A clinical trial to compare the safety and effectiveness of AT-527 with placebo in people with mild or moderate COVID-19

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

  • Doenças Infecciosas
  • COVID-19
  • Pneumonia por COVID-19
Observe que o status de recrutamento do estudo em seu centro pode ser diferente do status geral do estudo porque alguns centros de estudo podem recrutar mais cedo do que outros.
Status do estudo:

Terminado

Este estudo é realizado em
Cidades
  • Distrito Federal
  • Paraná
  • Pernambuco
  • São Paulo
Identificador de estudo:

NCT04889040 2020-005759-18 CV43043

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      A seguinte informação vem do site ClinicalTrials.gov publicamente disponível e foi editada para leigos.

      As informações abaixo se origina a partir do site ClinicalTrials.gov publicamente disponível e não foi modificado.

      Results Disclaimer

      Resumo do Estudo

      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.

      Hoffmann-La Roche Patrocinador
      Phase 3 Fase
      NCT04889040, CV43043, 2020-005759-18 Identificador de estudo
      RO7496998, Placebo Tratamento
      COVID-19 Condição
      Título

      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

      Critérios de elegibilidade

      Todos Gênero
      ≥12 Anos Idade
      Não Voluntários Saudáveis
      Critérios de Inclusão
      • 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
      Critérios de Exclusão
      • 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)

      For the latest version of this information please go to www.forpatients.roche.com

       

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