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

NCT ID: NCT04709835

Last Updated: 2022-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-03
• Study Completion Date: 2021-10-13

Brief Summary

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

AT-527 550 mg (1x550 mg)

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

Group Type: EXPERIMENTAL

AT-527

Intervention Type: DRUG

Results from Arm AT-527 500 mg determined the dose and regimen to be used for AT-527 1100 mg.

AT-527 1100 mg (4x275 mg)

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

Group Type: EXPERIMENTAL

AT-527

Intervention Type: DRUG

Results from Arm AT-527 500 mg determined the dose and regimen to be used for AT-527 1100 mg.

Interventions

AT-527

Results from Arm AT-527 500 mg determined the dose and regimen to be used for AT-527 1100 mg.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

RO7496998

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atea Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Hamilton Medical Research Group

Hamilton, Ontario, Canada

National and Kapodistrian University of Athens

Athens, , Greece

General State Hospital of Nikaia St Panteleimon

Nikaia Attikis, , Greece

Connolly Hospital

Dublin, , Ireland

Outpatient Clinic Adoria

Riga, , Latvia

The Family Physician's Practice of Dr. Maija Kozlovska

Salaspils, , Latvia

Hospital Universitario La Paz

Madrid, , Spain

Hospital Universitario Infanta Leonor

Madrid, , Spain

Chapel Street Medical Centre

Ashton-under-Lyne, , United Kingdom

Tower Family Healthcare - Moorgate Primary Care Ce

Bury, , United Kingdom

CPS Research

Glasgow, , United Kingdom

Chelsea and Westminster NHS Trust

London, , United Kingdom

Countries

Canada; Greece; Ireland; Latvia; Spain; United Kingdom

References

Boffito M, Dolan E, Singh K, Holmes W, Wildum S, Horga A, Pietropaolo K, Zhou XJ, Clinch B, Collinson N, Ukachukwu V. A Phase 2 Randomized Trial Evaluating the Antiviral Activity and Safety of the Direct-Acting Antiviral Bemnifosbuvir in Ambulatory Patients with Mild or Moderate COVID-19 (MOONSONG Study). Microbiol Spectr. 2023 Aug 17;11(4):e0007723. doi: 10.1128/spectrum.00077-23. Epub 2023 Jun 20.

Reference Type: DERIVED

PMID: 37338393 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-005366-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

WV43042

Identifier Type: -

Identifier Source: org_study_id