COVID - 19
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGRatutrelvir (83-0060) non-randomised
83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)
DRUGPaxlovid
Paxlovid (Nirmatrelvir+ Ritonavir , boosted 3CL-protease inhibitor)
DRUGRatutrelvir (83-0060)
83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)
Sponsors
Traws Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomized into 3 study arms (30 participant per arm) to receive study drug and standard of care therapy
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety based on adverse events incidence | 28 days | Adverse events incidence will be described using descriptive statistics methods |
| Safety based on adverse events severity | 28 days | Adverse events severity will be assessed by current version of CTCAE |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy based on Time (days) to sustained recovery of all targeted COVID-19 signs/symptoms through Day 28 | 28 days |
| Efficacy based on Time to sustained recovery of each targeted COVID-19 symptom through Day 28. | 28 days |
| PK characteristics of 83-0060 based on Maximum Plasma Concentration (Cmax) | 11 days |
| PK characteristics of 83-0060 based on Area under the concentration time curve from 0 to time of last quantifiable concentration (AUClast) | 11 days |
| PK characteristics of 83-0060 based on Time to Cmax ( Tmax) | 11 days |
Countries
Australia, South Korea, Taiwan, Uzbekistan
Contacts
CONTACTEkaterina Dokukina
Outcome results
None listed