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COVID-19 antibody drug trial halted early — little data to show

NCT ID NCT05081388

Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage study tested a new antibody drug (REGN14256) alone or with imdevimab in 25 adults with mild COVID-19 and no risk factors for severe illness. The goal was to check safety and whether the drug could lower virus levels. However, the trial was terminated early, so we have no clear results on how well it worked.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
REGN14256 and imdevimab (antibody drugs)
What this could lead to
If successful, this could provide a treatment option for COVID-19 patients without severe disease risk.
What could go wrong
The trial was terminated early with only 25 participants, so no conclusions can be drawn. Early-phase studies often fail to show benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

25 people

The number who actually took part.

Started

Nov 2021

Finished

Jun 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Phase 1 will enroll adult patients (≥18 years of age), Phase 2 will enroll adult patients, Phase 3 will enroll adult patients and an additional adolescent cohort of patients (≥12 and \<18 years of age) Key Inclusion Criteria: 1. For the adolescent cohort in Phase 3 only: Weighs ≥40 kg at randomization 2. Has SARS-CoV-2-positive antigen or molecular diagnostic test (by validated SARSCoV-2 antigen, RT-PCR, or other molecular diagnostic assay, using an appropriate sample such as nasopharyngeal \[NP\], nasal, oropharyngeal \[OP\], or saliva) ≤72 hours prior to randomization. A historical record of a positive result is acceptable as long as the sample was collected ≤72 hours prior to randomization 3. Has symptoms consistent with COVID-19 (as determined by the investigator) with onset ≤7 days before randomization, and doesn't have a medical condition or other factors associated with high risk for progression to severe COVID-19 as outlined in the exclusion criteria 4. Maintains O2 saturation ≥93% on room air Key Exclusion Criteria: 1. Has a medical condition or other factors associated with high risk for progression to severe COVID-19: 1. Cancer 2. Cardiovascular disease (such as heart failure, coronary artery disease, cardiomyopathies, congenital heart disease or hypertension) 3. Chronic lung disease including chronic obstructive pulmonary disease, asthma (moderate to severe), interstitial lung disease, cystic fibrosis, and pulmonary hypertension 4. Chronic kidney disease at any stage 5. Chronic liver disease (such as alcohol-related, nonalcoholic fatty liver disease, cirrhosis) 6. Dementia or other chronic neurological condition 7. Diabetes mellitus (type 1 or type 2) 8. Immunodeficiency disease or taking immunosuppressive treatment 9. Medical-related technological dependence \[for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)\] 10. Neurodevelopmental disorder (for example, cerebral palsy) or other condition that confers medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies) 11. Overweight (defined as BMI \>25 kg/m2) or obesity (defined as BMI ≥30 kg/m2) 12. Poorly controlled HIV infection or AIDS 13. Pregnancy 14. Sickle cell disease or thalassemia 15. Stroke or cerebrovascular disease 2. Prior, current (at randomization) or planned use (within time period given per CDC guidance \[90 days\]) of any authorized or approved vaccine for COVID-19 3. Was admitted to a hospital for COVID-19 prior to randomization, or is hospitalized (inpatient) for any reason at randomization 4. Has a known prior SARS-CoV-2 infection or positive SARS-CoV-2 serologic test 5. Has a positive SARS-CoV-2 antigen or molecular diagnostic test from a sample collected \>72 hours prior to randomization 6. Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, mAbs against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or within 5 half-lives of the investigational product (whichever is longer) prior to the screening visit 7. Prior, current, or any of the following treatments: COVID-19 convalescent plasma, mAbs against SARS-CoV-2, IVIG (any indication), systemic corticosteroids (any indication), or COVID-19 treatments (authorized, approved, or investigational) 8. Has known active infection with influenza or other non-SARS-CoV-2 respiratory pathogen, confirmed by a diagnostic test 9. Has been discharged, or is planned to be discharged, to a quarantine center 10. Has participated, is participating, or plans to participate in a clinical research study evaluating any authorized, approved, or investigational vaccine for COVID-19 11. For Phase 1only: Women of childbearing potential (WOCBP) who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment and for at least 6 months after study drug administration as described in the protocol Note: Other protocol-defined inclusion/ exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

Coronavinae infectious disease COVID-19

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SARS-CoV-2

Contacts and locations

Locations

  • AGA Clinical Trials

    Hialeah, Florida, 33012, United States

  • Advanced Diagnostics Clinic, River Oaks Hospital and Clinics

    Houston, Texas, 77027, United States

  • Ark Clinical Research

    Long Beach, California, 90806, United States

  • Bio-Medical Research LLC

    Miami, Florida, 33184, United States

  • Carolina Medical Research

    Clinton, South Carolina, 29325, United States

  • Charisma Research and Medical Center

    Miami Lakes, Florida, 33014, United States

  • Chicago Clinical Research Institute

    Chicago, Illinois, 60607, United States

  • Forte Family Practice

    Las Vegas, Nevada, 89103, United States

  • Global Medical Trials

    Miami, Florida, 33174, United States

  • IACT Health

    Columbus, Georgia, 31904, United States

  • NYC H+H / Jacobi Medical Center

    The Bronx, New York, 10461, United States

  • New York Health and Hospitals / Lincoln

    The Bronx, New York, 10451, United States

  • Olive Branch Family Medical Center

    Olive Branch, Mississippi, 38654, United States

  • PNS Clinical Research, LLC

    Mission Viejo, California, 92691, United States

  • PharmaTex Research, LLC

    Amarillo, Texas, 79109, United States

  • Project 4 Research, Inc.

    Miami, Florida, 33125, United States

  • Regeneron Research Site

    La Mesa, California, 91941, United States

  • Regeneron Research Site

    Ft. Pierce, Florida, 34982, United States

  • Regeneron Research Site

    Loxahatchee Groves, Florida, 33470, United States

  • Regeneron Research Site

    Winter Park, Florida, 32789, United States

  • Regeneron Research Site

    Ames, Iowa, 50010, United States

  • Regeneron Research Site

    Marrero, Louisiana, 70072, United States

  • Regeneron Research Site

    Wilmington, North Carolina, 28401, United States

  • Regeneron Research Site

    Dayton, Ohio, 45409, United States

  • Regeneron Research Site

    Houston, Texas, 77030, United States

  • Regeneron Research Site

    Houston, Texas, 77093, United States

  • Triple O Research Institute, P.A.

    West Palm Beach, Florida, 33407, United States

  • Universal Medical and Research Center, LLC

    Miami, Florida, 33126, United States

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