A Dose Finding, Efficacy and Safety Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19

Part of paid clinical trials in Jasper, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04828161
Phase
PHASE2/PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ensovibep — DRUG
    IV on day 1 only.
  • Placebo — DRUG
    IV on day 1 only.

Study Details

The purpose of this study is to establish the antiviral efficacy of ensovibep against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in humans, identify the optimal dose, and demonstrate its clinical value for treating COVID-19 in adult ambulatory patients.

Key Dates

First listed
Apr 1, 2021
Start date
May 10, 2021
Status verified
Jan 2026
Primary completion
Nov 18, 2021
Completion
Jan 27, 2022

Study Design

Enrollment
407 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 2 / Part A, ensovibep active treatment arm 1
    Phase 2 / Part A: ensovibep active treatment arm 1
  • Experimental: Phase 2 / Part A, ensovibep active treatment arm 2
    Phase 2 / Part A: ensovibep active treatment arm 2
  • Experimental: Phase 2 / Part A, ensovibep active treatment arm 3
    Phase 2 / Part A: ensovibep active treatment arm 3
  • Placebo Comparator: Phase 2 / Part A, Placebo
    Phase 2 / Part A: Placebo
  • Experimental: Phase 3/ Part B, ensovibep active treatment arm 4
    Phase 3/ Part B: ensovibep active treatment. Part B was not initiated.
  • Placebo Comparator: Phase 3/ Part B, Placebo arm
    Phase 3/ Part B: Placebo. Part B was not initiated.

Primary Outcome Measure

Part A: Time-Weighted Change From Baseline in Log10 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Through Day 8 [ Time Frame: Baseline (Day 1) and Days 3, 5 and 8 ]

Locations (27)

FacilityCityStateZIPSite coordinators
Jasper Summit Research, LLCJasperAlabama35501-
Benchmark Southern CaliforniaColtonCalifornia92324-
Ascada ResearchFullertonCalifornia92835-
Pacific Neuropsychiatric SpecialistsMission ViejoCalifornia92691-
Providence Family Medical CenterRedondo BeachCalifornia90277-
Future Innovative TreatmentsColorado SpringsColorado80907-
Boward Infectious Disease and Primary CareMargateFlorida33063-
Bio-Medical Research, LLCMiamiFlorida33184-
Life Spring Research FoundationMiamiFlorida33155-
Suncoast Research Group, LLCMiamiFlorida33135-
Panax Clinical Research, LLCMiami LakesFlorida33014-
AdventHealth TampaTampaFlorida33613-
Palm Beach Research CenterWest Palm BeachFlorida33409-
Gwinnett Research InstituteBufordGeorgia30519-
IACT HealthColumbusGeorgia31904-
Great Lakes Clinical TrialsChicagoIllinois60640-
Centennial Medical Group - Research DepartmentElkridgeMaryland21075-
Jefferson City Medical GroupJefferson CityMissouri65109-
Monroe Biomedical ResearchMonroeNorth Carolina28112-
Wilmington HealthWilmingtonNorth Carolina28412-
VitaLink ResearchGreenvilleSouth Carolina29615-
Clinical Research of Rock HillRock HillSouth Carolina29732-
1960 Family Practice, PAHoustonTexas77090-
Fairway Medical ClinicHoustonTexas77087-
Zion Urgent Care ClinicKatyTexas77494-
Family Practice CenterMcAllenTexas78501-
Epic Medical ResearchRed OakTexas75154-

Find similar trials in Jasper, AL

Nationwide
COVID-19 / long COVID trialsInfectious disease trials
By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Jasper Summit Research, LLC· Jasper, ALBenchmark Southern California· Colton, CAAscada Research· Fullerton, CAPacific Neuropsychiatric Specialists· Mission Viejo, CAProvidence Family Medical Center· Redondo Beach, CAFuture Innovative Treatments· Colorado Springs, CO

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