Study to Evaluate the Effects of RO7496998 (AT-527) in Non-Hospitalized Adult and Adolescent Participants With Mild or Moderate COVID-19

NCT04889040 | Terminated Phase 3 Results DMC

• 2 other identifiers: CV430432020-005759-18
• Study Type: interventional
• Target: 216
• Locations: 12 countries
• Sites: 50

Brief Summary

This study will evaluate the efficacy, safety, antiviral activity, and pharmacokinetics of study drug RO7496998 (AT-527) compared to placebo in non-hospitalized adult and adolescent participants with mild to moderate coronavirus disease 2019 (COVID-19) in the outpatient setting.

Conditions

COVID-19

Keywords

Coronavirus Disease 2019; COVID-19; antiviral drug; SARS-CoV-2; Mild to Moderate COVID-19; antiviral efficacy

Outcome Measures

Primary Outcomes (1)

• Time to Alleviation or Improvement of COVID-19 Symptoms (21.5 Hours)

  COVID-19 symptoms will be evaluated using the COVID-19 Symptom Diary (questions 1-12). The severity of each COVID-19 symptom will be recorded on a Likert scale (i.e none/mild/moderate/severe). The time to alleviation or improvement of COVID-19 symptoms is defined as follows: for new symptoms, it is defined as the length of time taken from randomization to the point at which a Score of 0 or 1 has been maintained for a duration of at least 21.5 hours. For preexisting symptoms, it is defined as the time from randomization to when a patient's symptoms have been maintained or improved (requires at least a single category improvement from baseline on the COVID-19 Symptom Diary Likert scale) for a duration of 21.5 hours.

  Up to 29 days

Secondary Outcomes (19)

• Time to Alleviation or Improvement of COVID-19 Symptoms (43 Hours)

  Up to 29 days

• Time to Alleviation of COVID-19 Symptoms (21.5 Hours)

  Up to 29 days

• Time to Alleviation of COVID-19 Symptoms (43 Hours)

  Up to 29 days

• Time to One-Category Improvement of Baseline Presenting COVID-19 Symptoms

  Up to 29 days

• Time to Alleviation of Individual Symptoms

  Up to 29 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The dose and regimen of the placebo will match that of AT-527.

Drug: Placebo

RO7496998 (AT-527)

EXPERIMENTAL

Orally administered, 550 mg twice daily (BID) for 5 days

Drug: RO7496998

Interventions

RO7496998 DRUG

275 mg tablets

Also known as: AT-527

RO7496998 (AT-527)

Placebo DRUG

Matching tablets

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive SARS-CoV-2 diagnostic test (RT-PCR or validated rapid antigen test) ≤72 hours prior to randomization
• 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

You may not qualify if:

• Clinical signs indicative of COVID-19 illness requiring hospitalization
• 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)

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Atea Pharmaceuticals, Inc.: collaborator

Study Sites (50)

Instituto Ave Pulmo

Mar del Plata, B7602DCK, Argentina

Location

Maison Médicale La Brèche

Châtelineau, 6200, Belgium

Location

Private Practice Dr Jean Benoit Martinot

Erpent, 5101, Belgium

Location

Medif

Gozée, 6534, Belgium

Location

L2 Ip Instituto de Pesquisas Clinicas Ltda ME; Centro Medico Hospitalar

Brasília, Federal District, 70200-730, Brazil

Location

Chronos Pesquisa Clinica

Taguatinga, Federal District, 72145-450, Brazil

Location

Hospital Nossa Senhora das Graças

Curitiba, Paraná, 80810-040, Brazil

Location

Hospital Agamenon Magalhães

Recife, Pernambuco, 52051-380, Brazil

Location

Conjunto Hospitalar do Mandaqui

São Paulo, São Paulo, 02401-400, Brazil

Location

Aalborg Universitetshospital

Aalborg, 9000, Denmark

Location

Rigshospitalet Copenhagen University Hospital

Copenhagen, DK-2100, Denmark

Location

Praxis am Ebertplatz

Cologne, 50668, Germany

Location

Higashiosaka city Medical Center

Higashiosaka-Shi, 578-0947, Japan

Location

Rinku General Medical Center

Izumisano, 598-0048, Japan

Location

Sagamihara Kyodo Hospital

Kanagawa, 252-5188, Japan

Location

Misyuku hospital

Meguro-Ku, 153-0051, Japan

Location

IUHW Narita Hospital

Narita, 286-8520, Japan

Location

Houjin Syadan Kouhoukai Takagi Hospital

Okawa-Shi, 831-0016, Japan

Location

Okayama City Hospital

Okayama, 700-8557, Japan

Location

Ome Municipal General Hospital

Ome-Shi, 198-0042, Japan

Location

National Hospital Organization Kinki-Chuo Chest Medical Center

Sakaishi, 591-8555, Japan

Location

Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai

Shinagawa City, 140-8522, Japan

Location

Edogawa Medicare Hospital

Tokyo, 133-0071, Japan

Location

Center Hospital of the National Center for Global Health and Medicine

Tokyo, 162-0052, Japan

Location

Tokyo Medical University Hachioji Medical Center

Tokyo, 193-0998, Japan

Location

CIMAB SA de CV

Torreón, Coahuila, 27000, Mexico

Location

Panamerican Clinical Research S.A de C.V.

Guadalajara, Jalisco, 44670, Mexico

Location

Clinstile S.A de C.V.

Mexico City, Mexico CITY (federal District), 06700, Mexico

Location

PanAmerican Clinical Research, Querétaro

Queréaro, Querétaro, 76230, Mexico

Location

Instituto Jalisciense de Investigacion Clinica S.A. de C.V.

Guadalajara, 44100, Mexico

Location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

México, Mexico

Location

Unidade Local de Saude de Matosinhos SA

Matosinhos Municipality, 4454-509, Portugal

Location

Prof. Dr. Matei Bals Institute of Infectious Diseases

Bucharest, 021105, Romania

Location

County Hospital Caracal

Caracal, 235200, Romania

Location

Sibiu Emergency Clinical County Hospital

Sibiu, 550245, Romania

Location

Hôpital Universitaire de Genève (HUG)

Geneva, 1211, Switzerland

Location

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

Gazi Universitesi Tip Fakultesi

Ankara, 06100, Turkey (Türkiye)

Location

Ankara University Medical Faculty - PPDS

Çankaya, 06590, Turkey (Türkiye)

Location

Ege University Medical Faculty

Izmir, 35100, Turkey (Türkiye)

Location

Karadeniz Technical University Faculty of Medicine

Trabzon, 61080, Turkey (Türkiye)

Location

Municipal Non-profit Enterprise ?City Clinical Hospital #13? of Kharkiv City Council

Kharkiv, Kharkiv Governorate, 61124, Ukraine

Location

Public Non-Profit Enterprise ?City Outpatient Clinic #9? of Kharkiv City Council

Kharkiv, Kharkiv Governorate, 61172, Ukraine

Location

CNPE City Clinical Hospital #6 of DCC

Dnipro, Kholm Governorate, 49074, Ukraine

Location

Medical Center LLC "Harmony of Beauty"

Kyiv, KIEV Governorate, 01135, Ukraine

Location

CNE Kyiv City Clinical Hospital#1 of Exec. Body

Kyiv, KIEV Governorate, 02091, Ukraine

Location

Kyiv Railway Clinical Hospital No2 of Branch Health Center of the JSC Ukrainian Rail

Kyiv, KIEV Governorate, 03049, Ukraine

Location

Polyclinic of Center of Medical Service and Rehabilitation of State JSHC Artem

Kyiv, KIEV Governorate, 04050, Ukraine

Location

Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1

Vinnytsia, Podolia Governorate, Ukraine

Location

Communal Non-Profit Enterprise City Hospital #7 of Zaporizhzhia City Council

Zaporizhzhia, Tavria Okruha, 69118, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 37928891 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

AT-511

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

The study was terminated with only 16% of the planned sample size.

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 17, 2021
• Study Start: April 28, 2021
• Primary Completion: December 2, 2021
• Study Completion: December 2, 2021
• Last Updated: January 5, 2024
• Results First Posted: January 5, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

CH (2); UA (9); DE (1); TU (4); JP (13); BE (3); ME (6); AR (1); DK (2); RO (3); BR (5); PT (1)