Coronavirus disease 2019 (COVID-19) MedDRA version: 23.1 Level: LLT Classification code 10084401 Term: COVID-19 respiratory infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: AT-527
Product Code: RO7496998
Pharmaceutical Form: Tablet
INN or Proposed INN: Not available yet
CAS Number: 2241337-84-6
Current Sponsor code: RO7496998
Other descriptive name: AT-511
Sponsors
F. Hoffmann La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age>=18 years at time of signing Informed Consent Form Positive SARS-CoV-2 diagnostic test (RT-PCR or rapid antigen test) at screening Has symptoms consistent with mild or moderate COVID-19, as determined by the investigator, with onset =65 years) yes F.1.3.1 Number of subjects for this age range 22
Exclusion criteria
Exclusion criteria: Clinical signs indicative of COVID-19 illness requiring hospitalization, defined as any of the following: shortness of breath at rest, respiratory rate >= 30, heart rate >= 125, peripheral capillary oxygen saturation (SpO2) <= 93% on room air Treatment with a therapeutic agent against SARS-CoV-2 including, but not limited to, other direct-acting antivirals, convalescent plasma, monoclonal antibodies against SARS-CoV-2, or intravenous immunoglobulin within 3 months or less than 5 drug-elimination half-lives (whichever is longer) prior to screening Requirement, in the opinion of the investigator, for any of the prohibited medications during the study Use of hydroxychloroquine or amiodarone within 3 months of screening Pregnant or breastfeeding, or intending to become pregnant during the study or within 30 days after the final dose of study drug. Women of childbearing potential must have a negative serum pregnancy test result at screening Abnormal laboratory test results at screening Clinically significant abnormal ECG, as determined by the Investigator, at screening Planned procedure or surgery during the study Known allergy or hypersensitivity to study drug or drug product excipients Substance abuse, as determined by the investigator, within 12 months prior to screening Poor peripheral venous access Malabsorption syndrome or other condition that would interfere with enteral absorption Any clinically significant history of epistaxis within the last 3 months and/or history of being hospitalized due to epistaxis of any previous occasion History of anaphylaxis Any uncontrolled serious medical condition or other clinically significant abnormality in laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • To evaluate the antiviral activity of AT 527 compared with placebo based on time to cessation of SARS-CoV-2 viral shedding, time to sustained non-detectable SARS-CoV-2 virus RNA, proportion of patients positive for SARS-CoV-2 virus RNA, and area under the curve in the amount of SARS-CoV-2 virus RNA • To evaluate the safety of AT 527 compared with placebo • To characterize the PK profile of AT 511 (free base form of AT-527) and its major metabolites • To evaluate the efficacy of AT 527 compared with placebo ;Main Objective: • To evaluate the antiviral activity of AT-527 compared with placebo based on change from baseline in amount of SARS-CoV-2 virus RNA;Primary end point(s): Change from baseline in amount of SARS-CoV-2 virus RNA as measured by RT-PCR at specified timepoints;Timepoint(s) of evaluation of this end point: 1. Baseline (Day 1) to Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Time to cessation of SARS-CoV-2 viral shedding as measured by RT-PCR 2. Time to sustained non-detectable SARS-CoV-2 virus RNA 3. Proportion of patients positive for SARS-CoV-2 virus RNA by RT-PCR at specified timepoints 4. Area under the curve in the amount of SARS-CoV-2 virus RNA as measured by RT-PCR 5. Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0 6. Change from baseline in targeted vital signs, including SpO2 7. Change from baseline in targeted clinical laboratory test results 8. Plasma concentration of AT-511 (free base form of AT-527), AT-551, AT-229, and AT-273 (surrogate for the intracellular concentration of the active triphosphate metabolite AT-9010) at specified timepoints 9. 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 10. The time to alleviation or improvement of COVID-19 symptoms (Items 1-12 of the COVID-19 symptom diary) maintained for a duration of 43 hours 11. Time to alleviation of COVID-19 symptoms defined as the length of time taken from start of treatment to the point at which the following criterion is met and maintained for at least 21.5 hours: Score of 0 or 1 on Items 1-12 of the COVID-19 Symptom Diary (without consideration for presence of pre-existing symptoms) 12. Time to alleviation of COVID-19 symptoms, defined as the length of time taken from start of treatment to the point at which the following criterion is met and maintained for at least 43 hours: Score of 0 or 1 on Items 1-12 of the COVID-19 Symptom Diary (without consideration for presence of pre-existing symptoms) 13. Duration of fever 14. Frequency of COVID-19-related complications 15. Time to alleviation of an individual symptom ;Timepoint(s) of evaluation of this end point: 1-4. Day 1 to Day 7 5. Up to Day 33 6. Baseline to Day 7 7. Baseline to Day 7 8. Day 1 to Day 7 9-15. Day 1 to Day 28 | — |
Countries
Bulgaria, Canada, Croatia, Greece, Ireland, Latvia, Lithuania, Poland, Spain, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
F.Hoffmann-La Roche, Ltd.
Outcome results
None listed