RecruitingPhase 2

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

Australia, South Korea90 participantsStarted 2025-09-16

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Confirmed SARS-CoV-2 infection for 120 h prior to randomization.
✓. Initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to randomization.
✓. 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:

Exclusion criteria

✕. History, current need for hospitalization or anticipated need for hospitalization for the medical treatment of COVID-19.
✕. Urgent or expected need for nasal high-flow oxygen therapy or positive pressure ventilation, invasive mechanical ventilation or ECMO.
✕. Known medical history of active liver disease .
✕. Receiving dialysis or history of moderate to severe renal impairment.
✕. Compromised immune system.
✕. Acute episode of chronic respiratory diseases, including bronchial asthma, chronic obstructive pulmonary disease within 30 days before screening.
✕. Suspected or confirmed concurrent active systemic infection..
✕. 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.

What they're measuring

Safety based on adverse events incidence

Timeframe: 28 days

Safety based on adverse events severity

Timeframe: 28 days

Trial details

NCT IDNCT07157007

SponsorTraws Pharma, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02

Contact for this trial

Ekaterina Dokukina

+38269728309 kdokukina@eilenther.com

View on ClinicalTrials.gov More COVID - 19 trials