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

NCT04889040

TerminatedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: COVID-19

Interventions: RO7496998, Placebo

Countries: Argentina, Belgium, Brazil, Denmark, Germany, Japan, Mexico, Portugal

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 overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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)
Locations (50)
  • Mar del Plata, Argentina
  • Châtelineau, Belgium
  • Erpent, Belgium
  • Gozée, Belgium
  • Brasília, Federal District, Brazil
  • Taguatinga, Federal District, Brazil
  • Curitiba, Paraná, Brazil
  • Recife, Pernambuco, Brazil
  • São Paulo, São Paulo, Brazil
  • Aalborg, Denmark
  • Copenhagen, Denmark
  • Cologne, Germany
  • Higashiosaka-Shi, Japan
  • Izumisano, Japan
  • Kanagawa, Japan
  • Meguro-Ku, Japan
  • Narita, Japan
  • Okawa-Shi, Japan
  • Okayama, Japan
  • Ome-Shi, Japan
  • Sakaishi, Japan
  • Shinagawa City, Japan
  • Tokyo, Japan
  • Tokyo, Japan
  • Tokyo, Japan
  • Torreón, Coahuila, Mexico
  • Guadalajara, Jalisco, Mexico
  • Mexico City, Mexico CITY (federal District), Mexico
  • Queréaro, Querétaro, Mexico
  • Guadalajara, Mexico
  • + 20 more on CT.gov