COVID-19Phase 3NCT05261139

EPIC-Peds: A Study to Learn About the Study Medicine Called PF-07321332 (Nirmatrelvir)/Ritonavir in Patients Under 18 Years of Age With COVID-19 That Are Not Hospitalized But Are at Risk for Severe Disease

A Phase 3 study testing nirmatrelvir and ritonavir in people with COVID-19, run by Pfizer at 73 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial summary

The purpose of this clinical trial is to learn about the safety, pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from your body after you take it), and efficacy (how well a study treatment works in the study) of the study medicine (called nirmatrelvir/ritonavir) for… Read more about this study

Who is it for?: Ages 0 to 17 years
Conditions the study is for: COVID-19
What is being tested?: nirmatrelvir and ritonavir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 73 sitesin 7 countries
Study dates: 7 Mar 2022to 30 Jul 2026
Phase: Phase 3
Are there results?: Not yet: the study is under way

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 0 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male and female, age 0 to < 18 years, able to swallow for some participants
Confirmed SARS-CoV-2 infection within 72 hours prior to enrollment
Initial onset of COVID-19 signs/symptoms within 5 days prior to the day of enrollment and at least 1 of the specified COVID-19 signs/symptoms present at enrollment
Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19

Who cannot join

History of or need for hospitalization for the medical treatment of COVID-19
Total bilirubin >=2X upper limit of normal (ULN) (except for Gilbert's syndrome)
Receiving dialysis or have known moderate to severe renal impairment
Suspected or confirmed concurrent active systemic infection other than COVID-19
History of hypersensitivity or other contraindication to any of the components of the study intervention
Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance or strong inducers of cytochrome P450 (CYP)3A4

Show all 9Show fewer

Has received or is expected to receive antibody treatment, antiviral treatment or convalescent COVID-19 plasma
Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 through the study follow up
Females who are pregnant or breastfeeding

Trial locations and contacts

73 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

Country

City, postcode or hospital

Sites recruiting now only

73 sites in 7 countries

United States50 sites, 24 recruiting

University of New Mexico Hospital, COVID-19 Research Clinic
Albuquerque, New Mexico, 87102
Terminated
University of New Mexico Clinical and Translational Science Center
Albuquerque, New Mexico, 87106
Terminated
Children's Healthcare of Atlanta - Arthur M. Blank Hospital
Atlanta, Georgia, 30329
Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Not yet recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Active, not recruiting
Suny University at Buffalo
Buffalo, New York, 14203
Not yet recruiting
Clinical and Translational Research Center
Chapel Hill, North Carolina, 27514
Terminated
investigational Drug Services Pharmacy, UNC Hospitals
Chapel Hill, North Carolina, 27514
Terminated
UNC Children's Hospital
Chapel Hill, North Carolina, 27514
Terminated
UNC Global Clinical Research North
Chapel Hill, North Carolina, 27514
Terminated
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27599
Terminated
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Active, not recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Active, not recruiting
Advanced Specialty Care
Commack, New York, 11725
Not yet recruiting
Stony Brook Medicine Clinical Research Center
East Setauket, New York, 11733
Not yet recruiting
Texas Children's Hospital
Houston, Texas, 77030
Not yet recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Active, not recruiting
Kaiser Permanente
Los Angeles, California, 90027
Active, not recruiting
UCLA David Geffen School of Medicine
Los Angeles, California, 90095
Not yet recruiting
UCLA
Los Angeles, California, 90095
Not yet recruiting
UH Landerbrook Health Center
Mayfield Heights, Ohio, 44124
Active, not recruiting
Biopharma Informatic, LLC
McAllen, Texas, 78503
Terminated
Life Spring Research Foundation
Miami, Florida, 33130
Recruiting
Childrens Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404
Not yet recruiting
Cohen Children's Medical Center
New Hyde Park, New York, 11040
Not yet recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Not yet recruiting
Children's Hospital & Medical Center
Omaha, Nebraska, 68114
Terminated
UH Parma Medical Center
Parma, Ohio, 44129
Active, not recruiting
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Active, not recruiting
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Not yet recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Active, not recruiting
The Miriam Hospital-Clinical Trials
Providence, Rhode Island, 02904
Active, not recruiting
UNC Children's Raleigh
Raleigh, North Carolina, 27607
Terminated
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi, 39157
Active, not recruiting
University of Utah
Salt Lake City, Utah, 84108
Not yet recruiting
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
Recruiting
Louisiana State University Health Sciences Shreveport
Shreveport, Louisiana, 71101
Recruiting
Avera McKennan Hospital & University Health Center
Sioux Falls, South Dakota, 57105
Terminated
Avera Research Institute - Sioux Falls
Sioux Falls, South Dakota, 57108
Terminated
St. Louis Children's Hospital
St Louis, Missouri, 63110
Not yet recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Not yet recruiting
Stony Brook University
Stony Brook, New York, 11794
Not yet recruiting
Upstate Health Care Center
Syracuse, New York, 13202
Not yet recruiting
Crouse Physicians Office Building
Syracuse, New York, 13210
Not yet recruiting
SUNY Upstate Medical University
Syracuse, New York, 13210
Not yet recruiting
Upstate Golisano Children's Hospital
Syracuse, New York, 13210
Not yet recruiting
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291
Terminated
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Active, not recruiting
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
Terminated

Other trials in United States

Mexico11 sites, 2 recruiting

Centenario Hospital Miguel Hidalgo
Aguascalientes, 20259
Not yet recruiting
JM Research SC
Cuernavaca, Morelos, 62290
Active, not recruiting
Unidad de Atención Médica e Investigación en Salud
Mérida, Yucatán, 97000
Active, not recruiting
Kohler & Milstein Research S.A. De C.V.
Mérida, Yucatán, 97070
Active, not recruiting
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatán S.
Mérida, Yucatán, 97130
Active, not recruiting
Instituto Nacional de Pediatria
Mexico City, Mexico City, 04530
Not yet recruiting
Hospital Infantil de Mexico Federico Gomez
Mexico City, Mexico City, 06720
Active, not recruiting
Fundación Santos y De la Garza Evia
Monterrey, Nuevo León, 64710
Active, not recruiting
Eukarya Pharmasite S.C.
Monterrey, Nuevo León, 64718
Terminated
Arké SMO S.A de C.V
Veracruz, 91900
Active, not recruiting
Sociedad de Metabolismo y Corazon S.C.
Veracruz, C.P. 91900
Active, not recruiting

Other trials in Mexico

Bulgaria5 sites, 4 recruiting

МHAT "Sveti Ivan Rilski" Gorna Oryahovitsa
Gorna Oryahovitsa, 5100
Not yet recruiting
"Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov -
Rousse, 7002
Not yet recruiting
Medical Center-1-Sevlievo EOOD
Sevlievo, 5400
Not yet recruiting
DCC "Alexandrovska"
Sofia, 1431
Terminated
Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD
Vratsa, 3000
Not yet recruiting

Other trials in Bulgaria

South Africa3 sites, 1 recruiting

Worthwhile Clinical Trials
Benoni, Gauteng, 1500
Active, not recruiting
CRISMO Research Centre
Germiston, Gauteng, 1401
Active, not recruiting
Botho Ke Bontle Health Services
Pretoria, Gauteng, 0184
Not yet recruiting

Other trials in South Africa

Japan2 sites, 2 recruiting

Tokyo Metropolitan Children's Medical Center
Fuchū, Tokyo, 183-8561
Not yet recruiting
Osaka City General Hospital
Osaka, 534-0021
Not yet recruiting

Other trials in Japan

Puerto Rico1 site, 1 recruiting

San Miguel Medical
Trujillo Alto, 00976
Not yet recruiting

Other trials in Puerto Rico

United Kingdom1 site

St. George's Hospital
London, England, SW17 0QT
Active, not recruiting

Other trials in United Kingdom

About this study

Official title: A PHASE 2/3, INTERVENTIONAL SAFETY, PHARMACOKINETICS, AND EFFICACY, OPEN-LABEL, MULTI-CENTER, SINGLE-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332 (NIRMATRELVIR)/RITONAVIR IN NONHOSPITALIZED SYMPTOMATIC PEDIATRIC PARTICIPANTS WITH COVID-19 WHO ARE AT RISK OF PROGRESSION TO SEVERE DISEASE

The study medicine will be given to patients under 18 years of age with COVID-19 that are not hospitalized but are at risk for severe disease.

Conditions: COVID-19
Being tested: nirmatrelvir, ritonavir
Keywords: Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2), Pediatrics
Medical subject headings: COVID-19

What participants receive

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

nirmatrelvirDrug
PF-07321332
ritonavirDrug
ritonavir

Study groups in NCT05261139
Study group	Role	What they receive
Cohort 1 nirmatrelvir/ritonavir	Experimental	nirmatrelvir/ritonavir will be given by tablets or powder by mouth twice a day for 5 days (10 doses total). Weight ≥40 kg 1. ≥12 to <18 years 2. ≥6 to <12 years Receives: Drug: nirmatrelvir; Drug: ritonavir
Cohort 2 nirmatrelvir/ritonavir	Experimental	nirmatrelvir/ritonavir will be given as powder by mouth twice a day for 5 days (10 doses total) Weight ≥20 to <40 kg, ≥6 to <18 years Receives: Drug: nirmatrelvir; Drug: ritonavir
Cohort 3 nirmatrelvir/ritonavir	Experimental	nirmatrelvir/ritonavir ≥2 to <6 years Receives: Drug: nirmatrelvir; Drug: ritonavir
Cohort 4 nirmatrelvir/ritonavir	Experimental	nirmatrelvir/ritonavir ≥1 month (≥28 days) to <2 years Receives: Drug: nirmatrelvir; Drug: ritonavir
Cohort 5 nirmatrelvir/ritonavir	Experimental	nirmatrelvir/ritonavir <1 month (<28 days) old Receives: Drug: nirmatrelvir; Drug: ritonavir

What is being measured

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

Cohort 1-2: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir
Measured: Day 1: 1 hour-post dose; Day 4: pre-dose; Day 5: pre-dose, and 1, and 2 hours post dose
Cohort 1-2: Area Under the Curve to the End of the Dosing Period (AUC0-tau) of nirmatrelvir and ritonavir
Measured: Day 1: 1 hour-post dose; Day 4: pre-dose; Day 5: pre-dose, and 1, and 2 hours post dose
Incidence of Treatment Emergent Adverse Events (TEAEs) leading to discontinuations.
Measured: From Baseline up through Day 34
Incidence of Serious Adverse Events (SAEs) leading to discontinuations.
Measured: From Baseline up through Day 34
Incidence of Adverse Events (AEs) leading to discontinuations.
Measured: From Baseline up through Day 34
Number of participants with change from Baseline in Vital Signs
Measured: From Baseline up through Day 34

Secondary outcomes (3)

Viral load assessment titers measured via reverse transcription polymerase chain reaction (RT-PCR) in nasopharyngeal or nasal swabs over time
Measured: Baseline, Day 5, 6, 10, 14 and 28
Proportion of participants with COVID-19 related hospitalization or death from any cause
Measured: From Baseline through Day 28
Patient assessment on acceptability and palatability of nirmatrelvir/ritonavir (film-coated tablets and oral powder)
Frequency of responses to visual questionnaire on taste.
Measured: At baseline only for tablets and after each dose for powder formulation

Timeline

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

7 Mar 202230 Jul 2026

First posted2 Mar 2022
Study start7 Mar 2022
Primary completion30 Jul 2026 (estimated)
Study completion30 Jul 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 160 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05261139
Sponsor's protocol ID: C4671026
Other IDs: 2023-509773-23-00, 2023
Status last verified: Jul 2025
First submitted: 25 Feb 2022
Last updated: 17 Jul 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Interested in taking part?

Pfizer CT.gov Call Center

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 2/3, INTERVENTIONAL SAFETY, PHARMACOKINETICS, AND EFFICACY, OPEN-LABEL, MULTI-CENTER, SINGLE-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332 (NIRMATRELVIR)/RITONAVIR IN NONHOSPITALIZED SYMPTOMATIC PEDIATRIC PARTICIPANTS WITH COVID-19 WHO ARE AT RISK OF PROGRESSION TO SEVERE DISEASE
ClinicalTrials.gov ID: NCT05261139
Acronym / sponsor ID: C4671026
Conditions: COVID-19
Keywords: Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2), Pediatrics
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 160 participants (estimated)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 7 Mar 2022 (actual)
Primary completion: 30 Jul 2026 (estimated)
Study completion: 30 Jul 2026 (estimated)
First posted: 2 Mar 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study medicine will be given to patients under 18 years of age with COVID-19 that are not hospitalized but are at risk for severe disease.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Cohort 1 nirmatrelvir/ritonavir	Experimental	Drug: nirmatrelvir, Drug: ritonavirnirmatrelvir/ritonavir will be given by tablets or powder by mouth twice a day for 5 days (10 doses total). Weight ≥40 kg 1. ≥12 to <18 years 2. ≥6 to <12 years
Cohort 2 nirmatrelvir/ritonavir	Experimental	Drug: nirmatrelvir, Drug: ritonavirnirmatrelvir/ritonavir will be given as powder by mouth twice a day for 5 days (10 doses total) Weight ≥20 to <40 kg, ≥6 to <18 years
Cohort 3 nirmatrelvir/ritonavir	Experimental	Drug: nirmatrelvir, Drug: ritonavirnirmatrelvir/ritonavir ≥2 to <6 years
Cohort 4 nirmatrelvir/ritonavir	Experimental	Drug: nirmatrelvir, Drug: ritonavirnirmatrelvir/ritonavir ≥1 month (≥28 days) to <2 years
Cohort 5 nirmatrelvir/ritonavir	Experimental	Drug: nirmatrelvir, Drug: ritonavirnirmatrelvir/ritonavir <1 month (<28 days) old

Who may qualify

Ages: 0 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Male and female, age 0 to < 18 years, able to swallow for some participants
Confirmed SARS-CoV-2 infection within 72 hours prior to enrollment
Initial onset of COVID-19 signs/symptoms within 5 days prior to the day of enrollment and at least 1 of the specified COVID-19 signs/symptoms present at enrollment
Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19

Key exclusion criteria (9 listed)

History of or need for hospitalization for the medical treatment of COVID-19
Total bilirubin >=2X upper limit of normal (ULN) (except for Gilbert's syndrome)
Receiving dialysis or have known moderate to severe renal impairment
Suspected or confirmed concurrent active systemic infection other than COVID-19
History of hypersensitivity or other contraindication to any of the components of the study intervention

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
nirmatrelvirPF-07321332	Drug	Cohort 1 nirmatrelvir/ritonavir, Cohort 2 nirmatrelvir/ritonavir, Cohort 3 nirmatrelvir/ritonavir, Cohort 4 nirmatrelvir/ritonavir, Cohort 5 nirmatrelvir/ritonavir
ritonavirritonavir	Drug	Cohort 1 nirmatrelvir/ritonavir, Cohort 2 nirmatrelvir/ritonavir, Cohort 3 nirmatrelvir/ritonavir, Cohort 4 nirmatrelvir/ritonavir, Cohort 5 nirmatrelvir/ritonavir

Primary outcome

Cohort 1-2: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir
Time frame: Day 1: 1 hour-post dose; Day 4: pre-dose; Day 5: pre-dose, and 1, and 2 hours post dose
Cohort 1-2: Area Under the Curve to the End of the Dosing Period (AUC0-tau) of nirmatrelvir and ritonavir
Time frame: Day 1: 1 hour-post dose; Day 4: pre-dose; Day 5: pre-dose, and 1, and 2 hours post dose
Incidence of Treatment Emergent Adverse Events (TEAEs) leading to discontinuations.
Time frame: From Baseline up through Day 34
Incidence of Serious Adverse Events (SAEs) leading to discontinuations.
Time frame: From Baseline up through Day 34
Incidence of Adverse Events (AEs) leading to discontinuations.
Time frame: From Baseline up through Day 34
Number of participants with change from Baseline in Vital Signs
Time frame: From Baseline up through Day 34

3 secondary outcomes

Viral load assessment titers measured via reverse transcription polymerase chain reaction (RT-PCR) in nasopharyngeal or nasal swabs over time
Time frame: Baseline, Day 5, 6, 10, 14 and 28
Proportion of participants with COVID-19 related hospitalization or death from any cause
Time frame: From Baseline through Day 28
Patient assessment on acceptability and palatability of nirmatrelvir/ritonavir (film-coated tablets and oral powder)
Time frame: At baseline only for tablets and after each dose for powder formulation

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

Pfizer CT.gov Call Center study director

Pfizer

73 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing nirmatrelvir and ritonavir in people with COVID-19, run by Pfizer at 73 sites in 7 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, Mexico, Bulgaria, South Africa, Japan and 2 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort 1-2: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir (time frame: Day 1: 1 hour-post dose; Day 4: pre-dose; Day 5: pre-dose, and 1, and 2 hours post dose). The study lists 6 primary outcomes in all. 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 NCT05261139.

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 17 Jul 2025.