Safety and Efficacy of Softgel KOVIR (TD0068) in the Combination Regimen With Background Treatment in COVID-19 Patients (KOVIR)

COVID-19 Clinical Trial

Official title:
Randomized, Double-blind, Placebo-controlled, Phase IIb Study, Safety Evaluation and Exploration of the Effect on Virologic Dynamics of Softgel KOVIR (TD.0068) in Combination With Background Therapy in Patients With Patients With COVID-19 Have Not Shown Signs of Acute Respiratory Failure.

Status Recruiting

Clinical Trial Summary

Clinical Trial Description

The acute pneumonia pandemic caused by a new strain of corona virus 2019 named as COVID-19 by the World Health Organization (WHO) is a pandemic caused by SARS-CoV-2 virus. The reported symptoms have included, but are not limited to fever or chills, cough, shortness of breath, muscle aches, headaches, loss of taste or smell, diarrhea, dizziness, sore throat, abdominal pain, anorexia, and vomiting. The capsule KOVIR is a product based on the traditional prescription which is used to treat the cold conditions, also known as the initial plague according to the theory of traditional medicine. The study timeline is expected from July 2021 to December 2022, including enrolment period, 14 days of treatment, data entry and analysis. The study compares between standard dose regimen of KOVIR combined with background treatment in COVID-19 patients and placebo combined with background treatment in COVID-19 patients. All participants will be treated and followed up in 14-day period. In case the participant meets the discharge criteria before 14 days, discontinuing the study drug will be done at the discretion of the investigators. Screening procedures occur at Day 1. Periodic assessments are conducted daily from Day 2-14. Finally, End of study visit is conducted. ;

Study Design

Related Conditions & MeSH terms

COVID-19

Clinical Trial Details

NCT number	NCT05082727
Study type	Interventional
Source	Sao Thai Duong Joint Stock Company
Contact	Thi Hong Van Nguyen
Phone	(+84)916451269
Email	vannh@thaiduong.com.vn
Status	Recruiting
Phase	Phase 2
Start date	July 1, 2021
Completion date	November 15, 2022

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.