Study to Evaluate the Effects of AT-527 in Non-Hospitalized Adult Patients With Mild or Moderate COVID-19

Roche

Status and phase: Completed; Phase 2

Conditions: COVID-19

Treatments: Drug: AT-527; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04709835

WV43042

2020-005366-34 (EudraCT Number)

Details and patient eligibility

About

This randomized study evaluates the antiviral activity, safety, efficacy and pharmacokinetics of AT-527 versus a placebo in participants with mild or moderate coronavirus disease (COVID-19) who are not hospitalized.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Positive SARS-CoV-2 diagnostic test (RT-PCR or rapid antigen test)at screening
• Has symptoms consistent with mild or moderate COVID-19, as determined by the investigator, with onset ≤5 days prior to randomization

Exclusion criteria

• Clinical signs indicative of COVID-19 illness requiring hospitalization, defined as any of the following: shortness of breath at rest, respiratory rate ≥30, heart rate ≥125, peripheral capillary oxygen saturation ≤93% on room air
• Treatment with a therapeutic agent against SARS-CoV-2 including, but not limited to, other direct acting antivirals, convalescent plasma, monoclonal antibodies against SARS CoV-2, or intravenous immunoglobulin within 3 months or less than 5 drug elimination half-lives (whichever is longer) prior to screening
• Requirement, in the opinion of the investigator, for any of the prohibited medications during the study
• Use of hydroxychloroquine or amiodarone within 3 months of screening
• Pregnant or breastfeeding, or intending to become pregnant during the study or within 30 days after the final dose of AT-527. Women of childbearing potential must have a negative urine pregnancy test result at screening
• Abnormal laboratory test results at screening
• Clinically significant abnormal ECG, as determined by the Investigator, at screening
• Planned procedure or surgery during the study
• Known allergy or hypersensitivity to study drug or drug product excipients
• Substance abuse, as determined by the investigator, within 12 months prior to screening
• Poor peripheral venous access
• Malabsorption syndrome or other condition that would interfere with enteral absorption
• Any clinically significant history of epistaxis within the last 3 months and/or history of being hospitalized due to epistaxis of any previous occasion
• History of anaphylaxis
• Any uncontrolled serious medical condition or other clinically significant abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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104 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants will receive AT-527-matched placebo twice a day (BID) on Days 1-5.

Treatment:

Drug: Placebo

AT-527 550 mg (1x550 mg)

Experimental group

Description:

Participants will receive 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.

Treatment:

Drug: AT-527

AT-527 1100 mg (4x275 mg)

Experimental group

Description:

Participants will receive 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.

Treatment:

Drug: AT-527