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

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ClinicalTrials.gov Identifier: NCT04828161
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : July 9, 2021
Sponsor:
Collaborators:
Novartis Pharmaceuticals
Iqvia Pty Ltd
Datamap
SYNLAB Analytics & Services Switzerland AG
Q2 Solutions
Information provided by (Responsible Party):
Molecular Partners AG

Brief Summary:
The purpose of this study is to establish the antiviral efficacy of ensovibep against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in humans, identify the optimal dose, and demonstrate its clinical value for treating COVID-19 in adult ambulatory patients

Condition or disease Intervention/treatment Phase
COVID-19 Drug: ensovibep Drug: Placebo Phase 2 Phase 3

Detailed Description:

Primary objectives:

Part A The primary objective of this Part is to demonstrate superiority of ensovibep, compared to placebo, in reducing SARS-CoV-2 viral load through Day 8.

Part B The primary objective of this Part is to demonstrate superiority of ensovibep, compared to placebo, in reducing the occurrence of hospitalizations (≥ 24 hours of acute care) and/or emergency room visits related to COVID-19 or death from any cause up to Day 29.

Secondary objectives:

Part A

The secondary objectives of this Part are:

  • To assess the effect of ensovibep, compared to placebo, in reducing the occurrence of hospitalizations (≥ 24 hours of acute care) and/or emergency room visits related to COVID-19 or death from any cause up to Day 29
  • To assess the effect of ensovibep, compared to placebo, in reducing COVID-19 symptoms through Day 29
  • To evaluate safety and tolerability of ensovibep
  • To characterize the pharmacokinetics (PK) of ensovibep

Part B

The secondary objectives of this Part are:

  • To assess the effect of ensovibep, compared to placebo, in reducing SARS-CoV-2 viral load through Day 8
  • To assess the effect of ensovibep, compared to placebo, in reducing COVID-19 symptoms up to Day 29
  • To evaluate the immunogenicity of ensovibep and its clinical relevance (pharmacokinetic, efficacy, and safety).
  • To evaluate safety and tolerability of ensovibep

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19 - The "EMPATHY" Trial
Actual Study Start Date : May 24, 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : June 2022

Arm Intervention/treatment
Experimental: ensovibep active treatment arm 1 Drug: ensovibep
Phase 2/ Part A : 3 active treatment arms vs placebo, IV on day 1 only Phase 3/ Part B: 1 active treatment arm (selected dose from Part A) vs placebo, IV on day 1 only
Other Name: MP0420

Experimental: ensovibep active treatment arm 2 Drug: ensovibep
Phase 2/ Part A : 3 active treatment arms vs placebo, IV on day 1 only Phase 3/ Part B: 1 active treatment arm (selected dose from Part A) vs placebo, IV on day 1 only
Other Name: MP0420

Experimental: ensovibep active treatment arm 3 Drug: ensovibep
Phase 2/ Part A : 3 active treatment arms vs placebo, IV on day 1 only Phase 3/ Part B: 1 active treatment arm (selected dose from Part A) vs placebo, IV on day 1 only
Other Name: MP0420

Placebo Comparator: Placebo Drug: Placebo
Phase 2/ Part A : 3 active treatment arms vs placebo, IV on day 1 only Phase 3/ Part B: 1 active treatment arm (selected dose from Part A) vs placebo, IV on day 1 only




Primary Outcome Measures :
  1. Part A - SARS-CoV-2 viral load [ Time Frame: 8 days (days 0, 3, 5 and 8) ]
    Time-weighted change from baseline (measured at Day 3, Day 5, and Day 8) in SARS-CoV-2 viral load in nasopharyngeal swabs through Day 8

  2. Part B - Occurrence of hospitalizations, emergency room visits or death [ Time Frame: up to day 29 ]
    Proportion of patients experiencing hospitalizations (≥ 24 hours of acute care) and/or emergency room visits related to COVID-19 or death from any cause up to Day 29.


Secondary Outcome Measures :
  1. Part A - Occurrence of hospitalizations, emergency room visits or death [ Time Frame: up to day 29 ]
    Proportion of patients experiencing hospitalizations (≥ 24 hours of acute care) and/or emergency room visits related to COVID-19 or death from any cause up to Day 29.

  2. Part A - Time to sustained clinical recovery [ Time Frame: up to day 29 ]
    Time to sustained clinical recovery, defined as (a) all symptoms from the modified FDA COVID-19 symptom list scored as moderate or severe at baseline are subsequently scored as mild or absent, AND (b) all symptoms from the modified FDA COVID-19 symptom list scored as mild or absent at baseline are subsequently scored as absent, with no subsequent worsening up to Day 29.

  3. Part A - Serious adverse events (SAEs) and AEs of Special Interest (AESIs) [ Time Frame: up to day 91 (EOS) ]
    In order to evaluate the safety and tolerability of ensovibep, the proportion of patients up to end of study with: (a) SAEs, including death from any cause and (b) AESIs, including infusion-related reactions (IRRs) CTCAE grade 2 or higher, will be assessed.

  4. Part A - Vital Signs: Heart Rate (bpm) [ Time Frame: up to day 91 (EOS) ]
  5. Part A - Vital Signs: Blood Pressure Systolic and Diastolic (mmHg) [ Time Frame: up to day 91 (EOS) ]
  6. Part A - Vital Signs: Body Temperature (°C) [ Time Frame: up to day 91 (EOS) ]
  7. Part A - Vital Signs: Respiratory Rate (breaths per minute) [ Time Frame: up to day 91 (EOS) ]
  8. Part A - Vital Signs: Oxygen Saturation (SpO2) [ Time Frame: up to day 91 (EOS) ]
  9. Part A - Number of Participants with Laboratory Abnormalities [ Time Frame: up to day 91 (EOS) ]
  10. Part A - Free and total ensovibep concentration in serum (mass per volume units) [ Time Frame: up to day 91 (EOS) ]
  11. Part A - Observed maximum concentration (Cmax) [ Time Frame: up to day 91 (EOS) ]
    The maximum observed concentration (Cmax) is estimated based on the serum concentrations.

  12. Part A - Time to Cmax (Tmax) [ Time Frame: up to day 91 (EOS) ]
  13. Part A - The area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) [ Time Frame: up to day 91 (EOS) ]
  14. Part A - The area under the concentration-time curve from time zero extrapolated to infinity time (AUCinf) [ Time Frame: up to day 91 (EOS) ]
  15. Part A - Terminal Elimination Half-Life (T½) [ Time Frame: up to day 91 (EOS) ]
  16. Part A - Terminal Elimination rate constant (λz) [ Time Frame: up to day 91 (EOS) ]
  17. Part A - The apparent volume of distribution during terminal phase associated with λz (Vz) [ Time Frame: up to day 91 (EOS) ]
  18. Part A - Apparent total body clearance of the drug from plasma (CL) [ Time Frame: up to day 91 (EOS) ]
  19. Part B - SARS-CoV-2 viral load [ Time Frame: 8 days (days 1, 3, 5 and 8) ]
    Time-weighted change from baseline (measured at Day 3, Day 5, and Day 8) in SARS-CoV-2 viral load in nasopharyngeal swabs through Day 8

  20. Part B - Time to sustained clinical recovery [ Time Frame: up to day 29 ]
    Time to sustained clinical recovery, defined as (a) all symptoms from the modified FDA COVID-19 symptom list scored as moderate or severe at baseline are subsequently scored as mild or absent, AND (b) all symptoms from the modified FDA COVID-19 symptom list scored as mild or absent at baseline are subsequently scored as absent, with no subsequent worsening up to Day 29.

  21. Part B - Proportion of patients with treatment-emergent ADAs (TE-ADA) [ Time Frame: up to day 91 (EOS) ]
    To evaluate the immunogenicity of ensovibep during the study and its clinical relevance (pharmacokinetic, efficacy and safety), proportion of patients exhibiting TE-ADA over time will be determined.

  22. Part B - SAEs and AESIs [ Time Frame: up to day 91 (EOS) ]
    In order to evaluate the safety and tolerability of ensovibep, the proportion of patients up to end of study with: (a) SAEs, including death from any cause and (b) AESIs, including IRRs CTCAE grade 2 or higher, will be assessed.

  23. Part B - Vital Signs: Heart Rate (bpm) [ Time Frame: up to day 91 (EOS) ]
  24. Part B - Vital Signs: Blood Pressure Systolic and Diastolic (mmHg) [ Time Frame: up to day 91 (EOS) ]
  25. Part B - Vital Signs: Body Temperature (°C) [ Time Frame: up to day 91 (EOS) ]
  26. Part B - Vital Signs: Respiratory Rate (breaths per minute) [ Time Frame: up to day 91 (EOS) ]
  27. Part B - Vital Signs: Oxygen Saturation (SpO2) [ Time Frame: up to day 91 (EOS) ]
  28. Part B - Number of Participants with Laboratory Abnormalities [ Time Frame: up to day 91 (EOS) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men or women ≥ 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. Understand and agree to comply with the planned study procedures.
  5. The patient or legally authorized representative give signed informed consent.

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 vaccination for COVID-19 is permitted.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04828161


Contacts
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Contact: Medical Director MPAG +41 44 755 7700 info@molecularpartners.com

Locations
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Sponsors and Collaborators
Molecular Partners AG
Novartis Pharmaceuticals
Iqvia Pty Ltd
Datamap
SYNLAB Analytics & Services Switzerland AG
Q2 Solutions
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Responsible Party: Molecular Partners AG
ClinicalTrials.gov Identifier: NCT04828161    
Other Study ID Numbers: MP0420-CP302
2021-000890-10 ( EudraCT Number )
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: July 9, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Molecular Partners AG:
ensovibep
COVID-19 treatment, symptom reduction, viral load reduction,
EMPATHY
SARS-COV-2
designed ankyrin repeat protein (DARPin®)
angiotensin-converting enzyme 2 (ACE2)
Symptomatic COVID-19 infected patients