Phase 2
Completed N=100
Study to Evaluate the Effects of AT-527 in Non-Hospitalized Adult Patients With Mild or Moderate COVID-19
Source: ClinicalTrials.gov NCT04709835 ↗Enrolled (actual)
100
Serious AEs
3.0%
Results posted
Oct 2022
Primary outcomePrimary: 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 — -1.16; -1.26; -2.42; -2.11 log10 copies/mL — p=0.7144
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
-1.16; -1.26; -2.42; -2.11; -3.13; -3.38 | 0.7144 |
| PRIMARY 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 |
-1.08; -1.18; -2.21; -2.31; -2.70; -2.78 | 0.7351 |
| SECONDARY Time to Cessation of SARS-CoV-2 Viral Shedding |
NA; NA; NA | — |
| SECONDARY Time to Sustained Non-Detectable SARS-CoV-2 Virus RNA |
NA; NA; NA | — |
| SECONDARY Percentage of Participants Positive for SARS-CoV-2 Virus RNA at Specified Timepoints |
100; 100; 96.7; 95.0; 100; 93.1 | — |
| SECONDARY Area Under the Curve (AUC) in the Amount of SARS-CoV-2 Virus RNA |
651.56; 733.70; 618.62 | — |
| SECONDARY Time to Alleviation or Improvement of COVID-19 Symptoms (21.5 Hours) |
43.4; 57.2; 56.4 | — |
| SECONDARY Time to Alleviation or Improvement of COVID-19 Symptoms (43 Hours) |
43.4; 57.2; 58.1 | — |
| SECONDARY Time to Alleviation of COVID-19 Symptoms (21.5 Hours) |
43.4; 57.2; 56.4 | — |
| SECONDARY Time to Alleviation of COVID-19 Symptoms (43 Hours) |
43.4; 57.2; 58.1 | — |
| SECONDARY Duration of Fever |
10.6 | — |
| SECONDARY Percentage of Participants With COVID-19 Related Complications |
0; 3.3; 3.3 | — |
| SECONDARY Time to Alleviation of an Individual Symptom |
27.6; 34.2; 32.7; 20.5; 24.1; 111.7 | — |
| SECONDARY Percentage of Participants With Adverse Events (AEs) |
27.5; 20.0; 33.3 | — |
| SECONDARY Plasma Concentrations of AT-511, AT-551, AT-229 and AT-273 for Participants Treated With 550 mg AT-527 |
1.3; 1950.5; 441.4; 254.2; 5.6; 415.7 | — |
| SECONDARY Plasma Concentrations of AT-511, AT-551, AT-229 and AT-273 for Participants Treated With 1100 mg AT-527 |
0.5; 3575.0; 852.4; 9.6; 316.7; 3568.9 | — |
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
Data sourced from ClinicalTrials.gov (NCT04709835). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.