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Um ensaio clínico para comparar a segurança e eficácia do AT-527 com placebo em pessoas com COVID-19 leve ou moderada
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
Detalhes básicos
Sponsor
Hoffmann-La Roche
Phase
Fase 3
Study Identifier
NCT04889040, CV43043, 2020-005759-18
Condition
COVID-19
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
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.
Eligibility Criteria
All
≥12 Years
No
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)
Esta página resume informações de sites de registro público, como ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com etc. Para saber mais sobre este estudo, consulte a guia Para profissionais médicos ou visite um desses sites.
As informações abaixo foram obtidas diretamente de sites de registro público, como ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com etc., e não foram editadas.
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For the latest version of this information please go to www.forpatients.roche.com
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