COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04627519

Keri Lestari, PhD

lestarikd@unpad.ac.id

2020-11-13

Unknown

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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.

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.

2

Universitas Padjadjaran

18

50

Indonesia

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

85

Length of stay

None

Phase 2

[{"arm_notes": "", "treatment_id": 93, "treatment_name": "Antioxidant therapy", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]