Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT04834856
Status:
COMPLETED
Last Update Posted:
2021-09-08
First Post:
2021-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Viral Clearance, PK and Tolerability of Ensovibep in COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000715987', 'term': 'ensovibep'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-07', 'studyFirstSubmitDate': '2021-04-06', 'studyFirstSubmitQcDate': '2021-04-06', 'lastUpdatePostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SARS-CoV-2 viral load', 'timeFrame': 'up to day 29', 'description': 'Changes from baseline to each time point of measurement in SARS-CoV-2 viral load in nasopharyngeal swabs'}, {'measure': 'SARS-CoV-2 viral cultures', 'timeFrame': 'up to day 29', 'description': 'Changes from baseline to each time point of measurement in SARS-CoV-2 viral cultures cultivated from nasopharyngeal swabs'}, {'measure': 'SARS-CoV-2 PCR days to negativity', 'timeFrame': 'up to day 29', 'description': 'Duration in days to SARS-CoV-2 PCR negativity'}, {'measure': 'Observed maximum concentration (Cmax)', 'timeFrame': 'up to day 91', 'description': 'The maximum observed concentration (Cmax) is estimated based on the serum concentrations.'}, {'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'}], 'secondaryOutcomes': [{'measure': '14 Common Covid-19 Related Symptoms score', 'timeFrame': 'up to day 29', 'description': 'Changes in the assessment of 14 Common Covid-19 Related Symptoms score'}, {'measure': 'Treatment-emergent (serious) adverse events ((S)AEs) and AEs of Special Interest (AESIs) including Infusion-related reactions (IRRs)', 'timeFrame': 'up to day 91', 'description': 'Treatment-emergent (S)AEs and AESIs, including infusion-related reactions (IRRs) will be assessed throughout the study'}, {'measure': 'Concomitant medication', 'timeFrame': 'up to day 91', 'description': 'Intake of concomitant medication will be assessed throughout the study'}, {'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', 'description': 'Local tolerability at injection site will be assessed via Visual Infusion Phlebitis score'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2', 'Corona', 'DARPin'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or non-pregnant women, between 18 and 70 years on the day of inclusion.\n* 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.\n* Positive test for SARS-CoV-2 in upper respiratory swab on the day of dosing (rapid antigen test).\n\nExclusion Criteria:\n\n* Requiring hospitalization at time of screening, or at time of study drug administration.\n* Oxygen saturation (SpO2) ≤ 93 percent (%) on room air at sea level, respiratory rate ≥ 30 per minute, or heart rate ≥125 per minute.\n* Any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.\n* Any co-morbidity requiring hospitalization or surgery within \\<7 days, or that is considered life-threatening within 29 days.\n* 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.\n* Prior or concurrent use of SARS-CoV-2 antiviral medication, including convalescent serum or anti-viral antibodies.\n* 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.\n* Women that are currently breast feeding, pregnant, or plan to get pregnant during the duration of the trial.\n* 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.\n* Subjects at high risk for of COVID-19 related complications or mortality'}, 'identificationModule': {'nctId': 'NCT04834856', 'briefTitle': 'Viral Clearance, PK and Tolerability of Ensovibep in COVID-19 Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Molecular Partners AG'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'MP0420-CP204'}, 'secondaryIdInfos': [{'id': '2021-000365-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ensovibep dose 1', 'interventionNames': ['Drug: ensovibep']}, {'type': 'EXPERIMENTAL', 'label': 'ensovibep dose 2', 'interventionNames': ['Drug: ensovibep']}], 'interventions': [{'name': 'ensovibep', 'type': 'DRUG', 'otherNames': ['MP0420'], 'description': '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.', 'armGroupLabels': ['ensovibep dose 1', 'ensovibep dose 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2333', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Centre for Human Drug Research', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Molecular Partners AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}