A Dose Finding, Efficacy and Safety Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19 (EMPATHY)

This is an interventional treatment trial for COVID-19 focused on measuring ensovibep, COVID-19 treatment, symptom reduction, viral load reduction,, EMPATHY, SARS-CoV-2, designed ankyrin repeat protein (DARPin®), angiotensin-converting enzyme 2 (ACE2) Read More

Part A Inclusion Criteria:

1. Males or females ≥ 18 years of age on the day of inclusion (no upper limit).
2. Presence of two or more COVID-19 symptoms and onset within 7 days prior to 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. Understands and agrees to comply with the planned study procedures.
5. The patient or legally authorized representative gives 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.
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-inflammatories [NSAIDs]) are permitted. Prior use of steroids for management of COVID-19 symptoms may be permitted, provided they can be stopped at study entry based on investigator judgement.Prior vaccination for COVID-19 is permitted.

Part B Inclusion Criteria:

1. Males or females ≥ 12 years of age on the day of inclusion (no upper limit) and with a body weight of ≥ 40kg
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 within 24 hours prior to dosing (rapid antigen test)

4. Presence of at least one of the following medical conditions or factors that places patients at higher risk for progression to severe COVID-19.

   • Age ≥ 60 years
   • Obesity [Body Mass Index (BMI) ≥30 kg/m2, or if age 12-17 years, have BMI ≥95th percentile for their age and gender based on CDC growth charts]
   • Chronic kidney disease
   • Diabetes
   • Hypertension
   • Immunosuppressive disease or immunosuppressive treatment
   • Cardiovascular disease (including congenital heart disease)
   • Chronic lung diseases
   • Cancer
   • Sickle cell disease
   • Neurodevelopmental disorders
   • Other medical conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
   • Having a medical-related technological dependence [for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)]
5. The patient or legally authorized representative understands and agrees to comply with the planned study procedures.
6. The patient, legally authorized representative, or parent/legal guardian gives signed informed consent and adolescents provide assent.

Part B 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 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 current SARS-CoV-2) that in the opinion of the investigator could constitute a risk when receiving study medication.
5. Any serious, unstable 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 10 days of dosing, or that is considered life-threatening within 29 days of dosing.
7. Prior use of ensovibep or participation in clinical trials in which ensovibep was studied.
8. Prior or concurrent use of any medication for treatment of the current COVID-19,infection, including antiviral agents (approved [e.g. remdesivir, Paxlovid, molnupiravir] or experimental [e.g. hydroxychloroquine, ivermectin]), convalescent serum, anti-viral antibodies, immunosuppressives or immunomodulators. Long-term treatment at stable doses for pre-existing conditions (e.g. anti-HIV medications, steroids (systemic or inhalational) for asthma, COPD, etc.) are permitted. Prior use of steroids for management of COVID-19 may be permitted provided they can be stopped before study dosing based on investigator judgement. Purely symptomatic therapies (e.g., over-the-counter [OTC] cough medications, acetaminophen, and nonsteroidal anti-inflammatory drugs [NSAIDs]) are permitted.
9. Prior vaccination for COVID-19 is permitted unless it occurred within the last 6 months prior to randomization. Patients who have been vaccinated against COVID19 (irrespective of product used and number of doses administered) qualify as prior vaccination.
10. Confirmed prior infection with SARS-CoV-2 within 6 months prior to randomization. The prior SARS-CoV-2 infection must have been confirmed by a direct diagnostic test (eg. rapid antigen test, RT-PCR). Novartis Confidential Page 59 of 131 Amended Clinical Trial Protocol Protocol No. MP0420-CP302 V02 (Track Changes) (CSKO136A12201J)
11. Are concurrently enrolled or were enrolled within the last 30 days or within 5 halflives (whichever is longer) in any other type of medical research judged not to be scientifically or medically compatible with this study.
12. Are pregnant or breast feeding.
13. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception at the time of dosing and for 13 weeks after dosing of study drug.