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

ConditionCOVID - 19
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTraws Pharma, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Ratutrelvir (83-0060) non-randomised
  • Paxlovid
  • Ratutrelvir (83-0060)

Treatment groups

90 Participants
are divided into 3 treatment groups

Locations

15
Australia
Novatrial2290, CharlestownNew South Wales, Australia
Key Health2000, SydneyNew South Wales, Australia
Momentum Clinical Research Taringa4068, BrisbaneQueensland, Australia
Paratus Clinical(Clinical Trials Institute, Torquay)3228, TorquayVictoria, Australia

Sponsors and collaborators

Traws Pharma, Inc.

Lead sponsor