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Slow enrollment rate
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
Not provided
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This is a randomized, double-blind, placebo-controlled pilot study of the efficacy and safety of baloxavir in combination with oseltamivir (standard of care) for the treatment of influenza in allogeneic stem cell transplant patients. Although there are no data about this treatment option currently available, the investigator hypothesizes that combination therapy may be more effective in clearing influenza virus infection and decreasing the rate of emergence of resistant influenza in immunocompromised human hosts.
This is a randomized double-blind placebo-controlled pilot study of the efficacy and safety of baloxavir in combination with oseltamivir (standard of care) for the treatment of influenza in allogeneic stem cell transplant patients. 30 SCT recipients will take part in the study. Participants with be randomly assigned (1:1) to either baloxavir + oseltamivir or baloxavir-matched placebo +oseltamivir. Before randomization, patients will be stratified by hospitalization status and influenza type A (yes/no).
Patients in the baloxavir combination arm will receive weight-adjusted baloxavir (40 mg for patients weighing <80 kg and 80 mg for those weighing ≥80 kg) at baseline and at day 4 and day 7. They will also receive oseltamivir 75 mg twice daily for 10 days. Patients in the baloxavir-matched placebo + oseltamivir arm will receive baloxavir-matched placebo at baseline and at day 3 and day 7and oseltamivir 75 mg twice daily for 10 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active and standard of care | Active Comparator | Active Baloxavir Marboxil and standard of care Oseltamivir |
|
| Placebo and standard of care | Placebo Comparator | Placebo-matched Baloxavir Marboxil and standard of care Oseltamivir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baloxavir Marboxil | Drug | Weight-adjusted Baloxavir Marboxil (40 mg for patients weighing <80 kg and 80 mg for those weighing ≥80 kg) at baseline, day 4, and day 7. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Influenza Viral RNA Loads From Baseline at the End of Treatment as Measured by Quantitative Real Time Polymerase Chain Reaction. | Influenza viral RNA loads will be measured by quantitative real time polymerase chain reaction. | Baseline; Day 10 |
| Between-treatment-arm Difference in the Change of Influenza Viral RNA Loads From Baseline at the End of Treatment as Measured by Quantitative Real Time Polymerase Chain Reaction. | Influenza viral load will be measured by the quantitative real time polymerase chain reaction. | Baseline; Day 10 |
| Between-treatment-arm Difference in the Change of Influenza Viral RNA Loads From Baseline at the End of Treatment as Measured by Influenza Plaque Assay (Replicating Virus). | Influenza viral load will be measured by the influenza plaque assay. | Baseline; Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Influenza Viral RNA Load From Baseline at Day 4 and Day 7 and 10 in Each Treatment Arm | Influenza viral RNA load will be measured by quantitative real time polymerase chain reaction. | Baseline; Day 4; Day 7; Day 10 |
| Difference in Change of Influenza Viral Loads From Baseline at Day 4, 7 and 10 Between the Two Treatment Arms as Measured by Quantitative Real Time Polymerase Chain Reaction |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mirella Salvatore, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28945480 | Background | Burnham P, Khush K, De Vlaminck I. Myriad Applications of Circulating Cell-Free DNA in Precision Organ Transplant Monitoring. Ann Am Thorac Soc. 2017 Sep;14(Supplement_3):S237-S241. doi: 10.1513/AnnalsATS.201608-634MG. | |
| 25115871 | Background | de Jong MD, Ison MG, Monto AS, Metev H, Clark C, O'Neil B, Elder J, McCullough A, Collis P, Sheridan WP. Evaluation of intravenous peramivir for treatment of influenza in hospitalized patients. Clin Infect Dis. 2014 Dec 15;59(12):e172-85. doi: 10.1093/cid/ciu632. Epub 2014 Aug 12. |
| Label | URL |
|---|---|
| Influenza Antiviral Medications: Summary for Clinicians | View source |
Not provided
Not provided
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Recruitment for this study was challenging because of changed flu seasonality and low flu cases following covid-19
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| ID | Title | Description |
|---|---|---|
| FG000 | Active and Standard of Care | Active Baloxavir Marboxil and standard of care Oseltamivir Baloxavir Marboxil: Weight-adjusted Baloxavir Marboxil (40 mg for patients weighing <80 kg and 80 mg for those weighing ≥80 kg) at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days. |
| FG001 | Placebo and Standard of Care | Placebo-matched Baloxavir Marboxil and standard of care Oseltamivir Placebo: Placebo at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants were not analyzed in the Active and Standard of Care arm because 0 participants were enrolled in that arm.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active and Standard of Care | Active Baloxavir Marboxil and standard of care Oseltamivir Baloxavir Marboxil: Weight-adjusted Baloxavir Marboxil (40 mg for patients weighing <80 kg and 80 mg for those weighing ≥80 kg) at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change of Influenza Viral RNA Loads From Baseline at the End of Treatment as Measured by Quantitative Real Time Polymerase Chain Reaction. | Influenza viral RNA loads will be measured by quantitative real time polymerase chain reaction. | The only patient that completed the study, was randomized into the placebo arm. | Posted | Number | copies per mL | Baseline; Day 10 |
|
1 month
0 Participants were analyzed in the Active and Standard of Care arm because 0 subjects were enrolled in that arm.
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 | Active and Standard of Care | Active Baloxavir Marboxil and standard of care Oseltamivir Baloxavir Marboxil: Weight-adjusted Baloxavir Marboxil (40 mg for patients weighing <80 kg and 80 mg for those weighing ≥80 kg) at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| renal insufficiency | Renal and urinary disorders | Systematic Assessment | Participant developed renal failure independently from study drug |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| alopecia | Skin and subcutaneous tissue disorders | alopecia | Systematic Assessment | Participant stated that she noticed increased hair loss during treatment |
Due to change in patterns of respiratory viruses, and low or no flu circulating, we were unable to enroll the target number of participants. The only participants enrolled were the 2 in the placebo arm, 1 of whom withdrew early on. No comparison is possible with only 1 placebo participant.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mirella Salvatore | Weill Cornell Medicine | (646) 318-8506 | mis2053@med.cornell.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2023 | Oct 17, 2024 | Prot_SAP_000.pdf |
Not provided
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Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000628402 | baloxavir |
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Placebo at baseline, day 4, and day 7. |
|
| Oseltamivir | Drug | Oseltamivir 75 mg twice daily for 10 days. |
|
|
Influenza viral RNA load will be measured by quantitative real time polymerase chain reaction. |
| Baseline; Day 4; Day 7; Day 10 |
| Change of Influenza Viral Loads From Baseline at Day 4, 7 and 10 as Measured by Influenza Plaque Assay (Replicating Virus) in Each Treatment Arm | Influenza viral load will be measured by the influenza plaque assay (replicating virus). | Baseline; Day 4; Day 7; Day 10 |
| Difference in Change of Influenza Viral Loads From Baseline at Day 4, 7 and 10 Between the Two Treatment Arms as Measured by Influenza Plaque Assay (Replicating Virus) | Influenza viral load will be measured by the influenza plaque assay (replicating virus). | Baseline; Day 4; Day 7; Day 10 |
| Time to Improvement of Individual Influenza Symptoms as Assessed by Patient-reported Outcome Measures on a Single Scale | Patients will self-assess the severity of 7 influenza-associated symptoms on a 4-point single scale with 0 indicating no symptoms and higher scores indicating mild, moderate, and severe symptoms. Time to improvement of individual influenza symptoms are defined as the time from the start of treatment to the time when each of the influenza symptoms are alleviated, maintained, or improved for a duration of at least 21.5 hours. These are defined as: pre-existing symptoms (cough, fatigue, or muscle/join pain that existed prior to influenza) that were worse at baseline and had improved at least 1 point from baseline; pre-existing symptoms not worse at baseline that maintained baseline severity; and new symptoms that were alleviated, defined as a symptom score of non (0) or mild (1). | Baseline to Day 30 |
| Percentage of Patients Who Experience Each Influenza-related Complications: Hospitalization, Death, Sinusitis, Otitis Media, Bronchitis, and Radiologically-confirmed Pneumonia as an Adverse Event After the Initiation of Study Treatment | A composite score of multiple measures will be used and calculated by count of patients who experience each influenza-related complications. Adverse events will only include those that are determined to be related to the study drug. | Day 1 to Day 30 |
| Time to Return to Preinfluenza Health Status | Preinfluenza health status will be measured on a score from 0 (worst possible health) to 10 (normal health [for someone your age and condition]). | Day 1 to Day 30 |
| Time to Viral Clearance, as Assessed by Difference in Percentage of Participants Positive by Influenza Plaque Assay at Each Time-point (in Each Treatment Group) | Time to viral clearance will be assessed by percentage of participants positive by influenza plaque assay at each time-point. | Baseline to Day 30 |
| Time to Viral Clearance, as Assessed by Difference in Percentage of Participants Positive by Quantitative Real Time Polymerase Chain Reaction | Time to viral clearance will be assessed by percentage of participants positive by qPCR at each time-point. | Baseline to Day 30 |
| Change of Treatment-emergent Variants of Neuraminidase and Polymerase Known to Confer Antiviral Resistance to Oseltamivir in Each Arm by Direct Next-generation Sequencing Symptoms | Treatment-emergent variants will be identified using direct next-generation sequencing of a comprehensive panel of genes. | Baseline to Day 30 |
| Percentage of Participants With Adverse Events (AEs) | Adverse events will only include those that are determined to be related to the study drug and will assess the safety and tolerability of Baloxavir in Combination with SOC treatment. | Day 1 to Day 15 |
| 26460048 | Background | De Vlaminck I, Martin L, Kertesz M, Patel K, Kowarsky M, Strehl C, Cohen G, Luikart H, Neff NF, Okamoto J, Nicolls MR, Cornfield D, Weill D, Valantine H, Khush KK, Quake SR. Noninvasive monitoring of infection and rejection after lung transplantation. Proc Natl Acad Sci U S A. 2015 Oct 27;112(43):13336-41. doi: 10.1073/pnas.1517494112. Epub 2015 Oct 12. |
| 24944192 | Background | De Vlaminck I, Valantine HA, Snyder TM, Strehl C, Cohen G, Luikart H, Neff NF, Okamoto J, Bernstein D, Weisshaar D, Quake SR, Khush KK. Circulating cell-free DNA enables noninvasive diagnosis of heart transplant rejection. Sci Transl Med. 2014 Jun 18;6(241):241ra77. doi: 10.1126/scitranslmed.3007803. |
| 21248682 | Background | Fiore AE, Fry A, Shay D, Gubareva L, Bresee JS, Uyeki TM; Centers for Disease Control and Prevention (CDC). Antiviral agents for the treatment and chemoprophylaxis of influenza --- recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2011 Jan 21;60(1):1-24. |
| 31107922 | Background | Fukao K, Ando Y, Noshi T, Kitano M, Noda T, Kawai M, Yoshida R, Sato A, Shishido T, Naito A. Baloxavir marboxil, a novel cap-dependent endonuclease inhibitor potently suppresses influenza virus replication and represents therapeutic effects in both immunocompetent and immunocompromised mouse models. PLoS One. 2019 May 20;14(5):e0217307. doi: 10.1371/journal.pone.0217307. eCollection 2019. |
| 30476172 | Background | Fukao K, Noshi T, Yamamoto A, Kitano M, Ando Y, Noda T, Baba K, Matsumoto K, Higuchi N, Ikeda M, Shishido T, Naito A. Combination treatment with the cap-dependent endonuclease inhibitor baloxavir marboxil and a neuraminidase inhibitor in a mouse model of influenza A virus infection. J Antimicrob Chemother. 2019 Mar 1;74(3):654-662. doi: 10.1093/jac/dky462. |
| 30184455 | Background | Hayden FG, Sugaya N, Hirotsu N, Lee N, de Jong MD, Hurt AC, Ishida T, Sekino H, Yamada K, Portsmouth S, Kawaguchi K, Shishido T, Arai M, Tsuchiya K, Uehara T, Watanabe A; Baloxavir Marboxil Investigators Group. Baloxavir Marboxil for Uncomplicated Influenza in Adults and Adolescents. N Engl J Med. 2018 Sep 6;379(10):913-923. doi: 10.1056/NEJMoa1716197. |
| 19281331 | Background | Harper SA, Bradley JS, Englund JA, File TM, Gravenstein S, Hayden FG, McGeer AJ, Neuzil KM, Pavia AT, Tapper ML, Uyeki TM, Zimmerman RK; Expert Panel of the Infectious Diseases Society of America. Seasonal influenza in adults and children--diagnosis, treatment, chemoprophylaxis, and institutional outbreak management: clinical practice guidelines of the Infectious Diseases Society of America. Clin Infect Dis. 2009 Apr 15;48(8):1003-32. doi: 10.1086/598513. |
| 23726392 | Background | Hu Y, Lu S, Song Z, Wang W, Hao P, Li J, Zhang X, Yen HL, Shi B, Li T, Guan W, Xu L, Liu Y, Wang S, Zhang X, Tian D, Zhu Z, He J, Huang K, Chen H, Zheng L, Li X, Ping J, Kang B, Xi X, Zha L, Li Y, Zhang Z, Peiris M, Yuan Z. Association between adverse clinical outcome in human disease caused by novel influenza A H7N9 virus and sustained viral shedding and emergence of antiviral resistance. Lancet. 2013 Jun 29;381(9885):2273-9. doi: 10.1016/S0140-6736(13)61125-3. Epub 2013 May 29. |
| 19591575 | Background | Lee N, Chan PK, Hui DS, Rainer TH, Wong E, Choi KW, Lui GC, Wong BC, Wong RY, Lam WY, Chu IM, Lai RW, Cockram CS, Sung JJ. Viral loads and duration of viral shedding in adult patients hospitalized with influenza. J Infect Dis. 2009 Aug 15;200(4):492-500. doi: 10.1086/600383. |
| 22311561 | Background | Lee N, Ison MG. Diagnosis, management and outcomes of adults hospitalized with influenza. Antivir Ther. 2012;17(1 Pt B):143-57. doi: 10.3851/IMP2059. Epub 2012 Feb 3. |
| 28094141 | Background | Marty FM, Vidal-Puigserver J, Clark C, Gupta SK, Merino E, Garot D, Chapman MJ, Jacobs F, Rodriguez-Noriega E, Husa P, Shortino D, Watson HA, Yates PJ, Peppercorn AF. Intravenous zanamivir or oral oseltamivir for hospitalised patients with influenza: an international, randomised, double-blind, double-dummy, phase 3 trial. Lancet Respir Med. 2017 Feb;5(2):135-146. doi: 10.1016/S2213-2600(16)30435-0. Epub 2017 Jan 14. |
| 24815805 | Background | Muthuri SG, Venkatesan S, Myles PR, Leonardi-Bee J, Al Khuwaitir TS, Al Mamun A, Anovadiya AP, Azziz-Baumgartner E, Baez C, Bassetti M, Beovic B, Bertisch B, Bonmarin I, Booy R, Borja-Aburto VH, Burgmann H, Cao B, Carratala J, Denholm JT, Dominguez SR, Duarte PA, Dubnov-Raz G, Echavarria M, Fanella S, Gao Z, Gerardin P, Giannella M, Gubbels S, Herberg J, Iglesias AL, Hoger PH, Hu X, Islam QT, Jimenez MF, Kandeel A, Keijzers G, Khalili H, Knight M, Kudo K, Kusznierz G, Kuzman I, Kwan AM, Amine IL, Langenegger E, Lankarani KB, Leo YS, Linko R, Liu P, Madanat F, Mayo-Montero E, McGeer A, Memish Z, Metan G, Mickiene A, Mikic D, Mohn KG, Moradi A, Nymadawa P, Oliva ME, Ozkan M, Parekh D, Paul M, Polack FP, Rath BA, Rodriguez AH, Sarrouf EB, Seale AC, Sertogullarindan B, Siqueira MM, Skret-Magierlo J, Stephan F, Talarek E, Tang JW, To KK, Torres A, Torun SH, Tran D, Uyeki TM, Van Zwol A, Vaudry W, Vidmar T, Yokota RT, Zarogoulidis P; PRIDE Consortium Investigators; Nguyen-Van-Tam JS. Effectiveness of neuraminidase inhibitors in reducing mortality in patients admitted to hospital with influenza A H1N1pdm09 virus infection: a meta-analysis of individual participant data. Lancet Respir Med. 2014 May;2(5):395-404. doi: 10.1016/S2213-2600(14)70041-4. Epub 2014 Mar 19. |
| 28302313 | Background | Paules C, Subbarao K. Influenza. Lancet. 2017 Aug 12;390(10095):697-708. doi: 10.1016/S0140-6736(17)30129-0. Epub 2017 Mar 13. |
| 19935413 | Background | Rothberg MB, Haessler SD. Complications of seasonal and pandemic influenza. Crit Care Med. 2010 Apr;38(4 Suppl):e91-7. doi: 10.1097/CCM.0b013e3181c92eeb. |
| 32449254 | Background | Salvatore M, Laplante JM, Soave R, Orfali N, Plate M, van Besien K, St George K. Baloxavir for the treatment of Influenza in allogeneic hematopoietic stem cell transplant recipients previously treated with oseltamivir. Transpl Infect Dis. 2020 Aug;22(4):e13336. doi: 10.1111/tid.13336. Epub 2020 Jun 10. |
| 30837531 | Background | Taniguchi K, Ando Y, Nobori H, Toba S, Noshi T, Kobayashi M, Kawai M, Yoshida R, Sato A, Shishido T, Naito A, Matsuno K, Okamatsu M, Sakoda Y, Kida H. Inhibition of avian-origin influenza A(H7N9) virus by the novel cap-dependent endonuclease inhibitor baloxavir marboxil. Sci Rep. 2019 Mar 5;9(1):3466. doi: 10.1038/s41598-019-39683-4. |
| Placebo and Standard of Care |
Placebo-matched Baloxavir Marboxil and standard of care Oseltamivir Placebo: Placebo at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Placebo-matched Baloxavir Marboxil and standard of care Oseltamivir Placebo: Placebo at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days. |
|
|
| Primary | Between-treatment-arm Difference in the Change of Influenza Viral RNA Loads From Baseline at the End of Treatment as Measured by Quantitative Real Time Polymerase Chain Reaction. | Influenza viral load will be measured by the quantitative real time polymerase chain reaction. | The only patient that completed the study, was randomized into the placebo arm. Difference cannot be calculated as one arm has zero patients. | Posted | Number | copies per mL | Baseline; Day 10 |
|
|
|
| Primary | Between-treatment-arm Difference in the Change of Influenza Viral RNA Loads From Baseline at the End of Treatment as Measured by Influenza Plaque Assay (Replicating Virus). | Influenza viral load will be measured by the influenza plaque assay. | The only patient that completed the study, was randomized into the placebo arm. Difference cannot be calculated as one arm has zero patients. | Posted | Number | PFU per mL | Baseline; Day 10 |
|
|
|
| Secondary | Change of Influenza Viral RNA Load From Baseline at Day 4 and Day 7 and 10 in Each Treatment Arm | Influenza viral RNA load will be measured by quantitative real time polymerase chain reaction. | The only patient that completed the study, was randomized into the placebo arm. | Posted | Number | copies per mL | Baseline; Day 4; Day 7; Day 10 |
|
|
|
| Secondary | Difference in Change of Influenza Viral Loads From Baseline at Day 4, 7 and 10 Between the Two Treatment Arms as Measured by Quantitative Real Time Polymerase Chain Reaction | Influenza viral RNA load will be measured by quantitative real time polymerase chain reaction. | The only patient that completed the study, was randomized into the placebo arm. Difference cannot be calculated as one arm has zero patients. | Posted | Number | copies per mL | Baseline; Day 4; Day 7; Day 10 |
|
|
|
| Secondary | Change of Influenza Viral Loads From Baseline at Day 4, 7 and 10 as Measured by Influenza Plaque Assay (Replicating Virus) in Each Treatment Arm | Influenza viral load will be measured by the influenza plaque assay (replicating virus). | The only patient that completed the study, was randomized into the placebo arm. | Posted | Number | PFU per mL | Baseline; Day 4; Day 7; Day 10 |
|
|
|
| Secondary | Difference in Change of Influenza Viral Loads From Baseline at Day 4, 7 and 10 Between the Two Treatment Arms as Measured by Influenza Plaque Assay (Replicating Virus) | Influenza viral load will be measured by the influenza plaque assay (replicating virus). | The only patient that completed the study, was randomized into the placebo arm. Difference cannot be calculated as one arm has zero patients. | Posted | Number | PFU per mL | Baseline; Day 4; Day 7; Day 10 |
|
|
|
| Secondary | Time to Improvement of Individual Influenza Symptoms as Assessed by Patient-reported Outcome Measures on a Single Scale | Patients will self-assess the severity of 7 influenza-associated symptoms on a 4-point single scale with 0 indicating no symptoms and higher scores indicating mild, moderate, and severe symptoms. Time to improvement of individual influenza symptoms are defined as the time from the start of treatment to the time when each of the influenza symptoms are alleviated, maintained, or improved for a duration of at least 21.5 hours. These are defined as: pre-existing symptoms (cough, fatigue, or muscle/join pain that existed prior to influenza) that were worse at baseline and had improved at least 1 point from baseline; pre-existing symptoms not worse at baseline that maintained baseline severity; and new symptoms that were alleviated, defined as a symptom score of non (0) or mild (1). | The only patient that completed the study, was randomized into the placebo arm. | Posted | Number | Days to recovery | Baseline to Day 30 |
|
|
|
| Secondary | Percentage of Patients Who Experience Each Influenza-related Complications: Hospitalization, Death, Sinusitis, Otitis Media, Bronchitis, and Radiologically-confirmed Pneumonia as an Adverse Event After the Initiation of Study Treatment | A composite score of multiple measures will be used and calculated by count of patients who experience each influenza-related complications. Adverse events will only include those that are determined to be related to the study drug. | The only patient that completed the study, was randomized into the placebo arm. | Posted | Number | Number of patients with complications. | Day 1 to Day 30 |
|
|
|
| Secondary | Time to Return to Preinfluenza Health Status | Preinfluenza health status will be measured on a score from 0 (worst possible health) to 10 (normal health [for someone your age and condition]). | The only patient that completed the study, was randomized into the placebo arm. | Posted | Number | Days | Day 1 to Day 30 |
|
|
|
| Secondary | Time to Viral Clearance, as Assessed by Difference in Percentage of Participants Positive by Influenza Plaque Assay at Each Time-point (in Each Treatment Group) | Time to viral clearance will be assessed by percentage of participants positive by influenza plaque assay at each time-point. | The only patient that completed the study, was randomized into the placebo arm. | Posted | Number | Days | Baseline to Day 30 |
|
|
|
| Secondary | Time to Viral Clearance, as Assessed by Difference in Percentage of Participants Positive by Quantitative Real Time Polymerase Chain Reaction | Time to viral clearance will be assessed by percentage of participants positive by qPCR at each time-point. | The only patient that completed the study, was randomized into the placebo arm. | Posted | Number | Days | Baseline to Day 30 |
|
|
|
| Secondary | Change of Treatment-emergent Variants of Neuraminidase and Polymerase Known to Confer Antiviral Resistance to Oseltamivir in Each Arm by Direct Next-generation Sequencing Symptoms | Treatment-emergent variants will be identified using direct next-generation sequencing of a comprehensive panel of genes. | The only patient that completed the study, was randomized into the placebo arm. | Posted | Number | Resistant variant | Baseline to Day 30 |
|
|
|
| Secondary | Percentage of Participants With Adverse Events (AEs) | Adverse events will only include those that are determined to be related to the study drug and will assess the safety and tolerability of Baloxavir in Combination with SOC treatment. | The only patient that completed the study, was randomized into the placebo arm. | Posted | Count of Participants | Participants | Day 1 to Day 15 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo and Standard of Care | Placebo-matched Baloxavir Marboxil and standard of care Oseltamivir Placebo: Placebo at baseline, day 4, and day 7. Oseltamivir: Oseltamivir 75 mg twice daily for 10 days. | 1 | 2 | 1 | 2 | 1 | 2 |
|
|
Not provided
Not provided
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Title | Measurements |
|---|
|
| Day 10 |
|
| Title | Measurements |
|---|
|
| Day 10 |
|
| Title | Measurements |
|---|
|
| Day 10 |
|
| Title | Measurements |
|---|
|
| Day 10 |
|