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
- Conditions
- CoronavirusCOVID-19SARS-CoV-210047438
- Registration Number
- NL-OMON50810
- Lead Sponsor
- Molecular Partners AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
1. Men or non-pregnant women, between 18 and 70 years on the day of inclusion.
2. 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.
3. Positive test for SARS-CoV-2 in upper respiratory swab on the day of dosing
(rapid antigen test).
4. Female subjects must agree to use highly effective contraception as
described in section 4.5.1 of the protocol or must be of non-child bearing
potential. A woman is considered to be of non-childbearing potential if she
meets one of the following criteria:
i. be post-menopausal (spontaneous amenorrhea for at least 12 months); or
ii. has no uterus, ovaries or fallopian tubes.
5. Agree to follow the contraception requirements of the trial as described in
section 4.5.1 of the protocol.
6. Understand and agree to comply with planned study procedures, including
nasopharyngeal swabs and venous blood samples.
7. Able to communicate well with the investigator in the Dutch language and has
provided signed informed consent.
1. Requiring hospitalization at time of screening, or at time of study drug
administration.
2. Oxygen saturation (SpO2) * 93 percent (%) on room air at sea level,
respiratory rate * 30 per minute, or heart rate *125 per minute.
3. Known allergies to any of the components used in the i.v. formulation of
ensovibep.
4. Any serious concomitant systemic disease, condition, or disorder that, in
the opinion of the investigator, should preclude participation in this study.
5. Any co-morbidity requiring hospitalization or surgery within <7 days, or
that is considered life-threatening within 29 days.
6. 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.
7. Prior or concurrent use of SARS-CoV-2 antiviral medication, including
convalescent serum or anti-viral antibodies.
8. 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.
9. Women that are currently breast feeding, pregnant, or plan to get pregnant
during the duration of the trial.
10. 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.
11. Subjects at high risk for of COVID-19 related complications or mortality,
defined as:
a. Age 50 to 70 years and at least one of the following other risk factors:
i. BMI >35 kg/m2
ii. Chronic Cardiac or pulmonary disease (e.g. atrial fibrillation, CAD, heart
failure, COPD, asthma), that might pose additional risks in study
participation, as per investigator decision
iii. Ongoing clinically significant neurological disease (e.g. stroke or any
other chronic debilitating neurological disease)
iv. Chronic kidney disease with GFR <60 ml/min, as per medical history
v. Rheumatic disease (e.g. rheumatoid arthritis, Systemic lupus erythematosus,
psoriatic arthritis)
vi. Cancer not in complete remission for >1 year (excluding baso -or
spinocellular skin cancers)
vii. Chronic liver disease (liver cirrhosis Child Pugh A/B/C or other disease
leading to liver dysfunction) as per medical history
b. Age < 50 years with 3 or more of the above-mentioned risk factors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* Changes from baseline to each time point of measurement in viral load<br /><br>(quantitative PCR) and viral cultures, as per assessment schedule<br /><br>* Duration in days to PCR negativity<br /><br>* Measurement of ensovibep in serum and assess PK paramenters (including Cmax,<br /><br>T1/2, Tmax, AUCinf, AUClast, CL, Vss)</p><br>
- Secondary Outcome Measures
Name Time Method <p>* Changes in the Assessment of 14 Common COVID-19-Related Symptoms score per<br /><br>the assessment schedule<br /><br>* Treatment-emergent (serious) adverse events ((S)AEs) throughout the study at<br /><br>every study visit<br /><br>* Adverse events of special interest (AESIs)<br /><br>* Infusion-related reactions (IRRs)<br /><br>* Concomitant medication throughout the study at every study visit<br /><br>* Vital signs (pulse rate (bpm), systolic blood pressure (mmHg), diastolic<br /><br>blood pressure (mmHg), respiratory rate, temperature (ºC), and oxygen<br /><br>saturation (%)) as per the assessment schedule<br /><br>* Clinical laboratory tests (hematology and blood chemistry) as per the<br /><br>assessment schedule<br /><br>* Physical examinations (symptom directed) at every study visit<br /><br>* Assessment of local tolerability at injection site (Visual Infusion Phlebitis<br /><br>score)</p><br>