CClinicalTrials.gg
Sign In
CompletedNCT04834856Updated Sep 8, 2021

Viral Clearance, PK and Tolerability of Ensovibep in COVID-19 Patients

A Phase 2 interventional study of ensovibep in Covid19, sponsored by Molecular Partners AG. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-09-08.

Sponsored by Molecular Partners AG · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
12
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This study will investigate how ensovibep is distributed throughout the body, the viral clearance and the tolerability of ensovibep in patients with symptomatic COVID-19 disease

02

Conditions studied

  • Covid19

Browse trials for

Keywords

  • SARS-CoV-2
  • Corona
  • DARPin
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Men or non-pregnant women, between 18 and 70 years on the day of inclusion.
  • Presence of one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat, malaise, fatigue, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion.
  • Positive test for SARS-CoV-2 in upper respiratory swab on the day of dosing (rapid antigen test).

Exclusion criteria

Exclusion Criteria:

  • Requiring hospitalization at time of screening, or at time of study drug administration.
  • Oxygen saturation (SpO2) ≤ 93 percent (%) on room air at sea level, respiratory rate ≥ 30 per minute, or heart rate ≥125 per minute.
  • 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 hospitalization or surgery within \<7 days, or that is considered life-threatening within 29 days.
  • A patient reported history (prior to the current episode) of a positive SARS-CoV-2 serology test or a history of PCR confirmed SARS-CoV-2 infection.
  • Prior or concurrent use of SARS-CoV-2 antiviral medication, including convalescent serum or anti-viral antibodies.
  • Concurrent enrollment in any other type of medical research for improving COVID-19 outcomes or that is judged by the investigator not to be scientifically or medically compatible with this study.
  • Women that are currently breast feeding, pregnant, or plan to get pregnant during the duration of the trial.
  • Severe immunocompromised status (primary immunodeficiency, supraphysiological dose of systemic corticosteroids, transplant patients, known untreated HIV and CD4 T-cells \<200/microliter) or use of any immunosuppressants that, in the opinion of the investigator, should preclude participation in this study.
  • Subjects at high risk for of COVID-19 related complications or mortality
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    ensovibep dose 1

    Drug: ensovibep

  • Experimental
    ensovibep dose 2

    Drug: ensovibep

Interventions

  • Drugensovibep

    The study will start with a low-dose cohort and after a safety review escalate to the higher dose cohort. One administration at day 1 by infusion.

    Also known as: MP0420

05

What researchers measure

Primary outcomes

  1. SARS-CoV-2 viral load

    Changes from baseline to each time point of measurement in SARS-CoV-2 viral load in nasopharyngeal swabs

    Time frame: up to day 29

  2. SARS-CoV-2 viral cultures

    Changes from baseline to each time point of measurement in SARS-CoV-2 viral cultures cultivated from nasopharyngeal swabs

    Time frame: up to day 29

  3. SARS-CoV-2 PCR days to negativity

    Duration in days to SARS-CoV-2 PCR negativity

    Time frame: up to day 29

  4. Observed maximum concentration (Cmax)

    The maximum observed concentration (Cmax) is estimated based on the serum concentrations.

    Time frame: up to day 91

  5. Terminal Elimination Half-Life (T½)

    Time frame: up to day 91

  6. Time to Cmax (Tmax)

    Time frame: up to day 91

  7. The area under the concentration-time curve from time zero extrapolated to infinity time (AUCinf)

    Time frame: up to day 91

  8. 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

  9. Apparent total body clearance of the drug from plasma (CL)

    Time frame: up to day 91

  10. Apparent volume of distribution at steady state (Vss)

    Time frame: up to day 91

Secondary outcomes

  1. 14 Common Covid-19 Related Symptoms score

    Changes in the assessment of 14 Common Covid-19 Related Symptoms score

    Time frame: up to day 29

  2. Treatment-emergent (serious) adverse events ((S)AEs) and AEs of Special Interest (AESIs) including Infusion-related reactions (IRRs)

    Treatment-emergent (S)AEs and AESIs, including infusion-related reactions (IRRs) will be assessed throughout the study

    Time frame: up to day 91

  3. Concomitant medication

    Intake of concomitant medication will be assessed throughout the study

    Time frame: up to day 91

  4. Vital Signs: Heart Rate (bpm)

    Time frame: up to day 91

  5. Vital Signs: Blood Pressure Systolic and Diastolic (mmHg)

    Time frame: up to day 91

  6. Vital Signs: Respiratory Rate (breaths per minute)

    Time frame: up to day 91

  7. Vital Signs: Body Temperature (°C)

    Time frame: up to day 91

  8. Vital Signs: Oxygen Saturation (SpO2)

    Time frame: up to day 91

  9. Clinical laboratory tests (hematology and blood chemistry)

    Time frame: up to day 91

  10. Physical examinations (symptom directed)

    Time frame: up to day 91

  11. Local tolerability at injection site

    Local tolerability at injection site will be assessed via Visual Infusion Phlebitis score

    Time frame: up to 90 min post dose

06

Study locations

1 site
  • Centre for Human Drug Research
    Leiden, 2333, Netherlands
07

Registry details

Key details

Study ID
NCT04834856
Lead sponsor
Molecular Partners AG
Responsible party
Sponsor
First posted
Apr 8, 2021
Start date
Apr 1, 2021
Primary completion
Aug 20, 2021
Completion
Aug 20, 2021
Last update
Sep 8, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

COVID-19→

Other studies from this sponsor

Molecular Partners AG

Start the discussion