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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
Eligible participants were randomized in two cohorts to receive COVID-HIG by IM, SC or IV in a 1:1:1 ratio and were stratified based on baseline SARS-CoV-2 IgG antibody status (low seropositive/seronegative; high seropositives were excluded). Up to 36 participants were planned to be enrolled and dosed in the study. A protocol amendment truncated the study to 23 randomized participants due to the impact of high circulating SARS-CoV-2 omicron cases on enrollment and participant retention. Participants were planned to be followed through Day 85 (approximately three half-lives), but the protocol was amended to shorten the study length to Day 57 due to timeline and PK considerations. The third substantial protocol amendment change was to remove the planned pseudovirus neutralization assay from the study due to its low sensitivity, limiting the PK analysis to the S-protein binding IgG immunoassay. PK time points included predose and postdose (from end of infusion/injection) 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, Days 2, 3, 4, 6, 8, 15, 29, 43 and 57.
Nasopharyngeal swabs for SARS-CoV-2 were collected throughout the study. Per protocol, participants who became SARS-CoV-2 positive could not be assessed for PK at time points after testing positive, as the assay could not distinguish COVID-HIG from native antibodies. Participants who became SARS-CoV-2 positive during the study had disease severity assessed using an Ordinal Outcome Scale and followed via telemedicine through the end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-HIG | Biological | Anti-SARS-CoV-2 Immunoglobulin (Human) [COVID-HIG] is a purified liquid immunoglobulin G (IgG) preparation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to 28 Days (AUC0-28d) After Dose of COVID-HIG. | AUC from time 0 to 28 days 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, and Day 29. | Day 1 to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparative Bioavailability: Area Under the Concentration-time Curve (AUC) From Time 0 to Last (AUC0-last) Ratios Between Administration Routes | AUC0-last ratios (bioavailability) compared between routes for comparable dose levels (COVID-HIG IM to SC; SC to IV; and IM to IV). Least square mean estimates and 90% confidence intervals were derived from ANOVA model with AUC0-last as dependent variable and administration route as fixed effect. Comparative bioavailability was defined as within [80%, 125%]. |
Inclusion Criteria:
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:
Participant understands and agrees to comply with planned study procedures.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gideon Akintunde, MD | Emergent BioSolutions | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qps-Mra, Llc | Miami | Florida | 33143 | United States | ||
| Bio-Kinetic Clinical Applications, LLC |
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| ID | Title | Description |
|---|---|---|
| FG000 | COVID-HIG Intramuscular (IM) | 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. COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) [COVID-HIG] is a purified liquid immunoglobulin G (IgG) preparation |
| FG001 | COVID-HIG Subcutaneous (SC) | 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. COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) [COVID-HIG] is a purified liquid immunoglobulin G (IgG) preparation |
| FG002 | COVID-HIG Intravenous (IV) | 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. COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) [COVID-HIG] is a purified liquid immunoglobulin G (IgG) preparation |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Data is from the safety population which includes all subjects who received any amount of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | COVID-HIG Intramuscular (IM) | 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. COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) [COVID-HIG] is a purified liquid immunoglobulin G (IgG) preparation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety population includes all participants who received any amount of study treatment. | Posted | Count of Participants | Participants | 72 hours |
|
Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.
Adverse events were unsolicited.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | COVID-HIG Intramuscular (IM) | 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. COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) [COVID-HIG] is a purified liquid immunoglobulin G (IgG) preparation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual Impairment | Eye disorders | MedDRA 23.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mila Mirceta, PhD, Senior Scientist, Clinical Research | Emergent BioSolutions Canada Inc | 204-275-4074 | mircetam@ebsi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 18, 2022 | Feb 6, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 11, 2022 | Feb 6, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 22, 2022 | Feb 6, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Participants in two cohorts will be enrolled and assigned equally to one of three study arms.
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|
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 |
| Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to 14 Days After Dose of COVID-HIG | AUC from time 0 to 14 days (AUC0-14d) of SARS-CoV-2 binding IgG antibodies after COVID-HIG. 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, and Day 15. | Day 1 to Day 15 |
| Pharmacokinetics Parameter of Apparent Terminal Elimination Half-life (T1/2) After Dose of COVID-HIG | The apparent terminal elimination half-life (T1/2) after dose of COVID-HIG. 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 Systemic Clearance (CL) After Dose of COVID-HIG | The systemic clearance (CL) of SARS-CoV-2 binding IgG antibodies after dose of COVID-HIG. . 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 |
| Pharmacokinetic Parameter of Volume of Distribution (Vz) After Dose of COVID-HIG | The volume of distribution (Vz) of SARS-CoV-2 binding IgG antibodies after dose of COVID-HIG. 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 |
| Day 1 to Day 57 |
| Springfield |
| Missouri |
| 65802 |
| United States |
| BG001 | COVID-HIG Subcutaneous (SC) | 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. COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) [COVID-HIG] is a purified liquid immunoglobulin G (IgG) preparation |
| BG002 | COVID-HIG Intravenous (IV) | 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. COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) [COVID-HIG] is a purified liquid immunoglobulin G (IgG) preparation |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Baseline weight | Mean | Standard Deviation | kilograms |
|
| Baseline body mass index | Mean | Standard Deviation | kilograms per meter squared (kg/m^2) |
|
| Baseline SARS-CoV-2 Antibody Status | As measured using the Diasorin LIAISON S1/S2 IgG assay. Seronegative indicates no detectable antibody (<15 AU/mL; <LLOQ). Seropositive indicates detectable antibody ≥15, but ≤80 AU/mL. Subjects with antibody level >80 AU/mL were excluded from the study (as per exclusion criteria #3). | Count of Participants | Participants |
|
| Enrollment per Study Site | Count of Participants | Participants |
|
Eligible participants 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. COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) [COVID-HIG] is a purified liquid immunoglobulin G (IgG) preparation |
| OG002 | COVID-HIG Intravenous (IV) | Eligible participants 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. COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) [COVID-HIG] is a purified liquid immunoglobulin G (IgG) preparation |
|
|
| Primary | 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. | Safety population includes all participants who received any amount of study treatment. | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Primary | 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. | Safety population includes all participants who received any amount of study treatment. | Posted | Count of Participants | Participants | Day 0 to Day 57 |
|
|
|
| Primary | 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. | Safety population includes all participants who received any amount of study treatment. | Posted | Number | Events | Day 0 to Day 57 |
|
|
|
| Primary | 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. | The PK population included all subjects who received COVID-HIG and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample, with samples occurring after a positive SARS-CoV-2 test result excluded). | Posted | Geometric Mean | 95% Confidence Interval | h*Alliance Units (AU)/mL | Day 1 to Day 57 |
|
|
|
| Primary | 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. | The PK population included all subjects who received COVID-HIG and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample, with samples occurring after a positive SARS-CoV-2 test result excluded). | Posted | Geometric Mean | 95% Confidence Interval | h*AU/mL | Day 1 to Day 57 |
|
|
|
| Primary | 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. | The PK population included all subjects who received COVID-HIG and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample, with samples occurring after a positive SARS-CoV-2 test result excluded). | Posted | Geometric Mean | 95% Confidence Interval | AU/mL | Day 1 to Day 57 |
|
|
|
| Primary | 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. | The PK population included all subjects who received COVID-HIG and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample, with samples occurring after a positive SARS-CoV-2 test result excluded). | Posted | Mean | Standard Deviation | hours | Day 1 to Day 57 |
|
|
|
| Primary | 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. | The PK population included all subjects who received COVID-HIG and had an adequate set of evaluable PK samples up to Day 29. | Posted | Geometric Mean | 95% Confidence Interval | AU/mL | Day 1 to Day 29 |
|
|
|
| Secondary | Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to 28 Days (AUC0-28d) After Dose of COVID-HIG. | AUC from time 0 to 28 days 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, and Day 29. | The PK population included all subjects who received COVID-HIG and had an adequate set of evaluable PK samples up to Day 29. | Posted | Geometric Mean | 95% Confidence Interval | h*AU/mL | Day 1 to Day 29 |
|
|
|
| Secondary | Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to 14 Days After Dose of COVID-HIG | AUC from time 0 to 14 days (AUC0-14d) of SARS-CoV-2 binding IgG antibodies after COVID-HIG. 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, and Day 15. | The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples up until Day 15. | Posted | Geometric Mean | 95% Confidence Interval | h*AU/mL | Day 1 to Day 15 |
|
|
|
| Secondary | Pharmacokinetics Parameter of Apparent Terminal Elimination Half-life (T1/2) After Dose of COVID-HIG | The apparent terminal elimination half-life (T1/2) after dose of COVID-HIG. 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. | The PK population included all subjects who received COVID-HIG and had an adequate set of evaluable PK samples. | Posted | Mean | Standard Deviation | hours | Day 1 to Day 57 |
|
|
|
| Secondary | Pharmacokinetics Parameter of Systemic Clearance (CL) After Dose of COVID-HIG | The systemic clearance (CL) of SARS-CoV-2 binding IgG antibodies after dose of COVID-HIG. . 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. | The PK population included all subjects who received COVID-HIG and had an adequate set of evaluable PK samples. | Posted | Mean | Standard Deviation | mL/h | Day 1 to Day 57 |
|
|
|
| Secondary | Pharmacokinetic Parameter of Volume of Distribution (Vz) After Dose of COVID-HIG | The volume of distribution (Vz) of SARS-CoV-2 binding IgG antibodies after dose of COVID-HIG. 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. | The PK population included all subjects who received COVID-HIG and had an adequate set of evaluable PK samples. | Posted | Geometric Mean | 95% Confidence Interval | mL | Day 1 to Day 57 |
|
|
|
| Other Pre-specified | Comparative Bioavailability: Area Under the Concentration-time Curve (AUC) From Time 0 to Last (AUC0-last) Ratios Between Administration Routes | AUC0-last ratios (bioavailability) compared between routes for comparable dose levels (COVID-HIG IM to SC; SC to IV; and IM to IV). Least square mean estimates and 90% confidence intervals were derived from ANOVA model with AUC0-last as dependent variable and administration route as fixed effect. Comparative bioavailability was defined as within [80%, 125%]. | The PK population included all subjects who received COVID-HIG and had an adequate set of evaluable PK samples. In each arm, there were n=7 in the COVID-HIG IM arm, n=8 in the COVID-HIG SC arm and n=7 in the COVID-HIG IV arm. The overall participants analyzed per group as indicated in this bioavailability comparison is the sum of each of the respective groups indicated in the title/description. | Posted | Number | 90% Confidence Interval | ratio | Day 1 to Day 57 |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 6 |
| 7 |
| EG001 | COVID-HIG Subcutaneous (SC) | 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. COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) [COVID-HIG] is a purified liquid immunoglobulin G (IgG) preparation | 0 | 8 | 0 | 8 | 3 | 8 |
| EG002 | COVID-HIG Intravenous (IV) | 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. COVID-HIG: Anti-SARS-CoV-2 Immunoglobulin (Human) [COVID-HIG] is a purified liquid immunoglobulin G (IgG) preparation | 0 | 7 | 0 | 7 | 4 | 7 |
| Food Poisoning | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Asymptomatic COVID-19 | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Bacterial Vulvovaginitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
|
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
|
|