Actively Recruiting
A Multicenter, Open-Label, Randomized Phase 2a Study to Evaluate Safety and Efficacy of Ratutrelvir and Standard of Care in Non-hospitalized Symptomatic Adult Participants With Mild to Moderate COVID-19
Led by Traws Pharma, Inc. · Updated on 2026-01-21
90
Participants Needed
15
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating Ratutrelvir (83-0060), a drug that inhibits the main protease of SARS-CoV-2, along with Paxlovid (Nirmatrelvir plus Ritonavir), to understand their safety and effectiveness in adults with mild to moderate COVID-19 who are not hospitalized. This open-label, randomized Phase 2a study aims to determine a safe and effective dose of Ratutrelvir and compare it with standard care, providing important information on how these treatments may help manage COVID-19 symptoms and recovery. Participants will be assigned to receive either Ratutrelvir or Paxlovid alongside standard care. The study is multicenter and open-label, meaning both researchers and participants know which treatment is given. The trial includes an experimental group receiving Ratutrelvir, a comparator group receiving Paxlovid, and a non-randomized group receiving Ratutrelvir. Treatment is given during the study period, and the research team monitors the drug's concentration in the blood to understand how it behaves in the body. During the 28-day study period, participants will be closely monitored for safety based on the occurrence and severity of any adverse events. The team will assess how long it takes for COVID-19 symptoms to improve and recover fully. Blood samples will be collected up to day 11 to analyze drug levels. Participants will undergo symptom evaluations regularly, and their health will be tracked throughout the study to ensure safety and gather data on treatment effects.
CONDITIONS
Brief Title
Early-stage Trial to Determine a Safe and Effective Dose for Ratutrelvir in Patients With Mild to Moderate COVID-19
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed SARS-CoV-2 infection within 120 hours before randomization
- Onset of COVID-19 signs or symptoms within 5 days before randomization
- At least one COVID-19 symptom with severity score of 1 or higher within 24 hours before Day 1
- Adult participants aged 18 years or older
- Non-hospitalized with mild to moderate COVID-19 symptoms
You will not qualify if you...
- History or current need for hospitalization for COVID-19 treatment
- Need for nasal high-flow oxygen therapy, positive pressure ventilation, invasive mechanical ventilation, or ECMO
- Known 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 or COPD within 30 days before screening
- Suspected or confirmed active systemic infection
- Received or expected to receive any SARS-CoV-2 vaccine dose within 4 months before or during the study
- Use of medications or substances that strongly induce CYP3A4 enzyme
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days
Participants receive study drugs including Ratutrelvir or Paxlovid to treat mild to moderate COVID-19 symptoms.
Multiple visits during treatment period
Trial Site Locations
Total: 15 locations
1
Novatrial
Charlestown, New South Wales, Australia, 2290
Actively Recruiting
2
Key Health
Sydney, New South Wales, Australia, 2000
Actively Recruiting
3
Momentum Clinical Research Taringa
Brisbane, Queensland, Australia, 4068
Actively Recruiting
4
Paratus Clinical(Clinical Trials Institute, Torquay)
Torquay, Victoria, Australia, 3228
Not Yet Recruiting
5
Chonnam National University Hospital
Gwangju, Donggu, South Korea, 61469
Not Yet Recruiting
6
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, Eunpyeong-gu, South Korea, 07441
Not Yet Recruiting
7
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea, 26426
Not Yet Recruiting
8
Inha University Hospital
Incheon, Jung-gu, South Korea, 22332
Not Yet Recruiting
9
Hallym University Sacred Heart Hospital Gangnam
Seoul, Seoul, South Korea, 07441
Not Yet Recruiting
10
Kaohsiung Medical University Hospital
Kaohsiung City, Kaohsiung, Taiwan, 807
Not Yet Recruiting
11
Taichung Veterans General Hospital
Taichung, Taichung, Taiwan, 407
Not Yet Recruiting
12
Taipei Medical University Hospital
Taipei, Taipei, Taiwan, 110
Not Yet Recruiting
13
Taoyuan General Hospital
Taoyuan, Taoyuan, Taiwan, 33004
Not Yet Recruiting
14
Chang Gung Memorial Hospital, Linkou Branch
Taoyuan, Taoyuan, Taiwan, 333
Not Yet Recruiting
15
Research Institute of Virology
Tashkent, Tashkent, Uzbekistan, 100194
Actively Recruiting
Research Team
E
Ekaterina Dokukina
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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