Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07157007

Early-stage Trial to Determine a Safe and Effective Dose for Ratutrelvir in Patients With Mild to Moderate COVID-19

Led by Traws Pharma, Inc. · Updated on 2026-01-21

90

Participants Needed

15

Research Sites

23 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is an Early-stage Clinical Trial to Determine a Safe and Effective Dose for Ratutrelvir in Patients With Mild to Moderate COVID-19. It will also learn about the safety of drug Ratutrelvir. Participants will take a study drug as well as a standard therapy. A descriptive statistics will be used to present the study results.

CONDITIONS

Official Title

Early-stage Trial to Determine a Safe and Effective Dose for Ratutrelvir in Patients With Mild to Moderate COVID-19

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  1. Confirmed SARS-CoV-2 infection for 120 h prior to randomization.
  2. Initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to randomization.
  3. At least one of the symptoms attributable to COVID-19 present within 24 hours prior to the Day 1 with the severity score of 1 or higher according to the following scoring system for the assessment of severity of:
Not Eligible

You will not qualify if you...

Medical Conditions:

  1. History, current need for hospitalization or anticipated need for hospitalization for the medical treatment of COVID-19.

  2. Urgent or expected need for nasal high-flow oxygen therapy or positive pressure ventilation, invasive mechanical ventilation or ECMO.

  3. Known medical history of active liver disease .

  4. Receiving dialysis or history of moderate to severe renal impairment.

  5. Compromised immune system.

  6. Acute episode of chronic respiratory diseases, including bronchial asthma, chronic obstructive pulmonary disease within 30 days before screening.

  7. Suspected or confirmed concurrent active systemic infection..

    Prior/Concomitant Therapy:

  8. Has received or is expected to receive any dose of a SARS-CoV-2 vaccine within 4 months of screening and during the participation in the study.

  9. Concomitant use of any medications or substances that are strong inducers of CYP3A4

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 15 locations

1

Novatrial

Charlestown, New South Wales, Australia, 2290

Actively Recruiting

2

Key Health

Sydney, New South Wales, Australia, 2000

Actively Recruiting

3

Momentum Clinical Research Taringa

Brisbane, Queensland, Australia, 4068

Actively Recruiting

4

Paratus Clinical(Clinical Trials Institute, Torquay)

Torquay, Victoria, Australia, 3228

Not Yet Recruiting

5

Chonnam National University Hospital

Gwangju, Donggu, South Korea, 61469

Not Yet Recruiting

6

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Seoul, Eunpyeong-gu, South Korea, 07441

Not Yet Recruiting

7

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea, 26426

Not Yet Recruiting

8

Inha University Hospital

Incheon, Jung-gu, South Korea, 22332

Not Yet Recruiting

9

Hallym University Sacred Heart Hospital Gangnam

Seoul, Seoul, South Korea, 07441

Not Yet Recruiting

10

Kaohsiung Medical University Hospital

Kaohsiung City, Kaohsiung, Taiwan, 807

Not Yet Recruiting

11

Taichung Veterans General Hospital

Taichung, Taichung, Taiwan, 407

Not Yet Recruiting

12

Taipei Medical University Hospital

Taipei, Taipei, Taiwan, 110

Not Yet Recruiting

13

Taoyuan General Hospital

Taoyuan, Taoyuan, Taiwan, 33004

Not Yet Recruiting

14

Chang Gung Memorial Hospital, Linkou Branch

Taoyuan, Taoyuan, Taiwan, 333

Not Yet Recruiting

15

Research Institute of Virology

Tashkent, Tashkent, Uzbekistan, 100194

Actively Recruiting

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Research Team

E

Ekaterina Dokukina

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Early-stage Trial to Determine a Safe and Effective Dose for Ratutrelvir in Patients With Mild to Moderate COVID-19 | DecenTrialz