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COVID-19Phase 2NCT05543707

PBI-0451 (Pomotrelvir) Phase 2 Study in Nonhospitalized Symptomatic Adults With COVID-19

A Phase 2 study testing PBI-0451 (Pomotrelvir) in people with COVID-19, run by Pardes Biosciences, Inc. at 54 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a phase 2 double-blind, randomized study of PBI-0451(Pomotrelvir) in nonhospitalized symptomatic adults with COVID-19. PBI-0451(Pomotrelvir) is a new chemical entity and inhibitor of the main protease of coronaviruses, including the SARS-CoV-2 that causes COVID-19 disease. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
COVID-19
What is being tested?
PBI-0451 (Pomotrelvir)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
242 participants
Where
54 sitesUnited States
Study dates
21 Sep 2022to 14 Apr 2023
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 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Can understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of any study procedures.
  • Onset of COVID-19 symptoms ≤ 5 days prior to randomization with a positive SARS-CoV-2 test ≤ 24 hours prior to randomization. Authorized NAAT or antigen tests that detect viral RNA or protein, respectively, are allowed.
  • Received primary vaccination series as defined by Centers for Disease Control and Prevention (CDC). Subjects should be advised during informed consent that alternate therapies may be available outside of study participation.
  • ≥ 2 symptoms of acute COVID-19 infection as determined by the investigator from the symptoms listed on the COVID-19 symptoms questionnaire present at randomization
  • Male and nonpregnant, nonlactating female subjects 18 to < 65 years of age. Females must have a negative serum or urine pregnancy test at screening and prior to the first dose of study drug unless permanently sterile or in a postmenopausal state (see Appendix 3).
  • Male and female subjects and/or their heterosexual partners must either be of nonchildbearing potential or must use effective contraception from screening through 90 days after the last dose of study drug (see Appendix 3)
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  • Female subjects must refrain from egg donation and in vitro fertilization during treatment and for ≥ 28 days after the last dose of study drug
  • Male subjects must refrain from sperm donation from screening through 90 days after the last dose of study drug
  • Normal 12-lead electrocardiogram (ECG) evaluation without clinically significant abnormalities
  • Able and willing to comply with all study requirements

Who cannot join

  • Considered at high-risk of developing severe illness from COVID-19 defined as ≥ 1 CDC underlying medical condition associated with an increased risk of developing severe illness from COVID-19 (see Appendix 5)
  • Unvaccinated against SARS-CoV-2 (defined as having not completed a primary vaccination series)
  • Any SARS-CoV-2 vaccination within 3 month prior to randomization or anticipated to receive a SARS-CoV-2 vaccination (including a booster) during the 28-day study period
  • Currently hospitalized or expected to require hospitalization for COVID-19 within 48 hours of randomization
  • Currently being treated or expected to be treated for COVID-19 with monoclonal antibodies, convalescent serum, or direct-acting antiviral agents (all potential subjects should be informed of evolving treatment options during informed consent that alternate therapies may or may not be available to them outside of study participation)
  • Any clinical condition or laboratory result considered by the investigator to indicate any unstable or poorly controlled underlying clinically significant medical condition(s), active disseminated infection (other than SARS-CoV-2), or other medical condition that could represent a risk to the subject, including increasing the likelihood of a safety event, affect subject compliance, or affect efficacy and/or safety data collected during the 28-day study period
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  • Known active liver disease, including nonalcoholic steatohepatitis/nonalcoholic fatty liver disease, chronic or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, primary biliary cirrhosis, Child-Pugh Class B or C, chronic alcoholic liver disease, or acute liver failure
  • Receiving dialysis or having known severe renal impairment (chronic kidney disease, Stage 4 or above)
  • Unable or unwilling to comply with the protocol procedures
  • Participating in another interventional study with an investigational compound or device, including those for COVID-19
  • Known prior participation in this study or another study involving PBI-0451(Pomotrelvir)
  • Females who are pregnant or breastfeeding
  • Oxygen saturation of < 94% on room air

Trial locations and contacts

54 sites in 1 country.

54 sites in 1 country

United States54 sites

  • Agile Clinical Research Trials, LLC

    Atlanta, Georgia, 30328

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • Franco A Felizarta MD

    Bakersfield, California, 93301-1692

  • TrueBlue Clinical Research- Brandon - HyperCore - PPDS

    Brandon, Florida, 33511-4850

  • Mercury Street Medical Group

    Butte, Montana, 59701-1652

  • Hope Clinical Research, LLC

    Canoga Park, California, 91303

  • Eagle Clinical Research

    Chicago, Illinois, 60621-3116

  • Safe Haven Clinical Research

    Clinton, Mississippi, 39056-5606

  • Centricity Research - Roswell - HyperCore - PPDS

    Columbus, Georgia, 31904

  • Beautiful Minds Clinical Research Center

    Cutler Bay, Florida, 33157

  • Zenos Clinical Research

    Dallas, Texas, 75230-6895

  • WellNow Urgent Care Troy Urgent Care

    Dayton, Ohio, 45424

  • Research Carolina Elite

    Denver, North Carolina, 28037-7929

  • Proactive Clinical Research, LLC Edinburg

    Edinburg, Texas, 78539-4660

  • Biopharma Informatic, LLC

    Encino, California, 91436

  • Care United Research, LLC

    Forney, Texas, 75126-4174

  • Clinical Trials Center of Middle Tennessee

    Franklin, Tennessee, 37067-5663

  • Ascada Research LLC

    Fullerton, California, 92835-3424

  • Indago Research and Health Center

    Hialeah, Florida, 33012-4174

  • Quality Research of South Florida

    Hialeah, Florida, 33016-1811

  • Mercy Family Clinic

    Houston, Texas, 75211

  • Xpress Trials

    Houston, Texas, 77036-8280

  • Diversified Medical Practices, P.A.

    Houston, Texas, 77084

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89128-0373

  • Epic Clinical Research

    Lewisville, Texas, 75057

  • Ark Clinical Research - Long Beach - Clinedge - PPDS

    Long Beach, California, 92868

  • Voyage Medical

    Mesa, Arizona, 85210

  • Gonzalez M.D. & Aswad M.D. Health Care Services

    Miami, Florida, 33125

  • Universal Medical and Research Center, LLC

    Miami, Florida, 33126

  • CCM Clinical Research Group

    Miami, Florida, 33133-4231

  • D&H National Research Centers

    Miami, Florida, 33155-3262

  • Allied Biomedical Research Institute

    Miami, Florida, 33155-4630

  • Florida International Medical Research

    Miami, Florida, 33155

  • P&S Research, LLC

    Miami, Florida, 33175

  • The Angel Medical Research Corporation

    Miami Lakes, Florida, 33016-1641

  • South Florida Research

    Miami Springs, Florida, 33166

  • EMINAT Research

    Miramar, Florida, 33027

  • Combined Research Orlando Phase I-IV LLC

    Orlando, Florida, 32803

  • Ormond Beach Clinical Research

    Ormond Beach, Florida, 32174

  • CTMD Research, Inc. - Palm Springs - Hunt - PPDS

    Palm Springs, Florida, 33406

  • IMIC Inc.

    Palmetto Bay, Florida, 33157-5503

  • VIP Trials

    San Antonio, Texas, 78230

  • Infectious Disease Consultants of the Treasure Coast

    Sebastian, Florida, 32958

  • Westchester General Hospital

    South Miami, Florida, 33143-5045

  • Revival Research Corporation - Clinedge - PPDS

    Sterling Heights, Michigan, 48312

  • Suffolk Multispecialty Research

    Suffolk, Virginia, 23435-3762

  • DBC Research

    Tamarac, Florida, 33321

  • Alliance Clinical Research-(Tampa)

    Tampa, Florida, 33615-3816

  • Valiance Clinical Research

    Tarzana, California, 91356-6695

  • STAT Research

    Vandalia, Ohio, 45377

  • Clinovacare Medical Clinical Research Center

    West Columbia, South Carolina, 29169

  • Veritas Health Care Group

    West Columbia, South Carolina, 29169

  • Palm Beach Research - ClinEdge - PPDS

    West Palm Beach, Florida, 33409

  • Allianz Research Institute - Colorado

    Westminster, California, 92683-4454

Other trials in United States

About this study

Official title: A Phase 2 Double-blind, Randomized Study to Evaluate the Antiviral Activity, Safety, and Efficacy of Orally Administered PBI-0451(Pomotrelvir) Compared With Placebo in Nonhospitalized Symptomatic Adults With COVID-19

This is a phase 2 double-blind, randomized study of PBI-0451(Pomotrelvir) in nonhospitalized symptomatic adults with COVID-19. PBI-0451(Pomotrelvir) is a new chemical entity and inhibitor of the main protease of coronaviruses, including the SARS-CoV-2 that causes COVID-19 disease. This study is designed to evaluate the antiviral activity, safety, and efficacy of orally administered PBI-0451(Pomotrelvir) compared with placebo.

Read the detailed description

Following randomization on Day 1, subjects will complete baseline assessments prior to receiving their first dose of study drug (PBI-0451 or placebo).

Randomization will be stratified as follows:

  • SARS-CoV-2 positive direct test diagnosis ≤ 3 days (target 30%) versus > 3 days from first onset of COVID-19 symptom(s) ≤ 5 days prior to randomization
  • Received primary vaccination series, alone versus any booster shots
  • PK substudy participation versus nonparticipation Study drug will be taken with food, approximately 12 hours between doses, at approximately the same time for each BID dose for the remainder of the 5 days of treatment.All subjects will have additional safety and efficacy assessments during the 28-day study period. A follow-up visit (eg, telephone visit, virtual visit, clinic visit, etc. as convenient) will be conducted at Week 24 (± 20 days) after the last dose of study drug for all subjects. Information regarding ongoing or recurrent COVID-19 symptoms, survival status, pregnancy status (for female subjects of childbearing potential and female partners of male subjects), and any hospitalizations or acute/critical care visits (eg, non-admitted hospital or other care facility)that have occurred since the last study visit will be collected. A team of medically qualified individuals, including but not limited to, the Sponsor and the CRO Medical Monitors, and the Drug Safety Consultant are responsible for ongoing review of all AEs, concomitant medications, laboratory values (including virology), and vital signs (including pulse oximetry), worsening of symptoms (COVID-19 symptom questionnaire, including dyspnea), acute/critical care visits (eg, nonadmitted hospital or other care facility), and study drug discontinuations, at a minimum monthly basis throughout the study, per the Safety Monitoring Plan. Subjects who experience severe COVID-19 illness (defined in this study as sustained pulse oximetry <94%, a respiratory rate of >30 breaths/min, or dyspnea that requires medical attention) should discontinue study drug and be immediately referred by the Investigator to emergency care or treated by the Investigator for standard of care treatment of symptoms including, but not limited to, other antivirals, supplemental oxygen, corticosteroids, Janus kinase inhibitors, or interleukin-6 blockers, in accordance with the NIH Treatment Guidelines (NIH 2022). The subject should continue participation in the study, with study drug discontinued, for safety follow-up and clinical outcome of the medically attended visit.
Conditions
COVID-19
Being tested
PBI-0451 (Pomotrelvir), Placebo
Keywords
COVID, SARS-CoV-2, Coronavirus
Medical subject headings
COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PBI-0451 (Pomotrelvir)Drug

    Also called Active

    2 × 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)

  • PlaceboDrug

    2 × placebo to match PBI-0451(Pomotrelvir) tablets administered orally BID with food for 5 days (10 total doses)

Study groups in NCT05543707
Study groupRoleWhat they receive
PBI-0451 (Pomotrelvir)ExperimentalPBI-0451(Pomotrelvir): 2 x 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)
Receives: Drug: PBI-0451 (Pomotrelvir)
PlaceboPlacebo comparatorPBI-0451(Pomotrelvir): 2 x placebo to match PBI-0451(Pomotrelvir) tablets administered orally twice daily (BID) with food for 5 days (10 total doses)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Virologic Efficacy of PBI-0451 (Pomotrelvir)

    The primary efficacy endpoint was the proportion of participants below LOD for infectious SARS-CoV-2 on Day 3 by IVA from MT nasal swabs for the mITTV analysis set.

    Measured: Day 3

Secondary outcomes (4)

  1. Safety and Tolerability of PBI-0451(Pomotrelvir)

    Number of treatment-emergent adverse events (AEs), serious adverse events (SAEs), discontinuations due to AEs, and Grade 3 or 4 laboratory abnormalities

    Measured: Day 1-28

  2. Clinical Efficacy of PBI-0451(Pomotrelvir) Versus Placebo Through Study Day 28

    Number of Pomotrelvir treated participants with sustained symptom resolution through Day 28 versus untreated Placebo participants

    Measured: Day 1 - 28

  3. Effect of PBI-0451(Pomotrelvir) on SARS-CoV-2

    Presence of SARS-CoV-2 virus, viral RNA or viral antigen based on IVA, quantitative reverse transcriptase polymerase chain reaction (qRT-PCR), and rapid antigen test (RAT), as specified in the Clinical Virology Analysis Plan (CVAP)

    Measured: Day 1-28

  4. Clinical Efficacy of PBI-0451(Pomotrelvir) Versus Placebo Through Study Day 1-28

    The median number of days to sustained resolution of of all 14 COVID-19 symptoms for the PBI-0451 vs Placebo groups through Day 28.

    Measured: Day 1-28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2022
  2. Study start21 Sep 2022
  3. Primary completion27 Jan 2023
  4. Study completion14 Apr 2023

Why it stopped: Interim analysis concluded primary endpoint was not met

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
242 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05543707
Sponsor's protocol ID
PBI-0451-0002
Other IDs
2022-001195-33
Status last verified
Aug 2024
First submitted
7 Sep 2022
Last updated
11 Dec 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Borroto-Esoda K, Wilfret D, Tong X, Plummer A, Kearney B, Kwong AD. SARS-CoV-2 viral dynamics in a placebo-controlled phase 2 study of patients infected with the SARS-CoV-2 Omicron variant and treated with pomotrelvir. Microbiol Spectr. 2024 Feb 6;12(2):e0298023. doi: 10.1128/spectrum.02980-23. Epub 2024 Jan 10.

    PubMed 38197702

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PBI-0451 (Pomotrelvir) in people with COVID-19, run by Pardes Biosciences, Inc. at 54 sites in United States.

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 10 inclusion and 13 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 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States. 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 11 Dec 2024). 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?

Virologic Efficacy of PBI-0451 (Pomotrelvir) (time frame: Day 3). 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 NCT05543707, 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 11 Dec 2024.

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