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

TERMINATEDPHASE3

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

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

NCT04889040•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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
+2 more criteria

Locations (50)

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

Key Dates

Start Date

April 28, 2021

Primary Completion Date

December 2, 2021

Completion Date

December 2, 2021

Last Updated

January 5, 2024

Enrollment

216

ACTUAL participants

Conditions

COVID-19

Interventions

RO7496998

DRUG

Placebo

DRUG

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COVID-19

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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