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

Roche

Status and phase: Terminated; Phase 3

Conditions: COVID-19

Treatments: Drug: RO7496998; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04889040

CV43043

2020-005759-18 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 216 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

216 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

The dose and regimen of the placebo will match that of AT-527.

Treatment:

Drug: Placebo

RO7496998 (AT-527)

Experimental group

Description:

Orally administered, 550 mg twice daily (BID) for 5 days

Treatment:

Drug: RO7496998