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COVID-19 drug trial halted early: what happened with ensovibep?

NCT ID NCT04828161

Disease control Sponsor: Novartis 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a single dose of ensovibep, a lab-made protein, in 407 adults with mild COVID-19 symptoms. The goal was to see if it could lower the amount of virus in the body and reduce hospitalizations. The trial was stopped early, so we don't have complete answers on how well it works.

What this could mean

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

Active substance
ensovibep (a lab-made protein designed to block the coronavirus)
What this could lead to
If it worked, ensovibep could have provided a new treatment option to reduce hospitalizations and speed recovery for people with mild-to-moderate COVID-19.
What could go wrong
The trial was terminated early, so we don't have full results on whether it works. It was also tested in a specific group of symptomatic adults, so findings may not apply to everyone.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

407 people

The number who actually took part.

Started

May 2021

Finished

Jan 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

18 years and older

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.

Part A Inclusion Criteria: 1. Men and women ≥ 18 years of age on the day of inclusion (no upper limit). 2. Presence of two or more of the following COVID-19 symptoms with an onset within 7 days of dosing: Feeling hot or feverish, cough, sore throat, low energy, or tiredness, headache, muscle or body aches, chills or shivering, and shortness of breath. 3. Positive test for SARS-CoV-2 in upper respiratory swab on the day of dosing (rapid antigen test). 4. Understand and agree to comply with the planned study procedures. 5. The patient or legally authorized representative give signed informed consent. Part A Exclusion Criteria: 1. Requiring hospitalization at time of screening, or at time of study drug administration. 2. Oxygen saturation (SpO2) ≤ 93% on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2) \< 300, respiratory rate ≥ 30 per minute, and heart rate ≥ 125 per minute. In India, patients with a respiratory rate ≥ 24 per minute or with an oxygen saturation ≤ 93% on room air (SpO2) are not eligible. 3. Known allergies to any of the components used in the formulation of the ensovibep or placebo. 4. Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides SARS-CoV-2) that in the opinion of the investigator could constitute a risk when taking intervention. 5. Any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study. 6. Any co-morbidity requiring surgery within 7 days of dosing, or that is considered life-threatening within 29 days of dosing. 7. Prior or concurrent use of any medication for treatment of COVID-19, including antiviral agents, convalescent serum, or anti-viral antibodies. Purely symptomatic therapies (e.g., over-the-counter \[OTC\] cough medications, acetaminophen, and nonsteroidal anti-inflammatory drugs \[NSAIDs\]) are permitted. Prior vaccination for COVID-19 is permitted. 8. Are concurrently enrolled or were enrolled within the last 30 days or within 5 half-lives (whichever is longer) in any other type of medical research judged not to be scientifically or medically compatible with this study. 9. Are pregnant or breast feeding. 10. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception at the time of dosing and for 11 weeks after dosing of study drug. Highly effective contraception methods include: 1. Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (i.e., calendar, ovulation, symptothermal, and postovulation methods) and withdrawal are not acceptable methods of contraception. 2. Female sterilization (have had bilateral surgical oophorectomy \[with or without hysterectomy\], total hysterectomy, or bilateral tubal ligation at least 6 weeks before taking study treatment). In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment. 3. Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that patient. 4. Use of oral, injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate \< 1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the informed consent form (ICF). 11. Patients in the USA who are at high risk of progression to severe COVID-19 illness or hospitalization must not be enrolled in Part A of this study as a placebo-controlled study may not be appropriate in this patient population due to the availability of anti-viral mAbs under EUA in the USA.

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Conditions

The condition(s) this trial relates to.

COVID-19

As listed by the trial registrant

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

COVID -19

Contacts and locations

Locations

  • 1960 Family Practice, PA

    Houston, Texas, 77090, United States

  • AdventHealth Tampa

    Tampa, Florida, 33613, United States

  • All India Institute of Medical Sciences - Nagpur

    Nagpur, Maharashtra, 441108, India

  • Ascada Research

    Fullerton, California, 92835, United States

  • BAPS Pramukhswami Hospital

    Surat, Gujarat, 395009, India

  • Benchmark Southern California

    Colton, California, 92324, United States

  • Bio-Medical Research, LLC

    Miami, Florida, 33184, United States

  • Boward Infectious Disease and Primary Care

    Margate, Florida, 33063, United States

  • Centennial Medical Group - Research Department

    Elkridge, Maryland, 21075, United States

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina, 29732, United States

  • Clinresco Centres (Pty) Ltd

    Kempton Park, 1619, South Africa

  • DJW Navorsing

    Krugersdorp, 1739, South Africa

  • Debreceni Egyetem

    Debrecen, 4031, Hungary

  • Dr JM Engelbrecht Trial Site

    Somerset West, Western Cape, 7130, South Africa

  • Durgabai Deshmukh Hospital & Research Centre

    Vidyānagar, Hyderabad, 500044, India

  • Enhancing Care Foundation

    Durban, 4052, South Africa

  • Epic Medical Research

    Red Oak, Texas, 75154, United States

  • FARMOVS (Pty) Ltd

    Bloemfontein, Free State, 9301, South Africa

  • Fairway Medical Clinic

    Houston, Texas, 77087, United States

  • Family Practice Center

    McAllen, Texas, 78501, United States

  • Future Innovative Treatments

    Colorado Springs, Colorado, 80907, United States

  • George Provincial Hospital

    George, Western Cape, 6529, South Africa

  • Government Medical College

    Aurangabad, Maharashtra, 431001, India

  • Government Medical College and Hospital

    Nagpur, Maharashtra, 440003, India

  • Grant Medical College & Sir J. J. Group of Hospitals

    Mumbai, Maharashtra, 400008, India

  • Great Lakes Clinical Trials

    Chicago, Illinois, 60640, United States

  • Gwinnett Research Institute

    Buford, Georgia, 30519, United States

  • IACT Health

    Columbus, Georgia, 31904, United States

  • Jasper Summit Research, LLC

    Jasper, Alabama, 35501, United States

  • Jefferson City Medical Group

    Jefferson City, Missouri, 65109, United States

  • Jongaie Research

    Pretoria, 183, South Africa

  • King George Hospital

    Visakhapatnam, Andhra Pradesh, 530002, India

  • Life Spring Research Foundation

    Miami, Florida, 33155, United States

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112, United States

  • Pacific Neuropsychiatric Specialists

    Mission Viejo, California, 92691, United States

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409, United States

  • Panax Clinical Research, LLC

    Miami Lakes, Florida, 33014, United States

  • Providence Family Medical Center

    Redondo Beach, California, 90277, United States

  • Sandton Medical Research Centre

    Sandton, Gauteng, 2196, South Africa

  • Shetty's Hospital

    Bengaluru, Karnataka, 560068, India

  • St. Theresa's Hospital

    Hyderabad, Telangana, 500018, India

  • Suncoast Research Group, LLC

    Miami, Florida, 33135, United States

  • UMC Utrecht

    Utrecht, 3584 CW, Netherlands

  • VHS-Infectious Disease Medical Centre

    Chennai, Tamil Nadu, 600113, India

  • VitaLink Research

    Greenville, South Carolina, 29615, United States

  • Wilmington Health

    Wilmington, North Carolina, 28412, United States

  • Wits Clinical Research

    Soweto, 2013, South Africa

  • Zion Urgent Care Clinic

    Katy, Texas, 77494, United States

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Other studies related to the condition(s) this trial covers.