| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005759-18 | EudraCT Number |
Not provided
Not provided
Based on program revaluation and in agreement with the co-development partner the sponsor took the decision to terminate this study.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Atea Pharmaceuticals, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This study will evaluate the efficacy, safety, antiviral activity, and pharmacokinetics of study drug RO7496998 (AT-527) compared to placebo in non-hospitalized adult and adolescent participants with mild to moderate coronavirus disease 2019 (COVID-19) in the outpatient setting.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | The dose and regimen of the placebo will match that of AT-527. |
|
| RO7496998 (AT-527) | Experimental | Orally administered, 550 mg twice daily (BID) for 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7496998 | Drug | 275 mg tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Alleviation or Improvement of COVID-19 Symptoms (21.5 Hours) | COVID-19 symptoms will be evaluated using the COVID-19 Symptom Diary (questions 1-12). The severity of each COVID-19 symptom will be recorded on a Likert scale (i.e none/mild/moderate/severe). The time to alleviation or improvement of COVID-19 symptoms is defined as follows: for new symptoms, it is defined as the length of time taken from randomization to the point at which a Score of 0 or 1 has been maintained for a duration of at least 21.5 hours. For preexisting symptoms, it is defined as the time from randomization to when a patient's symptoms have been maintained or improved (requires at least a single category improvement from baseline on the COVID-19 Symptom Diary Likert scale) for a duration of 21.5 hours. | Up to 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Alleviation or Improvement of COVID-19 Symptoms (43 Hours) | COVID-19 symptoms will be evaluated using the COVID-19 Symptom Diary (questions 1-12). The severity of each COVID-19 symptom will be recorded on a Likert scale (i.e none/mild/moderate/severe). The time to alleviation or improvement of COVID-19 symptoms is defined as follows: for new symptoms, it is defined as the length of time taken from randomization to the point at which a Score of 0 or 1 has been maintained for a duration of at least 43 hours. For preexisting symptoms, it is defined as the time from randomization to when a patient's symptoms have been maintained or improved (requires at least a single category improvement from baseline on the COVID-19 Symptom Diary Likert scale) for a duration of 43 hours. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Ave Pulmo | Mar del Plata | B7602DCK | Argentina | |||
| Maison Médicale La Brèche |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37928891 | Derived | Horga A, Saenz R, Yilmaz G, Simon-Campos A, Pietropaolo K, Stubbings WJ, Collinson N, Ishak L, Zrinscak B, Belanger B, Granier C, Lin K, C Hurt A, Zhou XJ, Wildum S, Hammond J. Oral bemnifosbuvir (AT-527) vs placebo in patients with mild-to-moderate COVID-19 in an outpatient setting (MORNINGSKY). Future Virol. 2023 Oct:10.2217/fvl-2023-0115. doi: 10.2217/fvl-2023-0115. Epub 2023 Nov 1. |
Not provided
Not provided
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm)
Not provided
Not provided
Not provided
Not provided
Not provided
Participants were non-hospitalized, with mild to moderate COVID-19, with or without risk factors for severe disease.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | The dose and regimen of the placebo will match that of AT-527. |
| FG001 | RO7496998 (AT-527) | Orally administered, 550 mg twice daily (BID) for 5 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 2, 2021 | May 30, 2022 |
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Matching tablets |
|
| Up to 29 days |
| Time to Alleviation of COVID-19 Symptoms (21.5 Hours) | Time from randomization 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. | Up to 29 days |
| Time to Alleviation of COVID-19 Symptoms (43 Hours) | Time from randomization 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. | Up to 29 days |
| Time to One-Category Improvement of Baseline Presenting COVID-19 Symptoms | Time from randomization to the point at which symptoms (Items 1-12 of the COVID-19 Symptom Diary) have improved by at least one category from baseline on the COVID-19 Symptom Diary Likert scale, maintained for at least 21.5 hours. | Up to 29 days |
| Time to Alleviation of Individual Symptoms | Time from randomization to the point at which the following criterion is met and maintained (for each individual symptom) for at least 21.5 hours. - Score of 0 or 1 for Items 1-14 of the COVID-19 Symptom Diary | Up to 29 days |
| Percentage of Participants Requiring Hospitalization for COVID-19 | Hospitalizations for COVID-19 are defined as SAEs for which the investigator has cited that the suspected cause was the disease under study and where there is a non-missing hospital admission date. | Up to Day 33 visit |
| Percentage of Participants With Greater Than or Equal to 1 COVID-19 Related Medically Attended Visit | Medically attended visit is defined as hospitalization, emergency room (ER) visit, urgent care visit, physician's office visit, or telemedicine visit, with the primary reason for the visit being COVID-19. | Up to Day 33 visit |
| Duration of Fever | Time to return to an afebrile state (temperature ≤ 37.5°C) maintained for at least 21.5 hours. | Up to 29 days |
| Percentage of Participants With COVID-19 Related Complications | COVID-related complications are defined as death, hospitalization, pneumonia, sepsis, coagulopathy, pericarditis/myocarditis and cardiac failure. Pneumonia, acute respiratory failure, sepsis, coagulopathy, pericarditis/myocarditis, and cardiac failure were adjudicated per blinded manual medical review of events by an internal adjudication team before study readout. | Up to Day 33 visit |
| Percentage of Participants With Any Post-Treatment Infection | Post-treatment infections were defined as any treatment-emergent adverse event with a primary system organ class of infections and infestations. | Up to Day 33 visit |
| Change From Baseline in the Amount of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus RNA | SARS-CoV-2 virus RNA will be measured by reverse-transcriptase quantitative polymerase chain reaction (RT-qPCR) | Baseline and on Days 3, 5, 7 and 14 |
| Time to Cessation of SARS-CoV-2 Viral Shedding | Defined as time from randomization to the first time when a negative qualitative virus RNA by RT-PCR test result is obtained. | Up to 14 days |
| Percentage of Participants Positive for SARS-CoV-2 Virus RNA at Specified Timepoints | Defined as percentage of participants with a positive qualitative virus RNA by RT-PCR. | Baseline and on Days 3, 5, 7 and 14 |
| Area Under the Curve (AUC) in the Amount of SARS-CoV-2 Virus RNA | Day 1 prior to dosing, Day 3, Day 5, Day 7 and Day 14 |
| Percentage of Participants With Adverse Events (AEs) | Up to Day 33 visit |
| Plasma Concentration of AT-511 at Specified Timepoints | AT-511 is the free base form of RO7496998 (AT-527). | Up to 7 days |
| Plasma Concentration of AT-551 at Specified Timepoints | AT-511 is the free base form of RO7496998 (AT-527). Major metabolites are AT-551, AT-229, and AT-273 (a surrogate for the intracellular concentration of the active triphosphate metabolite AT-9010) | Up to 7 days |
| Plasma Concentration of AT-229 at Specified Timepoints | AT-511 is the free base form of RO7496998 (AT-527). Major metabolites are AT-551, AT-229, and AT-273 (a surrogate for the intracellular concentration of the active triphosphate metabolite AT-9010) | Up to 7 days |
| Plasma Concentration of AT-273 at Specified Timepoints | AT-511 is the free base form of RO7496998 (AT-527). Major metabolites are AT-551, AT-229, and AT-273 (a surrogate for the intracellular concentration of the active triphosphate metabolite AT-9010) | Up to 7 days |
| Châtelineau |
| 6200 |
| Belgium |
| Private Practice Dr Jean Benoit Martinot | Erpent | 5101 | Belgium |
| Medif | Gozée | 6534 | Belgium |
| L2 Ip Instituto de Pesquisas Clinicas Ltda ME; Centro Medico Hospitalar | Brasília | Federal District | 70200-730 | Brazil |
| Chronos Pesquisa Clinica | Taguatinga | Federal District | 72145-450 | Brazil |
| Hospital Nossa Senhora das Graças | Curitiba | Paraná | 80810-040 | Brazil |
| Hospital Agamenon Magalhães | Recife | Pernambuco | 52051-380 | Brazil |
| Conjunto Hospitalar do Mandaqui | São Paulo | São Paulo | 02401-400 | Brazil |
| Aalborg Universitetshospital | Aalborg | 9000 | Denmark |
| Rigshospitalet Copenhagen University Hospital | Copenhagen | DK-2100 | Denmark |
| Praxis am Ebertplatz | Cologne | 50668 | Germany |
| Higashiosaka city Medical Center | Higashiosaka-Shi | 578-0947 | Japan |
| Rinku General Medical Center | Izumisano | 598-0048 | Japan |
| Sagamihara Kyodo Hospital | Kanagawa | 252-5188 | Japan |
| Misyuku hospital | Meguro-Ku | 153-0051 | Japan |
| IUHW Narita Hospital | Narita | 286-8520 | Japan |
| Houjin Syadan Kouhoukai Takagi Hospital | Okawa-Shi | 831-0016 | Japan |
| Okayama City Hospital | Okayama | 700-8557 | Japan |
| Ome Municipal General Hospital | Ome-Shi | 198-0042 | Japan |
| National Hospital Organization Kinki-Chuo Chest Medical Center | Sakaishi | 591-8555 | Japan |
| Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai | Shinagawa City | 140-8522 | Japan |
| Edogawa Medicare Hospital | Tokyo | 133-0071 | Japan |
| Center Hospital of the National Center for Global Health and Medicine | Tokyo | 162-0052 | Japan |
| Tokyo Medical University Hachioji Medical Center | Tokyo | 193-0998 | Japan |
| CIMAB SA de CV | Torreón | Coahuila | 27000 | Mexico |
| Panamerican Clinical Research S.A de C.V. | Guadalajara | Jalisco | 44670 | Mexico |
| Clinstile S.A de C.V. | Mexico City | Mexico CITY (federal District) | 06700 | Mexico |
| PanAmerican Clinical Research, Querétaro | Queréaro | Querétaro | 76230 | Mexico |
| Instituto Jalisciense de Investigacion Clinica S.A. de C.V. | Guadalajara | 44100 | Mexico |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | México | Mexico |
| Unidade Local de Saude de Matosinhos SA | Matosinhos Municipality | 4454-509 | Portugal |
| Prof. Dr. Matei Bals Institute of Infectious Diseases | Bucharest | 021105 | Romania |
| County Hospital Caracal | Caracal | 235200 | Romania |
| Sibiu Emergency Clinical County Hospital | Sibiu | 550245 | Romania |
| Hôpital Universitaire de Genève (HUG) | Geneva | 1211 | Switzerland |
| Universitätsspital Zürich | Zurich | 8091 | Switzerland |
| Gazi Universitesi Tip Fakultesi | Ankara | 06100 | Turkey (Türkiye) |
| Ankara University Medical Faculty - PPDS | Çankaya | 06590 | Turkey (Türkiye) |
| Ege University Medical Faculty | Izmir | 35100 | Turkey (Türkiye) |
| Karadeniz Technical University Faculty of Medicine | Trabzon | 61080 | Turkey (Türkiye) |
| Municipal Non-profit Enterprise ?City Clinical Hospital #13? of Kharkiv City Council | Kharkiv | Kharkiv Governorate | 61124 | Ukraine |
| Public Non-Profit Enterprise ?City Outpatient Clinic #9? of Kharkiv City Council | Kharkiv | Kharkiv Governorate | 61172 | Ukraine |
| CNPE City Clinical Hospital #6 of DCC | Dnipro | Kholm Governorate | 49074 | Ukraine |
| Medical Center LLC "Harmony of Beauty" | Kyiv | KIEV Governorate | 01135 | Ukraine |
| CNE Kyiv City Clinical Hospital#1 of Exec. Body | Kyiv | KIEV Governorate | 02091 | Ukraine |
| Kyiv Railway Clinical Hospital No2 of Branch Health Center of the JSC Ukrainian Rail | Kyiv | KIEV Governorate | 03049 | Ukraine |
| Polyclinic of Center of Medical Service and Rehabilitation of State JSHC Artem | Kyiv | KIEV Governorate | 04050 | Ukraine |
| Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1 | Vinnytsia | Podolia Governorate | Ukraine |
| Communal Non-Profit Enterprise City Hospital #7 of Zaporizhzhia City Council | Zaporizhzhia | Tavria Okruha | 69118 | Ukraine |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | The dose and regimen of the placebo will match that of AT-527. |
| BG001 | RO7496998 (AT-527) | Orally administered, 550 mg twice daily (BID) for 5 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Number of COVID-19 Symptoms Present at Baseline | All participants who were randomized to treatment, received a dose of study treatment, were reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) positive for SARS-CoV-2 at any point during the study and did not have missing data. | Mean | Standard Deviation | Number of Covid-19 Symptoms |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Alleviation or Improvement of COVID-19 Symptoms (21.5 Hours) | COVID-19 symptoms will be evaluated using the COVID-19 Symptom Diary (questions 1-12). The severity of each COVID-19 symptom will be recorded on a Likert scale (i.e none/mild/moderate/severe). The time to alleviation or improvement of COVID-19 symptoms is defined as follows: for new symptoms, it is defined as the length of time taken from randomization to the point at which a Score of 0 or 1 has been maintained for a duration of at least 21.5 hours. For preexisting symptoms, it is defined as the time from randomization to when a patient's symptoms have been maintained or improved (requires at least a single category improvement from baseline on the COVID-19 Symptom Diary Likert scale) for a duration of 21.5 hours. | All participants who were randomized to treatment, received a dose of study treatment, and were RT-qPCR positive for SARS-CoV-2 at any point during the study. | Posted | Median | 97.5% Confidence Interval | hours | Up to 29 days |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Time to Alleviation or Improvement of COVID-19 Symptoms (43 Hours) | COVID-19 symptoms will be evaluated using the COVID-19 Symptom Diary (questions 1-12). The severity of each COVID-19 symptom will be recorded on a Likert scale (i.e none/mild/moderate/severe). The time to alleviation or improvement of COVID-19 symptoms is defined as follows: for new symptoms, it is defined as the length of time taken from randomization to the point at which a Score of 0 or 1 has been maintained for a duration of at least 43 hours. For preexisting symptoms, it is defined as the time from randomization to when a patient's symptoms have been maintained or improved (requires at least a single category improvement from baseline on the COVID-19 Symptom Diary Likert scale) for a duration of 43 hours. | All participants who were randomized to treatment, received a dose of study treatment, and were RT-qPCR positive for SARS-CoV-2 at any point during the study. | Posted | Median | 97.5% Confidence Interval | hours | Up to 29 days |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Alleviation of COVID-19 Symptoms (21.5 Hours) | Time from randomization 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. | All participants who were randomized to treatment, received a dose of study treatment, and were RT-qPCR positive for SARS-CoV-2 at any point during the study. | Posted | Median | 97.5% Confidence Interval | hours | Up to 29 days |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Alleviation of COVID-19 Symptoms (43 Hours) | Time from randomization 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. | All participants who were randomized to treatment, received a dose of study treatment, and were RT-qPCR positive for SARS-CoV-2 at any point during the study. | Posted | Median | 97.5% Confidence Interval | hours | Up to 29 days |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to One-Category Improvement of Baseline Presenting COVID-19 Symptoms | Time from randomization to the point at which symptoms (Items 1-12 of the COVID-19 Symptom Diary) have improved by at least one category from baseline on the COVID-19 Symptom Diary Likert scale, maintained for at least 21.5 hours. | All participants who were randomized to treatment, received a dose of study treatment, were RT-qPCR positive for SARS-CoV-2 at any point during the study and with baseline symptoms. | Posted | Median | 97.5% Confidence Interval | hours | Up to 29 days |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Alleviation of Individual Symptoms | Time from randomization to the point at which the following criterion is met and maintained (for each individual symptom) for at least 21.5 hours. - Score of 0 or 1 for Items 1-14 of the COVID-19 Symptom Diary | All participants who were randomized to treatment, received a dose of study treatment, were RT-qPCR positive for SARS-CoV-2 at any point during the study and had a symptom score of >= 2 at baseline. | Posted | Median | 97.5% Confidence Interval | hours | Up to 29 days |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Requiring Hospitalization for COVID-19 | Hospitalizations for COVID-19 are defined as SAEs for which the investigator has cited that the suspected cause was the disease under study and where there is a non-missing hospital admission date. | All participants who were randomized to treatment, received a dose of study treatment, and were RT-qPCR positive for SARS-CoV-2 at any point during the study. | Posted | Number | 97.5% Confidence Interval | percentage of participants | Up to Day 33 visit |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Greater Than or Equal to 1 COVID-19 Related Medically Attended Visit | Medically attended visit is defined as hospitalization, emergency room (ER) visit, urgent care visit, physician's office visit, or telemedicine visit, with the primary reason for the visit being COVID-19. | All participants who were randomized to treatment, received a dose of study treatment, and were RT-qPCR positive for SARS-CoV-2 at any point during the study. | Posted | Number | 97.5% Confidence Interval | percentage of participants | Up to Day 33 visit |
|
| |||||||||||||||||||||||||||||
| Secondary | Duration of Fever | Time to return to an afebrile state (temperature ≤ 37.5°C) maintained for at least 21.5 hours. | All participants who were randomized to treatment, received a dose of study treatment, were RT-qPCR positive for SARS-CoV-2 at any point during the study, and had a fever at baseline. | Posted | Median | 97.5% Confidence Interval | hours | Up to 29 days |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With COVID-19 Related Complications | COVID-related complications are defined as death, hospitalization, pneumonia, sepsis, coagulopathy, pericarditis/myocarditis and cardiac failure. Pneumonia, acute respiratory failure, sepsis, coagulopathy, pericarditis/myocarditis, and cardiac failure were adjudicated per blinded manual medical review of events by an internal adjudication team before study readout. | All participants who were randomized to treatment, received a dose of study treatment, and were RT-qPCR positive for SARS-CoV-2 at any point during the study. | Posted | Number | 97.5% Confidence Interval | percentage of participants | Up to Day 33 visit |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Any Post-Treatment Infection | Post-treatment infections were defined as any treatment-emergent adverse event with a primary system organ class of infections and infestations. | All participants who were randomized to treatment, received a dose of study treatment, and were RT-qPCR positive for SARS-CoV-2 at any point during the study. | Posted | Number | 97.5% Confidence Interval | percentage of participants | Up to Day 33 visit |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Amount of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus RNA | SARS-CoV-2 virus RNA will be measured by reverse-transcriptase quantitative polymerase chain reaction (RT-qPCR) | All participants who were randomized to treatment, received a dose of study treatment, and were RT-qPCR positive for SARS-CoV-2 at any point during the study. | Posted | Mean | Standard Deviation | log10 copies/mL | Baseline and on Days 3, 5, 7 and 14 |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Cessation of SARS-CoV-2 Viral Shedding | Defined as time from randomization to the first time when a negative qualitative virus RNA by RT-PCR test result is obtained. | All participants who were randomized to treatment, received a dose of study treatment, and were RT-qPCR positive for SARS-CoV-2 at any point during the study. | Posted | Median | 97.5% Confidence Interval | days | Up to 14 days |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Positive for SARS-CoV-2 Virus RNA at Specified Timepoints | Defined as percentage of participants with a positive qualitative virus RNA by RT-PCR. | All participants who were randomized to treatment, received a dose of study treatment, and were RT-qPCR positive for SARS-CoV-2 at any point during the study. | Posted | Number | percentage of participants | Baseline and on Days 3, 5, 7 and 14 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Area Under the Curve (AUC) in the Amount of SARS-CoV-2 Virus RNA | All participants who were randomized to treatment, received a dose of study treatment, were RT-qPCR positive for SARS-CoV-2 at any point during the study, and had at least 2 or more virology assessments. | Posted | Mean | Standard Deviation | log10 copies/mL*hour | Day 1 prior to dosing, Day 3, Day 5, Day 7 and Day 14 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events (AEs) | All participants who received at least one dose of study treatment | Posted | Number | percentage of participants | Up to Day 33 visit |
|
| |||||||||||||||||||||||||||||||
| Secondary | Plasma Concentration of AT-511 at Specified Timepoints | AT-511 is the free base form of RO7496998 (AT-527). | All participants who received AT-527 and had at least one post-dose drug concentration measurement at a scheduled visit time point | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Up to 7 days |
|
| |||||||||||||||||||||||||||||
| Secondary | Plasma Concentration of AT-551 at Specified Timepoints | AT-511 is the free base form of RO7496998 (AT-527). Major metabolites are AT-551, AT-229, and AT-273 (a surrogate for the intracellular concentration of the active triphosphate metabolite AT-9010) | All participants who received AT-527 and had at least one post-dose drug concentration measurement at a scheduled visit time point | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Up to 7 days |
|
| |||||||||||||||||||||||||||||
| Secondary | Plasma Concentration of AT-229 at Specified Timepoints | AT-511 is the free base form of RO7496998 (AT-527). Major metabolites are AT-551, AT-229, and AT-273 (a surrogate for the intracellular concentration of the active triphosphate metabolite AT-9010) | All participants who received AT-527 and had at least one post-dose drug concentration measurement at a scheduled visit time point | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Up to 7 days |
|
| |||||||||||||||||||||||||||||
| Secondary | Plasma Concentration of AT-273 at Specified Timepoints | AT-511 is the free base form of RO7496998 (AT-527). Major metabolites are AT-551, AT-229, and AT-273 (a surrogate for the intracellular concentration of the active triphosphate metabolite AT-9010) | All participants who received AT-527 and had at least one post-dose drug concentration measurement at a scheduled visit time point | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Up to 7 days |
|
|
up to the Day 33 visit
Safety analyses were performed on the safety evaluable set, which consisted of all randomized participants who received at least one dose of study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | The dose and regimen of the placebo will match that of AT-527. | 0 | 71 | 7 | 71 | 5 | 71 |
| EG001 | AT-527 | Orally administered, 550 mg twice daily (BID) for 5 days | 0 | 141 | 5 | 141 | 11 | 141 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA version 24.1. | Non-systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA version 24.1. | Non-systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA version 24.1. | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 24.1. | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1. | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1. | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1. | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 24.1. | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 24.1. | Non-systematic Assessment |
|
The study was terminated with only 16% of the planned sample size.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 22, 2021 | May 30, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000713067 | AT-511 |
Not provided
Not provided
Not provided
|
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Day 1, 0 hour |
|
| ||||
| Day 1, 1 hour |
|
| ||||
| Day 1, 2 hours |
|
| ||||
| Day 1, 4 hours |
|
| ||||
| Day 5, 0 hour |
|
| ||||
| Day 5, 1 hour |
|
| ||||
| Day 5, 2 hours |
|
| ||||
| Day 5, 4 hours |
|
| ||||
| Day 5, 8 hours |
|
| ||||
| Day 5, 48 hours |
|
|
|
|
|