A Phase III study to evaluate the Efficacy, Safety, and Antiviral Activity of RO7496998 (AT-527) in Non-hospitalized Patients with Mild or Moderate COVID-19

JRCT ID: jRCT2031210070

Registered date:07/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: SARS-COV-2 infection
• Date of first enrollment: 16/06/2021
• Target sample size: 1386
• Countries of recruitment: Mexico,Japan,Argentina,Japan,Brazil,Japan,Columbia,Japan,Peru,Japan,Belgium,Japan,Denmark,Japan,France,Japan,Germany,Japan,Hungary,Japan,Italy,Japan,Poland,Japan,Russia,Japan,Serbia,Japan,Spain,Japan,Switzerland,Japan,Turkey,Japan,Ukraine,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): RO7496998 (AT-527): 550mg twice daily for 5days

Outcome(s)

Primary Outcome

Efficacy
The time to alleviation or improvement of COVID-19 symptoms (Items 1-12 of the COVID-19 symptom diary) maintained for a duration of 21.5 hours

Secondary Outcome

Efficacy, Safety, Phamacokinetics, Phamacodynamics, Phamacogenomics
1.Efficacy
-Time to alleviation of COVID-19 symptoms
-Proportion of patients requiring hospitalization for COVID-19
-Proportion of patients with >= 1 COVID-19 related medically attended visit through to study end
-Duration of fever
-Frequency of COVID-19 related complications
-Proportion of patients with any post-treatment infection
-Proportion of patients with all-cause mortality
-Change from baseline in amount of SARS-CoV-2 virus RNA, as measured by RT-qPCR at each timepoint
2.Safety
-Adverse events, Vital signs, Clinical laboratory test results
3.Phamacodynamics
-Plasma concentration of AT-511 (the free base form of RO7496998 [AT-527]), AT-551, AT-229, and AT-273 (a surrogate for the intracellular concentration of the active triphosphate metabolite AT-9010) at specified timepoints

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Age >=18 years (regardless of weight) or age >=12 to <18 under (weight >=40 kg ) at the time of signing informed consent (and assent)
- At least three of the following symptoms of at least moderate (score >=2 as per COVID-19 Symptom Diary) intensity: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills or sweats, feeling hot or feverish, nausea, vomiting, or diarrhea
- Positive SARS-CoV-2 diagnostic test withoin72 hours prior to randomization
- Symptoms consistent with mild or moderate COVID-19 with onset within 5 days before randomization
- For women of childbearing potential: agreement to remain abstinent or use adequate contraception during the study duration

Exclude criteria

- Admitted to a hospital prior to randomization at randomization due to COVID-19
- Is likely to experience imminent deterioration and require hospitalization
- Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization
- Treatment with a COVID-19 therapeutic agent against SARS-CoV-2 within the last 2 weeks prior to the screening visit
- Concomitant use of P-glycoprotein inhibitors or inducers
- Abnormal laboratory test results at screening

Related Information

• Primary Sponsor: Rebecca Saenz, M.D., Ph.D.
• Secondary ID(s): 2020-005759-18