A Multicenter, Randomized, Open-label, Controlled Trial to Assess Effectiveness and Safety of Rhea Health Tone® as add-on Therapy for COVID-19 in Hospitalized Adults in Indonesia
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Universitas Padjadjaran
- Enrollment
- 85
- Locations
- 4
- Primary Endpoint
- Length of stay
Study Overview
Brief Summary
This is a multicenter, randomized, open-label, controlled trial to evaluate the effectiveness and safety of Rhea Health Tone® as add-on therapy in hospitalized adults with COVID-19.
The study is a multi-center trial that will be conducted in up to approximately 2 sites nationally. New sites may be added as needed after appropriate assessment. Interim monitoring will be conducted to evaluate the arms and for safety and effectiveness. Any change would be accompanied by updated sample size.
Subjects will be assessed while hospitalized. All subjects will undergo a series of laboratory (inflammatory biomarkers (IL-6, hs-CRP, IFNγ), SGOT, SGPT and Creatinine, conversion rate by PCR, QTc prolongation by ECG, chest X-ray), clinical (clinical assessment, vital sign, concomitant medication, other medical conditions) and safety assessment (serious adverse event).
Randomization will be performed 1:1 for each arm. Arm 1 = Standard of Care (SoC) alone, arm 2 = SoC + Rhea Health Tone®.
Detailed Description
This is a multicenter, randomized, open-label, controlled trial to evaluate the effectiveness and safety of Rhea Health Tone® in hospitalized adults with COVID-19 confirmed by PCR.
The study is a multi-center trial that will be conducted in up to approximately 2 sites nationally. Interim monitoring will be conducted to evaluate the arms and for safety and effectiveness. Any change would be accompanied by an updated sample size.
Eligible patients are male or female adults (age ≥ 18 years up to 50 years old) recently admitted as in-patients, with mild to moderate COVID-19 confirmed by positive PCR that fulfill the inclusion and exclusion criteria stated in the protocol. Laboratory assessment include SGOT, SGPT and Creatinine at screening. The subjects must sign their consent in writing electronically beforehand. Total subjects = 69.
Subjects with any of these conditions will be excluded:
- Any allergy to any composition of Rhea Health Tone;
- Pregnant and breast feeding;
- History and co-morbid of severe underlying disease where treatment and follow up is not likely to be beneficial to the patient based on physician judgement (e.g. retinopathy, cardiovascular disease (QTc > 500 mdet (narrow QRS); QTc ≥ 550 mdet (wide QRS)), heart arrythmia, uncontrolled diabetes mellitus, hypertension, chronic pulmonary disease, asthma, chronic kidney disease (Creatinine > 2x upper limit of normal), liver disease (SGOT/SGPT > 2x upper limit of normal), chronic neurological disease, or etc.). This includes people requiring care in designated supported living facilities and severe dementia;
- Possibility of being transferred to a non-study-hospital within 72 hours.
- History of autoimmune disease, cancer, HIV AIDS
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female patients aged ≥ 18 years to 50 years old, who recently admitted as in-patients and have not received any standard of care yet, with COVID-19 confirmed by PCR with mild to moderate symptoms.
- •Female subjects of child-bearing age agree to take effective contraceptive measures during the study until seven days of the last oral medication of study product;
- •Willing to receive a random assignment to any designated treatment group and not participating in another study at the same time;
- •Willing for not using any other immunomodulator or treatment that might bias the study
- •Patient willing to provide informed consent.
Exclusion Criteria
- •Any allergy to any composition of Rhea Health Tone®;
- •Pregnant and breastfeeding;
- •History and co-morbid of severe underlying disease where treatment and follow up is not likely to be beneficial to the patient based on physician judgment (e.g. retinopathy, cardiovascular disease (QTc > 500 mdet (narrow QRS); QTc ≥ 550 mdet (wide QRS)), heart arrhythmia, uncontrolled diabetes mellitus, hypertension, chronic pulmonary disease, asthma, chronic kidney disease (Creatinine > 2x upper limit of normal), liver disease (SGOT/SGPT > 2x limit of normal), chronic neurological disease, or etc.). This includes people requiring care in designated supported living facilities and severe dementia;
- •Possibility of being transferred to a non-study-hospital within 72 hours.
- •History of autoimmune disease, cancer, HIV AIDS.
Outcomes
Primary Outcomes
Length of stay
Time Frame: From the date of randomization until the date of first documented subject discharge or death from any cause, assessed up to 10 days
Total days the subjects were hospitalized
Secondary Outcomes
- Inflammatory biomarkers 2(Will be examined at days 1st and 10th.)
- PCR conversion(Will be examined at days 1st , 7th, and 10th.)
- Inflammatory biomarkers 1(Will be examined at days 1st and 10th.)
- Duration of oxygenation(From the date of randomization until the date of first documented subject discharge or death from any cause, assessed up to 10 days)
- Duration of ventilation(From the date of randomization until the date of first documented subject discharge or death from any cause, assessed up to 10 days)
- Percentage of improvement of subjects' clinical status(From the date of randomization until the date of first documented subject discharge or death from any cause, assessed up to 10 days)
- Inflammatory biomarkers 3(Will be examined at days 1st and 10th.)
- X-Ray(From the date of informed consent signed by subject, until the date of first documented subject discharge or death from any cause, assessed up to 10 days)
Investigators
Keri Lestari
Prof. Dr. Keri Lestari, M.Si, S.Si, Apt.
Universitas Padjadjaran