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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-16

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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This is a multicenter, open-label, randomized Phase 2a study to evaluate the safety and efficacy of 83-0060 (Ratutrelvir) and Nirmatrelvir-Ritonavir (Paxlovid) in non-hospitalized symptomatic adult participants with mild to moderate COVID-19.

Conditions

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COVID - 19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized into 3 study arms (30 participant per arm) to receive study drug and standard of care therapy

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ratutrelvir (83-0060) non-randomised

Group Type EXPERIMENTAL

Ratutrelvir (83-0060) non-randomised

Intervention Type DRUG

83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)

Paxlovid

Standard of care

Group Type ACTIVE_COMPARATOR

Paxlovid

Intervention Type DRUG

Paxlovid (Nirmatrelvir+ Ritonavir , boosted 3CL-protease inhibitor)

Ratutrelvir (83-0060)

Group Type EXPERIMENTAL

Ratutrelvir (83-0060)

Intervention Type DRUG

83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)

Interventions

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Ratutrelvir (83-0060) non-randomised

83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)

Intervention Type DRUG

Paxlovid

Paxlovid (Nirmatrelvir+ Ritonavir , boosted 3CL-protease inhibitor)

Intervention Type DRUG

Ratutrelvir (83-0060)

83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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:

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novatrial

Charlestown, New South Wales, Australia

Site Status RECRUITING

Key Health

Sydney, New South Wales, Australia

Site Status RECRUITING

Momentum Clinical Research Taringa

Brisbane, Queensland, Australia

Site Status RECRUITING