Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
With
Atea Pharmaceuticals, Inc.
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
