A Multicenter, Phase III Randomized, Double-Blind, Placebo-Controlled, Outpatient Study to Evaluate the Efficacy, Safety, Antiviral Activity of RO7496998 (AT-527) in Patients With Mild or Moderate COVID-19

TerminadoFase 3ClinicalTrials.gov

ID: NCT04889040Tipo: INTERVENTIONALInicio: 28 de abr de 2021Fin estimado: 2 de dic de 2021

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 12 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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)

Intervenciones

drug

RO7496998

275 mg tablets

drug

Placebo

Matching tablets

Ubicaciones

Instituto Ave Pulmo

Mar del Plata, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

ColaboradorAtea Pharmaceuticals, Inc.

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