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

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ClinicalTrials.gov Identifier: NCT04709835
Recruitment Status : Recruiting
First Posted : January 14, 2021
Last Update Posted : September 17, 2021
Sponsor:
Collaborator:
Atea Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: AT-527 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : February 3, 2021
Estimated Primary Completion Date : September 22, 2021
Estimated Study Completion Date : September 22, 2021

Arm Intervention/treatment
Experimental: AT-527
Participants will receive 550 mg AT-527 twice a day (BID) in Cohort A. Cohorts B-E doses are to be determined.
Drug: AT-527
Results from Cohort A will determine the dose and regimen to be used for Cohort B. Cohort C, D and E dose and regimen will also be based on emerging data.
Other Name: RO7496998

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




Primary Outcome Measures :
  1. Change from Baseline in the Amount of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus RNA [ Time Frame: Up to Day 7 ]
    SARS-CoV-2 virus RNA will be measured by reverse-transcription polymerase chain reaction (RT-PCR).


Secondary Outcome Measures :
  1. Time to Cessation of SARS-CoV-2 Viral Shedding [ Time Frame: Up to Day 7 ]
    Time to cessation of viral shedding is defined as the time between the initiation of any study treatment and first time when the virus RNA by RT-PCR is below the limit of detection.

  2. Time to Sustained Non-Detectable SARS-CoV-2 Virus RNA [ Time Frame: Up to Day 7 ]
    Time to sustained non-detectable SARS-CoV-2 virus RNA is defined as the time from initiation of study treatment to the last timepoint when the virus RNA by RT-PCR is below the limit of detection.

  3. Proportion of Participants Positive for SARS-CoV-2 Virus RNA at Specified Timepoints [ Time Frame: Up to Day 7 ]
  4. Area Under the Curve (AUC) in the Amount of SARS-CoV-2 Virus RNA [ Time Frame: Up to Day 7 ]
    AUC in the amount of SARS-CoV-2 virus RNA from baseline to the last sample timepoint.

  5. Time to Alleviation or Improvement of COVID-19 Symptoms (21.5 hours) [ Time Frame: Up to 28 Days ]
    Alleviation of symptoms is defined as the length of time taken from start of treatment to the point at which a Score of 0 or 1 has been maintained for a duration of at least 21.5 hours. Improvement of symptoms is defined as at least a single category improvement from baseline on the Likert scale.

  6. Time to Alleviation or Improvement of COVID-19 Symptoms (43 hours) [ Time Frame: Up to 28 Days ]
    Alleviation of symptoms is defined as the length of time taken from start of treatment to the point at which a Score of 0 or 1 has been maintained for a duration of at least 43 hours. Improvement of symptoms is defined as at least a single category improvement from baseline on the Likert scale.

  7. Time to Alleviation of COVID-19 Symptoms (21.5 hours) [ Time Frame: Up to 28 Days ]
    Alleviation of symptoms is defined as the length of time taken from start of treatment to the point at which the following criteria are met and maintained for at least 21.5 hours: Score of 0 or 1 on Items 1-12 of the COVID-19 Symptom Diary (without consideration for presence of pre-existing symptoms).

  8. Time to Alleviation of COVID-19 Symptoms (43 hours) [ Time Frame: Up to 28 Days ]
    Alleviation of symptoms is defined as the length of time taken from start of treatment to the point at which the following criteria are met and maintained for at least 43 hours: Score of 0 or 1 on Items 1-12 of the COVID-19 Symptom Diary (without consideration for presence of pre-existing symptoms).

  9. Duration of Fever [ Time Frame: Up to 28 Days ]
    Defined as the time to return to an afebrile state (temperature ≤ 37.5°C) maintained for at least 21.5 hours

  10. Frequency of COVID-19 Related Complications [ Time Frame: Up to 33 Days ]
    Examples of COVID-19 related complications include death, hospitalization, radiologically confirmed pneumonia, acute respiratory failure, sepsis, coagulopathy, pericarditis, myocarditis, and cardiac failure.

  11. Time to Alleviation of an Individual Symptom [ Time Frame: Up to 28 Days ]

    Time to alleviation of an individual symptom is defined as the time taken from the start of treatment to the point at which the following criterion is met and maintained (for each individual symptom) for at least 21.5 hours:

    • Score of 0 or 1 for Items 1-12 of the COVID-19 Symptom Diary.
    • Score of 0 for Items 13 and 14 of the COVID-19 Symptom Diary.

  12. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to 33 Days ]
  13. Plasma Concentration of AT-511, AT-551, AT-229 and AT-273 [ Time Frame: Up to Day 7 ]
    AT-511 is the free base form of AT-527. Its major metabolites are AT-551, AT-229, and AT 273.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04709835


Contacts
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Contact: WV43042 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 global-roche-genentech-trials@gene.com

Locations
Show Show 43 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Atea Pharmaceuticals, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04709835    
Other Study ID Numbers: WV43042
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases