SARS-CoV-2 study: Secutrelvir
Official title A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
ClinicalTrials.gov ID: NCT07743580
What this study is testing
What is Secutrelvir?
An investigational oral tablet being studied as a potential treatment for COVID-19 in high‑risk adults and adolescents.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see if secutrelvir works and is safe for people who have COVID‑19 symptoms but are not in the hospital and are at high risk of severe illness.
- Who it's for
- Symptomatic adults and adolescents who are not hospitalized and are at high risk of severe COVID‑19.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Must be 12 to \<18 years of age (where permitted by local regulations) with a body weight ≥40 kilograms, or ≥18 years of age regardless of body...
- Presence of risk factors for progression to severe COVID-19 at the time of screening.
- Must have ≥1 COVID-19 signs/symptoms that are at least mild in severity, and the symptoms must still be present in the 24 hours prior to...
- Confirmed SARS-CoV-2 infection, as determined by any SARS-CoV-2 test (for example, quantitative reverse transcription polymerase chain reaction...
- Must be assigned by chance within 72 hours of symptom onset, defined as the time when the first COVID-19 symptom occurs.
You likely can't join if
- Planned \>24 hours hospitalization for any medical procedure through Day 28.
- Documented respiratory infection (for example, influenza, respiratory syncytial virus) other than COVID-19 within the 14 days prior to the screening...
- Known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy).
- Total bilirubin ≥2\ upper limit of normal (ULN) (except for Gilbert's syndrome)
- Aspartate aminotransferase or alanine aminotransferase ≥3\ ULN
- Suspected or confirmed COVID-19 unrelated to the current episode within 6 months prior to randomization or, for moderately immunocompromised...
See the full eligibility criteria
- Must be 12 to \<18 years of age (where permitted by local regulations) with a body weight ≥40 kilograms, or ≥18 years of age regardless of body weight, at the time of signing the informed consent form.
- Presence of risk factors for progression to severe COVID-19 at the time of screening.
- Must have ≥1 COVID-19 signs/symptoms that are at least mild in severity, and the symptoms must still be present in the 24 hours prior to randomization.
- Confirmed SARS-CoV-2 infection, as determined by any SARS-CoV-2 test (for example, quantitative reverse transcription polymerase chain reaction, antigen test) approved according to local regulations, of any respiratory...
- Must be assigned by chance within 72 hours of symptom onset, defined as the time when the first COVID-19 symptom occurs.
- Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- A women of childbearing potential must have a negative urine pregnancy test within 24 hours prior to receiving the investigational intervention.
- Unable or unwilling to take other locally available COVID-19 antivirals (for example, nirmatrelvir/ritonavir, molnupiravir, remdesivir, ensitrelvir). Key
- Planned \>24 hours hospitalization for any medical procedure through Day 28.
- Documented respiratory infection (for example, influenza, respiratory syncytial virus) other than COVID-19 within the 14 days prior to the screening visit.
- Known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy).
- Total bilirubin ≥2\ upper limit of normal (ULN) (except for Gilbert's syndrome)
- Aspartate aminotransferase or alanine aminotransferase ≥3\ ULN
- Suspected or confirmed COVID-19 unrelated to the current episode within 6 months prior to randomization or, for moderately immunocompromised participants, within 3 months prior to randomization.
- Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the investigational intervention.
- Ongoing long COVID-19 or post-acute sequelae of COVID-19 diagnosis.
- Current severely immunocompromised conditions.
- Antiviral agents (for example, remdesivir, nirmatorelvir/ritonavir, molnupiravir, ensitrelvir) within 30 days or 5 half-lives (whichever is longer) prior to randomization
- Anti-SARS-CoV-2 monoclonal antibodies and COVID-19 convalescent plasma within 6 months prior to randomization Note: Other protocol-define criteria apply
The study team makes the final eligibility decision.
Where it is enrolling
- Hialeah, Florida, United States
- Miami, Florida, United States
- North Miami Beach, Florida, United States
- Cincinnati, Ohio, United States
- Kasugai-Shi, Aiti, Japan
- Chiba, Chiba, Japan
- Fukuoka, Fukuoka, Japan
- Annaka-Shi, Gunma, Japan
- Fujioka-Shi, Gunma, Japan
- Koyagimachi, Gunma, Japan
- Maebashi, Gunma, Japan
- Takasaki-shi, Gunma, Japan
- Akashi-Shi, Hyôgo, Japan
- Himeji-shi, Hyôgo, Japan
- Tsuchiura-Shi, Ibaraki, Japan
- Tsukuba, Ibaraki, Japan
- Morioka, Iwate, Japan
- Kawasaki-shi, Kanagawa, Japan
- Shiga, Kusatsu, Japan
- Sendai, Miyagi, Japan
+ 15 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Hialeah, Florida, United States; Miami, Florida, United States; North Miami Beach, Florida, United States; Cincinnati, Ohio, United States; Kasugai-Shi, Aiti, Japan; Chiba, Chiba, Japan and 29 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.