A Phase 2 interventional study of Ratutrelvir (83-0060) non-randomised and Paxlovid in COVID - 19, sponsored by Traws Pharma, Inc.. Completed at 1 site in Uzbekistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Traws Pharma, Inc. · Phase 2, Interventional, and Treatment
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.
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.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 93 is close to the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Traws Pharma, Inc. is the lead sponsor of 35 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Medical Conditions:
Suspected or confirmed concurrent active systemic infection..
Prior/Concomitant Therapy:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Ratutrelvir (83-0060) non-randomised
Standard of care
Drug: Paxlovid
Drug: Ratutrelvir (83-0060)
83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)
Paxlovid (Nirmatrelvir+ Ritonavir , boosted 3CL-protease inhibitor)
83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)
Safety based on adverse events incidence
Adverse events incidence will be described using descriptive statistics methods
Time frame: 28 days
Safety based on adverse events severity
Adverse events severity will be assessed by current version of CTCAE
Time frame: 28 days
Efficacy based on Time (days) to sustained recovery of all targeted COVID-19 signs/symptoms through Day 28
Time frame: 28 days
Efficacy based on Time to sustained recovery of each targeted COVID-19 symptom through Day 28.
Time frame: 28 days
PK characteristics of 83-0060 based on Maximum Plasma Concentration (Cmax)
Time frame: 11 days
PK characteristics of 83-0060 based on Area under the concentration time curve from 0 to time of last quantifiable concentration (AUClast)
Time frame: 11 days
PK characteristics of 83-0060 based on Time to Cmax ( Tmax)
Time frame: 11 days
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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