A COVID-19 Study to Evaluate Safety and PK of COVID-HIG Administered Through IM, SC, or IV Routes as a Single Dose Regimen to SARS-CoV-2 Uninfected Adults
Condition: SARS-CoV-2 Infection
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      It is hypothesized that COVID-HIG in all three routes of administration (intramuscular [IM],
      subcutaneous [SC], and intravenous [IV]) is well-tolerated and that concentrations of
      SARS-CoV-2 antibodies will be measurable over time, with derived pharmacokinetic (PK)
      parameters in line with immunoglobulin product class kinetics.
    

Detailed description: 
      This will be a Phase 1, two-center, open-label, randomized study to evaluate one dose level
      of COVID-HIG administered IM or SC for safety and PK in healthy adults compared to COVID-HIG
      administered intravenously. Approximately 36 adult participants will be targeted to be
      enrolled in the study. Enrollment into the study will be staggered, wherein no more than
      three participants will be randomized and dosed on the first day with at least one hour
      between dosing of each participant. On the second day, up to two more subjects will be
      randomized and dosed. The remaining participants will be randomized and dosed, with no more
      than 5 participants dosed per day. Safety data will be reviewed by a Safety Monitoring
      Committee (SMC) (consisting of at least three independent external members) after all 12
      participants in Cohort 1 have completed at least 72 hours of safety follow-up. An overall
      decision by the SMC will be made whether to proceed with full randomization (1:1:1) and
      dosing of the remaining study participants (Cohort 2, n=24). Participants will be stratified
      based on their SARS-CoV-2 antibody status (positive/negative) at screening.

      Study enrollment and administration of study treatments may be paused by the PI or medical
      monitor for safety review by the SMC if any of the following occur after study product
      administration and during the enrollment period:

        -  One or more serious adverse event(s) [SAE(s)].

        -  Three or more of the same Grade 3 adverse events (AEs)

        -  Three or more Grade 2 hypersensitivity AEs

      If any participants become positive for SARS-CoV-2 during the study follow-up period, they
      will be assessed using an Ordinal Outcome Scale until symptom resolution and will be followed
      until they complete their last scheduled follow-up visit. Participants who test positive for
      SARS-CoV-2 will be excluded from PK analyses.
    

Intervention name(s): COVID-HIG
Intervention type(s): Biological
Intervention description(s): Anti-SARS-CoV-2 Immunoglobulin (Human) [COVID-HIG] is a purified liquid immunoglobulin G (IgG) preparation
Other intervention name(s): NP-028
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be enrolled and assigned equally to one of 3 study arms.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19; Coronavirus disease 2019; Severe acute respiratory syndrome coronavirus 2; immunoglobulins; intravenous; subcutaneous; intramuscular