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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002156-84 | EudraCT Number | ||
| 63623872FLZ3001 | Other Identifier | Janssen Research & Development, LLC |
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Study terminated early (date of study termination decision: 28 August 2020) as a result of the outcome of the pre-planned Interim Analysis.
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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, adult, and elderly hospitalized participants with influenza A infection. The study will be conducted in 3 phases: screening phase, double-blind treatment period of 5 days (with the possibility to extend treatment period by 5 days for participants who will enter an optional double-blind extension treatment arm), and post treatment follow-up period of 23 days. Study evaluations will include efficacy, pharmacokinetic, biomarkers, safety and tolerability. The duration of participation in study for each participant is 28 days, except for participants receiving extended treatment, for whom study duration will be up to 33 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm 1 (pimodivir + Standard-of-Care [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 SOC treatment. Participants who meet all treatment extension criteria as defined in the protocol may receive an additional 5 day course of same treatment as received at study start. The SOC treatment is determined by investigator based on local practice, may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of SOC should be started no later than the day when participants initially receive pimodivir. An influenza antiviral as part of SOC cannot be changed (example, switching one influenza antiviral for another) during either treatment period or extension phase, with the exception that an influenza antiviral may be discontinued in case of 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 morning of Day 6) along with SOC treatment. Participants who meet all treatment extension criteria as defined in protocol may receive an additional 5 day course of same treatment as received at study start. The SOC treatment determined by investigator based on local practice, 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 of first study drug intake. An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during either treatment period/extension phase, with the exception that an influenza antiviral may be discontinued in 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). Participants who meet treatment extension criteria may receive an additional 5 day course of the same treatment as received at study start (on Days 6 through 10). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Hospital Recovery Scale on Day 6 | The hospital recovery scale assesses a participant's clinical status. The scale provides 6 mutually exclusive conditions ordered from best to worst: 1) not hospitalized; 2) non-ICU hospitalization, not requiring supplemental oxygen; 3) non-ICU hospitalization, requiring supplemental oxygen; 4) admitted to the ICU, not requiring invasive mechanical ventilation; 5) requiring invasive mechanical ventilation; and 6) death. | Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Hospital Discharge | The time to hospital discharge was defined as the time from start of study drug to hospital discharge. | Up to Day 33 |
| Number of Participants With Adjudicated Influenza Complications |
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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 | ||
| Nea Baptist Clinic |
| 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. | |
| 33248473 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pimodivir + SOC | Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid. |
| 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 | Jun 11, 2019 | Mar 19, 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). Participants who meet treatment extension criteria may receive an additional 5 day course of the same treatment as received at study start (on Days 6 through 10). |
|
| 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 started no later than the day when participants initially receive pimodivir. An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during either the treatment period or extension phase, with the exception that an influenza antiviral may be discontinued in the case of a suspected AE. |
|
Influenza complications include pulmonary complications (such as respiratory failure, primary viral pneumonia, secondary bacterial pneumonia [including pneumonia attributable to unusual pathogens], exacerbations of chronic underlying pulmonary diseases such as chronic obstructive pulmonary disease [COPD] and asthma) and extrapulmonary complications (such as cardiovascular and cerebrovascular diseases [for example, myocardial infarction, congestive heart failure, arrhythmia, stroke], muscular disorders [for example, myositis, rhabdomyolysis], central nervous system [CNS] involvement, acute exacerbation of chronic kidney disease, decompensation of previously controlled diabetes mellitus, other infections [for example, sinusitis and otitis]).
| Up to Day 33 |
| 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. | Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 14 and 19 |
| 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 33 |
| 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 33 |
| Plasma Concentration of Pimodivir | Plasma concentration of Pimodivir was reported. | Day 1: 1 hour30minutes to 6 hours postdose, Day 3: Predose, Day 5: Predose and 1 hour30minutes to 6 hours postdose, Day 6: 12 hours postdose |
| 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 were collected at predefined time points for clinical laboratory testing. | Up to Day 33 |
| Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | Number of participants with clinically significant changes in Electrocardiogram (ECG) was reported. | Up to Day 33 |
| 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) was reported. | Up to Day 33 |
| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| UCSF Fresno | Fresno | California | 93701 | United States |
| Miller Children's at Long Beach Medical Center | Long Beach | California | 90806 | United States |
| Stanford University School of Medicine | Stanford | California | 94306-5640 | United States |
| Destin Pulmonary Critical Care, PLLS. | Santa Rosa Beach | Florida | 32459 | United States |
| Northside Hospital | Atlanta | Georgia | 30342 | United States |
| Augusta University | Augusta | Georgia | 30912 | United States |
| Anne Arundel Medical Center | Annapolis | Maryland | 21401 | United States |
| University Of Maryland Medical Center | Baltimore | Maryland | 21201-1595 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Wayne State Univ School of Medicine | Detroit | Michigan | 48201 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Wayne State University | Detroit | Michigan | 97205 | United States |
| Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research | Kalamazoo | Michigan | 49008 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| William Beaumont Hospital | Troy | Michigan | 48085 | United States |
| Regents of the University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Mercury Street Medical Group, PLLC | Butte | Montana | 59701 | United States |
| Saint Michaels Medical Center | Newark | New Jersey | 07102 | United States |
| Holy Name Medical Center | Teaneck | New Jersey | 07666 | United States |
| Montefiore Medical Center PRIME | The Bronx | New York | 10467 | United States |
| UC Health LLC | Cincinnati | Ohio | 45229 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Lowcountry Infectious Diseases | Charleston | South Carolina | 29414 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| DM Clinical Research | Tomball | Texas | 77375 | United States |
| Hospital Interzonal General de Agudos Dr. Jose Penna | Bahía Blanca | B8001DDU | Argentina |
| CEMIC (Centro de Educación Médica e Investigaciones Clínicas) | C.a.b.a. | 1431 | Argentina |
| Hospital Nuestra Señora de la Misericordia | Córdoba | 5000 | Argentina |
| Hospital Rawson | Córdoba | 5000 | Argentina |
| Hospital San Roque | Córdoba | 5000 | Argentina |
| Hospital Cordoba | Córdoba | X5004CDT | Argentina |
| Hospital Privado Centro Medico de Cordoba | Córdoba | X5016KEH | Argentina |
| Sanatorio Juan XXIII | General Roca | 8332 | Argentina |
| Instituto Medico Platense | La Plata | B1900AVG | Argentina |
| Hospital Italiano de La Plata | La Plata Lpl Lpl | 1900 | Argentina |
| Hospital Universitario Austral | Pilar | B1629ODT | Argentina |
| Sanatorio Britanico S.A. | Rosario | 2000 | Argentina |
| Flinders Medical Centre | Bedford Park | 5042 | Australia |
| Box Hill Hospital | Box Hill | 3128 | Australia |
| The Alfred Hospital | Melbourne | 3004 | Australia |
| Royal Melbourne Hospital | Melbourne | 3050 | Australia |
| Mater Hospital Brisbane | South Brisbane | 4101 | Australia |
| Townsville Hospital | Townsville | 4814 | Australia |
| AKH - Medizinische Universitat Wien | Vienna | 1090 | Austria |
| SMZ Süd - Kaiser Franz Josef Spital Wien | Vienna | 1100 | Austria |
| Social Medizinisches Zentrum Baumgartner Höhe - Otto Wagner Spital | Vienna | 1140 | Austria |
| CHU Saint-Pierre | Brussels | 1000 | Belgium |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| ULB Hôpital Erasme | Brussels | 1070 | Belgium |
| Santa Casa de Misericordia de Belo Horizonte | Belo Horizonte | 30150-221 | Brazil |
| Cardresearch - Cardiologia Assistencial | Belo Horizonte | 30150-240 | Brazil |
| Infection Control Ltda | Brasil | 30110-063 | 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 |
| Irmandade Santa Casa de Misericordia de Porto Alegre | Porto Alegre | 90050-170 | Brazil |
| Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS | Porto Alegre | 90610-000 | Brazil |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base | São José do Rio Preto | 15090-000 | Brazil |
| Irmandade Santa Casa de Misericordia de Sao Paulo | São Paulo | 01221-020 | Brazil |
| Fundacao Jose Luiz Egydio Setubal | São Paulo | 01227-200 | Brazil |
| Hosp. Da Luz Lisboa | São Paulo | 04013-060 | Brazil |
| SHATPPD - Ruse Ltd. | Rousse | 7002 | Bulgaria |
| SHATPPD - Sofia District EOOD | Sofia | 1202 | Bulgaria |
| Fifth Multiprofile Hospital for Active Treatment - MHAT - Sofia EAD | Sofia | 1233 | Bulgaria |
| Multiprofile Hospital for Active Treatment - MHAT Lyulin EAD | Sofia | 1336 | Bulgaria |
| Military Medical Academy - Sofia | Sofia | 1606 | Bulgaria |
| MHAT Dr Stefan Cherkezov | Veliko Tarnovo | 5000 | Bulgaria |
| University of British Columbia | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Health Sciences North Horizon Sante-Nord | Greater Sudbury | Ontario | P3E5J1 | Canada |
| Hospital Dr Sotero del Rio | Puente Alto | 8150000 | Chile |
| Hospital El Pino | San Bernardo | 13560 | Chile |
| The Third Xiangya Hospital, Central South University | Changsha | 410013 | China |
| Nanfang Hospital | Guangzhou | 510515 | China |
| Wuxi People s Hospital | Wuxi | 214000 | China |
| Henan Provincial Peoples Hospital | Zhengzhou | China |
| Fakultni nemocnice Brno | Brno | 625 00 | Czechia |
| Nemocnice Kyjov, p.o. | Kyjov | 697 01 | Czechia |
| Nemocnice Na Bulovce | Prague | 180 81 | Czechia |
| Centre Hospitalier d'Agen | Agen | 47923 | France |
| CHU Amiens - Hopital Sud | Amiens | 80054 | France |
| Hopital Louis Mourier | Colombes | 92700 | France |
| Centre Hospitalier Intercommunal de Créteil | Créteil | 94010 | France |
| CHU Dijon | Dijon | 21000 | France |
| Centre Hospitalier Départemental | La Roche S/ Yon Cedex 9 | 85925 | France |
| CHU de Grenoble Hopital Albert Michallon | La Tronche | 38043 | France |
| CHU de Limoges Hopital Dupuytren | Limoges | 87042 | France |
| Hopital Edouard Herriot - CHU Lyon | Lyon | 69003 | France |
| Hopital Nord Marseille | Marseille | 13915 | 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 Saint Louis | Paris | 75475 | France |
| Hopital Cochin | Paris | 75679 | France |
| CHU Poitiers - Hopital la Miletrie | Poitiers | 86021 | France |
| CHU Saint Etienne Hopital Nord | Saint-Etienne | 42055 | France |
| Universitaetsklinikum Koelnt | Cologne | 50937 | Germany |
| Klinikum Donaustauf | Donaustauf | 93093 | Germany |
| Universitaetsklinik Erlangen | Erlangen | 91054 | Germany |
| Universitaetsklinikum Giessen und Marburg GmbH | Hessen | 35392 | Germany |
| Universitaetsklinikum Schleswig-Holstein - Campus Luebeck | Lübeck | 23538 | Germany |
| Klinikum Weiden | Weiden | 92637 | Germany |
| Veszprem Megyei Tudogyogyintezete | Farkasgyepü | 8582 | Hungary |
| Tudogyogyintezet Torokbalint | Törökbálint | 2045 | Hungary |
| Zydus Hospital-Ahmedabad | Ahmedabad | 380054 | India |
| Rajiv Gandhi Institute of Medical Sciences | Balaga | 532001 | India |
| M S Ramaiah Memorial Hospital | Bangalore | 560054 | India |
| Apollo Hospitals International Limited | Gandhinagar | 382424 | India |
| Aware Global Hospital | Hyderabad | 500035 | India |
| S. R. Kalla Memorial General Hospital | Jaipur | 302001 | India |
| Eternal Heart Care Centre | Jaipur | 302020 | India |
| Ajanta Research Cemtre | Lucknow | 226005 | India |
| Midland Healthcare & Research Center | Lucknow | 226006 | India |
| Vinaya Hospital and Research Center | Mangalore | 575003 | 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 |
| Fortis Flight Lieutenant Rajan Dhall Hospital | New Delhi | 110070 | India |
| Lifepoint Multispecialty Hospital | Pune | 411023 | India |
| Sahyadri Speciality Hospital | Pune | 411038 | India |
| Shree Giriraj Multispeciality Hospital | Rajkot | 360005 | India |
| BAPS Pramukhswami Hospital | Surat | 395009 | India |
| Haemek Medical Center | Afula | 18101 | Israel |
| Barzilai Medical Center | Ashkelon | 78278 | Israel |
| Soroka University Medical Center | Beersheba | 84101 | Israel |
| Bnai Zion Medical Center | Haifa | 31048 | Israel |
| Rambam Health Care Campus | Haifa | 3109601 | Israel |
| Wolfson Medical Center | Holon | 58100 | Israel |
| Hadassah University Hospita Ein Kerem | Jerusalem | 91120 | Israel |
| Sapir Medical Center, Meir Hospital | Kfar Saba | 4428164 | Israel |
| Galilee Medical Center | Nahariya | 2210001 | Israel |
| Rabin Medical Center Beilinson Campus | Petah Tikva | 49100 | Israel |
| Chaim Sheba Medical Center | Ramat Gan | 52621 | Israel |
| Kaplan Medical Center | Rehovot | 7610001 | Israel |
| Ziv Medical Center | Safed | 13100 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| Fondazione IRCCS Ospedale Maggiore Policlinico,Mangiagalli e Regina Elena | Milan | 20122 | Italy |
| Ospedale San Giuseppe - Fatebenefratelli | Milan | 20123 | Italy |
| Ospedale San Raffaele- Sede Distaccata Ospedale S. Raffaele Turro | Milan | 20127 | Italy |
| 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 Maggiore della Carità | Novara | 28100 | Italy |
| Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone | Palermo | 90127 | Italy |
| Lazzaro Spallanzani IRCCS | Roma | 149 | Italy |
| Azienda Ospedaliera Universitaria Integrata Verona | Verona | 37126 | Italy |
| Regional Hospital of Liepaja | Liepāja | LV-3414 | Latvia |
| Hospital of Rezekne | Rēzekne | LV-4600 | Latvia |
| Children's Clinical University Hospital | Riga | LV-1004 | Latvia |
| Riga East Clinical University Hospital | Riga | LV-1038 | Latvia |
| Pauls Stradins Clinical University Hospital | Riga | LV1002 | Latvia |
| Centre of Tuberculosis and Lung Diseases | Riga District | LV-2118 | Latvia |
| Vidzemes Hospital | Valmiera | LV-4201 | Latvia |
| Klaipeda University Hospital | Klaipėda | 92288 | Lithuania |
| Siauliai Republican Hospital, Public Institution | Šiauliai | 76231 | Lithuania |
| Infectious Diseases Center of Vilnius University Hospital Santaros klinikos | Vilnius | 08117 | Lithuania |
| Hospital Sultanah Bahiyah | Alor Star | 5460 | Malaysia |
| Hospital Queen Elizabeth | Kota Kinabalu | 88586 | Malaysia |
| Hospital Sultanah Nur Zahirah | Kuala | 20400 | Malaysia |
| Hospital Umum Sarawak | Kuching | 93586 | Malaysia |
| Hospital Miri | Miri | 98000 | Malaysia |
| Hospital Tuanku Jaafar | Seremban | 70300 | Malaysia |
| Hospital Sibu | Sibu | 96000 | Malaysia |
| Hospital Sungai Buloh | Sungai Buloh | 47000 | Malaysia |
| Hospital Taiping | Taiping | 34000 | Malaysia |
| JM Research, SC | Cuernavaca | 62290 | Mexico |
| Hospital Civil de Guadalajara Fray Antonio Alcalde | Guadalajara | 44280 | Mexico |
| Hospital Civil de Guadalajara Dr. Juan I. Menchaca | Guadalajara | 44340 | Mexico |
| Hospital Infantil de Mexico Federico Gomez | Mexico City | 6720 | Mexico |
| Hospital Universitario Dr Jose Eleuterio Gonzalez | México | 64460 | Mexico |
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | 5223 GZ | Netherlands |
| Albert Schweitzer Ziekenhuis | Dordrecht | 3318 AT | Netherlands |
| UMC Utrecht | Utrecht | 3584 CX | Netherlands |
| Gelre Ziekenhuizen Zutphen | Zutphen | 7207 AE | Netherlands |
| Christchurch Hospital | Christchurch | 8011 | New Zealand |
| Waikato Hospital | Hamilton | 3240 | New Zealand |
| Tauranga Hospital | Tauranga | 3143 | New Zealand |
| Wellington Hospital | Wellington | 6021 | New Zealand |
| Clinica Peruano Americana S.A | Trujillo | 13007 | Peru |
| Szpital Miejski ZOZ | Dębica | 39-200 | 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 |
| City Hospital #8 | Chelyabinsk | 454000 | Russia |
| Clinical Infectious Diseases Hospital n. a. S.P. Botkin | Saint Petersburg | 193167 | Russia |
| Clinical Infectious Diseases Hospital n. a. S.P. Botkin | Saint Petersburg | 195067 | Russia |
| LLC Reafarm | Stavropol | 355000 | Russia |
| Clinical Hospital #3 | Yaroslavl | 150007 | Russia |
| National University Hospital | Singapore | 117599 | Singapore |
| Tan Tock Seng Hospital | Singapore | 308433 | Singapore |
| Changi General Hospital | Singapore | 529889 | Singapore |
| DFNsP Bratislava | Bratislava | 83340 | Slovakia |
| Nemocnica Malacky, Nemocnicna A.S. | Malacky | 90122 | Slovakia |
| Nemocnica s poliklinikou S. Kukuru Michalovce, a.s. | Michalovce | 07101 | Slovakia |
| Nemocnica arm. generala L. Svobodu Svidnik, a.s., | Svidník | 08901 | Slovakia |
| Clinical Research Centre University of Cape Town | Cape Town | 7925 | South Africa |
| Johese Unitas | Centurion | 157 | South Africa |
| Abdullah, IA | Durban | 4001 | South Africa |
| Sebastian, Peter | Durban | 4001 | South Africa |
| DJW Research | Krugersdorp | 1739 | South Africa |
| Emmed Research | Pretoria | 0084 | South Africa |
| Into Research | Pretoria | 0181 | South Africa |
| Limpopo Clinical Research Initiative | Thabazimbi | 380 | 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 |
| The Catholic university of Korea, St. Vincent's Hospital | Gyeonggi-do | 16247 | South Korea |
| Hallym University Dongtan Sacred Heart Hospital | Hwaseong-si | 18450 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21565 | 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 | 152-703 | South Korea |
| Hosp Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hosp. Univ. Donostia | Donostia / San Sebastian | 20014 | Spain |
| Hosp. Gral. Univ. de Elche | Elche | 3203 | Spain |
| Hosp. Univ. de Getafe | Getafe | 28905 | Spain |
| Hosp. Univ. San Cecilio | Granada | 18012 | Spain |
| Hosp. Univ. Virgen de Las Nieves | Granada | 18014 | Spain |
| Hosp. Univ. de Bellvitge | L'Hospitalet de Llobregat | 08907 | Spain |
| Hosp. Univ. de La Princesa | Madrid | 28006 | Spain |
| Hosp. Univ. Ramon Y Cajal | Madrid | 28034 | 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. De Mataro | Mataró | 08304 | Spain |
| Hosp. Clinico Univ. de Santiago | Santiago de Compostela | 15706 | Spain |
| Hosp. Mutua Terrassa | Terrassa | 08221 | Spain |
| Hosp. Alvaro Cunqueiro | Vigo | 36213 | Spain |
| Department for Heart Failure and Valvular Disease | Malmö | 205 02 | Sweden |
| Norrlands Universitetssjukhus | Umeå | 901 87 | Sweden |
| Akademiska Sjukhuset | Uppsala | 75185 | Sweden |
| Kaohsiung Medical University Chung Ho Memorial Hospital | Kaohsiung City | 80756 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Tri-Service General Hospital | Taipei | 114 | Taiwan |
| Taipei Medical University-Wan Fang Hospital | Taipei | 116 | Taiwan |
| Siriraj Hospital | Bangkok | 10700 | Thailand |
| Bamrasnaradura Infectious Disease Institute | Muang | 11000 | Thailand |
| Srinagarind Hospital | Muang | 40002 | Thailand |
| Bumrungrad Hospital | Wattana | 10110 | Thailand |
| Hacettepe University Medical Faculty | Ankara | 06100 | Turkey (Türkiye) |
| Adnan Menderes University | Aydin | 09100 | Turkey (Türkiye) |
| Dicle University Medical Faculty | Diyarbakır | 21280 | Turkey (Türkiye) |
| Kocaeli University Medical Faculty | Kocaeli | 41380 | Turkey (Türkiye) |
| Hacettepe University Medical Faculty | Samanpazarı | 06100 | Turkey (Türkiye) |
| Karadeniz Teknik University Medical Faculty | Trabzon | 61100 | Turkey (Türkiye) |
| Kharkiv MA of PGE Ch of inf.dis. BO Kharkiv Reg.Cl.inf.Hosp. | Kharkiv | 61096 | Ukraine |
| Kyiv Oleksandrivska Clinical Hospital | Kyiv | 1601 | 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 |
| Communal Institution Central City Hospital | Zhytomyr | 10002 | Ukraine |
| Aberdeen Royal Infirmary | Aberdeen | AB25 2ZB | United Kingdom |
| Western General Hospital | Edinburgh | EH4 2XU | United Kingdom |
| Leeds General Infirmary | Leeds | LS1 3EX | United Kingdom |
| North Manchester General Hospital | Manchester | M8 5RB | United Kingdom |
| Musgrove Park Hospital | Taunton | TA1 5DA | United Kingdom |
| Bach Mai Hospital | Hanoi | 100000 | Vietnam |
| National Hospital for Tropical Diseases | Hanoi | 100000 | Vietnam |
| Thanh Nhan Hospital | Hanoi | Vietnam |
| Children's Hospital 1 | Ho Chi Minh City | Vietnam |
| Children's Hospital 2 | Ho Chi Minh City | Vietnam |
| Nguyen Tri Phuong Hospital | Ho Chi Minh City | Vietnam |
| Young B, Tan TT, Leo YS. The place for remdesivir in COVID-19 treatment. Lancet Infect Dis. 2021 Jan;21(1):20-21. doi: 10.1016/S1473-3099(20)30911-7. Epub 2020 Nov 26. No abstract available. |
Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid. |
| 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 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid. |
| BG001 | Placebo + SOC | Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid. |
| 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 | Number of Participants With Hospital Recovery Scale on Day 6 | The hospital recovery scale assesses a participant's clinical status. The scale provides 6 mutually exclusive conditions ordered from best to worst: 1) not hospitalized; 2) non-ICU hospitalization, not requiring supplemental oxygen; 3) non-ICU hospitalization, requiring supplemental oxygen; 4) admitted to the ICU, not requiring invasive mechanical ventilation; 5) requiring invasive mechanical ventilation; and 6) death. | Intent-To-Treat infected (ITT-i) set includes all participants from the RAND analysis set who received at least 1 dose of study drug and had a confirmed infection with influenza A. Here, N (number of participants analyzed) defined as participants evaluable for this outcome measure. Here, "n (number analyzed)" is defined as participants analyzed for specified category. | Posted | Count of Participants | Participants | Day 6 |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Hospital Discharge | The time to hospital discharge was defined as the time from start of study drug to hospital discharge. | The Intent-To-Treat infected (ITT-i) set includes all participants from the RAND (randomized participants with a randomization date time at or before the date time of first intake of study drug, or with a randomization date time and no study drug intake) analysis set who received at least 1 dose of study drug and who had a confirmed infection with influenza A and were analyzed by planned treatment. | Posted | Median | 95% Confidence Interval | hours | Up to Day 33 |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adjudicated Influenza Complications | Influenza complications include pulmonary complications (such as respiratory failure, primary viral pneumonia, secondary bacterial pneumonia [including pneumonia attributable to unusual pathogens], exacerbations of chronic underlying pulmonary diseases such as chronic obstructive pulmonary disease [COPD] and asthma) and extrapulmonary complications (such as cardiovascular and cerebrovascular diseases [for example, myocardial infarction, congestive heart failure, arrhythmia, stroke], muscular disorders [for example, myositis, rhabdomyolysis], central nervous system [CNS] involvement, acute exacerbation of chronic kidney disease, decompensation of previously controlled diabetes mellitus, other infections [for example, sinusitis and otitis]). | The Intent-To-Treat infected (ITT-i) set includes all participants from the RAND analysis set who received at least 1 dose of study drug and who had a confirmed infection with influenza A and were analyzed by planned treatment. Here, "n (number analyzed)" is defined as number of participants analyzed for specified category. | Posted | Count of Participants | Participants | Up to Day 33 |
| |||||||||||||||||||||||||||||||
| 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. | Intent-To-Treat infected (ITT-i) set includes all participants from the RAND analysis set who received at least 1 dose of study drug and who had a confirmed infection with influenza A. Here, N (number of participants analyzed) defined as participants evaluable for this outcome measure. "n (number analyzed)" is defined as number of participants analyzed for specified category. | Posted | Mean | Standard Deviation | Log 10 viral particles per milliliter | Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 14 and 19 |
|
| |||||||||||||||||||||||||||||
| 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) 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 33 |
|
| ||||||||||||||||||||||||||||||
| 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). | Intent-To-Treat infected (ITT-i) set includes all participants from the RAND analysis set who received at least 1 dose of study drug and who had a confirmed infection with influenza A. | Posted | Count of Participants | Participants | Up to Day 33 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Plasma Concentration of Pimodivir | Plasma concentration of Pimodivir was 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. Here, N (number of participants analyzed) defined as participants evaluable for this outcome measure. "n (number analyzed)" is defined as number of participants analyzed for specified category. | Posted | Mean | Standard Deviation | Nanogram per milliliter (ng/mL) | Day 1: 1 hour30minutes to 6 hours postdose, Day 3: Predose, Day 5: Predose and 1 hour30minutes to 6 hours postdose, Day 6: 12 hours postdose |
|
| |||||||||||||||||||||||||||||
| 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 were collected at predefined time points for clinical laboratory testing. | 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 33 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | Number of participants with clinically significant changes in Electrocardiogram (ECG) was 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 33 |
|
| ||||||||||||||||||||||||||||||
| 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) was 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 33 |
|
|
Up to Day 33
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 | 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 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid | 4 | 163 | 13 | 163 | 81 | 163 |
| EG001 | Placebo + SOC | Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid. | 0 | 163 | 15 | 163 | 82 | 163 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Left Ventricular Failure | Cardiac disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Left Ventricular Failure | Cardiac disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Abscess Limb | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Parotitis | 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 |
| |
| Pneumonia Escherichia | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pneumonia Klebsiella | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pneumonia Pneumococcal | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Postoperative Wound Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Acute Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Aspiration | 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 |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pulmonary Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Respiratory Distress | 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 |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Venous Thrombosis Limb | Vascular disorders | MedDRA Version 22.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Anaemia of Chronic Disease | Blood and lymphatic system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypereosinophilic Syndrome | Blood and lymphatic system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Macrocytosis | Blood and lymphatic system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Neutropenia | 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 |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Cardiac Failure Acute | Cardiac disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Cardiomegaly | Cardiac disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Myocardial Ischaemia | Cardiac disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Supraventricular Tachycardia | Cardiac disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dermoid Cyst | Congenital, familial and genetic disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Ear Pain | Ear and labyrinth disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Chalazion | Eye disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Conjunctivitis Allergic | Eye disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | 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 |
| |
| Diarrhoea Haemorrhagic | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Oral Pruritus | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Multiple Organ Dysfunction Syndrome | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Nodule | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | 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 Function Abnormal | Hepatobiliary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hepatitis Toxic | Hepatobiliary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Abscess Limb | 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 |
| |
| Cellulitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Clostridium Difficile Colitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Fungal Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Fungal Skin Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Genital Herpes | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Herpes Simplex | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Oral Fungal Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Oral Herpes | 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 |
| |
| Pneumonia Haemophilus | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pneumonia Staphylococcal | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Staphylococcal Bacteraemia | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Superinfection Bacterial | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection Staphylococcal | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Vulvovaginal Candidiasis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Haematuria Traumatic | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Traumatic Haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Abnormal | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | 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 Creatine Phosphokinase Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Blood Uric Acid Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Electrocardiogram Abnormal | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Gamma-Glutamyltransferase Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hepatic Enzyme Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Lipase 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 |
| |
| Platelet Count Decreased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Transaminases Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Diabetic Metabolic Decompensation | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Fluid Overload | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Fluid Retention | 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 |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | 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 |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Metabolic Acidosis | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Arthritis | 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 |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dizziness Exertional | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dizziness Postural | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Intercostal Neuralgia | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Psychomotor Hyperactivity | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Alcohol Withdrawal Syndrome | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Panic Attack | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Chronic Kidney Disease | Renal and urinary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dysuria | 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 |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Menstruation Irregular | Reproductive system and breast disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pelvic 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 |
| |
| Atelectasis | 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 |
| |
| Dysphonia | 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 |
| |
| Dyspnoea Exertional | 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 |
| |
| Hypersensitivity Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypoxia | 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 |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pulmonary Mass | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pulmonary Oedema | 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 |
| |
| Sputum Increased | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dermatitis Allergic | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Night Sweats | 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 |
| |
| Rash Erythematous | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Rash Macular | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Seborrhoeic Dermatitis | 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 |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Aortic Dilatation | Vascular disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypertensive Crisis | Vascular disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Thrombophlebitis | 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 only.
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 | Mar 19, 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 |
|
| AUSTRIA |
|
| BELGIUM |
|
| BRAZIL |
|
| BULGARIA |
|
| CANADA |
|
| CHILE |
|
| FRANCE |
|
| GERMANY |
|
| INDIA |
|
| ISRAEL |
|
| ITALY |
|
| LATVIA |
|
| LITHUANIA |
|
| MALAYSIA |
|
| MEXICO |
|
| NETHERLANDS |
|
| NEW ZEALAND |
|
| POLAND |
|
| RUSSIAN FEDERATION |
|
| SINGAPORE |
|
| SLOVAKIA |
|
| SOUTH AFRICA |
|
| SPAIN |
|
| SWEDEN |
|
| TAIWAN |
|
| THAILAND |
|
| TURKEY |
|
| UKRAINE |
|
| UNITED KINGDOM |
|
| UNITED STATES |
|
| VIETNAM |
|
| Any time since onset influenza: Non-ICU hospitalization, not requiring supplemental oxygen |
|
|
| Any time since onset influenza: Non-ICU hospitalization, requiring supplemental oxygen |
|
|
| Any time since onset influenza: Admitted to the ICU, not requiring invasive mechanical ventilation |
|
|
| Any time since onset influenza: Requiring invasive mechanical ventilation |
|
|
| Any time since onset influenza: Death |
|
|
| Time since onset influenza less than or equal to (<=)72 hour (h): Not hospitalized |
|
|
| Time since onset influenza <=72h: Non-ICU hospitalization, not requiring supplemental oxygen |
|
|
| Time since onset influenza <=72h: Non-ICU hospitalization, requiring supplemental oxygen |
|
|
| Time since onset influenza <=72h: Admitted to the ICU, not requiring invasive mechanical ventilation |
|
|
| Time since onset influenza <=72h: Requiring invasive mechanical ventilation |
|
|
| Time since onset influenza <=72h: Death |
|
|
| Time since onset influenza greater than (>) 72h: Not hospitalized |
|
|
| Time since onset influenza >72h: Non-ICU hospitalization, not requiring supplemental oxygen |
|
|
| Time since onset influenza >72h: Non-ICU hospitalization, requiring supplemental oxygen |
|
|
| Time since onset influenza >72h: Admitted to the ICU, not requiring invasive mechanical ventilation |
|
|
| Time since onset influenza >72h: Requiring invasive mechanical ventilation |
|
|
| Time since onset influenza >72h: Death |
|
|
|
|
Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
|
|
| Participants |
|
|
|
| Participants |
|
|
|
|
|
|