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

• Sponsor: Molecular Partners AG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04834856
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.6
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: ensovibep	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2a Open Label, Non-comparative, Single Dose Escalation Study to Evaluate the Dynamics of Viral Clearance, Pharmacokinetics and Tolerability of Ensovibep in Patients With Symptomatic COVID-19 Disease
• Actual Study Start Date: Apr 1, 2021
• Actual Primary Completion Date: Aug 20, 2021
• Actual Study Completion Date: Aug 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ensovibep dose 1	Drug: ensovibep; 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.; Other Names: MP0420
Experimental: ensovibep dose 2	Drug: ensovibep; 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.; Other Names: MP0420

Outcome Measures

Primary Outcome Measures

1. SARS-CoV-2 viral load [up to day 29]

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

2. SARS-CoV-2 viral cultures [up to day 29]

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

3. SARS-CoV-2 PCR days to negativity [up to day 29]

   Duration in days to SARS-CoV-2 PCR negativity

4. Observed maximum concentration (Cmax) [up to day 91]

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

5. Terminal Elimination Half-Life (T½) [up to day 91]

6. Time to Cmax (Tmax) [up to day 91]

7. The area under the concentration-time curve from time zero extrapolated to infinity time (AUCinf) [up to day 91]

8. The area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) [up to day 91]

9. Apparent total body clearance of the drug from plasma (CL) [up to day 91]

10. Apparent volume of distribution at steady state (Vss) [up to day 91]

Secondary Outcome Measures

1. 14 Common Covid-19 Related Symptoms score [up to day 29]

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

2. Treatment-emergent (serious) adverse events ((S)AEs) and AEs of Special Interest (AESIs) including Infusion-related reactions (IRRs) [up to day 91]

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

3. Concomitant medication [up to day 91]

   Intake of concomitant medication will be assessed throughout the study

4. Vital Signs: Heart Rate (bpm) [up to day 91]

5. Vital Signs: Blood Pressure Systolic and Diastolic (mmHg) [up to day 91]

6. Vital Signs: Respiratory Rate (breaths per minute) [up to day 91]

7. Vital Signs: Body Temperature (°C) [up to day 91]

8. Vital Signs: Oxygen Saturation (SpO2) [up to day 91]

9. Clinical laboratory tests (hematology and blood chemistry) [up to day 91]

10. Physical examinations (symptom directed) [up to day 91]

11. Local tolerability at injection site [up to 90 min post dose]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Human Drug Research	Leiden		Netherlands	2333

Sponsors and Collaborators

• Molecular Partners AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Molecular Partners AG
• ClinicalTrials.gov Identifier: NCT04834856
• Other Study ID Numbers: MP0420-CP204; 2021-000365-33
• First Posted: Apr 8, 2021
• Last Update Posted: Sep 8, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Molecular Partners AG: SARS-CoV-2; Corona; DARPin
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Sep 8, 2021