Status:

COMPLETED

Randomized Controlled Clinical Trial to Evaluate The Efficacy and Safety of Healthtone as Prophylaxis for COVID-19

Lead Sponsor:

Indonesia University

Conditions:

COVID-19

Eligibility:

All Genders

18-65 years

Phase:

NA

Brief Summary

Background : Coronavirus disease known as COVID-19 is caused by the SARS-CoV-2. Transmission of SARS CoV-2 is spreading from human to human through direct or indirect droplets, this disease then sprea...

Detailed Description

This study is a double-blind randomized clinical trial on the human resources population at Persahabatan Central General Hospital, Jakarta. Subjects who have agreed to be included in the study will u...

Eligibility Criteria

Inclusion

  • Age 18-65 years old
  • Human resources in persahabatan central general hospital while being a research subject
  • Wear PPE according to their respective work standards.
  • Not previously infected with COVID-19, or have been infected with COVID-19 19 previously with non-reactive IgG serological results.
  • Have not received a COVID-19 vaccine or have received 2nd dose of vaccine COVID-19 but manifest non-reactive IgG serological results
  • Subject voluntarily gave written consent to participate in this research.

Exclusion

  • Patients with severe comorbid factors such as: uncontrolled congestive heart disease, renal insufficiency, coronary heart disease, chronic liver disease, diabetes mellitus with complications, uncontrolled hypertension or crisis hypertension, immunocompromised, CNS disorders (such as stroke, epilepsy, Alzheimer's, meningitis) , cancer, HIV, AIDS.
  • Subjects who are pregnant or breastfeeding.
  • Subjects who cannot be included in the study according to consideration of the researcher.
  • Subjects who are in the process of taking other drug clinical trials.
  • Subjects with a history of allergy to the components of the test drug.

Key Trial Info

Start Date :

March 3 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 17 2022

Estimated Enrollment :

92 Patients enrolled

Trial Details

Trial ID

NCT05308615

Start Date

March 3 2021

End Date

March 17 2022

Last Update

May 2 2022

Active Locations (1)

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Departemen Pulmonology and Respiratory, Faculty of Medicine Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, Indonesia, 10430