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Effectiveness and Safety of Rhea Health Tone® as add-on Therapy for COVID-19 in Hospitalized Adults in Indonesia

NCT04627519 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2021-06-10

No results posted yet for this study

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®.

Conditions

  • Covid19

Interventions

DIETARY_SUPPLEMENT

Rhea Health Tone®

Rhea Health Tone® 2 ml twice daily after the meal (every 12 hours)

Sponsors & Collaborators

  • PT. Rhea Pharmaceutical Sciences Indonesia

    collaborator UNKNOWN

  • Prodia Diacro Laboratories P.T.

    collaborator INDUSTRY

  • Universitas Padjadjaran

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-09
Primary Completion
2021-05-19
Completion
2021-09-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04627519 on ClinicalTrials.gov