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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002149-13 | EudraCT Number |
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| Name | Class |
|---|---|
| MediVector, Inc. | INDUSTRY |
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The purpose of this study is to determine if favipiravir is effective in reducing the time to resolution of influenza symptoms.
The purpose of this study is to determine if a 5-day regimen of favipiravir reduces the time to alleviation of influenza symptoms, resolution of fever, and viral shedding, in subjects with uncomplicated influenza compared to no treatment (e.g. placebo).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| favipiravir | Active Comparator |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| favipiravir | Drug | Administered twice daily over 5 consecutive days for a total of 10 doses.
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to alleviation of all primary influenza symptoms and fever | Time from the start of study treatment until alleviation of all primary influenza symptoms (i.e. cough, sore throat, headache, nasal congestion, body aches and pains, fatigue) and to resolution of fever. Subjects will be considered to have symptoms alleviated if individual symptoms are no greater than mild and are confirmed to be no greater than mild at least 21.5 hours later. Similarly, resolution of fever is defined as temperature (oral) measurements to be < 38.0°C (<100.4°F) for subjects < 65 years old and < 37.8°C (100.0°F) for subjects ≥ 65 years old, and measurements are confirmed at least 21.5 hours later. For the primary endpoint, the time periods of alleviation/fever resolution must be concurrent for symptoms and temperature. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to alleviation each of the primary influenza symptoms and fever | Time from the start of study treatment until alleviation of each of the following influenza symptoms (cough, sore throat, headache, nasal congestion, body aches and pains, and fatigue) and to resolution of fever. Subjects will be considered to have symptoms alleviated if individual symptoms are no greater than mild and are confirmed to be no greater than mild at least 21.5 hours later. Similarly, resolution of fever is defined as temperature (oral) measurements to be < 38.0°C (<100.4°F) for subjects < 65 years old and < 37.8°C (100.0°F) for subjects ≥ 65 years old, and measurements are confirmed at least 21.5 hours later. Additional analyses of symptoms, including assessment of the impact of relevant covariates, will be specified in the Statistical Analysis Plan. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in viral load | Changes in viral load (nasopharyngeal swabs) as measured by quantitative polymerase chain reaction (qPCR) and in the determination of median tissue culture infective dose (TCID50), from nasopharyngeal swabs at Visits 2, 3, 4, and 5; and log-transformed viral load (by qPCR and TCID50) area under the curves (AUCs). | 15 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carol Epstein, MD | MediVector, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 06117 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35639525 | Derived | Hayden FG, Lenk RP, Stonis L, Oldham-Creamer C, Kang LL, Epstein C. Favipiravir Treatment of Uncomplicated Influenza in Adults: Results of Two Phase 3, Randomized, Double-Blind, Placebo-Controlled Trials. J Infect Dis. 2022 Nov 11;226(10):1790-1799. doi: 10.1093/infdis/jiac135. |
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|
| Placebo | Drug | Administered twice daily over 5 consecutive days for a total of 10 doses. |
|
| 21 days |
| To characterize the PK of favipiravir when used under clinical conditions | Population PK analysis of favipiravir with assessment of maximum plasma concentration (Cmax), minimum plasma concentration (Cmin), and total daily exposure AUC(0-24h) on Visits 1, 2, 3, 4 and 5 | 21 days |
| Safety |
Adverse events and clinical laboratory tests for systemic safety including hematology, clinical chemistry, and urinalysis |
| 21 days |
| Birmingham |
| Alabama |
| 35209 |
| United States |
| Hunstville | Alabama | 35801 | United States |
| Hot Springs | Arkansas | 71913 | United States |
| Los Angeles | California | 90017 | United States |
| Los Angeles | California | 90020 | United States |
| Orange | California | 92866 | United States |
| Sacramento | California | 95825 | United States |
| San Diego | California | 92120 | United States |
| San Diego | California | 92128 | United States |
| Tustin | California | 92780 | United States |
| Upland | California | 91786 | United States |
| Colorado Springs | Colorado | 80904 | United States |
| Hamden | Connecticut | 65140 | United States |
| Bradenton | Florida | 34205 | United States |
| Brooksville | Florida | 34601 | United States |
| Gainesville | Florida | 32605 | United States |
| Gainesville | Florida | 32607 | United States |
| Hialeah | Florida | 33012 | United States |
| Hialeah | Florida | 33016 | United States |
| Lakeland Hills | Florida | 33805 | United States |
| Miami | Florida | 33126 | United States |
| Miami | Florida | 33135 | United States |
| Miami | Florida | 33137 | United States |
| Miami | Florida | 33173 | United States |
| Saint Cloud | Florida | 34769 | United States |
| South Miami | Florida | 33143 | United States |
| St. Petersburg | Florida | 33709 | United States |
| Tampa | Florida | 33606 | United States |
| Atlanta | Georgia | 30312 | United States |
| Snellville | Georgia | 30039 | United States |
| Bardstown | Kentucky | 40004 | United States |
| Monroe | Louisiana | 71201 | United States |
| Opelousas | Louisiana | 70570 | United States |
| Flint | Michigan | 48504 | United States |
| Omaha | Nebraska | 68114 | United States |
| Las Vegas | Nevada | 89121 | United States |
| Hickory | North Carolina | 28601 | United States |
| Morganton | North Carolina | 28655 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Lansdale | Pennsylvania | 19446 | United States |
| Pittsburgh | Pennsylvania | 15236 | United States |
| Smithfield | Pennsylvania | 15478 | United States |
| Uniontown | Pennsylvania | 15401 | United States |
| Gaffney | South Carolina | 29341 | United States |
| Greenville | South Carolina | 29615 | United States |
| Greer | South Carolina | 29651 | United States |
| Simpsonville | South Carolina | 29681 | United States |
| Arlington | Texas | 76012 | United States |
| Austin | Texas | 78756 | United States |
| Carrollton | Texas | 75010 | United States |
| Forth Worth | Texas | 76104 | United States |
| Houston | Texas | 77062 | United States |
| Plano | Texas | 75093 | United States |
| San Antonio | Texas | 78207 | United States |
| Salt Lake City | Utah | 84109 | United States |
| Salt Lake City | Utah | 84121 | United States |
| South Jordan | Utah | 84095 | United States |
| Arlington | Virginia | 22203 | United States |
| La Crosse | Wisconsin | 54601 | United States |
| Bedford Park | South Australia | 05042 | Australia |
| Deurne | Antwerpen | 2100 | Belgium |
| Brussels | Brussels Capital | 1080 | Belgium |
| Gozée | Hainaut | 6534 | Belgium |
| Mont-sur-Marchienne | Hainaut | 6032 | Belgium |
| Halen | Limburg | 3545 | Belgium |
| Ham | Limburg | 3945 | Belgium |
| Chenée | Liège | 4032 | Belgium |
| Deurne | 2100 | Belgium |
| Gribomont | 6887 | Belgium |
| Linkebeek | 1630 | Belgium |
| Gabrovo | Gabrovo | 5300 | Bulgaria |
| Haskovo | Haskovo | 6300 | Bulgaria |
| Plovdiv | Plovdiv | 4002 | Bulgaria |
| Smolyan | Smolyan | 4700 | Bulgaria |
| Sofia | Sofia-Grad | 1000 | Bulgaria |
| Varna | Varna | 9000 | Bulgaria |
| Veliko Tarnovo | Veliko Tarnovo | 5000 | Bulgaria |
| Burgas | 8000 | Bulgaria |
| Burgas | 8112 | Bulgaria |
| Gabrovo | 5300 | Bulgaria |
| Plovdiv | 4000 | Bulgaria |
| Plovdiv | 4002 | Bulgaria |
| Rousse | 7001 | Bulgaria |
| Rousse | 7002 | Bulgaria |
| Samokov | 2000 | Bulgaria |
| Sevlievo | 5400 | Bulgaria |
| Sliven | 8800 | Bulgaria |
| Smolyan | 4700 | Bulgaria |
| Sofia | 1000 | Bulgaria |
| Sofia | 1303 | Bulgaria |
| Sofia | 1431 | Bulgaria |
| Sofia | 1463 | Bulgaria |
| Sofia | 1505 | Bulgaria |
| Sofia | 1618 | Bulgaria |
| Varna | 9020 | Bulgaria |
| Veliko Tarnovo | 5000 | Bulgaria |
| Balassagyarmat | 2660 | Hungary |
| Budapest | 1135 | Hungary |
| Csongrád | 6640 | Hungary |
| Debrecen | 4043 | Hungary |
| Gödöllő | 2100 | Hungary |
| Gyula | 5700 | Hungary |
| Nyíregyháza | Hungary |
| Zalaegerszeg | 8900 | Hungary |
| Nijverdal | Overijssel | 7442 LS | Netherlands |
| Hoogvliet | South Holland | 3192 JN | Netherlands |
| Lieshout | 5737 CB | Netherlands |
| Nijverdal | 7442 LS | Netherlands |
| Rotterdam | 3039 BD | Netherlands |
| The Hague | 2526 HW | Netherlands |
| Zwijndrecht | 3334 CL | Netherlands |
| Auckland | North Island | 0612 | New Zealand |
| Christchurch | South Island | New Zealand |
| Hamilton | Waikato Region | 3204 | New Zealand |
| Tauranga | 3143 | New Zealand |
| Torun | Kuyavian-Pomeranian Voivodeship | 87-100 | Poland |
| Tarnów | Lesser Poland Voivodeship | 33-100 | Poland |
| Oleśnica | Lower Silesian Voivodeship | 56-400 | Poland |
| Wroclaw | Lower Silesian Voivodeship | 53-301 | Poland |
| Wroclaw | Lower Silesian Voivodeship | 54-144 | Poland |
| Świdnik | Lublin Voivodeship | 21-040 | Poland |
| Lodz | Lódzkie | 91-463 | Poland |
| Zgierz | Lódzkie | 95-100 | Poland |
| Łosice | Masovian Voivodeship | 08-200 | Poland |
| Dębica | Podkarpackie Voivodeship | 39-200 | Poland |
| Rzeszów | Podkarpackie Voivodeship | 35-055 | Poland |
| Katowice | Silesian Voivodeship | 40-211 | Poland |
| Katowice | Silesian Voivodeship | 40-772 | Poland |
| Katowice | 40-211 | Poland |
| Katowice | 40-752 | Poland |
| Krakow | 31-011 | Poland |
| Krakow | 31-637 | Poland |
| Lódz | 93-328 | Poland |
| Ostróda | 14-100 | Poland |
| Oświęcim | 32-600 | Poland |
| Arkangelsk | 163000 | Russia |
| Kazan' | 420012 | Russia |
| Moscow | 129090 | Russia |
| Novosibirsk | 630051 | Russia |
| Novosibirsk | 630099 | Russia |
| Ryazan | 390005 | Russia |
| Saint Petersburg | 194044 | Russia |
| Saint Petersburg | 196247 | Russia |
| Saint Petersburg | 198328 | Russia |
| Saint Petersburg | Russia |
| Saratov | 410028 | Russia |
| Tomsk | 634050 | Russia |
| Vladimir | 600023 | Russia |
| Yaroslavl | 150007 | Russia |
| Bloemfontein | Free State | 9301 | South Africa |
| Bryanston | Gauteng | 2021 | South Africa |
| Johannesburg | Gauteng | 1619 | South Africa |
| Johannesburg | Gauteng | 1818 | South Africa |
| Johannesburg | Gauteng | 2113 | South Africa |
| Pretoria | Gauteng | 0081 | South Africa |
| Pretoria | Gauteng | 0084 | South Africa |
| Pretoria | Gauteng | 0140 | South Africa |
| Pretoria | Gauteng | 1501 | South Africa |
| Sophiatown, Johannesburg | Gauteng | 2129 | South Africa |
| Soweto | Gauteng | 1818 | South Africa |
| Dundee | KwaZulu-Natal | 3000 | South Africa |
| eManzimtoti | KwaZulu-Natal | 4126 | South Africa |
| Middelburg | Mpumalanga | 1050 | South Africa |
| Witbank | Mpumalanga | 1035 | South Africa |
| Cape Town | Western Cape | 7130 | South Africa |
| Cape Town | Western Cape | 7965 | South Africa |
| Cape Town | Western Cape | 8002 | South Africa |
| Paarl | Western Cape | 7646 | South Africa |
| Worcester | Western Cape | 6850 | South Africa |
| Cape Town | 7572 | South Africa |
| Durban | 4068 | South Africa |
| eMkhomazi | 4170 | South Africa |
| Johannesburg | 2113 | South Africa |
| Krugersdorp | 1724 | South Africa |
| Potchefstroom | 2531 | South Africa |
| Pretoria | 0001 | South Africa |
| Sophiatown, Johannesburg | 2129 | South Africa |
| Welkom | 9459 | South Africa |
| Alicante | Alicante | 03610 | Spain |
| Benidorm | Alicante | 03500 | Spain |
| Orihuela | Alicante | 03300 | Spain |
| Badalona | Barcelona | 08917 | Spain |
| Barcelona | Barcelona | 08041 | Spain |
| Castellon | Castellón | 12005 | Spain |
| Barcelona | Catalonia | 08036 | Spain |
| Llançà | Girona | 17490 | Spain |
| Tarragona | Tarragona | 43007 | Spain |
| Barcelona | 08028 | Spain |
| Barcelona | 08907 | Spain |
| Malmö | Skåne County | SE-21152 | Sweden |
| Stockholm | Södermanland County | SE-11157 | Sweden |
| Stockholm | Södermanland County | SE-11522 | Sweden |
| Uppsala | Uppsala Ian | SE-75185 | Sweden |
| Gothenburg | Västra Götaland County | SE-41345 | Sweden |
| Karlskrona | SE-37141 | Sweden |
| Linköping | SE-58216 | Sweden |
| Malmö | SE-20502 | Sweden |
| Uppsala | SE-75185 | Sweden |
| Diyarbakır | Diyarbakır | 21280 | Turkey (Türkiye) |
| Izmir | İzmir | 35210 | Turkey (Türkiye) |
| Konya | Konya | 42075 | Turkey (Türkiye) |
| Trabzon | Trabzon | 61080 | Turkey (Türkiye) |
| Ankara | 06100 | Turkey (Türkiye) |
| Düzce | 81600 | Turkey (Türkiye) |
| Erzurum | 25240 | Turkey (Türkiye) |
| Eskişehir | 26480 | Turkey (Türkiye) |
| Izmir | 35100 | Turkey (Türkiye) |
| Samsun | 55139 | Turkey (Türkiye) |
| Chernivtsi | Chernivtsi Oblast | 58005 | Ukraine |
| Ivano-Frankivsk | Ivano-Frankivsk Oblast | 76018 | Ukraine |
| Kharkiv | Kharkiv Oblast | 61007 | Ukraine |
| Kyiv | Kyïvs'ka Oblast | 02002 | Ukraine |
| Kyiv | Kyïv | 04050 | Ukraine |
| Odesa | Odesa Oblast | 65023 | Ukraine |
| Odesa | Odesa Oblast | 65114 | Ukraine |
| Ternopil | Ternopil Oblast | 46008 | Ukraine |
| Vinnytsia | Vinnytsia Oblast | 21029 | Ukraine |
| Kharkiv | 61052 | Ukraine |
| Kherson | 73013 | Ukraine |
| Kyiv | 01601 | Ukraine |
| Kyiv | 02232 | Ukraine |
| Kyiv | 04050 | Ukraine |
| Poltava | 36000 | Ukraine |
| Sumy | 40015 | Ukraine |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D005334 | Fever |
| D003371 | Cough |
| D006261 | Headache |
| D015508 | Nasal Obstruction |
| D010612 | Pharyngitis |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D009668 | Nose Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
| D010038 | Otorhinolaryngologic Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C462182 | favipiravir |
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