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

Traws Pharma, Inc.

Status and phase: Enrolling; Phase 2

Conditions: COVID - 19

Treatments: Drug: Ratutrelvir (83-0060); Drug: Ratutrelvir (83-0060) non-randomised; Drug: Paxlovid

Study type: Interventional

Funder types: Industry

Identifiers

NCT07157007

83-0060-0002

Details and patient eligibility

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.

Full description

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Ratutrelvir (83-0060) non-randomised

Experimental group

Treatment:

Drug: Ratutrelvir (83-0060) non-randomised

Paxlovid

Active Comparator group

Description:

Standard of care

Treatment:

Drug: Paxlovid

Ratutrelvir (83-0060)

Experimental group

Treatment:

Drug: Ratutrelvir (83-0060)