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

  • STATUS
    Recruiting
  • End date
    Jun 16, 2022
  • participants needed
    2100
  • sponsor
    Molecular Partners AG
Updated on 16 July 2021

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

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

Details
Condition *COVID-19, Covid-19
Treatment Placebo, ensovibep
Clinical Study IdentifierNCT04828161
SponsorMolecular Partners AG
Last Modified on16 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Men or women 18 years of age on the day of inclusion (no upper limit)
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
Positive test for SARS-CoV-2 in upper respiratory swab on the day of dosing (rapid antigen test)
Understand and agree to comply with the planned study procedures
The patient or legally authorized representative give signed informed consent

Exclusion Criteria

Requiring hospitalization at time of screening, or at time of study drug administration
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
Known allergies to any of the components used in the formulation of the ensovibep or placebo
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
Any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study
Any co-morbidity requiring surgery within 7 days of dosing, or that is considered life-threatening within 29 days of dosing
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note