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

NCT04709835 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: WV430422020-005366-34
• Study Type: interventional
• Target: 104
• Locations: 6 countries
• Sites: 12

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

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in the Amount of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus RNA for AT-527 550 mg and Matched Placebo

  SARS-CoV-2 virus RNA was measured by reverse-transcription polymerase chain reaction (RT-PCR) from nasopharyngeal (NP) swabs. The change from baseline was estimated from an ANCOVA model with baseline viral load as a covariate. Reported here is the adjusted mean change from baseline. A negative change from baseline indicates an improvement.

  Baseline, Day 3, Day 5, Day 7

• Change From Baseline in the Amount of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus RNA for AT-527 1100 mg and Pooled Placebo

  SARS-CoV-2 virus RNA was measured by reverse-transcription polymerase chain reaction (RT-PCR) from NP swabs. The change from baseline was estimated from an ANCOVA model with baseline viral load as a covariate. Reported here is the adjusted mean change from baseline. A negative change from baseline indicates an improvement.

  Baseline, Day 3, Day 5, Day 7

Secondary Outcomes (14)

• Time to Cessation of SARS-CoV-2 Viral Shedding

  Up to Day 7

• Time to Sustained Non-Detectable SARS-CoV-2 Virus RNA

  Up to Day 7

• Percentage of Participants Positive for SARS-CoV-2 Virus RNA at Specified Timepoints

  Baseline, Day 3, Day 5, Day 7

• Area Under the Curve (AUC) in the Amount of SARS-CoV-2 Virus RNA

  Baseline, Day 3, Day 5, Day 7

• Time to Alleviation or Improvement of COVID-19 Symptoms (21.5 Hours)

  Up to 28 Days

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

AT-527 550 mg (1x550 mg)

EXPERIMENTAL

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

Drug: AT-527

AT-527 1100 mg (4x275 mg)

EXPERIMENTAL

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

Drug: AT-527

Interventions

AT-527 DRUG

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

Also known as: RO7496998

AT-527 1100 mg (4x275 mg); AT-527 550 mg (1x550 mg)

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Atea Pharmaceuticals, Inc.: collaborator

Study Sites (12)

Hamilton Medical Research Group

Hamilton, Ontario, L8M 1K7, Canada

Location

National and Kapodistrian University of Athens

Athens, 115 28, Greece

Location

General State Hospital of Nikaia St Panteleimon

Nikaia Attikis, 184 54, Greece

Location

Connolly Hospital

Dublin, 15, Ireland

Location

Outpatient Clinic Adoria

Riga, LV-1011, Latvia

Location

The Family Physician's Practice of Dr. Maija Kozlovska

Salaspils, LV-2121, Latvia

Location

Hospital Universitario La Paz

Madrid, 280146, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Chapel Street Medical Centre

Ashton-under-Lyne, OL6 6EW, United Kingdom

Location

Tower Family Healthcare - Moorgate Primary Care Ce

Bury, BL9 0NJ, United Kingdom

Location

CPS Research

Glasgow, G20 0XA, United Kingdom

Location

Chelsea and Westminster NHS Trust

London, SW3 6JJ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37338393 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

AT-511

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 14, 2021
• Study Start: February 3, 2021
• Primary Completion: September 17, 2021
• Study Completion: October 13, 2021
• Last Updated: October 26, 2022
• Results First Posted: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share

Locations

GR (2); LA (2); ES (2); IE (1); GB (4); CA (1)