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

NCT ID: NCT04828161

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 407 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-10
• Study Completion Date: 2022-01-27

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.

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 during the study and its clinical relevance (PK, efficacy and safety)
• To evaluate safety and tolerability of ensovibep

Although Amendment 2 was created, modifications for this amendment are not reflected as it was never approved or implemented in the US. The study was conducted under Global Protocol Amendment 1, the last active version of the protocol.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Phase 2 / Part A, ensovibep active treatment arm 1

Phase 2 / Part A: ensovibep active treatment arm 1

Group Type: EXPERIMENTAL

ensovibep

Intervention Type: DRUG

IV on day 1 only.

Phase 2 / Part A, ensovibep active treatment arm 2

Phase 2 / Part A: ensovibep active treatment arm 2

Group Type: EXPERIMENTAL

ensovibep

Intervention Type: DRUG

IV on day 1 only.

Phase 2 / Part A, ensovibep active treatment arm 3

Phase 2 / Part A: ensovibep active treatment arm 3

Group Type: EXPERIMENTAL

ensovibep

Intervention Type: DRUG

IV on day 1 only.

Phase 2 / Part A, Placebo

Phase 2 / Part A: Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

IV on day 1 only.

Phase 3/ Part B, ensovibep active treatment arm 4

Phase 3/ Part B: ensovibep active treatment. Part B was not initiated.

Group Type: EXPERIMENTAL

ensovibep

Intervention Type: DRUG

IV on day 1 only.

Phase 3/ Part B, Placebo arm

Phase 3/ Part B: Placebo. Part B was not initiated.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

IV on day 1 only.

Interventions

ensovibep

IV on day 1 only.

Intervention Type: DRUG

Placebo

IV on day 1 only.

Intervention Type: DRUG

Other Intervention Names

MP0420

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Molecular Partners AG

INDUSTRY

Sponsor Role: collaborator

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jasper Summit Research, LLC

Jasper, Alabama, United States

Benchmark Southern California

Colton, California, United States

Ascada Research

Fullerton, California, United States

Pacific Neuropsychiatric Specialists

Mission Viejo, California, United States

Providence Family Medical Center

Redondo Beach, California, United States

Future Innovative Treatments

Colorado Springs, Colorado, United States

Boward Infectious Disease and Primary Care

Margate, Florida, United States

Suncoast Research Group, LLC

Miami, Florida, United States

Life Spring Research Foundation

Miami, Florida, United States

Bio-Medical Research, LLC

Miami, Florida, United States

Panax Clinical Research, LLC

Miami Lakes, Florida, United States

AdventHealth Tampa

Tampa, Florida, United States

Palm Beach Research Center

West Palm Beach, Florida, United States

Gwinnett Research Institute

Buford, Georgia, United States

IACT Health

Columbus, Georgia, United States

Great Lakes Clinical Trials

Chicago, Illinois, United States

Centennial Medical Group - Research Department

Elkridge, Maryland, United States

Jefferson City Medical Group

Jefferson City, Missouri, United States

Monroe Biomedical Research

Monroe, North Carolina, United States

Wilmington Health

Wilmington, North Carolina, United States

VitaLink Research

Greenville, South Carolina, United States

Clinical Research of Rock Hill

Rock Hill, South Carolina, United States

Fairway Medical Clinic

Houston, Texas, United States

1960 Family Practice, PA

Houston, Texas, United States

Zion Urgent Care Clinic

Katy, Texas, United States

Family Practice Center

McAllen, Texas, United States

Epic Medical Research

Red Oak, Texas, United States

Debreceni Egyetem

Debrecen, , Hungary

King George Hospital

Visakhapatnam, Andhra Pradesh, India

BAPS Pramukhswami Hospital

Surat, Gujarat, India

Durgabai Deshmukh Hospital & Research Centre

Vidyānagar, Hyderabad, India

Shetty's Hospital

Bengaluru, Karnataka, India

Government Medical College

Aurangabad, Maharashtra, India

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

Mumbai, Maharashtra, India

Government Medical College and Hospital

Nagpur, Maharashtra, India

All India Institute of Medical Sciences - Nagpur

Nagpur, Maharashtra, India

VHS-Infectious Disease Medical Centre

Chennai, Tamil Nadu, India

St. Theresa's Hospital

Hyderabad, Telangana, India

UMC Utrecht

Utrecht, , Netherlands

FARMOVS (Pty) Ltd

Bloemfontein, Free State, South Africa

Sandton Medical Research Centre

Sandton, Gauteng, South Africa

George Provincial Hospital

George, Western Cape, South Africa

Dr JM Engelbrecht Trial Site

Somerset West, Western Cape, South Africa

Enhancing Care Foundation

Durban, , South Africa

Clinresco Centres (Pty) Ltd

Kempton Park, , South Africa

DJW Navorsing

Krugersdorp, , South Africa

Jongaie Research

Pretoria, , South Africa

Wits Clinical Research

Soweto, , South Africa

Countries

United States; Hungary; India; Netherlands; South Africa

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2021-000890-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CSKO136A12201J

Identifier Type: OTHER

Identifier Source: secondary_id

MP0420-CP302

Identifier Type: -

Identifier Source: org_study_id