Loading clinical trials...

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

COMPLETEDPHASE2

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

A Phase II Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Antiviral Activity, Safety, Pharmacokinetics, and Efficacy of RO7496998 (AT-527) in Non-Hospitalized Adult Patients With Mild or Moderate COVID-19

NCT04709835•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+5 more criteria

Locations (12)

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

Key Dates

Start Date

February 3, 2021

Primary Completion Date

September 17, 2021

Completion Date

October 13, 2021

Last Updated

October 26, 2022

Enrollment

104

ACTUAL participants

Conditions

COVID-19

Interventions

AT-527

DRUG

Placebo

DRUG

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

NCT07221162

COVID-19

View study

RECRUITINGNA

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

NCT06082518

Post COVID-19 ConditionPost-COVID-19 Syndrome+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 26, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease

Dime La VerDAD: Verify, Debunk, and Disseminate

Positron Emission Tomography (PET) Imaging of Thrombosis