Clinical trial NCT04709835: Study to Evaluate the Effects of AT-527 in Non-Hospitalized Adult Patients With Mild or Moderate COVID-19
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Atea Pharmaceuticals, Inc.
First posted: 2021-01-14
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: Baseline, Day 3, Day 5, Day 7
measure: 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
timeFrame: Baseline, Day 3, Day 5, Day 7
Secondary outcomes:
measure: Time to Cessation of SARS-CoV-2 Viral Shedding
timeFrame: Up to Day 7
measure: Time to Sustained Non-Detectable SARS-CoV-2 Virus RNA
timeFrame: Up to Day 7
measure: Percentage of Participants Positive for SARS-CoV-2 Virus RNA at Specified Timepoints
timeFrame: Baseline, Day 3, Day 5, Day 7
measure: Area Under the Curve (AUC) in the Amount of SARS-CoV-2 Virus RNA
timeFrame: Baseline, Day 3, Day 5, Day 7
measure: Time to Alleviation or Improvement of COVID-19 Symptoms (21.5 Hours)
timeFrame: Up to 28 Days
measure: Time to Alleviation or Improvement of COVID-19 Symptoms (43 Hours)
timeFrame: Up to 28 Days
measure: Time to Alleviation of COVID-19 Symptoms (21.5 Hours)
timeFrame: Up to 28 Days
measure: Time to Alleviation of COVID-19 Symptoms (43 Hours)
timeFrame: Up to 28 Days
measure: Duration of Fever
timeFrame: Up to 28 Days
measure: Percentage of Participants With COVID-19 Related Complications
timeFrame: Up to 33 Days
measure: Time to Alleviation of an Individual Symptom
timeFrame: Up to 28 Days
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Up to 33 Days
measure: Plasma Concentrations of AT-511, AT-551, AT-229 and AT-273 for Participants Treated With 550 mg AT-527
timeFrame: Day 1: pre-dose, 1 hour, 3 hours; Day 3: pre-dose; Day 5: pre-dose, 3 hours, 48 hours
measure: Plasma Concentrations of AT-511, AT-551, AT-229 and AT-273 for Participants Treated With 1100 mg AT-527
timeFrame: Day 1: pre-dose, 1 hour, 4 hours; Day 3: pre-dose; Day 5: pre-dose, 1 hour, 4 hours, 48 hours
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Medical Research Group
state: Ontario
city: Athens
country: Greece
facility: National and Kapodistrian University of Athens
city: Nikaia Attikis
country: Greece
facility: General State Hospital of Nikaia St Panteleimon
city: Dublin
country: Ireland
facility: Connolly Hospital
city: Rīga
country: Latvia
facility: Outpatient Clinic Adoria
city: Salaspils
country: Latvia
facility: The Family Physician's Practice of Dr. Maija Kozlovska
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Ashton-under-Lyne
country: United Kingdom
facility: Chapel Street Medical Centre
city: Bury
country: United Kingdom
facility: Tower Family Healthcare - Moorgate Primary Care Ce
city: Glasgow
country: United Kingdom
facility: CPS Research
city: London
country: United Kingdom
facility: Chelsea and Westminster NHS Trust
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: