Mild to Moderate coronavirus disease 2019 (COVID-19) MedDRA version: 23.1 Level: LLT Classification code 10084401 Term: COVID-19 respiratory infection System Organ Class: 100000004862
Conditions
Sponsors
F. Hoffmann La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age >=18 years (regardless of weight) at the time of signing informed consent or age >=12 to =40 kilogram) at the time of signing informed consent (and assent) Ability to comply with all aspects of the study protocol, including providing samples for virology, in the opinion of the investigator 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 Positive severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) diagnostic test (reverse-transcriptase polymerase chain reaction [RT-PCR] or validated rapid antigen test) =12 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 against SARS-CoV-2 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-2) intravenous immunoglobulin or other emergency use authorization (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 (P-gp) inhibitors or inducers Known allergy or hypersensitivity to components of study drug Pregnant or breastfeeding, or intending to become pregnant during the study or within 30 days after the final dose of RO7496998 (AT-527) 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. This exclusion does not apply to patients with stable chronic viral infections, such as chronic HCV or HIV providing other eligibility criteria are met 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): 1.Time to alleviation or improvement of COVID-19 symptoms (Items 1-12 of the COVID-19 symptom diary) maintained for a duration of 21.5 hours defined as follows: For new symptoms: time from randomization to the alleviation of COVID 19 symptoms (i.e., a score of 0 [none] or 1 [mild] on the COVID 19 Symptom Diary) For preexisting symptoms: time from randomization to when a patient’s symptoms have been maintained or improved (Note: Improved requires at least a single category improvement from baseline on the COVID-19 Symptom Diary Likert scale) ;Main Objective: To evaluate the efficacy of RO7496998 (AT-527) compared with placebo based on the time to alleviation or improvement of COVID-19 symptoms;Secondary Objective: -To evaluate the efficacy of RO7496998 (AT-527) compared with placebo (defined as the time from randomization to the point at which the following criterion is met and maintained for at least 21.5 hours) based on: Time to alleviation or improvement of COVID-19 symptoms Time to alleviation of symptoms Time to one-category improvement of baseline presenting COVID-19 symptoms Time to alleviation of individual symptoms Proportion of patients requiring hospitalization for COVID-19 Proportion of patients with >=1 COVID-19 related medically attended visit through to study end Duration of fever Frequency of COVID-19 related complications, Proportion of patients with any post-treatment infection Proportion of patients with all-cause mortality -To evaluate the antiviral activity of RO7496998 (AT-527) compared with placebo -To evaluate the safety of RO7496998 (AT-527) compared with placebo -To characterize the pharmacokinetic (PK) profile of AT-511 and major metabolites in plasma ;Timepoint(s) of evaluation of this end point: 1. Day 1 to day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Time to alleviation or improvement of COVID-19 symptoms (Items 1-12 of the COVID-19 Symptom Diary) maintained for a duration of 43 hours, defined as follows: For new symptoms: time from randomization to the alleviation of COVID 19 symptoms (i.e., a score of 0 [none] or 1 [mild] on the COVID 19 Symptom Diary) For preexisting symptoms: time from randomization to when a patient’s symptoms have been maintained or improved (Note: Improved requires at least a single category improvement from baseline on the COVID-19 Symptom Diary Likert scale) 2.Time to alleviation of COVID-19 symptoms defined as the time from randomization to the point at which the following criterion is met and maintained for at least 21.5 hours: Score of 0 or 1 for Items 1-12 of the COVID-19 Symptom Diary 3.Time to alleviation of COVID-19 symptoms defined as the time from randomization to the point at which the following criterion is met and maintained for at least 43 hours: Score of 0 or 1 for Items 1-12 of the COVID-19 Symptom Diary 4.Time to one-category improvement of baseline presenting COVID-19 symptoms (Items 1-12 of the COVID-19 Symptom Diary) maintained for a duration of 21.5 hours defined as time from randomization to when the symptoms have improved by at least one category from baseline on the COVID-19 Symptom Diary Likert scale 5.Time to alleviation of individual symptoms, defined as the time from randomization to the point at which the following criterion is met and maintained (for each individual symptom) for at least 21.5 hours: Score of 0 or 1 for Items 1-14 of the COVID-19 Symptom Diary 6.Proportion of patients requiring hospitalization for COVID-19 7.Proportion of patients with >=1 COVID-19 related medically attended visit through to study end (defined as hospitalization, emergency room [ER] visit, urgent care visit, physician’s office visit, or telemedicine visit, with the primary reason for the visit being COVID-19) 8.Duration of fever (time to return t | — |
Countries
Argentina, Belgium, Brazil, Colombia, Denmark, France, Germany, Hungary, Italy, Japan, Mexico, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, Spain, Switzerland, Turkey, Ukraine, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann La Roche Ltd.
Outcome results
None listed