Study to Evaluate the Effects of RO7496998 (AT-527) in Non-Hospitalized Adult and Adolescent Participants With Mild or Moderate COVID-19
NCT ID: NCT04889040
Last Updated: 2024-01-05
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
216 participants
INTERVENTIONAL
2021-04-28
2021-12-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
The dose and regimen of the placebo will match that of AT-527.
Placebo
Matching tablets
RO7496998 (AT-527)
Orally administered, 550 mg twice daily (BID) for 5 days
RO7496998
275 mg tablets
Interventions
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RO7496998
275 mg tablets
Placebo
Matching tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least three of the following symptoms of at least moderate (score ≥2 as per COVID-19 Symptom Diary) intensity: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills or sweats, feeling hot or feverish, nausea, vomiting, or diarrhea.
* Has symptoms consistent with mild or moderate COVID-19, as determined by the investigator, with onset ≤5 days before dosing on Day 1
Exclusion Criteria
* Admitted to a hospital prior to randomization or is hospitalized (inpatient) at randomization due to COVID-19
* In the opinion of the investigator, is likely to experience imminent deterioration and require hospitalization
* Treatment with an investigational drug within 5 half-lives or 3 months (whichever is longer) of randomization
* Treatment with a COVID-19 therapeutic agent including, but not limited to, other direct or indirect acting antivirals against SARS-CoV-2 (such as remdesivir or favipiravir), systemic or inhaled steroids (such as dexamethasone or inhaled budesonide), colchicine, ivermectin, interferons, convalescent plasma, monoclonal antibodies against SARS CoV-2 or interleukin 6 (IL-6), intravenous immunoglobulin or other EUA-approved treatments within 3 months or less than 5 drug elimination half-lives (whichever is longer) prior to the screening visit
* Concomitant use of P-glycoprotein inhibitors or inducers listed as prohibited therapy in the protocol
* Known allergy or hypersensitivity to components of study drug
* Abnormal laboratory test results at screening
* Requirement of any prohibited medications during the study
* Other known active viral or bacterial infection at the time of screening, such as influenza
* Any clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, could jeopardize the safety of the patient or affect patient compliance or safety/efficacy observations during the study
* COVID-19 vaccination within ≤ 40-days prior to enrollment (second dose if applicable)
12 Years
ALL
No
Sponsors
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Atea Pharmaceuticals, Inc.
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Instituto Ave Pulmo
Mar del Plata, , Argentina
Maison Médicale La Brèche
Châtelineau, , Belgium
Private Practice Dr Jean Benoit Martinot
Erpent, , Belgium
Medif
Gozée, , Belgium
L2 Ip Instituto de Pesquisas Clinicas Ltda ME; Centro Medico Hospitalar
Brasília, Federal District, Brazil
Chronos Pesquisa Clinica
Taguatinga, Federal District, Brazil
Hospital Nossa Senhora das Graças
Curitiba, Paraná, Brazil
Hospital Agamenon Magalhães
Recife, Pernambuco, Brazil
Conjunto Hospitalar do Mandaqui
São Paulo, São Paulo, Brazil
Aalborg Universitetshospital
Aalborg, , Denmark
Rigshospitalet Copenhagen University Hospital
Copenhagen, , Denmark
Praxis am Ebertplatz
Cologne, , Germany
Higashiosaka city Medical Center
Higashiosaka-Shi, , Japan
Rinku General Medical Center
Izumisano, , Japan
Sagamihara Kyodo Hospital
Kanagawa, , Japan
Misyuku hospital
Meguro-Ku, , Japan
IUHW Narita Hospital
Narita, , Japan
Houjin Syadan Kouhoukai Takagi Hospital
Okawa-Shi, , Japan
Okayama City Hospital
Okayama, , Japan
Ome Municipal General Hospital
Ome-Shi, , Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakaishi, , Japan
Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai
Shinagawa City, , Japan
Edogawa Medicare Hospital
Tokyo, , Japan
Center Hospital of the National Center for Global Health and Medicine
Tokyo, , Japan
Tokyo Medical University Hachioji Medical Center
Tokyo, , Japan
CIMAB SA de CV
Torreón, Coahuila, Mexico
Panamerican Clinical Research S.A de C.V.
Guadalajara, Jalisco, Mexico
Clinstile S.A de C.V.
Mexico City, Mexico CITY (federal District), Mexico
PanAmerican Clinical Research, Querétaro
Queréaro, Querétaro, Mexico
Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
Guadalajara, , Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
México, , Mexico
Unidade Local de Saude de Matosinhos SA
Matosinhos Municipality, , Portugal
Prof. Dr. Matei Bals Institute of Infectious Diseases
Bucharest, , Romania
County Hospital Caracal
Caracal, , Romania
Sibiu Emergency Clinical County Hospital
Sibiu, , Romania
Hôpital Universitaire de Genève (HUG)
Geneva, , Switzerland
Universitätsspital Zürich
Zurich, , Switzerland
Gazi Universitesi Tip Fakultesi
Ankara, , Turkey (Türkiye)
Ankara University Medical Faculty - PPDS
Çankaya, , Turkey (Türkiye)
Ege University Medical Faculty
Izmir, , Turkey (Türkiye)
Karadeniz Technical University Faculty of Medicine
Trabzon, , Turkey (Türkiye)
Municipal Non-profit Enterprise ?City Clinical Hospital #13? of Kharkiv City Council
Kharkiv, Kharkiv Governorate, Ukraine
Public Non-Profit Enterprise ?City Outpatient Clinic #9? of Kharkiv City Council
Kharkiv, Kharkiv Governorate, Ukraine
CNPE City Clinical Hospital #6 of DCC
Dnipro, Kholm Governorate, Ukraine
Medical Center LLC "Harmony of Beauty"
Kyiv, KIEV Governorate, Ukraine
CNE Kyiv City Clinical Hospital#1 of Exec. Body
Kyiv, KIEV Governorate, Ukraine
Kyiv Railway Clinical Hospital No2 of Branch Health Center of the JSC Ukrainian Rail
Kyiv, KIEV Governorate, Ukraine
Polyclinic of Center of Medical Service and Rehabilitation of State JSHC Artem
Kyiv, KIEV Governorate, Ukraine
Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1
Vinnytsia, Podolia Governorate, Ukraine
Communal Non-Profit Enterprise City Hospital #7 of Zaporizhzhia City Council
Zaporizhzhia, Tavria Okruha, Ukraine
Countries
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References
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Horga A, Saenz R, Yilmaz G, Simon-Campos A, Pietropaolo K, Stubbings WJ, Collinson N, Ishak L, Zrinscak B, Belanger B, Granier C, Lin K, C Hurt A, Zhou XJ, Wildum S, Hammond J. Oral bemnifosbuvir (AT-527) vs placebo in patients with mild-to-moderate COVID-19 in an outpatient setting (MORNINGSKY). Future Virol. 2023 Oct:10.2217/fvl-2023-0115. doi: 10.2217/fvl-2023-0115. Epub 2023 Nov 1.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-005759-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CV43043
Identifier Type: -
Identifier Source: org_study_id
NCT05126576
Identifier Type: -
Identifier Source: nct_alias
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