Clinical trial NCT04834856: Viral Clearance, PK and Tolerability of Ensovibep in COVID-19 Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Covid19
Keywords: SARS-CoV-2
Corona
DARPin
Lead sponsor: Molecular Partners AG
Sponsor class: INDUSTRY
First posted: 2021-04-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: SARS-CoV-2 viral load
timeFrame: up to day 29
measure: SARS-CoV-2 viral cultures
timeFrame: up to day 29
measure: SARS-CoV-2 PCR days to negativity
timeFrame: up to day 29
measure: Observed maximum concentration (Cmax)
timeFrame: up to day 91
measure: Terminal Elimination Half-Life (T½)
timeFrame: up to day 91
measure: Time to Cmax (Tmax)
timeFrame: up to day 91
measure: The area under the concentration-time curve from time zero extrapolated to infinity time (AUCinf)
timeFrame: up to day 91
measure: The area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
timeFrame: up to day 91
measure: Apparent total body clearance of the drug from plasma (CL)
timeFrame: up to day 91
measure: Apparent volume of distribution at steady state (Vss)
timeFrame: up to day 91
Secondary outcomes:
measure: 14 Common Covid-19 Related Symptoms score
timeFrame: up to day 29
measure: Treatment-emergent (serious) adverse events ((S)AEs) and AEs of Special Interest (AESIs) including Infusion-related reactions (IRRs)
timeFrame: up to day 91
measure: Concomitant medication
timeFrame: up to day 91
measure: Vital Signs: Heart Rate (bpm)
timeFrame: up to day 91
measure: Vital Signs: Blood Pressure Systolic and Diastolic (mmHg)
timeFrame: up to day 91
measure: Vital Signs: Respiratory Rate (breaths per minute)
timeFrame: up to day 91
measure: Vital Signs: Body Temperature (°C)
timeFrame: up to day 91
measure: Vital Signs: Oxygen Saturation (SpO2)
timeFrame: up to day 91
measure: Clinical laboratory tests (hematology and blood chemistry)
timeFrame: up to day 91
measure: Physical examinations (symptom directed)
timeFrame: up to day 91
measure: Local tolerability at injection site
timeFrame: up to 90 min post dose
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Centre for Human Drug Research
Study officials:
References: