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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002217-59 | EudraCT Number | ||
| 63623872FLZ3002 | Other Identifier | Janssen Research & Development, LLC |
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Based on interim Analysis outcome being futile for FLZ3001; decision was taken to stop (early terminate) both FLZ3001/3002. There was no safety concern.
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The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.
This double-blind (neither researchers nor participants know what treatment participant is receiving) study will evaluate efficacy/safety of pimodivir in combination with SOC treatment versus placebo in combination with SOC treatment in adolescent (13 to 17 years), adult (18 to 65 years), and elderly (greater than [>] 65 but less than or equal to [<=] 85 years) non-hospitalized participants with influenza A infection who are at risk of developing complications. The study will be conducted in 3 phases: screening phase, double-blind treatment period (5 days), a post treatment follow-up period (23 days). Study evaluations include efficacy, clinical and virological outcomes, pharmacokinetics (PK), PK/pharmacodynamics, biomarkers, safety and tolerability. The duration of participation in the study for each participant is 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm 1 (pimodivir + SOC treatment) | Experimental | Participants will receive pimodivir 600 milligram (mg), orally, twice daily, for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of pimodivir on Day 1 [evening], dosing will continue until the morning of Day 6) along with Standard-of-Care (SOC) treatment. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be made before randomization. The influenza antiviral should be started no later than Day 2 morning (up to noon). An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during the treatment period, with the exception that an influenza antiviral may be discontinued in the case of a suspected adverse event (AE). |
|
| Treatment Arm 2 (placebo + SOC treatment) | Placebo Comparator | Participants will receive placebo matching to pimodivir orally, twice daily, for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of placebo on Day 1 [evening], dosing will continue until the morning of Day 6) along with SOC treatment. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be made before randomization. The influenza antiviral should be started no later than Day 2 morning (up to noon). An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during the treatment period, with the exception that an influenza antiviral may be discontinued in the case of a suspected AE. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pimodivir 600 mg | Drug | Participants will receive pimodivir 600 mg, orally, twice daily, for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of pimodivir on Day 1 [evening], dosing will continue until the morning of Day 6). |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Resolution of 7 Primary Influenza-related Symptoms as Assessed by the Patient-Reported Outcome (PRO) Measure Flu-Intensity and Impact Questionnaire (Flu-iiQ) | The Flu-iiQ is a PRO that measures influenza symptom intensity (none, mild, moderate, or severe) on a 4 point Likert response rating scale ranging from 0 to 3, where "0" represents the absence of symptom and "3" represents the severe symptom. The resolution of influenza-related symptoms is defined as the beginning of the 24-hour period that 7 influenza symptoms (cough, sore throat, headache, nasal congestion, feeling feverish, body aches and pains, fatigue) are at most mild or at least back to previous level of symptom severity in case the participant reported the symptom as pre-existing. | Up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Hospitalized After Treatment Initiation | The number of participants hospitalized after treatment initiation were reported. | Up to Day 28 |
| Viral Load Over Time | Viral load over time was measured by quantitative real time polymerase chain reaction (qRT-PCR) and viral culture in the mid-turbinate (MT) nasal swabs and endotracheal samples. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Alabama Clinical Therapeutics, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39172627 | Derived | Leopold L, Vingerhoets J, Deleu S, Nalpas C, Weber K, van Dromme I, Lowson D, Michiels B, van Duijnhoven W. Efficacy and Safety of Pimodivir Combined With Standard of Care in Hospitalized and Nonhospitalized High-Risk Adolescents and Adults With Influenza A Infection. J Infect Dis. 2025 Feb 4;231(1):e132-e143. doi: 10.1093/infdis/jiae408. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pimodivir + SOC | Participants received 600 milligrams (mg) pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. |
| FG001 | Placebo + SOC |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Feb 9, 2018 | Apr 30, 2021 |
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| Placebo | Drug | Participants will receive placebo matching to pimodivir, orally twice daily for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of placebo on Day 1 [evening], dosing will continue until the morning of Day 6). |
|
| SOC Treatment | Other | Participants may receive SOC treatment as a part of background therapy. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be made before randomization. The influenza antiviral should be started no later than Day 2 morning (up to noon). |
|
| Baseline, Day 3, 6, 10, 14 |
| Number of Participants With Emergence of Viral Resistance to Pimodivir | Emergence of viral resistance to pimodivir was detected by genotyping and/or phenotyping. Nasal MT swabs and endotracheal samples were used for sequence analysis of the polymerase basic protein (PB)2 region of the influenza polymerase gene, and of neuraminidase (NA) genes for participants using an NA inhibitor (NAI) as part of their Standard of Care (SOC). | Up to Day 28 |
| Plasma Concentration of Pimodivir | Plasma concentration of Pimodivir was reported. | Day 3, 6, 7 |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | Up to Day 28 |
| Number of Participants With Clinically Significant Changes in Laboratory Tests | Number of participants with clinically significant changes in laboratory tests were reported. Blood samples for hematology, serum chemistry, and urinalysis was collected at predefined time points for clinical laboratory testing. | Up to Day 28 |
| Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | Number of participants with clinically significant changes in Electrocardiogram (ECG) were reported. | Up to Day 28 |
| Number of Participants With Clinically Significant Changes in Vital Signs | Number of participants with clinically significant changes in vital signs (temperature, pulse rate, respiratory rate and blood pressure) were reported. | Up to Day 28 |
| Birmingham |
| Alabama |
| 35235 |
| United States |
| Cahaba Research Inc | Birmingham | Alabama | 35242 | United States |
| Scottsboro Quick Care Clinic | Scottsboro | Alabama | 35768 | United States |
| SC Clinical Research Inc. | California City | California | 92844 | United States |
| Research Center of Fresno Inc | Fresno | California | 93702 | United States |
| Allied Clinical Research | Gold River | California | 95670 | United States |
| Innovative Clinical Research Inc | Harbor City | California | 90710 | United States |
| Om Research LLC | Lancaster | California | 93534 | United States |
| Ark Clinical Research | Long Beach | California | 90806 | United States |
| Miller Children's Hospital | Long Beach | California | 90806 | United States |
| Downtown LA Research Center, Inc | Los Angeles | California | 90017 | United States |
| California Allergy & Asthma Medical Group Inc. | Los Angeles | California | 90025 | United States |
| Adam D. Karns, MD | Los Angeles | California | 90036 | United States |
| Lucita M. Cruz Md Inc | Norwalk | California | 90650 | United States |
| Asclepes Research | Panorama City | California | 91402 | United States |
| Center for Clinical Trials LLC | Paramount | California | 90723 | United States |
| Benchmark Research | Sacramento | California | 95684 | United States |
| Medical Associates Research Group, Inc. | San Diego | California | 92123 | United States |
| San Diego Sports Medicine & Family Health Center | San Diego | California | 92129 | United States |
| West Coast Clinical Research, LLC | San Ramon | California | 94582 | United States |
| Stanford University | Stanford | California | 94305-5640 | United States |
| Lynn Institute | Colorado Springs | Colorado | 80920 | United States |
| Complete Family Care | Northglenn | Colorado | 80234 | United States |
| Paradigm Clinical Research Centers, Inc. | Wheat Ridge | Colorado | 80033 | United States |
| Chase Medical Research, LLC | Waterbury | Connecticut | 06708 | United States |
| Emerson Clinical Research Institute | Washington D.C. | District of Columbia | 20011 | United States |
| Moonshine Research Center, Inc | Doral | Florida | 33166 | United States |
| Best Quality Research Inc | Hialeah | Florida | 33016 | United States |
| Floridian Clinical Research LLC | Hialeah | Florida | 33016 | United States |
| The community Research of South Florida | Hialeah | Florida | 33016 | United States |
| Encore Medical Research, LLC | Hollywood | Florida | 46112 | United States |
| Homestead Associates in Research Inc | Homestead | Florida | 33032 | United States |
| Care Partners Clinical Research | Jacksonville | Florida | 32218 | United States |
| Premier Medical Group | Lady Lake | Florida | 32159 | United States |
| Sima Research Clinic | Miami | Florida | 33125 | United States |
| Universal Clinical Research Associates | Miami | Florida | 33134 | United States |
| South Florida Research Center Inc. | Miami | Florida | 33135 | United States |
| A Plus Research | Miami | Florida | 33144 | United States |
| Nuren Medical & Research Center | Miami | Florida | 33144 | United States |
| Coral Research Clinic Corp | Miami | Florida | 33175 | United States |
| New Horizon Research Center | Miami | Florida | 33175 | United States |
| Vista Health Research, LLC | Miami | Florida | 33176 | United States |
| Crystal Biomedical Research | Miami Lakes | Florida | 33014 | United States |
| Combined Research Orlando | Orlando | Florida | 32803 | United States |
| Clinical NeuroScience Solutions Inc | Orlando | Florida | 32806 | United States |
| Omega Research Consultants | Orlando | Florida | 32810 | United States |
| Pines Care Research Center Inc | Pembroke Pines | Florida | 33026 | United States |
| South Broward Research, LLC | Pembroke Pines | Florida | 33027 | United States |
| Destin Pulmonary Critical Care, PLLS. | Santa Rosa Beach | Florida | 32459 | United States |
| Vita Health and Medical center | Tamarac | Florida | 33319 | United States |
| Asclepes Research | Weeki Wachee | Florida | 34607 | United States |
| Axcess Medical Research, LLC | Wellington | Florida | 33414 | United States |
| Cozy Research, Llc | Zephyrhills | Florida | 33541 | United States |
| Snake River Research, PLLC | Idaho Falls | Idaho | 83404 | United States |
| Saltzer Medical Group | Nampa | Idaho | 83686 | United States |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| Investigators Research Group, LLC | Brownsburg | Indiana | 46112 | United States |
| Medisphere Medical Research Center, Llc | Evansville | Indiana | 47714 | United States |
| Hutchinson Clinic | Hutchinson | Kansas | 67502 | United States |
| The Research Group of Lexington, LLC | Lexington | Kentucky | 40503 | United States |
| Clinical Trials Management, LLC | Metairie | Louisiana | 70006 | United States |
| Medpharmics, LLC | Metairie | Louisiana | 70006 | United States |
| North Star Clinical Research, LLC | Shreveport | Louisiana | 71104 | United States |
| University Of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21218 | United States |
| Centennial Medical Group | Elkridge | Maryland | 21075 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Wayne State Univ School of Medicine | Detroit | Michigan | 48201 | United States |
| Wayne State University | Detroit | Michigan | 97205 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Tri County Research, Inc. | Sterling Heights | Michigan | 48310-3503 | United States |
| William Beaumont Hospital | Troy | Michigan | 48085 | United States |
| Arcturus Healthcare PLC | Troy | Michigan | 48098 | United States |
| Craig A. Spiegel, MD | Bridgeton | Missouri | 63044 | United States |
| Mercury Street Medical Group, PLLC | Butte | Montana | 59701 | United States |
| Montana Medical Research | Missoula | Montana | 59808 | United States |
| Barrett Clinic P.C. | La Vista | Nebraska | 68128 | United States |
| Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Next Phase Research Alliance | Las Vegas | Nevada | 89119 | United States |
| Saint Michaels Medical Center | Newark | New Jersey | 07102 | United States |
| Accellacare Research of Cary | Cary | North Carolina | 27518 | United States |
| Onsite Clinical Solutions | Clemmons | North Carolina | 27012 | United States |
| Carolina Institute for Clinical Research | Fayetteville | North Carolina | 28304 | United States |
| clinical research of Gastonia | Gastonia | North Carolina | 28054 | United States |
| Hickory Research Center. | Hickory | North Carolina | 28601 | United States |
| Monroe Biomedical Research | Monroe | North Carolina | 28112 | United States |
| Burke Primary Care | Morganton | North Carolina | 28655 | United States |
| PMG Research of Rocky Mount, LLC | Rocky Mount | North Carolina | 27804 | United States |
| PMG Research of Wilmington, LLC | Wilmington | North Carolina | 28401 | United States |
| Clinical Trials of America | Winston-Salem | North Carolina | 27103 | United States |
| Southeastern Research Center LLC | Winston-Salem | North Carolina | 27103 | United States |
| Dayton Clinical Research | Dayton | Ohio | 45406 | United States |
| Buckeye Health and Research, LLC | Hilliard | Ohio | 43027 | United States |
| Lancaster General Hospital | Lancaster | Pennsylvania | 29720 | United States |
| Detweiler Family Medicine and Associates | Lansdale | Pennsylvania | 19446 | United States |
| Albert Einstein Healthcare Network | Philadelphia | Pennsylvania | 19141 | United States |
| Preferred Primary Care Physicians Research | Pittsburgh | Pennsylvania | 15236 | United States |
| Frontier Clinical Research | Smithfield | Pennsylvania | 15478 | United States |
| Preferred Primary Care Physicians Research | Uniontown | Pennsylvania | 15401 | United States |
| AAPRI Clinical Research Institute | Warwick | Rhode Island | 02886 | United States |
| Spectrum Medical Research | Gaffney | South Carolina | 29341 | United States |
| DeGarmo Institute of Medical Research | Greer | South Carolina | 29651 | United States |
| PMG Research of Charleston, LLC | Mt. Pleasant | South Carolina | 29464 | United States |
| Fusion Clinical Research of Spartanburg | Spartanburg | South Carolina | 29301 | United States |
| Invocare Clinical Research Center | West Columbia | South Carolina | 29169 | United States |
| Health Concepts | Rapid City | South Dakota | 57702 | United States |
| PMG Research of Bristol | Bristol | Tennessee | 37620 | United States |
| PMG Research of Knoxville | Jefferson City | Tennessee | 37760 | United States |
| PMG Research of Knoxville | Knoxville | Tennessee | 37912 | United States |
| HIRG, LLC dba Health Innovation Research Group | Arlington | Texas | 76014 | United States |
| ACRC Trials | Austin | Texas | 78735 | United States |
| Family Medicine Associates of Texas | Carrollton | Texas | 75010 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| WR-Global Medical Research, LLC | DeSoto | Texas | 75115 | United States |
| University Of Texas Medical Branch At Galveston | Galveston | Texas | 77555 | United States |
| San Gabriel Clinical Research, LLC | Georgetown | Texas | 78626 | United States |
| BI Research Center | Houston | Texas | 77043 | United States |
| West Houston Clinical Research Service | Houston | Texas | 77055 | United States |
| Northwest Med Care,P.A. | Houston | Texas | 77070 | United States |
| Southwest Clinical Trials | Houston | Texas | 77074 | United States |
| Dairy Ashford Family Practice | Houston | Texas | 77077 | United States |
| JM Research.PLLC | Houston | Texas | 77083 | United States |
| PCP for Life | Houston | Texas | 77093-6731 | United States |
| SMS Clinical Research LLC | Mesquite | Texas | 75149 | United States |
| Village Health Partners | Plano | Texas | 75024 | United States |
| Tekton Research Inc. | San Antonio | Texas | 78240 | United States |
| DM Clinical Research | San Antonio | Texas | 78249 | United States |
| Renovatio Clinical | The Woodlands | Texas | 77380 | United States |
| ClinPoint Trials | Waxahachie | Texas | 75165 | United States |
| Val Hansen | Bountiful | Utah | 84010 | United States |
| Ericksen Research and Development | Clinton | Utah | 84015 | United States |
| J. Lewis research Inc./ Foothill Family Clinic South | Draper | Utah | 84020 | United States |
| Advanced Research Institute | Ogden | Utah | 84405 | United States |
| Granger Medical Clinic-Riverton | Riverton | Utah | 84065 | United States |
| J. Lewis research Inc./ Foothill Family Care | Salt Lake City | Utah | 84109 | United States |
| J. Lewis research Inc./ Foothill Family Clinic South | Salt Lake City | Utah | 84121 | United States |
| J. Lewis Research Inc/ FirstMed East | Salt Lake City | Utah | 84121 | United States |
| J. Lewis Research Inc./Jordan River Family Medicine | South Jordan | Utah | 84095 | United States |
| Millennium Clinical Trials LLC | Arlington | Virginia | 22203 | United States |
| Hospital Interzonal General de Agudos Dr. Jose Penna | Bahía Blanca | B8001DDU | Argentina |
| CEMIC Saavedra | Ciudad de Buenos Aires | 1431 | Argentina |
| Hospital Nuestra Señora de la Misericordia | Córdoba | 5000 | Argentina |
| Hospital Rawson | Córdoba | 5000 | Argentina |
| Hospital San Roque | Córdoba | 5000 | Argentina |
| Sanatorio Allende | Córdoba | X5000JHQ | Argentina |
| Hospital Cordoba | Córdoba | X5004CDT | Argentina |
| Hospital Privado Centro Medico de Cordoba | Córdoba | X5016KEH | Argentina |
| Sanatorio Juan XXIII | General Roca | 8332 | Argentina |
| Sanatorio del Oeste Ituzaingo | Ituzaingo | 1714 | Argentina |
| Instituto Medico Platense | La Plata | B1900AVG | Argentina |
| Hospital Italiano de La Plata | La Plata Lpl Lpl | 1900 | Argentina |
| Sanatorio Britanico S.A. | Rosario | 2000 | Argentina |
| Instituto Del Buen Aire | Santa Fe | 3000 | Argentina |
| Northside Health | Coffs Harbour | 2450 | Australia |
| Mater Hospital Brisbane | South Brisbane | 4101 | Australia |
| AKH - Medizinische Universitat Wien | Vienna | 1090 | Austria |
| SMZ Süd - Kaiser Franz Josef Spital Wien | Vienna | 1100 | Austria |
| CHU Saint-Pierre | Brussels | 1000 | Belgium |
| Hopital Erasme | Brussels | 1070 | Belgium |
| Institut Jules Bordet | Brussels | 1070 | Belgium |
| De Meulemeester, Marc | Gozée | 6534 | Belgium |
| Jaak Mortelmans | Ham | 3945 | Belgium |
| Quartier du Furgy 4 | Herbeumont | 6887 | Belgium |
| Research Link | Linkebeek | 1630 | Belgium |
| BVBA Dr. Luc Capiau | Massemen | 9230 | Belgium |
| Testumed | Tessenderlo | 3980 | Belgium |
| Santa Casa de Misericordia de Belo Horizonte | Belo Horizonte | 30150-221 | Brazil |
| Infection Control Ltda | Brasil | 30110-063 | Brazil |
| Hrpc Ulbratech - Ulbra | Canoas | 92425 | Brazil |
| Centro de Estudos Clínicos do Interior Paulista - CECIP | Jaú | 17201-150 | Brazil |
| CMIP - Centro Mineiro de Pesquisa Ltda | Juiz de Fora | 36010 570 | Brazil |
| Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo | Passo Fundo | 99010-080 | Brazil |
| Hospital das Clinicas de Porto Alegre | Porto Alegre | 90035-903 | Brazil |
| Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS | Porto Alegre | 90610-000 | Brazil |
| CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda. | Rio de Janeiro | 22271-100 | Brazil |
| Pesquisare Saude | Santo André | 09080-110 | Brazil |
| CEMEC - Centro Multidisciplinar de Estudos Clínicos | São Bernardo do Campo | 09780-000 | Brazil |
| Irmandade Santa Casa de Misericordia de Sao Paulo | São Paulo | 01221-020 | Brazil |
| Fundacao Jose Luiz Egydio Setubal | São Paulo | 01227-200 | Brazil |
| SHATPPD - Ruse Ltd. | Rousse | 7002 | Bulgaria |
| MHAT Knyaginya Klementina | Sofia | 1233 | Bulgaria |
| MHAT 'Lyulin' EAD | Sofia | 1336 | Bulgaria |
| Acibadem City Clinic Tokuda Hospital | Sofia | 1407 | Bulgaria |
| DCC II- Sofia EOOD | Sofia | 1606 | Bulgaria |
| Medical Center 'N. I. Pirogov', EOOD | Sofia | 1606 | Bulgaria |
| Medical Center Excelsior OOD | Sofia | 1606 | Bulgaria |
| Military Medical Academy - Sofia | Sofia | 1606 | Bulgaria |
| MHAT Dr Stefan Cherkezov | Veliko Tarnovo | 5000 | Bulgaria |
| MC 'Sv. Ivan Rilski', OOD | Vidin | 3700 | Bulgaria |
| The Bailey Clinic | Red Deer | Alberta | T4N 6V7 | Canada |
| Commonwealth Medical Clinic | Mount Pearl | Newfoundland and Labrador | A1N 1W7 | Canada |
| Aggarwal and associates Ltd | Brampton | Ontario | L6T 0G1 | Canada |
| SKDS Research Inc. | Newmarket | Ontario | L3Y 5G8 | Canada |
| Bluewater Clinical Research Group Inc. | Sarnia | Ontario | N7T 4X3 | Canada |
| Dr. Anil K Gupta Medicine Professional Corporation | Toronto | Ontario | M9V 4B4 | Canada |
| Recherche Clinique Sigma Inc. | Québec | Quebec | G1G 4A2 | Canada |
| Hospital El Pino | San Bernardo | 13560 | Chile |
| Centro de Investigacion del Maule | Talca | 00000 | Chile |
| Hospital de Niños y Cunas | Viña | Chile |
| Chinese PLA General Hospital | Beijing | 100853 | China |
| Fuzhou General Hospital of Nanjing Military Command | Fuzhou | 350000 | China |
| The First Affiliated Hospital of NanChang University | Nanchang | 330006 | China |
| Wuxi People s Hospital | Wuxi | 214000 | China |
| Henan Provincial Peoples Hospital | Zhengzhou | China |
| ADMED s.r.o. | České Budějovice | 37006 | Czechia |
| Sanare, s.r.o. | České Budějovice | 37006 | Czechia |
| Nemocnice Kyjov, p.o. | Kyjov | 697 01 | Czechia |
| Praktik Pb s.r.o | Příbram | 26101 | Czechia |
| SARKAMED s.r.o. | Slaný | 274 01 | Czechia |
| Prakticky lekar | Sokolov | 356 01 | Czechia |
| Private GP Ilme Last | Paide | 72712 | Estonia |
| Vee Family Doctor's Center OY | Paide | 72713 | Estonia |
| OU Innomedica | Tallinn | 10117 | Estonia |
| Merelahe Family Doctors Center | Tallinn | 10617 | Estonia |
| Pirita Family Doctors Centre | Tallinn | 11911 | Estonia |
| Family Doctors Pullerits & Gavronski | Tartu | 51014 | Estonia |
| Centre Hospitalier d'Agen | Agen | 47923 | France |
| Centre Hospitalier Intercommunal de Créteil | Créteil | 94010 | France |
| Centre Hospitalier Départemental | La Roche S/ Yon Cedex 9 | 85925 | France |
| CHU de Grenoble Hopital Albert Michallon | La Tronche | 38043 | France |
| CHU Nantes - Hotel Dieu | Nantes | 44093 | France |
| CHU De Nice Hopital De l'Archet | Nice | 06202 | France |
| Hôpital Bichat - Claude Bernard | Paris | 75018 | France |
| Hopital Cochin | Paris | 75679 Cedex 14 | France |
| Universitaetsklinikum Koelnt | Cologne | 50937 | Germany |
| MECS GmbH Cottbus | Cottbus | 03050 | Germany |
| Jung, Thomas | Deggingen | 73326 | Germany |
| Universitaetsklinik Erlangen | Erlangen | 91054 | Germany |
| Universitaetsklinikum Giessen und Marburg GmbH | Giessen | 35392 | Germany |
| Gemeinschaftspraxis Dr. Klein/ Minnich | Künzing | 94550 | Germany |
| Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut | Leipzig | 04249 | Germany |
| DRC Gyogyszervizsgalo Kozpont Kft | Balatonfüred | 8230 | Hungary |
| Clinexpert Kft | Budapest | 1033 | Hungary |
| Obudai Egeszsegugyi Centrum Kft | Budapest | 1036 | Hungary |
| Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu | Budapest | 1122 | Hungary |
| Strázsahegy Medicina Bt | Budapest | 1171 | Hungary |
| Pestszentimrei Gyermekrendelő | Budapest | 1188 | Hungary |
| Bugat Pal Korhaz | Gyöngyös | 3200 | Hungary |
| Futurenest Klinikai Kutato Kft. | Miskolc | 3527 | Hungary |
| Mohacsi Korhaz | Mohács | 7700 | Hungary |
| Borbanya Praxis Eu. Kft. | Nyíregyháza | 4400 | Hungary |
| Medifarma-98 Kft. | Nyíregyháza | 4400 | Hungary |
| DRC Szentendre | Szentendre | 2000 | Hungary |
| Tudogyogyintezet Torokbalint | Törökbálint | 2045 | Hungary |
| DRC Zamardi | Zamárdi | 8621 | Hungary |
| DRC Zirc | Zirc | 8420 | Hungary |
| Rajiv Gandhi Institute of Medical Sciences | Balaga | 532001 | India |
| M S Ramaiah Memorial Hospital | Bangalore | 560054 | India |
| S. R. Kalla Memorial General Hospital | Jaipur | 302001 | India |
| Midland Healthcare & Research Center | Lucknow | 226006 | India |
| Kasturba Medical College Hospital | Manipal | 576104 | India |
| Suretech Hospital and Research Centre Limited | Nagpur | 400012 | India |
| Siddhi Hospital | Nashik | 422007 | India |
| BLK Super Specialty Hospital | New Delhi | 110005 | India |
| Sir Ganga Ram Hospital | New Delhi | 110060 | India |
| Sahyadri Speciality Hospital | Pune | 411004 | India |
| Lifepoint Multispecialty Hospital | Pune | 411023 | India |
| Shree Giriraj Multispeciality Hospital | Rajkot | 360005 | India |
| Unique Hospital | Surat | 395002 | India |
| BAPS Pramukhswami Hospital | Surat | 395009 | India |
| Barzilai Medical Center | Ashkelon | 78278 | Israel |
| Bnai Zion Medical Center | Haifa | 31048 | Israel |
| Galilee Medical Center | Nahariya | 22100 | Israel |
| Chaim Sheba Medical Center | Ramat Gan | 52621 | Israel |
| Kaplan Medical Center | Rehovot | 7610001 | Israel |
| Ziv Medical Center | Safed | 13100 | Israel |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | 20162 | Italy |
| AOU Policlinico di Modena | Modena | 41124 | Italy |
| Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo | Monza | 20052 | Italy |
| Azienda Ospedaliera Universitaria Integrata Verona | Verona | 37126 | Italy |
| Liga Kozlovska family doctor practice | Balvi | LV4501 | Latvia |
| OLVI Medical Centre | Daugavpils | LV-5401 | Latvia |
| Baiba Bake GP practice | Jelgava | LV3001 | Latvia |
| Ruta Eglite's Private Practice | Kuldīga | LV-3301 | Latvia |
| Inese Cebere GP practice | Liepāja | LV-3401 | Latvia |
| S. Boreiko Doctor's Practice | Ogre | LV-5001 | Latvia |
| Children's Clinical University Hospital | Riga | LV-1004 | Latvia |
| Clinic of GP A.Lasmanis 'ALMA' | Riga | LV-1010 | Latvia |
| Health Centre 4 | Riga | LV-1012 | Latvia |
| Inese Petrova General Practitioner Practice | Tukums | LV-3101 | Latvia |
| Medical Practice BINI | Ventspils | LV3601 | Latvia |
| Auki Sveikas | Kaunas | 44175 | Lithuania |
| Silainiai Family Health Center, JSC | Kaunas | 48259 | Lithuania |
| Saules Seimos Medicinos Centras, JSC | Kaunas | 49449 | Lithuania |
| Hospital of Lithuanian University of Health Sciences Kaunas Clinics | Kaunas | LT-50009 | Lithuania |
| Siauliai Republican Hospital, Public Institution | Šiauliai | 76231 | Lithuania |
| Inlita, JSC, Lazdynai KTC clinical trial site | Vilnius | 4130 | Lithuania |
| Central Outpatient Clinic | Vilnius | LT-01117 | Lithuania |
| Inlita, JSC | Vilnius | LT-08406 | Lithuania |
| Vilnius University Hospital Santaros Klinikos, Public Institution | Vilnius | LT-08661 | Lithuania |
| Klinik Kesihatan Cheras Baru | Cheras Baru | 56100 | Malaysia |
| Klinik Kesihatan Kuang | Kuang | 48050 | Malaysia |
| Hospital Miri | Miri | 98000 | Malaysia |
| Hospital Taiping | Taiping | 34000 | Malaysia |
| Hospital Cardiologica Aguascalientes | Aguascalientes | 20230 | Mexico |
| Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada S.C. | Culiacán | 80230 | Mexico |
| Centro de Investigacion Medico Biologica y Terapia Avanzada CIMBYTA | Guadalajara | 44130 | Mexico |
| Hospital Civil de Guadalajara Fray Antonio Alcalde | Guadalajara | 44280 | Mexico |
| Hospital Civil de Guadalajara Dr. Juan I. Menchaca | Guadalajara | 44340 | Mexico |
| Centro Medico Jojutla | Jojutla | 62900 | Mexico |
| Hospital Infantil de Mexico Federico Gomez | Mexico City | 6720 | Mexico |
| Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez' | Monterrey | 64460 | Mexico |
| Clinical Trials Mexico S.A. de C.V. | Pahucha | 42070 | Mexico |
| Huisartsenpraktijk Zijtregtop | Rotterdam | 3037 AN | Netherlands |
| Huisartsenpraktijk Mangal | The Hague | 2565 KV | Netherlands |
| Huisartsenpraktijk Top | Zwijndrecht | 3334 SB | Netherlands |
| Southern Clinical Trials Ltd | Auckland | 1050 | New Zealand |
| Culloden Research Ltd | Papamoa | 3118 | New Zealand |
| Lakeland Family Medical Services Ltd | Rotorua | 3010 | New Zealand |
| Wellington Hospital | Wellington | 6021 | New Zealand |
| Complejo Hospitalario San Pablo | Lima | 33 | Peru |
| Clínica Sanna San Borja | Lima | 41 | Peru |
| Clínica Internacional | Lima | Lima 01 | Peru |
| Hospital Maria Auxiliadora | Lima | LIMA 29 | Peru |
| Clinica Peruano Americana S.A | Trujillo | 13007 | Peru |
| Malopolskie Centrum Alergologii | Krakow | 31-624 | Poland |
| ETG Lodz | Lodz | 90 302 | Poland |
| Powiatowe Centrum Medyczne w Wolowie Sp z o o | Specjalistyczna W Brzegu Dolnym | 58 120 | Poland |
| Gabinet Lekarski Pediatryczno-Alergologiczny | Sucha Beskidzka | 34-200 | Poland |
| NZOZ Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska | Wroclaw | 51 162 | Poland |
| Centrum Medyczne w Lancucie Sp.z o.o. | Łańcut | 37-100 | Poland |
| Institute Of Epidimiology And Microbiology | Kazan' | 420015 | Russia |
| Limited Liability company 'MSMC' Euromed | Omsk | 644024 | Russia |
| LLC Outpatient department of Private Security Guards and Detectives | Saint Petersburg | 192007 | Russia |
| LLC Institute of Medical Examinations | Saint Petersburg | 196084 | Russia |
| LLC Kurator | Saint Petersburg | 196240 | Russia |
| FSBI 'Scientific and Research Institute of Flu' of the MoH of the RF | Saint Petersburg | 197376 | Russia |
| LLC 'ArsVite' | Stavropol | 355020 | Russia |
| Siberian State Medical University | Tomsk | 634061 | Russia |
| Clinical Hospital #3 | Yaroslavl | 150007 | Russia |
| SBEI HPE 'Yaroslavl State Medical University' of the MoH of the RF | Yaroslavl | 150010 | Russia |
| Alersa, S.R.O. | Košice | 04022 | Slovakia |
| Nemocnica s poliklinikou S. Kukuru Michalovce, a.s. | Michalovce | 07101 | Slovakia |
| Plucna ambulancia Hrebenar, s.r.o. | Spišská Nová Ves | 05201 | Slovakia |
| Nemocnica arm. generala L. Svobodu Svidnik, a.s., | Svidník | 08901 | Slovakia |
| Cardiology Clinical Research | Alberton | 1449 | South Africa |
| Josha Research | Bloemfontein | 9301 | South Africa |
| Dr Dindar & Partner | Breyten | 2330 | South Africa |
| Endocare Research | Cape Town | 7646 | South Africa |
| Uhuru Clinical Trial Centre | Cape Town | 7764 | South Africa |
| Dr EL Janari Private Practice | Cape Town | 7945 | South Africa |
| Precise Clinical Solutions | Chatsworth | 4092 | South Africa |
| Abdullah, IA | Durban | 4001 | South Africa |
| Sebastian, Peter | Durban | 4001 | South Africa |
| Pillai, P | Durban | 4068 | South Africa |
| Govind, U | Durban | 4096 | South Africa |
| Jeevren Reddy, MD | Durban | 4450 | South Africa |
| Global Clinical Research SA | Durban North | 4051 | South Africa |
| CRISMO Bertha Gxowa Research Centre | Johannesburg | 1401 | South Africa |
| Peermed Clinical Trial Centre | Kempton Park | 1619 | South Africa |
| DJW Research | Krugersdorp | 1739 | South Africa |
| Aliwal Shoal Medical Centre | KwaZulu-Natal | 4170 | South Africa |
| Dr A Jacovides Clinical Trials Inc. | Midrand | 1685 | South Africa |
| Dr AA Mahomed Medical Centre | Moloto South | 1022 | South Africa |
| Newtown Clinical Research | Newtown | 2113 | South Africa |
| Pillay, SR | Ottawa | 4339 | South Africa |
| Smartmed Research Centre | Port Elizabeth | 6020 | South Africa |
| Emmed Research | Pretoria | 0084 | South Africa |
| Botho ke Bontle Health Services | Pretoria | 0101 | South Africa |
| Into Research | Pretoria | 0181 | South Africa |
| Jongaie Research | Pretoria | 0183 | South Africa |
| Queenswood Clinical Trial Centre | Pretoria | 0186 | South Africa |
| Engelbrecht, I | Pretoria | 157 | South Africa |
| Johese Clinical Research | Pretoria | 1692 | South Africa |
| Wits Clinical Research | Soweto | 2013 | South Africa |
| Limpopo Clinical Research Initiative | Thabazimbi | 380 | South Africa |
| Clinteam Vaal Clinical Trial Centre | Van Der Bijl | 1911 | South Africa |
| Welkom Clinical Trial Centre | Welkom | 9460 | South Africa |
| Moriana Clinical Research | Winnie Mandela | 9400 | South Africa |
| Chungbuk National University Hospital | Cheongju-si | 28644 | South Korea |
| Yonsei University Wonju Severance Christian Hospital | Gangwon-do | 220-701 | South Korea |
| Korea University Ansan Hospital | Gyeonggi-do | 15355 | South Korea |
| Hallym University Dongtan Sacred Heart Hospital | Hwaseong-si | 18450 | South Korea |
| Inha University Hospital | Incheon | 22322 | South Korea |
| The Catholic University of Korea, Incheon St. Mary's Hospital | Incheon | 403-720 | South Korea |
| Dong-A University Hospital | Pusan | 602-715 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Konkuk University Medical Center | Seoul | 05030 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Hallym University Kangnam Sacred Heart Hospital | Seoul | 07441 | South Korea |
| Korea University Guro Hospital | Seoul | 8308 | South Korea |
| The Catholic university of Korea ST Vincent Hospital | Suwon | 16247 | South Korea |
| Hosp. Gral. Univ. de Elche | Elche | 03203 | Spain |
| Hosp. Univ. San Cecilio | Granada | 18012 | Spain |
| Hosp. Univ. Virgen de Las Nieves | Granada | 18014 | Spain |
| Hosp. Univ. de La Princesa | Madrid | 28006 | Spain |
| Hosp. Clinico San Carlos | Madrid | 28040 | Spain |
| Hosp. Univ. 12 de Octubre | Madrid | 28041 | Spain |
| Hosp. Univ. La Paz | Madrid | 28046 | Spain |
| Hosp. Univ. Hm Monteprincipe | Madrid | 28660 | Spain |
| Hosp. Clinico Univ. de Santiago | Santiago de Compostela | 15706 | Spain |
| Hosp. Alvaro Cunqueiro | Vigo | 36213 | Spain |
| Department for Heart Failure and Valvular Disease | Malmö | 205 02 | Sweden |
| City Diabetes | Stockholm | 11157 | Sweden |
| Norrlands Universitetssjukhus | Umeå | 901 87 | Sweden |
| Akademiska Sjukhuset | Uppsala | 75185 | Sweden |
| Taipei Medical University Shuang-Ho Hospital | New Taipei City | 23561 | Taiwan |
| Kuang Tien General Hospital, Shalu | Taichung | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Taipei Medical University | Taipei | 110 | Taiwan |
| Taipei Medical University-Wan Fang Hospital | Taipei | 116 | Taiwan |
| The Hospital for Tropical Diseases | Bangkok | 10400 | Thailand |
| Siriraj Hospital | Bangkok | 10700 | Thailand |
| Srinagarind Hospital | Muang | 40002 | Thailand |
| Bamrasnaradura Infectious Disease Institute | Nonthaburi | 11000 | Thailand |
| Bumrungrad Hospital | Wattana | 10110 | Thailand |
| Hacettepe University Medical Faculty | Ankara | 06100 | Turkey (Türkiye) |
| Adnan Menderes University | Aydin | 09100 | Turkey (Türkiye) |
| Uludag University Medical Faculty | Bursa | 16059 | Turkey (Türkiye) |
| Diyarbakir University Medical Faculty | Diyarbakır | 21080 | Turkey (Türkiye) |
| Kocaeli University Medical Faculty | Kocaeli | 41380 | Turkey (Türkiye) |
| Hacettepe University Medical Faculty | Samanpazarı | 06100 | Turkey (Türkiye) |
| Karadeniz Teknik University Medical Faculty | Trabzon | 61080 | Turkey (Türkiye) |
| Med San Unit OJSC Kharkiv S.OrdzhonikidzeTractor Plant Dept of Ther KMA PGE | Kharkiv | 61106 | Ukraine |
| Kyiv Oleksandrivska Clinical Hospital | Kyiv | 1601 | Ukraine |
| Odesa City Municipal Institution Polyclinic #20 | Odesa | 65114 | Ukraine |
| Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy | Poltava | 36000 | Ukraine |
| CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM | Vinnytsia | 21021 | Ukraine |
| Swan Lane Medical Centre | Bolton | BL 6 6QT | United Kingdom |
| Bodey Medical Centre | Manchester | M14 6WP | United Kingdom |
| Barlow Medical Centre | Manchester | M20 2RN | United Kingdom |
| West Timperley Medical Centre | Manchester | WA14 5PF | United Kingdom |
| Northenden Group Practice | Northenden | M22 4DH | United Kingdom |
| Bach Mai Hospital | Hanoi | 100000 | Vietnam |
| National Hospital for Tropical Diseases | Hanoi | 100000 | Vietnam |
| Nguyen Tri Phuong Hospital | Ho Chi Minh City | Vietnam |
Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment.
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pimodivir + SOC | Participants received 600 milligrams (mg) pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. |
| BG001 | Placebo + SOC | Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. |
| 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 Resolution of 7 Primary Influenza-related Symptoms as Assessed by the Patient-Reported Outcome (PRO) Measure Flu-Intensity and Impact Questionnaire (Flu-iiQ) | The Flu-iiQ is a PRO that measures influenza symptom intensity (none, mild, moderate, or severe) on a 4 point Likert response rating scale ranging from 0 to 3, where "0" represents the absence of symptom and "3" represents the severe symptom. The resolution of influenza-related symptoms is defined as the beginning of the 24-hour period that 7 influenza symptoms (cough, sore throat, headache, nasal congestion, feeling feverish, body aches and pains, fatigue) are at most mild or at least back to previous level of symptom severity in case the participant reported the symptom as pre-existing. | The Intent-To-Treat infected (ITT-i) Set included all randomized participants who received at least 1 dose of study drug and who had confirmed infection with influenza A and analyzed by planned treatment. | Posted | Median | 95% Confidence Interval | hours | Up to Day 28 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Hospitalized After Treatment Initiation | The number of participants hospitalized after treatment initiation were reported. | The Intent-To-Treat infected (ITT-i) Set included all randomized participants who received at least 1 dose of study drug and who had confirmed infection with influenza A and analyzed by planned treatment. | Posted | Count of Participants | Participants | Up to Day 28 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Viral Load Over Time | Viral load over time was measured by quantitative real time polymerase chain reaction (qRT-PCR) and viral culture in the mid-turbinate (MT) nasal swabs and endotracheal samples. | The Intent-To-Treat infected (ITT-i) Set included all randomized participants who received at least 1 dose of study drug and who had confirmed infection with influenza A and analyzed by planned treatment. Here N (number of participants analyzed) are participants evaluable for this outcome measure and "n (number analyzed)" signifies number of participants analyzed for specified categories. | Posted | Mean | Standard Deviation | log 10 viral particles per milliliter | Baseline, Day 3, 6, 10, 14 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Emergence of Viral Resistance to Pimodivir | Emergence of viral resistance to pimodivir was detected by genotyping and/or phenotyping. Nasal MT swabs and endotracheal samples were used for sequence analysis of the polymerase basic protein (PB)2 region of the influenza polymerase gene, and of neuraminidase (NA) genes for participants using an NA inhibitor (NAI) as part of their Standard of Care (SOC). | Population included participants from ITT-i set with both baseline and post-baseline sequencing data. | Posted | Count of Participants | Participants | Up to Day 28 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentration of Pimodivir | Plasma concentration of Pimodivir was reported. | The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated. Here, N (number of participants analyzed) signifies participants evaluable for this outcome measure and "n (number analyzed)" signifies number of participants analyzed for specified categories. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Day 3, 6, 7 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated. | Posted | Count of Participants | Participants | Up to Day 28 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Laboratory Tests | Number of participants with clinically significant changes in laboratory tests were reported. Blood samples for hematology, serum chemistry, and urinalysis was collected at predefined time points for clinical laboratory testing. | The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated. | Posted | Count of Participants | Participants | Up to Day 28 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | Number of participants with clinically significant changes in Electrocardiogram (ECG) were reported. | The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated. | Posted | Count of Participants | Participants | Up to Day 28 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Vital Signs | Number of participants with clinically significant changes in vital signs (temperature, pulse rate, respiratory rate and blood pressure) were reported. | The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated. | Posted | Count of Participants | Participants | Up to Day 28 |
|
|
Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
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 | Pimodivir + SOC | Participants received 600 milligrams (mg) pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. | 0 | 273 | 3 | 273 | 122 | 273 |
| EG001 | Placebo + SOC | Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. | 1 | 271 | 4 | 271 | 99 | 271 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacteraemia | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pneumonia Pneumococcal | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Streptococcal Sepsis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Polycythaemia | Blood and lymphatic system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Ear Pain | Ear and labyrinth disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Tympanic Membrane Disorder | Ear and labyrinth disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Conjunctival Haemorrhage | Eye disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Aphthous Ulcer | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Faeces Soft | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Gastrointestinal Pain | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hiatus Hernia | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Infrequent Bowel Movements | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Lip Disorder | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pancreatic Atrophy | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Feeling Jittery | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Impaired Healing | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Peripheral Swelling | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Vessel Puncture Site Bruise | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hepatic Steatosis | Hepatobiliary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Seasonal Allergy | Immune system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Acute Sinusitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Adenoviral Upper Respiratory Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Bronchitis Bacterial | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Candida Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Ear Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Gastroenteritis Rotavirus | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Gastroenteritis Viral | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Kidney Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Otitis Externa | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Otitis Media | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Otitis Media Acute | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pneumonia Bacterial | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Skin Candida | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Amylase Abnormal | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Amylase Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Blood Bilirubin | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Blood Glucose Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Blood Potassium Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Blood Pressure Decreased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Blood Pressure Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Gamma-Glutamyltransferase Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Glomerular Filtration Rate Decreased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hepatic Enzyme Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| International Normalised Ratio Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Liver Function Test Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pancreatic Enzymes Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Transaminases Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Joint Stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Spinal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Intercostal Neuralgia | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Loss of Consciousness | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Glycosuria | Renal and urinary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Renal Pain | Renal and urinary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Testicular Pain | Reproductive system and breast disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Bronchitis Chronic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Nasal Mucosal Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pharyngeal Erythema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Cold Sweat | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Skin Exfoliation | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Skin Lesion | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Ischaemia | Vascular disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA Version 22.1 | Non-systematic Assessment |
|
As the study was terminated early after a pre-planned interim analysis which showed futility, the Sponsor decided not to perform the complete analysis planned per protocol. Hence, data was collected and analyzed for safety and selected efficacy parameters.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director Medical Leader | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 1, 2020 | Apr 30, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000605010 | pimodivir |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| AUSTRALIA |
|
| BELGIUM |
|
| BRAZIL |
|
| BULGARIA |
|
| CANADA |
|
| ESTONIA |
|
| FRANCE |
|
| GERMANY |
|
| HUNGARY |
|
| INDIA |
|
| ITALY |
|
| LATVIA |
|
| LITHUANIA |
|
| MALAYSIA |
|
| MEXICO |
|
| POLAND |
|
| RUSSIAN FEDERATION |
|
| SOUTH AFRICA |
|
| SOUTH KOREA |
|
| SPAIN |
|
| SWEDEN |
|
| TAIWAN |
|
| THAILAND |
|
| TURKEY |
|
| UKRAINE |
|
| UNITED KINGDOM |
|
| UNITED STATES |
|
|
|
|
|
|
|
|
|