A study to evaluate the Efficacy, Safety, and Antiviral Activity of RO7496998 (AT-527) in Patients with Mild or Moderate COVID-19
- Conditions
- MedDRA version: 23.1Level: LLTClassification code 10084401Term: COVID-19 respiratory infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]Mild to Moderate coronavirus disease 2019 (COVID-19)
- Registration Number
- EUCTR2020-005759-18-FR
- Lead Sponsor
- F. Hoffmann La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 1386
Age >=18 years (regardless of weight) at the time of signing informed consent or age >=12 to <18 years (weight >=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) <=72 hours prior to randomization
Symptoms consistent with mild or moderate COVID-19, as determined by the Investigator, with onset <=5 days before randomization
For women of childbearing potential and girls at or beyond menarche (age >=12 to <18 years): agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 30 days after the final dose of RO7496998 (AT-527)
Are the trial subjects under 18? yes
Number of subjects for this age range: 150
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1236
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 30 days (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, dexamethasone, interferons, convalescent plasma, monoclonal antibodies against SARS CoV-2, intravenous immunoglobulin or other emergency use authorization (EUA)-approved treatments within the last 2 weeks 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
Known active viral or bacterial infection at the time of screening
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method