ImmunocompromisedPhase 3NCT05074433

A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults

A Phase 3 study testing casirivimab+imdevimab in people with Immunocompromised, run by Regeneron Pharmaceuticals at 67 sites in 2 countries.

Terminated

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

Official record

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Trial summary

The primary objective of the study is to evaluate the effect of casirivimab+imdevimab, compared with placebo, in preventing symptomatic SARS-CoV-2 infection in immunocompromised participants. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Immunocompromised
What is being tested?: casirivimab+imdevimab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 66 participants
Where: 67 sitesin 2 countries
Study dates: 25 Oct 2021to 18 May 2022
Phase: Phase 3
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 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Meets ≥1 of the following criteria:
Is immunocompromised, including people with transplant, who have cancer, primary immunodeficiencies, HIV, rheumatological disease, autoimmune disease, multiple sclerosis OR
Currently taking immunosuppressant drugs
Have been fully vaccinated against COVID-19 or deemed medically ineligible to receive full course of vaccine
Has documented negative serology/antibody response in an anti-SARS-CoV-2 spike protein IgG clinical test or ≤50 U/mL on the Elecsys® SARS-CoV-2 S Total Ig test
Tested negative for the COVID-19 virus within 72 hours prior to randomization

Who cannot join

Weighs <40 kg (only applies to participants ≥12 to <18 years of age)
Has any signs or symptoms consistent with COVID-19
Past COVID-19 infection within 90 days prior to randomization
Planned use of any investigational, authorized, or approved vaccine for COVID-19 within 90 days of the last dose of study drug
Prior, current, or planned use of any of COVID-19 convalescent plasma, other monoclonal antibodies against SARS-CoV-2 or any COVID-19 treatment
Is planned to begin immunoglobulin (IVIG) or immunoglobulin (SCIG) therapy, is planned to have a change to existing IVIG or SCIG, or has been on a chronic stable dose of their IVIG or SCIG regimen for less than 90 days prior to screening

Show all 10Show fewer

Has any known active acute respiratory infection
Has persistent (refractory to treatment for ≥14 days) bacterial or fungal infection
Has known allergy or hypersensitivity to components of the study drugs
NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply

Trial locations and contacts

67 sites in 2 countries.

Country

City, postcode or hospital

67 sites in 2 countries

United States66 sites

PharmaTex Research, LLC
Amarillo, Texas, 79109
University of Michigan
Ann Arbor, Michigan, 48109
Regeneron Study Site
Atlanta, Georgia, 30322
University Of Colorado
Aurora, Colorado, 80045
Central Texas Clinical Research
Austin, Texas, 78705
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, 33180
Institute of Human Virology
Baltimore, Maryland, 21201
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Laboratory of Clinical Immunology and Microbiology, NIAID
Bethesda, Maryland, 20892
Central Alabama Research
Birmingham, Alabama, 35205
Tufts Medical Center
Boston, Massachusetts, 02111
Regeneron Study Site
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Maimonides Cancer Center
Brooklyn, New York, 11220
Gabrail Cancer Center Research
Canton, Ohio, 44718
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, 60625
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756
Regeneron Study Site
Cleveland, Ohio, 44195
Miami Valley Hospital
Dayton, Ohio, 45409
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Midway Immunology and Research Center
Ft. Pierce, Florida, 34982
Spectrum Health
Grand Rapids, Michigan, 49503
Elixia COVID-19
Hollywood, Florida, 33024
Therapeutic Concepts, PA
Houston, Texas, 77004
Houston Methodist Hospital
Houston, Texas, 77030
MD Anderson Cancer Center
Houston, Texas, 77030
Synergy Group Medical,LLC
Houston, Texas, 77087
University of Iowa
Iowa City, Iowa, 52242
West Tennessee Research Institute
Jackson, Tennessee, 38305
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205
Regeneron Study Site
Long Beach, California, 90806
Regeneron Study Site
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Wisconsin - Madison
Madison, Wisconsin, 53792
Regeneron Study Site
Marietta, Georgia, 30060
AppleMed Research Group, LLC
Miami, Florida, 33126
De La Cruz Research Center, LLC
Miami, Florida, 33184
Burke Primary Care
Morganton, North Carolina, 28655
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Tulane University
New Orleans, Louisiana, 70112
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Regeneron Study Site
New York, New York, 10032-3729
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Regeneron Study Site 2
New York, New York, 10065
Regeneron Study Site
North Haven, Connecticut, 06473-2195
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Stanford University
Palo Alto, California, 94304
Penn Prevention Clinical Research Site
Philadelphia, Pennsylvania, 19104
Temple University
Philadelphia, Pennsylvania, 19140
Regeneron Study Site
Providence, Rhode Island, 02903
Regeneron Study Site
Richmond, Virginia, 23219
Mayo Clinic
Rochester, Minnesota, 55905
Regeneron Study Site
Rochester, New York, 14642
University of California
Sacramento, California, 95817
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Regeneron Study Site
Seattle, Washington, 98109
Swedish Medical Center- First Hill
Seattle, Washington, 98122
Regeneron Study Site
Stanford, California, 94305
Regeneron Study Site
Syracuse, New York, 13210
SUNY Upstate Medical University
Syracuse, New York, 13215
University of South Florida
Tampa, Florida, 33606
Holy Name
Teaneck, New Jersey, 07666
Montefiore Medical Center
The Bronx, New York, 10467
Georgetown University
Washington D.C., District of Columbia, 20007
James R Berenson MD Inc.
West Hollywood, California, 90069
Florida Medical Clinic, LLC
Zephyrhills, Florida, 33542

Other trials in United States

Mexico1 site

Regeneron Study Site
Cuauhtémoc, Mexico City, 6700

Other trials in Mexico

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies as Pre-Exposure Prophylaxis to Prevent COVID-19 in Immunocompromised Participants

The primary objective of the study is to evaluate the effect of casirivimab+imdevimab, compared with placebo, in preventing symptomatic SARS-CoV-2 infection in immunocompromised participants.

The secondary objectives of the study are:

To evaluate the safety and tolerability of repeated SC injections of casirivimab+imdevimab in the study population
To characterize concentrations of casirivimab and imdevimab in serum over time
To assess the immunogenicity of casirivimab and imdevimab

Conditions: Immunocompromised
Being tested: casirivimab+imdevimab, Placebo
Keywords: Non-response to COVID-19 vaccination, COVID-19, Immunocompromised, weakened immune system
Medical subject headings: COVID-19

What participants receive

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

casirivimab+imdevimabDrug
Also called REGN-COV2, REGN10933, REGN10987, REGEN-COV™
Co-administered sequentially subcutaneous (SC)
PlaceboDrug
Administered SC

Study groups in NCT05074433
Study group	Role	What they receive
casirivimab+imdevimab Initial + Q4W	Experimental	Initial subcutaneous (SC) dose, then SC dose every 4 weeks (Q4W) Receives: Drug: casirivimab+imdevimab
casirivimab+imdevimab Q4W	Experimental	SC dose Q4W Receives: Drug: casirivimab+imdevimab
casirivimab+imdevimab Q12W	Experimental	SC dose every 12 weeks (Q12W) Receives: Drug: casirivimab+imdevimab
Placebo	Placebo comparator	SC dose Q4W Receives: Drug: Placebo

What is being measured

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

Cumulative Incidence of Symptomatic (Broad Term), RT-PCR-confirmed SARS-CoV-2 Infection Cases During the EAP
Cumulative incidence of symptomatic (broad term), RT-PCR-confirmed SARS-CoV-2 infection cases during the Efficacy Assessment Period (EAP)
Measured: The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days

Secondary outcomes (11)

Number of Participants With Grade ≥3 Treatment-emergent Adverse Events (TEAEs) During the EAP
Measured: The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days
Number of Participants With Grade ≥3 Treatment-emergent Adverse Events (TEAEs) During the Follow-Up Period
Measured: End of EAP to the end of the Follow-Up Period (Day 169 to 205, approximately ~1 months)
Number of Participants With TEAEs Leading to Study Drug Discontinuation During the EAP
Measured: The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days
Number of Participants With TEAEs Leading to Study Drug Discontinuation During the Follow-Up Period
Measured: End of EAP to the end of the Follow-Up Period (Day 169 to 205, approximately ~1 months)
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the EAP
Measured: The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days
Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Follow-Up Period
Measured: End of EAP to the end of the Follow-Up Period (Day 169 to 205, approximately ~1 months)
Incidence of Adverse Events of Special Interest (AESIs) During the EAP
Measured: The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days
Concentration of Casirivimab Over Time
Measured: Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group
Concentration of Imdevimab Over Time
Measured: Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group
Incidence of Anti-drug Antibodies (ADA) Over Time
Measured: Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group
Incidence of Neutralizing Antibodies (NAb) to Each mAb Over Time
Measured: Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group

Timeline

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

25 Oct 202118 May 2022

First posted12 Oct 2021
Study start25 Oct 2021
Primary completion18 May 2022
Study completion18 May 2022

Why it stopped: Emerging SARS-CoV2 variants impacting susceptibility to study drug

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.
Other trials for ImmunocompromisedStudies of the same condition, open and under way.
More trials run by Regeneron PharmaceuticalsThe 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: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05074433
Sponsor's protocol ID: R10933-10987-COV-2176
Other IDs: 2021-005222-14
Status last verified: Oct 2025
First submitted: 8 Oct 2021
Last updated: 20 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

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 locations

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All Immunocompromised trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies as Pre-Exposure Prophylaxis to Prevent COVID-19 in Immunocompromised Participants
ClinicalTrials.gov ID: NCT05074433
Acronym / sponsor ID: R10933-10987-COV-2176
Conditions: Immunocompromised
Keywords: Non-response to COVID-19 vaccination, COVID-19, Immunocompromised, weakened immune system
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Emerging SARS-CoV2 variants impacting susceptibility to study drug
Enrolment: 66 participants (actual)
Lead sponsor: Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 25 Oct 2021 (actual)
Primary completion: 18 May 2022 (actual)
Study completion: 18 May 2022 (actual)
First posted: 12 Oct 2021 (actual)
Results: Posted 24 Jul 2023

Clinical summary

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

The primary objective of the study is to evaluate the effect of casirivimab+imdevimab, compared with placebo, in preventing symptomatic SARS-CoV-2 infection in immunocompromised participants.

The secondary objectives of the study are:

To evaluate the safety and tolerability of repeated SC injections of casirivimab+imdevimab in the study population
To characterize concentrations of casirivimab and imdevimab in serum over time
To assess the immunogenicity of casirivimab and imdevimab

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
casirivimab+imdevimab Initial + Q4W	Experimental	Drug: casirivimab+imdevimabInitial subcutaneous (SC) dose, then SC dose every 4 weeks (Q4W)
casirivimab+imdevimab Q4W	Experimental	Drug: casirivimab+imdevimabSC dose Q4W
casirivimab+imdevimab Q12W	Experimental	Drug: casirivimab+imdevimabSC dose every 12 weeks (Q12W)
Placebo	Placebo comparator	Drug: PlaceboSC dose Q4W

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Meets ≥1 of the following criteria:
Have been fully vaccinated against COVID-19 or deemed medically ineligible to receive full course of vaccine
Has documented negative serology/antibody response in an anti-SARS-CoV-2 spike protein IgG clinical test or ≤50 U/mL on the Elecsys® SARS-CoV-2 S Total Ig test
Tested negative for the COVID-19 virus within 72 hours prior to randomization

Key exclusion criteria (10 listed)

Weighs <40 kg (only applies to participants ≥12 to <18 years of age)
Has any signs or symptoms consistent with COVID-19
Past COVID-19 infection within 90 days prior to randomization
Planned use of any investigational, authorized, or approved vaccine for COVID-19 within 90 days of the last dose of study drug
Prior, current, or planned use of any of COVID-19 convalescent plasma, other monoclonal antibodies against SARS-CoV-2 or any COVID-19 treatment

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
casirivimab+imdevimabAlso: REGN-COV2, REGN10933, REGN10987, REGEN-COV™Co-administered sequentially subcutaneous (SC)	Drug	casirivimab+imdevimab Initial + Q4W, casirivimab+imdevimab Q12W, casirivimab+imdevimab Q4W
PlaceboAdministered SC	Drug	Placebo

Primary outcome

Cumulative Incidence of Symptomatic (Broad Term), RT-PCR-confirmed SARS-CoV-2 Infection Cases During the EAP
Time frame: The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days
Cumulative incidence of symptomatic (broad term), RT-PCR-confirmed SARS-CoV-2 infection cases during the Efficacy Assessment Period (EAP)

11 secondary outcomes

Number of Participants With Grade ≥3 Treatment-emergent Adverse Events (TEAEs) During the EAP
Time frame: The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days
Number of Participants With Grade ≥3 Treatment-emergent Adverse Events (TEAEs) During the Follow-Up Period
Time frame: End of EAP to the end of the Follow-Up Period (Day 169 to 205, approximately ~1 months)
Number of Participants With TEAEs Leading to Study Drug Discontinuation During the EAP
Time frame: The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days
Number of Participants With TEAEs Leading to Study Drug Discontinuation During the Follow-Up Period
Time frame: End of EAP to the end of the Follow-Up Period (Day 169 to 205, approximately ~1 months)
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the EAP
Time frame: The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days
Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Follow-Up Period
Time frame: End of EAP to the end of the Follow-Up Period (Day 169 to 205, approximately ~1 months)
Incidence of Adverse Events of Special Interest (AESIs) During the EAP
Time frame: The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days
Concentration of Casirivimab Over Time
Time frame: Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group
Concentration of Imdevimab Over Time
Time frame: Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group
Incidence of Anti-drug Antibodies (ADA) Over Time
Time frame: Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group
Incidence of Neutralizing Antibodies (NAb) to Each mAb Over Time
Time frame: Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group

Results and safety

Results posted to the registry on 24 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	16	7
Casirivimab+Imdevimab Initial + Q4W	17	8
Casirivimab+Imdevimab Q4W	16	9
Casirivimab+Imdevimab Q12W	17	11

Primary outcome: Cumulative Incidence of Symptomatic (Broad Term), RT-PCR-confirmed SARS-CoV-2 Infection Cases During the EAP

Time frame: The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days. Number (95% Confidence Interval). Unit: Cumulative Incidence Percentage

Measure	Placebo n = 16	Casirivimab+Imdevimab Initial + Q4W n = 17	Casirivimab+Imdevimab Q4W n = 16	Casirivimab+Imdevimab Q12W n = 17
Value	38.1 (5.7 to 72.2)	14.3 (2.1 to 37.5)	30.4 (1.3 to 72.0)	21.4 (2.4 to 53.0)

Placebo vs Casirivimab+Imdevimab Initial + Q4W: Hazard Ratio (HR): 0.563 (95% CI 0.093 to 3.393), Cox proportional hazard model
Placebo vs Casirivimab+Imdevimab Q4W: Hazard Ratio (HR): 0.460 (95% CI 0.072 to 2.929), Cox proportional hazard model
Placebo vs Casirivimab+Imdevimab Q12W: Cox Proportional Hazard: 0.609 (95% CI 0.101 to 3.668), Cox proportional hazard model

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose to end of follow up (approximately 7 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 16 (6.3%)	7 of 16 (43.8%)	1 of 16
REGN10933+REGN10987 1200mg Loading Dose and 600mg SC Q4W	1 of 17 (5.9%)	5 of 17 (29.4%)	1 of 17
REGN10933+REGN10987 300mg SC Q4W	0 of 16 (0%)	10 of 16 (62.5%)	0 of 16
REGN10933+REGN10987 300mg SC Q12W	2 of 17 (11.8%)	8 of 17 (47.1%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Related trials for Immunocompromised

Not yet recruitingPhase 4
Oral Switch in Bloodstream Infections in Immunocompromised Children
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RecruitingPhase 2
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
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RecruitingPhase 2
Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System
Locally Recurrent Skin Squamous Cell Carcinoma, Metastatic Skin Squamous Cell Carcinoma
RecruitingObservational study
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RecruitingObservational study
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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.

Clinical Trial Management study director

Regeneron Pharmaceuticals

67 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing casirivimab+imdevimab in people with Immunocompromised, run by Regeneron Pharmaceuticals at 67 sites in 2 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 6 inclusion and 10 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 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States, Mexico. 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 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?

Yes. Results are posted in the registry (first posted 24 Jul 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?

Cumulative Incidence of Symptomatic (Broad Term), RT-PCR-confirmed SARS-CoV-2 Infection Cases During the EAP (time frame: The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days). 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 NCT05074433.

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 20 Oct 2025.