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

  • Infectious Diseases
  • COVID-19
  • COVID-19 Pneumonia
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Terminated

This study runs in
Cities
  • Aalborg
  • Ankara
  • București
  • Caracal
  • chatelet
  • Ciudad de México
  • Distrito Federal
  • Dnipro
  • edogawa-city
  • Genève
  • Guadalajara
  • Hachioji
  • Higashiosaka
  • İzmir
  • Izumisano
  • Kharkiv
  • Kyiv
  • Köln
  • København
  • Mar del Plata
  • Matosinhos
  • Namur
  • okawa
  • Okayama
  • ome
  • Ota City
  • Paraná
  • Pernambuco
  • Sagamihara
  • Sakai
  • Santiago de Querétaro
  • Shinagawa City
  • Shinjuku City
  • Sibiu
  • São Paulo
  • thuin
  • Torreón
  • Trabzon
  • Vinnytsia
  • Zaporizhzhia
  • Zürich
Study Identifier:

NCT04889040 2020-005759-18 CV43043

      Show study locations

      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Study 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.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT04889040, CV43043, 2020-005759-18 Study Identifier
      RO7496998, Placebo Treatments
      COVID-19 Condition
      Official Title

      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

      Eligibility Criteria

      All Gender
      ≥12 Years Age
      No 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
      • 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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