A COVID-19 Study to Evaluate Safety and PK of COVID-HIG Administered Through IM, SC, or IV Routes to SARS-CoV-2 Uninfected Adults

NCT05142306 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: EBS-CVH-006
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objectives of this open-label trial were to evaluate the safety and pharmacokinetics (PK) of Anti-SARS-CoV-2 Immunoglobulin (Human) Investigational Product (COVID-HIG) administered intramuscularly (IM), subcutaneously (SC), or intravenously (IV) as a single dose in healthy adults 18-59 years of age with body mass index ≤35 kg/m\^2. Prior studies examined IV administration, and the secondary objective of the present study was to compare PK among the three administration routes. No placebo group was included in the phase 1 randomized design. The exploratory objective was to evaluate disease severity in participants that became positive for SARS-CoV-2.

Conditions

SARS-CoV-2 Infection

Keywords

COVID-19; Coronavirus disease 2019; Severe acute respiratory syndrome coronavirus 2; immunoglobulins; intravenous; subcutaneous; intramuscular

Outcome Measures

Primary Outcomes (9)

• Participants With Adverse Events (AEs) up to 72 Hours Post-dosing

  Number of participants with AEs and severity of AEs up to 72 hours post-dosing.

  72 hours

• Participants With Adverse Events That Led to Discontinuation or Temporary Suspension of Study Treatment

  Number of participants and severity of AEs that led to discontinuation or temporary suspension of study treatment.

  Day 1

• Participants With AEs and SAEs After Study Treatment

  Number of participants with adverse events (AEs) and serious adverse events (SAEs) up to 56 days post-administration of a single dose of COVID-HIG.

  Day 0 to Day 57

• Total Number of AEs and SAEs After Study Treatment

  Number of adverse events (AEs) and serious adverse events (SAEs) in all participants reporting AEs/SAEs up to 56 days post-dosing.

  Day 0 to Day 57

• Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-last) of SARS-CoV-2 Antibodies After Dose of COVID-HIG

  The area under the concentration-time curve from time 0 to the last quantifiable concentration of SARS-CoV-2 binding IgG antibodies after COVID-HIG dose. Data for PK calculations was collected: pre-dose, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 3, Day 4, Day 6, Day 8, Day 15, Day 29, Day 43, and Day 57.

  Day 1 to Day 57

• Pharmacokinetics Parameter of Area Under the Concentration-time (AUC) From Time 0 to Infinity (AUC0-inf) After Dose of COVID-HIGIV

  Area under the concentration-time curve from time 0 to the last quantifiable concentration plus the additional area extrapolated to infinity of SARS-CoV-2 binding IgG antibodies after COVID-HIG dose. Data for PK calculations was collected: pre-dose, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 3, Day 4, Day 6, Day 8, Day 15, Day 29, Day 43, and Day 57.

  Day 1 to Day 57

• Pharmacokinetics Parameter of Maximum Observed Concentration (Cmax) of SARS-CoV-2 Antibodies Observed After Dose of COVID-HIG

  The Cmax of SARS-CoV-2 binding IgG antibodies observed after COVID-HIG dose. Data for PK calculations was collected: pre-dose, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 3, Day 4, Day 6, Day 8, Day 15, Day 29, Day 43, and Day 57.

  Day 1 to Day 57

• Pharmacokinetics Parameter of Time at Which Cmax Occurs After Dose of COVID-HIG

  Time at which Cmax occurs (Tmax) after COVID-HIG dose. Data for PK calculations was collected: pre-dose, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 3, Day 4, Day 6, Day 8, Day 15, Day 29, Day 43, and Day 57.

  Day 1 to Day 57

• Pharmacokinetics Parameter of Trough Concentration of SARS-CoV-2 Antibodies Observed 28 Days After Dose (Cmin28d) of COVID-HIG

  The observed trough concentration of SARS-CoV-2 binding IgG antibodies 28 days after COVID-HIG dose. Data for PK calculations was collected: pre-dose, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 3, Day 4, Day 6, Day 8, Day 15, and Day 29.

  Day 1 to Day 29

Secondary Outcomes (5)

• Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to 28 Days (AUC0-28d) After Dose of COVID-HIG.

  Day 1 to Day 29

• Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to 14 Days After Dose of COVID-HIG

  Day 1 to Day 15

• Pharmacokinetics Parameter of Apparent Terminal Elimination Half-life (T1/2) After Dose of COVID-HIG

  Day 1 to Day 57

• Pharmacokinetics Parameter of Systemic Clearance (CL) After Dose of COVID-HIG

  Day 1 to Day 57

• Pharmacokinetic Parameter of Volume of Distribution (Vz) After Dose of COVID-HIG

  Day 1 to Day 57

Other Outcomes (1)

• Comparative Bioavailability: Area Under the Concentration-time Curve (AUC) From Time 0 to Last (AUC0-last) Ratios Between Administration Routes

  Day 1 to Day 57

Study Arms (3)

COVID-HIG Intramuscular

EXPERIMENTAL

Eligible subjects will be randomized to receive an 8.5mL dose of COVID-HIG by IM injections. COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.

Biological: COVID-HIG

COVID-HIG Subcutaneous

EXPERIMENTAL

Eligible subjects will be randomized to receive an 8.5mL dose of COVID-HIG by SC injections. COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.

Biological: COVID-HIG

COVID-HIG Intravenous

EXPERIMENTAL

Eligible subjects will be randomized to receive an 8.5mL dose of COVID-HIG by IV infusion. COVID-HIG: COVID-HIG is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2.

Biological: COVID-HIG

Interventions

COVID-HIG BIOLOGICAL

Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation

Also known as: NP-028

COVID-HIG Intramuscular; COVID-HIG Intravenous; COVID-HIG Subcutaneous

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able and willing to provide written informed consent (voluntarily signed by the participant) prior to performing study procedures.
• Females and males 18-59 years of age.
• Have a body mass index (BMI) less than or equal to 35.0 kg/m\^2
• Healthy, based on medical history (no chronic disease, no chronic therapy, no ongoing acute condition within four weeks prior to dosing), normal physical examination (no clinically significant findings in the opinion of the investigator), and screening laboratory assessments (no clinically significant findings in the opinion of the investigator).
• No clinical symptoms suspicious for COVID-19 infection, as well as SARS-CoV-2 Immunoglobulin M (IgM) antibody negative and no laboratory evidence of current SARS-CoV-2 infection (i.e., reverse transcription polymerase chain reaction (RT-PCR) negative for SARS-CoV-2) at Screening.
• Females must not be pregnant, or trying to become pregnant as demonstrated by either of the following A or B:
• A. Not of childbearing potential: surgically sterile (at least six weeks post bilateral salpingectomy, bilateral oophorectomy, or hysterectomy); or post-menopausal (history of ≥12 consecutive months without menses prior to randomization in the absence of other pathologic or physiologic causes and confirmed by follicle stimulating hormone \[FSH\] level ≥40 mIU/mL) OR
• B. Women of childbearing potential who are not planning to be pregnant during the study period who meet all of criteria i-iii:
• i. Negative serum pregnancy test at the Screening Visit. ii. Negative urine pregnancy test on Day 1 (a positive test will result in discontinuation from intervention).
• iii. Using one of the following highly effective methods of contraception during the study:
• Combined estrogen and progestogen, or progestogen-only hormonal contraception associated with inhibition of ovulation (e.g., implants, pills, patches) initiated ≥30 days prior to Study Day 1.
• Intrauterine device (IUD) or hormone releasing intrauterine system (IUS) inserted ≥30 days prior to Study Day 1.
• Participant understands and agrees to comply with planned study procedures.

You may not qualify if:

• Use of any investigational product within 30 days or SARS-CoV-2 monoclonal antibodies and COVID-19 convalescent plasma within 90 days prior to Screening or anticipated receipt during the study follow-up period, or participant plans to participate in another clinic study during the study period.
• Receipt of 1 or 2 doses COVID-19 vaccine within 60 days prior to screening or during the study follow-up period.
• SARS-CoV-2 IgG antibody levels \>80 AU/mL as determined by the Diasorin LIAISON SARS-CoV-2 S1/S2 IgG antibody assay.
• History of allergy or hypersensitivity to blood or plasma products or to COVID-HIG excipients (proline, PS80).
• History of allergy to latex or rubber.
• History of hemolytic anemia.
• History of Immunoglobulin A (IgA) deficiency.
• Receipt of any blood product within the past 12 months.
• Plasma donation within 7 days or blood loss/donation (\>450 mL) within 56 days of dosing.
• History of known congenital or acquired immunodeficiency or receipt of immunosuppressive therapy (e.g., prednisone or equivalent for more than two consecutive weeks within the past three months).
• History of thrombosis or hypercoagulable state with increased risk of thrombosis.
• Receipt of a live vaccine within 30 days prior to screening or anticipated receipt of a live vaccine during the study period.
• Currently pregnant, breastfeeding, or planning to become pregnant during the study.
• History of, or suspected substance abuse problem (including alcohol).
• Any planned elective surgery or procedure during the follow-up period that impacts study compliance.

Sponsors & Collaborators

• Emergent BioSolutions: lead
• United States Department of Defense: collaborator

Study Sites (2)

Qps-Mra, Llc

Miami, Florida, 33143, United States

Location

Bio-Kinetic Clinical Applications, LLC

Springfield, Missouri, 65802, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Mila Mirceta, PhD, Senior Scientist, Clinical Research
• Organization: Emergent BioSolutions Canada Inc

mircetam@ebsi.com

204-275-4074

Study Officials

• Gideon Akintunde, MD

  Emergent BioSolutions

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants in two cohorts will be enrolled and assigned equally to one of three study arms.

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 2, 2021
• Study Start: December 7, 2021
• Primary Completion: March 28, 2022
• Study Completion: May 31, 2022
• Last Updated: June 8, 2025
• Results First Posted: May 20, 2024

Record last verified: 2025-05

Locations

US (2)