COVID-19Phase 2NCT04396106
Safety and Efficacy of AT-527 in Subjects With Moderate Coronavirus Disease (COVID-19) in a Hospital Setting
A Phase 2 study testing AT-527 in people with COVID-19, run by Atea Pharmaceuticals, Inc. at 37 sites in 10 countries.
Trial summary
The objectives of this study are to evaluate the safety, tolerability, antiviral activity and efficacy of AT-527 in adult subjects ≥18 years of age with moderate COVID-19 and risk factors for poor outcomes (such as obesity (BMI>30), hypertension, diabetes or asthma). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- AT-527
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 37 sitesin 10 countries
- Study dates
- 26 May 2020to 28 Feb 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized or in a hospital-affiliated confinement facility
- SARS-CoV-2 positive
- Initial COVID-19 symptom onset within 5 days prior to Screening
- SpO2 ≥ 93% on room air or requires ≤ 2L/min oxygen by nasal cannula or mask to maintain SpO2 ≥ 93%
- Must also have a history of at least one of the following known risk factors for poor outcomes: obesity (BMI>30), hypertension, diabetes or asthma.
Who cannot join
- Severe or critical COVID-19 illness: RR ≥30, HR ≥125, SpO2 <93% on room air or requires >2L/min oxygen by nasal cannula or mask to maintain SpO2 ≥93%, systolic blood pressure < 90 mm Hg, diastolic blood pressure < 60 mm Hg or PaO2/FiO2 <300
- Requires mechanical ventilation
- Lobar or segmental consolidation on chest imaging.
- Treatment with other drugs thought to possibly have activity against SARS-CoV-2
- ALT or AST > 5 x upper limit of normal (ULN)
- Female subject is pregnant or breastfeeding
- Has received or is expected to receive any dose of a SARS-CoV-2 vaccine before the Day 14 visit (Part B).
Trial locations and contacts
37 sites in 10 countries.
37 sites in 10 countries
United States15 sites
Atea Study Site
Atlanta, Georgia, 30303
Atea Study Site
Boston, Massachusetts, 02115
Atea Study Site
Butte, Montana, 59701
Atea Study Site
Charleston, South Carolina, 29425
Atea Study Site
Charlotte, North Carolina, 28204
Atea Study Site
Chicago, Illinois, 60611
Atea Study Site
Chicago, Illinois, 60612
Atea Study Site
Cincinnati, Ohio, 45219
Atea Study Site
Columbia, South Carolina, 29203
Atea Study Site
Columbus, Ohio, 43203
Atea Study Site
Davis, California, 95817
Atea Study Site
Los Angeles, California, 90017
Atea Study Site
Orlando, Florida, 32804
Atea Study Site
Scottsdale, Arizona, 85258
Atea Study Site
Washington D.C., District of Columbia, 20037
Brazil5 sites
Atea Study Site
Belo Horizonte
Atea Study Site
Brasília
Atea Study Site
Campo Largo
Atea Study Site
Porto Alegre
Atea Study Site
São Paulo
South Africa5 sites
Atea Study Site
Bloemfontein
Atea Study Site
Cape Town
Atea Study Site
Centurion
Atea Study Site
George
Atea Study Site
Worcester
Spain3 sites
Atea Study Site
Barcelona
Atea Study Site
Madrid
Atea Study Site
Pozuelo de Alarcón
About this study
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AT-527 in Subjects With Moderate COVID-19
The objectives of this study are to evaluate the safety, tolerability, antiviral activity and efficacy of AT-527 in adult subjects ≥18 years of age with moderate COVID-19 and risk factors for poor outcomes (such as obesity (BMI>30), hypertension, diabetes or asthma). Eligible subjects will be randomized to blinded AT-527 (nucleotide analog) tablets or matching placebo tablets to be administered orally for 5 days. Part A will evaluate an AT-527 dose of 550 mg BID and Part B will evaluate a second dose of AT-527 (1100 mg BID). Local supportive standard of care (SOC) will be allowed for all subjects. Efficacy, antiviral activity and safety observations will be compared for treatment with active AT-527 tablets vs. placebo tablets.
- Conditions
- COVID-19
- Being tested
- AT-527, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-527Drug
One 550 mg tablet of AT-527 administered every ~12 hours (twice a day) for a total of 5 days
PlaceboOther
One placebo tablet administered every ~12 hours (twice a day) for a total of 5 days
AT-527Drug
Two 550 mg tablets of AT-527 administered every ~12 hours (twice a day) for a total of 5 days
PlaceboOther
Two placebo tablets administered every ~12 hours (twice a day) for a total of 5 days
| Study group | Role | What they receive |
|---|---|---|
| AT-527 - 550 mg BID | Active comparator | Part A Receives: Drug: AT-527 |
| Placebo for 550 mg BID | Placebo comparator | Part A Receives: Other: Placebo |
| AT-527 - 1100 mg BID | Active comparator | Part B Receives: Drug: AT-527 |
| Placebo for 1100 mg BID | Placebo comparator | Part B Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportions (Active vs. Placebo) of Subjects With Progressive Respiratory Insufficiency (PRI) on or Before Day 14.
Progressive respiratory insufficiency defined as a ≥ 2-tier increase in respiratory support methods required to maintain satisfactory oxygenation (SpO2 ≥ 93%), using the 6-tier hierarchical scale of respiratory support methods, within the 14-day study period.
Level 1:Normal oxygenation on room air (SpO2 ≥93), no need for supplemental O2 Level 2:Persistent hypoxemia on room air (SpO2 <93) with requirement for low-level supplemental O2 by nasal cannula/mask (up to 2L/min) to maintain SpO2 ≥93 Level 3:Requirement for higher levels of passive supplemental O2 by nasal cannula or mask (≥2 L/min) to maintain SpO2 ≥93 Level 4:Requirement for oxygenation by positive-pressure devices Level 5:Required invasive respiratory support (intubated mechanical ventilation or ECMO) Level 6:Death
Measured: Day 14
Secondary outcomes (1)
Change From Baseline in Amount of SARS-CoV-2 Virus RNA by Nasopharyngeal Swab
Change in the viral load as measured by swab of the upper part of the pharynx.
Measured: Through Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start26 May 2020
- Primary completion10 Jan 2022
- Study completion28 Feb 2022
Why it stopped: Study closed out early due to evolving COVID-19 standard of care
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atea Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396106
- Sponsor's protocol ID
- AT-03A-001
- Status last verified
- Feb 2023
- First submitted
- 16 May 2020
- Last updated
- 9 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Horga A, Kuritzkes DR, Kowalczyk JJ, Pietropaolo K, Belanger B, Lin K, Perkins K, Hammond J. Phase II study of bemnifosbuvir in high-risk participants in a hospital setting with moderate COVID-19. Future Virol. 2023 Jun;18(8):489-500. doi: 10.2217/fvl-2023-0064. Epub 2023 Jun 23.
PubMed 38051993
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AT-527 in Subjects With Moderate COVID-19
- ClinicalTrials.gov ID
- NCT04396106
- Acronym / sponsor ID
- AT-03A-001
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed out early due to evolving COVID-19 standard of care
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Atea Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 May 2020 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 20 May 2020 (actual)
- Results
- Posted 9 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to evaluate the safety, tolerability, antiviral activity and efficacy of AT-527 in adult subjects ≥18 years of age with moderate COVID-19 and risk factors for poor outcomes (such as obesity (BMI>30), hypertension, diabetes or asthma). Eligible subjects will be randomized to blinded AT-527 (nucleotide analog) tablets or matching placebo tablets to be administered orally for 5 days. Part A will evaluate an AT-527 dose of 550 mg BID and Part B will evaluate a second dose of AT-527 (1100 mg BID). Local supportive standard of care (SOC) will be allowed for all subjects. Efficacy, antiviral activity and safety observations will be compared for treatment with active AT-527 tablets vs. placebo tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AT-527 - 550 mg BID | Active comparator | Drug: AT-527Part A |
| Placebo for 550 mg BID | Placebo comparator | Other: PlaceboPart A |
| AT-527 - 1100 mg BID | Active comparator | Drug: AT-527Part B |
| Placebo for 1100 mg BID | Placebo comparator | Other: PlaceboPart B |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hospitalized or in a hospital-affiliated confinement facility
- SARS-CoV-2 positive
- Initial COVID-19 symptom onset within 5 days prior to Screening
- SpO2 ≥ 93% on room air or requires ≤ 2L/min oxygen by nasal cannula or mask to maintain SpO2 ≥ 93%
- Must also have a history of at least one of the following known risk factors for poor outcomes: obesity (BMI>30), hypertension, diabetes or asthma.
Key exclusion criteria (7 listed)
- Severe or critical COVID-19 illness: RR ≥30, HR ≥125, SpO2 <93% on room air or requires >2L/min oxygen by nasal cannula or mask to maintain SpO2 ≥93%, systolic blood pressure < 90 mm Hg, diastolic blood pressure < 60 mm Hg or PaO2/FiO2 <300
- Requires mechanical ventilation
- Lobar or segmental consolidation on chest imaging.
- Treatment with other drugs thought to possibly have activity against SARS-CoV-2
- ALT or AST > 5 x upper limit of normal (ULN)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AT-527One 550 mg tablet of AT-527 administered every ~12 hours (twice a day) for a total of 5 days | Drug | AT-527 - 550 mg BID |
| PlaceboOne placebo tablet administered every ~12 hours (twice a day) for a total of 5 days | Other | Placebo for 550 mg BID |
| AT-527Two 550 mg tablets of AT-527 administered every ~12 hours (twice a day) for a total of 5 days | Drug | AT-527 - 1100 mg BID |
| PlaceboTwo placebo tablets administered every ~12 hours (twice a day) for a total of 5 days | Other | Placebo for 1100 mg BID |
Primary outcome
Proportions (Active vs. Placebo) of Subjects With Progressive Respiratory Insufficiency (PRI) on or Before Day 14.
Time frame: Day 14
Progressive respiratory insufficiency defined as a ≥ 2-tier increase in respiratory support methods required to maintain satisfactory oxygenation (SpO2 ≥ 93%), using the 6-tier hierarchical scale of respiratory support methods, within the 14-day study period. Level 1:Normal oxygenation on room air (SpO2 ≥93), no need for supplemental O2 Level 2:Persistent hypoxemia on room air (SpO2 <93) with requirement for low-level supplemental O2 by nasal cannula/mask (up to 2L/min) to maintain SpO2 ≥93 Level 3:Requirement for higher levels of passive supplemental O2 by nasal cannula or mask (≥2 L/min) to maintain SpO2 ≥93 Level 4:Requirement for oxygenation by positive-pressure devices Level 5:Required invasive respiratory support (intubated mechanical ventilation or ECMO) Level 6:Death
1 secondary outcome
Change From Baseline in Amount of SARS-CoV-2 Virus RNA by Nasopharyngeal Swab
Time frame: Through Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38051993Horga A, Kuritzkes DR, Kowalczyk JJ, Pietropaolo K, Belanger B, Lin K, Perkins K, Hammond J. Phase II study of bemnifosbuvir in high-risk participants in a hospital setting with moderate COVID-19. Future Virol. 2023 Jun;18(8):489-500. doi: 10.2217/fvl-2023-0064. Epub 2023 Jun 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
37 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AT-527 in people with COVID-19, run by Atea Pharmaceuticals, Inc. at 37 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Brazil, South Africa, Spain, Argentina and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportions (Active vs. Placebo) of Subjects With Progressive Respiratory Insufficiency (PRI) on or Before Day 14. (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04396106, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.