Early-stage Trial to Determine a Safe and Effective Dose for Ratutrelvir in Patients With Mild to Moderate COVID-19
Recruiting
Phase 2Interventional Study
COVID - 19
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
90 (estimated)
Sponsor
Traws Pharma, Inc. · Industry
Who this trial is looking for
This trial is looking for people with mild to moderate COVID-19. Participants will take the study drug Ratutrelvir along with standard treatment to help determine the right dose and check for safety.
Are You a Good Fit for This Trial?
You may be able to join if
I have a confirmed infection of SARS-CoV-2.
I started showing COVID-19 symptoms within the last 5 days.
I have at least one COVID-19 symptom present within the last 24 hours.
You may not be able to join if
I have a history or need for hospitalization because of COVID-19.
I need or may need oxygen therapy or mechanical ventilation.
I have a history of active liver disease.
I am receiving dialysis or have severe kidney issues.
I have a weakened immune system.
I had an acute episode of chronic respiratory disease in the last 30 days.
I have a concurrent active infection.
I have received a SARS-CoV-2 vaccine in the last 4 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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City
State
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Status
Eligibility Criteria
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 seve…
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
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