shortness of breath, chest pain or pressure), muscle aches, nausea, abdominal discomfort, and drowsiness, and to identify any other symptoms they were experiencing. The largest number of different symptoms reported by the enrolled patients was 16 and the average number of different symptoms reported was approximately 7.
None of the trial subjects was hospitalized and there was no death. The efficacy of RGC-COV19TM was not affected by timing of symptom onset or underlying risk factor. Results were consistent across all ages, gender, races and ethnicity demographic among subjects.
Symptoms elimination
Of the 51 subjects, 48 patients (94.1%) had all mild-to-moderate symptoms eliminated (except for Sensory Dysfunction or occasional cough) within six days. 46 of 51 patients (90.2%) reported elimination of one or more symptoms after one day of treatment, which is considerably better than the 83.8% response reported in the EARTH-A Trial. On average, subject reported elimination of all symptoms (except Sensory Dysfunction and occasional cough) 3.6 days after starting treatment.
Clearing the virus - negative RT-PCR test
Subjects took RT-PCR tests every other day during the study. In Malaysia, the threshold for ‘not detected’ is above 40, meaning a CT value of 40 or lesser means a person is COVID-19 positive while a CT value of more than 40 means a person tested negative for COVID-19. Of the 51 subjects in the study, 23.5% (n=12) tested negative for COVID-19 by the end of the study. The remaining 36 subjects who reported all symptoms eliminated (excluding Sensory Dysfunction and/or occasional cough) before the end of the study (averaging recovery period of 3.4 days) were not further tested for COVID-19.
Sensory dysfunction and breathing difficulty
Sensory dysfunction (loss or reduce of sense of smell or taste) appears to linger beyond the six-day study period for many subjects. Prior to receiving treatment, 17 of 51 subjects reported sensory dysfunction. 11 of the subjects regained their sense of smell and/or taste at the end of the six-day study, while the other six reported improvement.
Prior to treatment, 15 patients reported experiencing a combination of dyspnea (difficulty in breathing) and persistent chest pain. 10 of these 15 patients no longer experienced difficulty in breathing and/or persistent chest pain after 1 full dose of RGC-COV19TM.
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