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

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Molecular Partners AG
• Collaborators: Datamap; Iqvia Pty Ltd; Novartis Pharmaceuticals; Q2 Solutions; SYNLAB Analytics & Services Switzerland AG

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.