Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002741-18 | EudraCT Number |
Not provided
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The study was stopped early as it was determined there would not be a statistically significant treatment effect associated with the primary endpoint due to the low number of events.
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The goal of this clinical study is to test how well the study drug, obeldesivir (GS-5245), works and how safe it is in treating coronavirus disease 2019 (COVID-19) in participants that have a higher risk of getting a serious illness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obeldesivir | Experimental | Participants will receive obeldesivir 350 mg orally twice daily for 5 days. |
|
| Placebo | Placebo Comparator | Participants will receive placebo-to-match obeldesivir orally twice daily for 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obeldesivir | Drug | Tablets administered orally without regard to food. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Coronavirus Disease 2019 (COVID-19) Related Hospitalization or All-Cause Death by Day 29 | COVID-19-related hospitalization was defined as ≥ 24 hours of acute care for a reason related to COVID-19, in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with COVID-19. This included specialized acute medical care units within an assisted living facility or nursing home. This did not include hospitalization for the purposes of public health and/or clinical trial execution. The date and duration of hospital admission, and primary reason for hospitalization (including if the hospitalization was related to COVID-19) were recorded. Percentages were rounded off. | Up to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) | TEAEs were defined as 1 or both of the following: Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug. Any AEs leading to premature discontinuation of study drug. Percentages were rounded off. | First dose date up to 5 Days plus 30 Days |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculdade de Medicina da Universidade Federal de Minas Gerais | Belo Horizonte - MG | 30130-100 | Brazil | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41565160 | Derived | Hedskog C, Rodriguez L, Hu Y, Li J, Han D, Peinovich N, Martinez C, Ho PY, Perry JK, Gonzalez Del Castillo JM, Koullias Y, Martin R, Hyland RH. SARS-CoV-2 resistance analyses from the Phase 3 BIRCH study of obeldesivir in high-risk nonhospitalized participants with COVID-19. Antiviral Res. 2026 Mar;247:106351. doi: 10.1016/j.antiviral.2026.106351. Epub 2026 Jan 19. | |
| 40694627 |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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515 participants were screened.
Participants were enrolled at study sites in the South America, Europe, North America, Africa and Asia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Obeldesivir | Participants received obeldesivir 350 mg orally twice daily for 5 days. |
| FG001 | Placebo | Participants received placebo-to-match obeldesivir orally twice daily for 5 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 29, 2023 | Sep 27, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Obeldesivir Placebo | Drug | Placebo tablets administered orally without regard to food. |
|
| Percentage of Participants Experiencing Laboratory Abnormalities | Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days. Percentages were rounded off. | First dose date up to 5 Days plus 30 Days |
| Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation | A treatment emergent AE is defined as an AE that occurs or worsens in severity on or after the date of the first dose of study drug but no later than 30 days after the permanent discontinuation of study drug or an AE leading to discontinuation of study drug. A SAE is defined as an event that, at any dose, resulted in any of the following: death, life-threatening, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, or a medically important event or reaction. Percentages were rounded off. | First dose date up to 5 Days plus 30 Days |
| Percentage of Participants With All-Cause Hospitalization by Day 29 | All-cause hospitalization was defined as ≥ 24 hours of acute care, in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with COVID-19. This includes specialized acute medical care units within an assisted living facility or nursing home. This does not include hospitalization for the purposes of public health and/or clinical study execution. The date and duration of hospital admission, and primary reason for hospitalization (including if the hospitalization is related to COVID-19) were recorded. Percentages were rounded off. | Up to Day 29 |
| Percentage of Participants With COVID-19-Related Medically Attended Visits (MAVs) or All-Cause Death by Day 29 | Medically attended visits were defined as interactions with health care professionals other than study staff or designees including hospitalization; in-person emergency, urgent, or primary care visits; or any other in-person visit attended by the participant and a health care professional. The nature and cause of the visit were identified. KM estimates were used in the outcome measure analysis. Percentages were rounded off. | Up to Day 29 |
| Percentage of Participants With COVID-19-Related MAVs by Day 29 | Medically attended visits were defined as interactions with health care professionals other than study staff or designees including hospitalization; in-person emergency, urgent, or primary care visits; or any other in-person visit attended by the participant and a health care professional. The nature and cause of the visit were identified. KM estimates were used in the outcome measure analysis. Percentages were rounded off. | Up to Day 29 |
| Percentage of Participants With All-cause Death by Day 29 | Percentages were rounded off. | Up to Day 29 |
| Time to COVID-19 Symptom Alleviation by Day 15 | Time to COVID-19 symptom alleviation was calculated as symptom alleviation date/time minus the first dose date/time. Symptom alleviation was evaluated for the 15 targeted symptoms using symptoms of infection with coronavirus-19 (SIC) questionnaire. The SIC questionnaire assessed all targeted symptoms, alleviation was defined as the SIC rating of 0, or at least 3 points decrease in rating from baseline, or an answer "No" to the question for at least 48 consecutive hours. | Up to Day 15 |
| Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5 | The mixed model for repeated measures (MMRM) was used for analysis. | Day 5 |
| Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir) | Day 1, 0.75 and 2 hours postdose and Day 5 predose and 0.75 hours postdose |
| L2iP Instituto de Pesquisas Clínicas |
| Brasília - DF |
| 70200-730 |
| Brazil |
| Centro de Pesquisa Clinica da Universidade Municipal de São Caetano do Sul (USCS) | São Caetano Do Sul - SP | 09530-905 | Brazil |
| Multiprofile Hospital for Active Treatment Puls AD, Department of Internal Diseases | Blagoevgrad | 2700 | Bulgaria |
| Medical Center Asklepii OOD | Dupnitsa | 2600 | Bulgaria |
| Specialìzed Hosp¡tal for Active Trealment of Pneumophthisiatric Diseases Haskovo EOOD, Department of pneumology and phthisiatry | Haskovo | 6300 | Bulgaria |
| Medical Center Zdrave-1 OOD | Kozloduy | 3320 | Bulgaria |
| Diagnostic Consultative Center 1 - Lon EOOD | Lom | 3600 | Bulgaria |
| Medical Center Hera EOOD, Montana | Montana | 3400 | Bulgaria |
| Multiprofile Hospital for Active Treatment Dr. Stamen Iliev AD, Department of Pneumology Phthisiatrics | Montana | 3400 | Bulgaria |
| Medical Center Medconsult Pleven OOD | Pleven | 5800 | Bulgaria |
| Diagnostic Consultative Center Sveti Georgi EOOD | Plovdiv | 4000 | Bulgaria |
| MHAT Sveta Karidad EAD, First Department of Anesthesiology and Intensive Care | Plovdiv | 4004 | Bulgaria |
| Multiprofile Hospital for Active Treatment Sveti Panteleymon EOOD, First Department of Internal Diseases | Plovdiv | 4004 | Bulgaria |
| Medical Center Prolet EOOD | Rousse | 7002 | Bulgaria |
| Multiprofile Hospital for Active Treatment - Samokov EOOD, Department of Internal Diseases | Samokov | 2000 | Bulgaria |
| Medical Center Unimed EOOD | Sevlievo | 5400 | Bulgaria |
| Diagnostic and Consulting Center Aleksandrovska EOOD | Sofia | 1431 | Bulgaria |
| Medical Center Hera EOOD | Sofia | 1510 | Bulgaria |
| Diagnostic Consultative Center XX - Sofia EOOD | Sofia | 1618 | Bulgaria |
| Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa EOOD, Department of Pneumology | Vratsa | 3000 | Bulgaria |
| Hamilton Medical Research Group | Hamilton | L8M 1K7 | Canada |
| Dr. Anil K. Gupta Medicine Professional Corporation | Toronto | M9V 4B4 | Canada |
| Vancouver ID Research and Care Centre Society | Vancouver | V6Z 2C9 | Canada |
| CHU de Montpellier-Hopital La Colombiere | Montpellier | 34090 | France |
| Hopital Pitie Salpetriere | Paris | 75651 | France |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | 4031 | Hungary |
| Unita Operativa Di Malattie Infettive Ospedale San Raffaele S.r.l. | Milan | 20127 | Italy |
| IUHW Narita Hospital | Chibaken | 286-0124 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| Suita Municipal Hospital | Suita | 564-8567 | Japan |
| Panamerican Clinical Research Mexico S.A. de C.V. | Col. El Salitre Juriquilla | 13030 | Mexico |
| Neurociencias Estudios Clinicos S.C. | Culiacan Sinaloa | 80020 | Mexico |
| PanAmerican Clinical Research Mexico S.A de C.V. | Guadalajara | 44670 | Mexico |
| Clinstile, S.A. De C.V. | Mexico City | 06700 | Mexico |
| EME RED Hospitalaria | Mérida | 97000 | Mexico |
| Kohler & Milstein Research S.A de C.V. | Mérida | 97070 | Mexico |
| Oaxaca Site Management Organization S.C. | Oaxaca City | 68000 | Mexico |
| FAICIC S. de R.L. de C.V. | Veracruz | 91900 | Mexico |
| Ginemedica OVO 21 | Wroclaw | 50414 | Poland |
| ETG Lodz | Zgierz | 95-100 | Poland |
| ClinMedica Research | Skierniewice | Łódź Voivodeship | 96-100 | Poland |
| Hospital CUF Descobertas | Lisbon | 1998-018 | Portugal |
| Centro Hospitalar de Entre Douro e Vouga - Hospital de Sao Sebaststiao | Santa Maria da Feira | 4520-211 | Portugal |
| Hospital da Luz - Arrabida | Vila Nova de Gaia | 4099-346 | Portugal |
| "Prof. Dr. Matei Bals" National Institute for Infectious Diseases | Bucharest | 021105 | Romania |
| County Hospital Caracal | Caracal | 235200 | Romania |
| Sibiu Emergency Clinical County Hospital | Sibiu | 550253 | Romania |
| National Centre for Infectious Diseases, Tan Tock Seng Hospital | Singapore | 308433 | Singapore |
| Madibeng Centre for Research | Brits | 0250 | South Africa |
| Clinresco Centres (Pty) Ltd | City of Johannesburg | 1619 | South Africa |
| Synapta Clinical Research Centre | Durban | 4001 | South Africa |
| Perinatal HIV Research Unit (PHRU) | Johannesburg | 2013 | South Africa |
| Global Clinical Trials | Pretoria | 0001 | South Africa |
| Jongaie Research | Pretoria West | 0183 | South Africa |
| Limpopo Clinical Research Initiative | Thabazimbi | 0380 | South Africa |
| FCRN Clinical Trial Centre (Pty) Ltd | Vereeniging | 1938 | South Africa |
| ChungNam National University Hospital | Daejeon | 35015 | South Korea |
| Chonnam National University Bitgoeul Hospital | Gwangju | 61748 | South Korea |
| Korea University Guro Hospital | Seoul | 152-703 | South Korea |
| Hospital Universitario Virgen de Las Nieves. | A Gudiña | 32540 | Spain |
| Hospital General Universitario Dr. Balmis | Alicante | 3010 | Spain |
| Hospital Universitari Germans Trias i Pujol | Badalona | 08916 | Spain |
| CAP La Mina | Barcelona | 8007 | Spain |
| Hospital HM Nou Delfos | Barcelona | 8023 | Spain |
| Hospital Universitario Virgen del Rocio | Las Cabezas de San Juan | 41730 | Spain |
| Hospital Universitario Infanta Leonor | Madrid | 28031 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario Puerta de Hierro - Majadahonda | Majadahonda | 28222 | Spain |
| Hospital General Universitario Reina Sofia | Murcia | 30003 | Spain |
| Hospital Universitario Son Espases | Palma de Mallorca | 07120 | Spain |
| Hospital Universitaro y Politecnico La Fe | Valencia | 46016 | Spain |
| Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation | Hualien City | 970 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Tao-Yuan General Hospital | Taoyuan City | 320 | Taiwan |
| Kaohsiung Veterans General Hospital | Zuo Ying Qu | 813 | Taiwan |
| Acibadem University School of Medicine Atakent Hospital | Trabzon | 61030 | Turkey (Türkiye) |
| Ormeau Clinical Trials Limited | Belfast | BT7 2EB | United Kingdom |
| Lakeside Healthcare | Corby | NN17 2UR | United Kingdom |
| CPS Research | Glasgow | G20 0XA | United Kingdom |
| Streinu-Cercel A, Castagna A, Chang SC, Chen YS, Koullias Y, Mozaffarian A, Hyland RH, Humeniuk R, Caro L, Davies S, Rodriguez L, Hedskog C, Chen S, Etchevers K, Behenna-Renton N, Llewellyn J, Osinusi A, Duff F, Barrat Hernandez A, McNally D, Simon-Campos JA, Leal FE, Fouche LF, Gonzalez Del Castillo JM. Efficacy and Safety of Obeldesivir in High-Risk Nonhospitalized Patients With COVID-19 (BIRCH): A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study. Clin Infect Dis. 2026 Feb 9;82(1):e24-e32. doi: 10.1093/cid/ciaf406. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The All Randomized Analysis Set included all participants who were randomized in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Obeldesivir | Participants received obeldesivir 350 mg orally twice daily for 5 days. |
| BG001 | Placebo | Participants received placebo-to-match obeldesivir orally twice daily 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 |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Baseline Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load | The Safety Analysis Set included all participants who received at least 1 dose of study drug with data available were analyzed. One participant randomized to placebo arm received obeldesivir and was counted in obeldesivir group for the analysis of this baseline measure. | Mean | Standard Deviation | log10 copies/mL |
|
| 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 | Percentage of Participants With Coronavirus Disease 2019 (COVID-19) Related Hospitalization or All-Cause Death by Day 29 | COVID-19-related hospitalization was defined as ≥ 24 hours of acute care for a reason related to COVID-19, in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with COVID-19. This included specialized acute medical care units within an assisted living facility or nursing home. This did not include hospitalization for the purposes of public health and/or clinical trial execution. The date and duration of hospital admission, and primary reason for hospitalization (including if the hospitalization was related to COVID-19) were recorded. Percentages were rounded off. | The Full Analysis Positive Set included all randomized participants who received at least 1 dose of study drug and were SARS-CoV-2 positive at baseline as confirmed by cepheid's xpert xpress coronavirus-2/flu/respiratory syncytial virus plus test or SARS-CoV-2 reverse transcriptase quantitative polymerase chain reaction test from the central laboratory. | Posted | Number | percentage of participants | Up to Day 29 |
|
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| Secondary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) | TEAEs were defined as 1 or both of the following: Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug. Any AEs leading to premature discontinuation of study drug. Percentages were rounded off. | The Safety Analysis Set included all participants who received at least 1 dose of study drug. One participant randomized to placebo arm received obeldesivir and was counted in obeldesivir group for the analysis of this outcome measure. | Posted | Number | percentage of participants | First dose date up to 5 Days plus 30 Days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing Laboratory Abnormalities | Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days. Percentages were rounded off. | Participants from the Safety Analysis Set who had available post baseline data were analyzed. One participant randomized to placebo arm received obeldesivir and was counted in obeldesivir group for the analysis of this outcome measure. | Posted | Number | percentage of participants | First dose date up to 5 Days plus 30 Days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation | A treatment emergent AE is defined as an AE that occurs or worsens in severity on or after the date of the first dose of study drug but no later than 30 days after the permanent discontinuation of study drug or an AE leading to discontinuation of study drug. A SAE is defined as an event that, at any dose, resulted in any of the following: death, life-threatening, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, or a medically important event or reaction. Percentages were rounded off. | Participants in the Safety Analysis Set were analyzed. One participant randomized to placebo arm received obeldesivir and was counted in obeldesivir group for the analysis of this outcome measure. | Posted | Number | percentage of participants | First dose date up to 5 Days plus 30 Days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With All-Cause Hospitalization by Day 29 | All-cause hospitalization was defined as ≥ 24 hours of acute care, in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with COVID-19. This includes specialized acute medical care units within an assisted living facility or nursing home. This does not include hospitalization for the purposes of public health and/or clinical study execution. The date and duration of hospital admission, and primary reason for hospitalization (including if the hospitalization is related to COVID-19) were recorded. Percentages were rounded off. | Participants in the Full Analysis Positive Set were analyzed. | Posted | Number | percentage of participants | Up to Day 29 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With COVID-19-Related Medically Attended Visits (MAVs) or All-Cause Death by Day 29 | Medically attended visits were defined as interactions with health care professionals other than study staff or designees including hospitalization; in-person emergency, urgent, or primary care visits; or any other in-person visit attended by the participant and a health care professional. The nature and cause of the visit were identified. KM estimates were used in the outcome measure analysis. Percentages were rounded off. | Participants in the Full Analysis Positive Set were analyzed. | Posted | Number | percentage of participants | Up to Day 29 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With COVID-19-Related MAVs by Day 29 | Medically attended visits were defined as interactions with health care professionals other than study staff or designees including hospitalization; in-person emergency, urgent, or primary care visits; or any other in-person visit attended by the participant and a health care professional. The nature and cause of the visit were identified. KM estimates were used in the outcome measure analysis. Percentages were rounded off. | Participants in the Full Analysis Positive Set were analyzed. | Posted | Number | percentage of participants | Up to Day 29 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With All-cause Death by Day 29 | Percentages were rounded off. | Participants in the Full Analysis Positive Set were analyzed. | Posted | Number | percentage of participants | Up to Day 29 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to COVID-19 Symptom Alleviation by Day 15 | Time to COVID-19 symptom alleviation was calculated as symptom alleviation date/time minus the first dose date/time. Symptom alleviation was evaluated for the 15 targeted symptoms using symptoms of infection with coronavirus-19 (SIC) questionnaire. The SIC questionnaire assessed all targeted symptoms, alleviation was defined as the SIC rating of 0, or at least 3 points decrease in rating from baseline, or an answer "No" to the question for at least 48 consecutive hours. | Participants in the Full Analysis Positive Set with Covid19 symptoms who completed Symptoms of Infection With Coronavirus-19 at baseline were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to Day 15 |
|
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| Secondary | Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5 | The mixed model for repeated measures (MMRM) was used for analysis. | Virology Analysis Set included all randomized participants who received at least 1 dose of study drug and had baseline SARS-CoV-2 viral load greater than or equal to lower limit of quantitation. | Posted | Least Squares Mean | Standard Error | log10 copies/mL | Day 5 |
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| Secondary | Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir) | Pharmacokinetic Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least 1 non missing concentration value reported by the PK laboratory with available data were analyzed . | Posted | Mean | Standard Deviation | ng/mL | Day 1, 0.75 and 2 hours postdose and Day 5 predose and 0.75 hours postdose |
|
|
All-cause mortality, Adverse events: First dose date up to 5 Days plus 30 Days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. One participant randomized to placebo arm accidentally received obeldesivir and was counted in obeldesivir group for the analysis of all-cause mortality and adverse events.
Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
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 | Obeldesivir | Participants received obeldesivir 350 mg orally twice daily for 5 days. | 0 | 234 | 2 | 234 | 0 | 234 |
| EG001 | Placebo | Participants received placebo-to-match obeldesivir orally twice daily for 5 days. | 1 | 234 | 2 | 231 | 0 | 231 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
Not provided
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 22, 2024 | Sep 27, 2024 | SAP_001.pdf |
Not provided
| 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
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| Canada |
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| South Korea |
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| Turkey |
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| Taiwan |
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| Brazil |
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| Italy |
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| Mexico |
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| South Africa |
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| Bulgaria |
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| France |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Day 1, 0.75 hours postdose |
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| Day 1, 2 hours postdose |
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| Day 5, Predose |
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| Day 5, 0.75 hours postdose |
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