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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1147-8470 | Other Identifier | UTN |
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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 | Day 1: 1800 mg (1st loading dose), 1800 mg (2nd loading dose) Days 2-5: 800 mg BID (3rd to 10th dose) |
|
| placebo | Placebo Comparator | Day 1: 1800 mg (1st loading dose), 1800 mg (2nd loading dose) Days 2-5: 800 mg BID (3rd to 10th dose) |
|
| 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 | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to alleviation of 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 | 21 days |
| To characterize the PK of favipiravir when used under clinical conditions |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in viral load | Changes in viral load as measured from nasopharyngeal swabs | 15 days |
| Safety | Adverse events and clinical laboratory tests for systemic safety including hematology, clinical chemistry, and urinalysis |
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 | 35209 | 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 |
| 21 days |
| Birmingham |
| Alabama |
| 35242 |
| United States |
| Huntsville | Alabama | 35801 | United States |
| Camp Verde | Arizona | 86322 | United States |
| Mesa | Arizona | 85202 | United States |
| Little Rock | Arkansas | 72205 | United States |
| Anaheim | California | 92804 | United States |
| Carmichael | California | 95608 | United States |
| Chula Vista | California | 91911 | United States |
| Fountain Valley | California | 92708 | United States |
| Fresno | California | 93702 | United States |
| Garden Grove | California | 92844 | United States |
| Gold River | California | 95670 | United States |
| Harbor City | California | 90710 | United States |
| La Mesa | California | 91942 | United States |
| Lomita | California | 90717 | United States |
| Los Angeles | California | 90017 | United States |
| Modesto | California | 95350 | United States |
| North Hollywood | California | 91606 | United States |
| Northridge | California | 91325 | United States |
| Oceanside | California | 92056 | United States |
| Paramount | California | 90723 | United States |
| Roseville | California | 95661 | United States |
| San Diego | California | 92103 | United States |
| San Diego | California | 92120 | United States |
| San Gabriel | California | 91776 | United States |
| Stockton | California | 95204 | United States |
| Upland | California | 91786 | United States |
| Centennial | Colorado | 80112 | United States |
| Colorado Springs | Colorado | 80907 | United States |
| Colorado Springs | Colorado | 80909 | United States |
| Colorado Springs | Colorado | 80920 | United States |
| Denver | Colorado | 80246 | United States |
| Glenwood Springs | Colorado | 81601 | United States |
| Waterbury | Connecticut | 06708 | United States |
| Celebration | Florida | 34747 | United States |
| Clearwater | Florida | 33761 | United States |
| Delray Beach | Florida | 33484 | United States |
| Edgewater | Florida | 32132 | United States |
| Hialeah | Florida | 33010 | United States |
| Hialeah | Florida | 33012 | United States |
| Hialeah | Florida | 33016 | United States |
| Jacksonville | Florida | 32216 | United States |
| Kissimmee | Florida | 34759 | United States |
| Lauderdale Lakes | Florida | 33319 | United States |
| Lynn Haven | Florida | 32444 | United States |
| Miami | Florida | 33134 | United States |
| Miami | Florida | 33135 | United States |
| Miami | Florida | 33144 | United States |
| Miami | Florida | 33155 | United States |
| Miami | Florida | 33173 | United States |
| Miami | Florida | 33175 | United States |
| New Port Richey | Florida | 34653 | United States |
| New Smyrna Beach | Florida | 32169 | United States |
| Ormond Beach | Florida | 32174 | United States |
| Pembroke Pines | Florida | 33026 | United States |
| Plantation | Florida | 33322 | United States |
| Port Orange | Florida | 32127 | United States |
| Saint Cloud | Florida | 34769 | United States |
| South Miami | Florida | 33143 | United States |
| Summerfield | Florida | 34491 | United States |
| Tampa | Florida | 33607 | United States |
| Atlanta | Georgia | 30328 | United States |
| Dunwoody | Georgia | 30338 | United States |
| Norcross | Georgia | 30092 | United States |
| Oakwood | Georgia | 30566 | United States |
| Riverdale | Georgia | 30274 | United States |
| Snellville | Georgia | 30078 | United States |
| Idaho Falls | Idaho | 83404 | United States |
| Twin Falls | Idaho | 83301 | United States |
| Brownsburg | Indiana | 46112 | United States |
| Evansville | Indiana | 47714 | United States |
| Wichita | Kansas | 67203 | United States |
| Bardstown | Kentucky | 40004 | United States |
| Monroe | Louisiana | 71201 | United States |
| New Orleans | Louisiana | 70115 | United States |
| Opelousas | Louisiana | 70570 | United States |
| Columbia | Maryland | 21045 | United States |
| Towson | Maryland | 21204 | United States |
| Watertown | Massachusetts | 02472 | United States |
| Worcester | Massachusetts | 01655 | United States |
| Madison Heights | Michigan | 48071 | United States |
| Troy | Michigan | 48085 | United States |
| St Louis | Missouri | 63110 | United States |
| Billings | Montana | 59102 | United States |
| Butte | Montana | 59701 | United States |
| Missoula | Montana | 59808 | United States |
| Bellevue | Nebraska | 68005 | United States |
| Las Vegas | Nevada | 89102 | United States |
| Las Vegas | Nevada | 89109 | United States |
| Las Vegas | Nevada | 89119 | United States |
| Las Vegas | Nevada | 89123 | United States |
| Lodi | New Jersey | 07644 | United States |
| New York | New York | 10016 | United States |
| Calabash | North Carolina | 28467 | United States |
| Charlotte | North Carolina | 28207 | United States |
| Charlotte | North Carolina | 28210 | United States |
| Greensboro | North Carolina | 27410 | United States |
| Hickory | North Carolina | 28601 | United States |
| Huntersville | North Carolina | 28078 | United States |
| Lexington | North Carolina | 27292 | United States |
| Morganton | North Carolina | 28655 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Kettering | Ohio | 45429 | United States |
| Toledo | Ohio | 43617 | United States |
| Wadsworth | Ohio | 44281 | United States |
| Ashland | Oregon | 97520 | United States |
| Belle Vernon | Pennsylvania | 15812 | United States |
| Clairton | Pennsylvania | 15025 | United States |
| Indiana | Pennsylvania | 15701 | United States |
| Scottdale | Pennsylvania | 15683 | United States |
| Smithfield | Pennsylvania | 15478 | United States |
| Tyrone | Pennsylvania | 16686 | United States |
| Uniontown | Pennsylvania | 15401 | United States |
| Cumberland | Rhode Island | 02864 | United States |
| Greenville | South Carolina | 29607 | United States |
| Greenville | South Carolina | 29615 | United States |
| Greer | South Carolina | 29651 | United States |
| Murrells Inlet | South Carolina | 29576 | United States |
| North Myrtle Beach | South Carolina | 29582 | United States |
| Rock Hill | South Carolina | 29732 | United States |
| Rapid City | South Dakota | 57702 | United States |
| Bristol | Tennessee | 37620 | United States |
| Franklin | Tennessee | 37067 | United States |
| Jackson | Tennessee | 38305 | United States |
| Smyrna | Tennessee | 37167 | United States |
| Allen | Texas | 75013 | United States |
| Carrollton | Texas | 75006 | United States |
| Corpus Christi | Texas | 78414 | United States |
| Dallas | Texas | 75218 | United States |
| Houston | Texas | 77024 | United States |
| Houston | Texas | 77036 | United States |
| Houston | Texas | 77055 | United States |
| Houston | Texas | 77074 | United States |
| Houston | Texas | 77077 | United States |
| McKinney | Texas | 75069 | United States |
| Plano | Texas | 75024 | United States |
| Plano | Texas | 75093 | United States |
| San Antonio | Texas | 78229 | United States |
| Sealy | Texas | 77474 | United States |
| Sugar Land | Texas | 77479 | United States |
| Victoria | Texas | 77901 | United States |
| Draper | Utah | 84020 | United States |
| Salt Lake City | Utah | 84121 | United States |
| South Jordan | Utah | 84095 | United States |
| Newport News | Virginia | 23606 | United States |
| Spokane | Washington | 99204 | United States |
| La Palta | Buenos Aires | B1900AVG | Argentina |
| Buenos Aires | Ciudad Autónoma de BuenosAires | C1426ABP | Argentina |
| Córdoba | Córdoba Province | 5000 | Argentina |
| Córdoba | Córdoba Province | X5000 | Argentina |
| Rosario | Santa Fe Province | 2000 | Argentina |
| Santa Fe | Santa Fe Province | 3000 | Argentina |
| Buenos Aires | B1722FJN | Argentina |
| Buenos Aires | B6500BWQ | Argentina |
| Mar del Plata | Argentina |
| Ramos Mejía | B1704ETD | Argentina |
| San Miguel de Tucumán | T400IAR | Argentina |
| Vicente López | B1602DQD | Argentina |
| Belo Horizonte | Minas Gerais | 30150-221 | Brazil |
| Juiz de Fora | Minas Gerais | 36010-570 | Brazil |
| Curitiba | Paraná | 80050-350 | Brazil |
| Passo Fundo | Rio Grande do Sul | 99010-080 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90610270 | Brazil |
| Campinas | São Paulo | 13059-900 | Brazil |
| Santo André | São Paulo | 09060-650 | Brazil |
| Santo André | São Paulo | 09080-110 | Brazil |
| São Paulo | São Paulo | 01323-020 | Brazil |
| São Paulo | São Paulo | 04038-905 | Brazil |
| São Paulo | São Paulo | 04231-030 | Brazil |
| Brasília | 70710-905 | Brazil |
| Calgary | Alberta | T3C 1S5 | Canada |
| Edmonton | Alberta | T5A 4L8 | Canada |
| Vancouver | British Columbia | V5Z 4E1 | Canada |
| Vancouver | British Columbia | V6J 1S3 | Canada |
| Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Mount Pearl | Newfoundland and Labrador | A1N 2C3 | Canada |
| St. John's | Newfoundland and Labrador | A1A 3R5 | Canada |
| Burlington | Ontario | L7M 4Y1 | Canada |
| Cambridge | Ontario | N1R 7L6 | Canada |
| Corunna | Ontario | N0N1G0 | Canada |
| Hamilton | Ontario | L8L 5G8 | Canada |
| London | Ontario | N6H 4P2 | Canada |
| Newmarket | Ontario | L3Y 5G8 | Canada |
| Oshawa | Ontario | L1H 7K4 | Canada |
| Sarnia | Ontario | N7T 4X3 | Canada |
| Scarborough Village | Ontario | M1R3A6 | Canada |
| Toronto | Ontario | M9V 4B4 | Canada |
| Toronto | Ontario | M9W 4L6 | Canada |
| Drummondville | Quebec | J2B 7T1 | Canada |
| Montreal | Quebec | H4N 3C5 | Canada |
| Québec | Quebec | G3K 2P8 | Canada |
| Sainte-Foy | Quebec | G1W 4R4 | Canada |
| Sherbrooke | Quebec | J1H1Z1 | Canada |
| Victoriaville | Quebec | G6P 6P6 | Canada |
| Saskatoon | Saskatchewan | S7K 3H3 | Canada |
| Medellín | Antioquia | Colombia |
| Bogotá | Cundinamarca | Colombia |
| Cali | Valle de Cauca | 8940575 | Colombia |
| Cali | Valle del Cauca Department | 760036 | Colombia |
| Medellín | Colombia |
| Santo Domingo | National District | 10514 | Dominican Republic |
| Santo Domingo | National District | 11205 | Dominican Republic |
| Santo Domingo | National District | Dominican Republic |
| Santa Tecla | La Libertad Department | 01501 | El Salvador |
| San Salvador | San Salvador Department | 01101 | El Salvador |
| Guatemala City | Departamento de Guatemala | 01009 | Guatemala |
| Guatemala City | Departamento de Guatemala | 01010 | Guatemala |
| Chihuahua City | Chihuahua | 31203 | Mexico |
| León | Guanajanto | 37520 | Mexico |
| León | Guanajuato | 37320 | Mexico |
| Acapulco de Juárez | Guerrero | 39670 | Mexico |
| El Salto | Jalisco | 45680 | Mexico |
| Guadalajara | Jalisco | 44100 | Mexico |
| Guadalajara | Jalisco | 44130 | Mexico |
| Guadalajara | Jalisco | 44160 | Mexico |
| Guadalajara | Jalisco | 44280 | Mexico |
| Zapopan | Jalisco | 45116 | Mexico |
| Distrito Federal | Mexico City | 03720 | Mexico |
| Distrito Federal | Mexico City | 07020 | Mexico |
| Cuernavaca | Morelos | 62210 | Mexico |
| Cuernavaca | Morelos | 62240 | Mexico |
| Monterrey | Nuevo León | 64460 | Mexico |
| Culiacán | Sinaloa | 80020 | Mexico |
| Xalapa | Veracruz | 91020 | Mexico |
| Cuautitlán Izcalli | 45769 | Mexico |
| Guanajanto | 36090 | Mexico |
| Mexico City | 01710 | Mexico |
| Mexico City | 06700 | Mexico |
| Mexico City | 11550 | Mexico |
| Tlalnepantla | 54055 | Mexico |
| Arequipa | Arequipa | Arequipa 54 | Peru |
| Cusco | Departamento de Cusco | Cusco 84 | Peru |
| Ica | Ica | 227396 | Peru |
| Trujillo | La Libertad | Peru |
| Lima | Lima Province | Lima 01 | Peru |
| Lima | Lima Province | Lima 11 | Peru |
| Lima | Lima Province | Lima 21 | Peru |
| Lima | Lima Province | Lima 27 | Peru |
| Lima | Lima Province | Lima 32 | Peru |
| Miraflores | Lima region | Lima 18 | Peru |
| Loreto | Loreto | Peru |
| Piura | Piura | Peru |
| Manati | 00674 | Puerto Rico |
| San Juan | 00917 | Puerto Rico |
| San Juan | 00927 | Puerto Rico |
| 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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