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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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This study is designed to evaluate three dose levels of Anti-SARS-CoV-2 Immunoglobulin Intravenous (Human) (COVID-HIGIV) for safety and pharmacokinetics (PK) in healthy adults. Twenty-eight healthy adult subjects will be enrolled into the study to receive a single dose of COVID-HIGIV or placebo with 84 days of safety and PK follow-up post-administration.
This study will be a Phase 1, single-center, randomized, double-blind, placebo-controlled design to assess safety and PK of COVID-HIGIV in healthy adults.
In total, 28 healthy adult subjects are to be enrolled and randomized 2:2:2:1 into four study treatment arms to receive a single intravenous (IV) infusion of one of three COVID-HIGIV dose levels or saline placebo, respectively.
The enrollment/dosing of the first seven subjects in the study will be staggered. Available safety data will be reviewed by Study Monitoring Committee (SMC) after seven subjects have completed at least 72 hours of safety follow-up. Subjects will be followed up for safety and PK up to 84 days post-administration.
The SMC will perform overall ongoing review of safety data during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-HIGIV Dose Level 1 (100 mg/kg) | Experimental | Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg). |
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| COVID-HIGIV Dose Level 2 (200 mg/kg) | Experimental | Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg). |
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| COVID-HIGIV Dose Level 3 (400 mg/kg) | Experimental | Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg). |
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| Dose Placebo (saline) | Placebo Comparator | Eligible subjects randomized to receive a single IV infusion of saline placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-HIGIV | Biological | COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects With Adverse Events (AEs) up to 3 Days Post-dosing | Number of subjects with AEs and severity of AEs up to 3 days post-dosing. | Day 1 through Day 4 |
| Subjects With Adverse Events That Led to Discontinuation or Temporary Suspension of IV Infusion | Number of subjects and severity of treatment emergent adverse events (TEAEs) that led to discontinuation or temporary suspension of IV infusion. | 0 hours to 2.5 hours |
| Subjects With AEs and SAEs After IV Infusion | Number of subjects with TEAEs and SAEs up to 84 days post-dosing. | Day 1 through Day 85 |
| Total Number of AEs and SAEs After IV Infusion | Number of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) in all subjects reporting TEAEs/SAEs up to 84 days post-dosing. | Day 1 through Day 85 |
| Pharmacokinetics (PK) 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-HIGIV | The area under the concentration-time curve from time 0 to the last quantifiable concentration of SARS-CoV-2 binding IgG antibodies after COVID-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85. | Day 1 through Day 85 |
| 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 |
|---|---|---|
| Body-weight Normalized Pharmacokinetics Parameter of Maximum Observed Concentration of SARS-CoV-2 Antibodies Observed After Dose of COVID-HIGIV | The body-weight normalized Cmax (CmaxBWN) of SARS-CoV-2 binding antibodies observed after COVID-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85. |
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Inclusion Criteria:
Able and willing to provide written informed consent (voluntarily signed by the subject) prior to performing study procedures.
Females and males 18-60 years of age, inclusive.
Have a body mass index (BMI) less than or equal to 35.0 kg/m2.
Women who are either:
A) Not of childbearing potential: either surgically sterile (at least six weeks post bilateral tubal ligation, bilateral oophorectomy or hysterectomy); or post-menopausal (defined as ≥50 years of age with a history of ≥12 months without menses prior to randomization in the absence of other pathologic or physiologic causes, following cessation of exogenous sex-hormonal treatment); OR
B) Women of childbearing potential (WOCBP) who are not planning to be pregnant during the study period and meet all of the following criteria:
Negative serum pregnancy test (PT) at Screening; and Negative PT prior to dosing at Day 1; and
Use of a highly effective contraception during the study period:
Subject understands and agrees to comply with planned study procedures.
Healthy as determined by the Principal Investigator based on medical history, physical exam, vital signs, urinalysis, blood chemistry and hematology test results at Screening and evidence of no prior exposure to SARS-CoV-2 (i.e., Reverse transcription polymerase chain reaction [RT-PCR] negative for SARS-CoV-2 and negative for SARS-CoV-2 antibodies) at Screening.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Cabell, MD, MHS | Emergent BioSolutions | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36852998 | Derived | Liu STH, Mirceta M, Lin G, Anderson DM, Broomes T, Jen A, Abid A, Reich D, Hall C, Aberg JA. Safety, Tolerability, and Pharmacokinetics of Anti-SARS-CoV-2 Immunoglobulin Intravenous (Human) Investigational Product (COVID-HIGIV) in Healthy Adults: a Randomized, Controlled, Double-Blinded, Phase 1 Study. Antimicrob Agents Chemother. 2023 Mar 16;67(3):e0151422. doi: 10.1128/aac.01514-22. Epub 2023 Feb 28. |
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Study Protocol and Statistical Analysis Plan (redacted) to be shared.
By April 2025 for up to 2 years
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| ID | Title | Description |
|---|---|---|
| FG000 | COVID-HIGIV Dose Level 1 (100 mg/kg) | Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg). COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion. |
| FG001 | COVID-HIGIV Dose Level 2 (200 mg/kg) | Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg). COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion. |
| FG002 | COVID-HIGIV Dose Level 3 (400 mg/kg) | Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg). COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion. |
| FG003 | Dose Placebo (Saline) | Eligible subjects randomized to receive a single IV infusion of saline placebo. Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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-HIGIV Dose Level 1 (100 mg/kg) | Eligible subjects will be randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg). COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion. |
| 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 | Subjects With Adverse Events (AEs) up to 3 Days Post-dosing | Number of subjects with AEs and severity of AEs up to 3 days post-dosing. | Safety population includes all subjects who received any amount of study treatment. | Posted | Count of Participants | Participants | Day 1 through Day 4 |
|
Adverse events were collected from Day 1 (Dosing Day) through Day 85 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-HIGIV Dose Level 1 (100 mg/kg) | Eligible subjects will be randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg). COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA (23.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Representative | Emergent BioSolutions Canada Inc. | 204-275-4074 | ctgov@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 | Apr 21, 2021 | Mar 28, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 8, 2021 | Mar 28, 2022 | SAP_001.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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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Placebo (saline) | Other | The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion. |
|
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-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85.
| Day 1 through Day 85 |
| Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to 14 Days After Dose of COVID-HIGIV | AUC from time 0 to 14 days (AUC0-14d) of SARS-CoV-2 binding IgG antibodies after COVID-HIGIV. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, and Day 15. | Day 1 through Day 15 |
| Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to 28 Days (AUC0-28d) After Dose of COVID-HIGIV | AUC from time 0 to 28 days of SARS-CoV-2 binding IgG antibodies after COVID-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, and Day 29. | Day 1 through Day 29 |
| Pharmacokinetics Parameter of Maximum Observed Concentration (Cmax) of SARS-CoV-2 Antibodies Observed After Dose of COVID-HIGIV | The Cmax of SARS-CoV-2 binding IgG antibodies observed after COVID-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85. | Day 1 through Day 85 |
| Pharmacokinetics Parameter of Time at Which Cmax Occurs After Dose of COVID-HIGIV | Time at which Cmax occurs (Tmax) after COVID-HIGIV at each dose level .Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85. | Day 1 through Day 85 |
| Pharmacokinetics Parameter of Trough Concentration of SARS-CoV-2 Antibodies Observed 28 Days After Dose (Cmin28d) of COVID-HIGIV | The observed trough concentration of SARS-CoV-2 binding IgG antibodies 28 days after COVID-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, and Day 29. | Day 1 through Day 29 |
| Pharmacokinetics Parameter of Apparent Terminal Elimination Half-life (T1/2) After Dose of COVID-HIGIV | The apparent terminal elimination half-life (T1/2) after dose of COVID-HIGIV. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85. | Day 1 through Day 85 |
| Pharmacokinetics Parameter of Systemic Clearance (CL) After Dose of COVID-HIGIV | The systemic clearance (CL) of SARS-CoV-2 binding IgG antibodies after dose of COVID-HIGIV. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85. | Day 1 through Day 85 |
| Pharmacokinetics Parameter of Volume of Distribution (Vz) After Dose of COVID-HIGIV | The volume of distribution (Vz) of SARS-CoV-2 binding IgG antibodies after dose of COVID-HIGIV. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85. | Day 1 through Day 85 |
| Day 1 through Day 85 |
| Body-weight Normalized 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-HIGIV | The body-weight normalized area under the concentration-time curve from time 0 to the last quantifiable concentration of SARS-CoV-2 binding IgG antibodies after COVID-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85. | Day 1 through Day 85 |
| Body-weight Normalized Pharmacokinetics Parameter of Area Under the Concentration-time (AUC) From Time 0 to the Last Quantifiable Concentration of SARS-CoV-2 Antibodies Plus the Additional Area Extrapolated to Infinity (AUC0-inf) After Dose of COVID-HIGIV | The body-weight normalized 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-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85. | Day 1 through Day 85 |
| Body-weight Normalized Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to 14 Days (AUC0-14d) After Dose of COVID-HIGIV | Body-weight normalized AUC from time 0 to 14 days of SARS-CoV-2 binding IgG antibodies after COVID-HIGIV. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, and Day 15. | Day 1 through Day 15 |
| Body-weight Normalized Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to 28 Days (AUC0-28d) After Dose of COVID-HIGIV | AUC from time 0 to 28 days of SARS-CoV-2 binding IgG antibodies after COVID-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, and Day 29. | Day 1 through Day 29 |
| Body-weight Normalized Pharmacokinetics Parameter of Trough Concentration of SARS-CoV-2 Antibodies Observed 28 Days After Dose (Cmin28d) of COVID-HIGIV | The body-weight normalized observed trough concentration of SARS-CoV-2 binding IgG antibodies 28 days after COVID-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, and Day 29. | Day 1 through Day 29 |
| Lost to Follow-up |
|
| BG001 |
| COVID-HIGIV Dose Level 2 (200 mg/kg) |
Eligible subjects will be randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg). COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion. |
| BG002 | COVID-HIGIV Dose Level 3 (400 mg/kg) | Eligible subjects will be randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg). COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion. |
| BG003 | Dose Placebo (Saline) | Eligible subjects will be randomized to receive a single IV infusion of saline placebo. Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | centimeters |
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| Baseline weight | Mean | Standard Deviation | kilograms |
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| Baseline body mass index | Mean | Standard Deviation | kilograms per meter squared (kg/m^2) |
|
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg). COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion. |
| OG002 | COVID-HIGIV Dose Level 3 (400 mg/kg) | Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg). COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion. |
| OG003 | Dose Placebo (Saline) | Eligible subjects randomized to receive a single IV infusion of saline placebo. Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion. |
|
|
| Primary | Subjects With Adverse Events That Led to Discontinuation or Temporary Suspension of IV Infusion | Number of subjects and severity of treatment emergent adverse events (TEAEs) that led to discontinuation or temporary suspension of IV infusion. | Safety population includes all subjects who received any amount of study treatment. | Posted | Count of Participants | Participants | 0 hours to 2.5 hours |
|
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| Primary | Subjects With AEs and SAEs After IV Infusion | Number of subjects with TEAEs and SAEs up to 84 days post-dosing. | Safety population includes all subjects who received any amount of study treatment. | Posted | Count of Participants | Participants | Day 1 through Day 85 |
|
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| Primary | Total Number of AEs and SAEs After IV Infusion | Number of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) in all subjects reporting TEAEs/SAEs up to 84 days post-dosing. | Safety population includes all subjects who received any amount of study treatment. | Posted | Number | Events | Day 1 through Day 85 |
|
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| Primary | Pharmacokinetics (PK) 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-HIGIV | The area under the concentration-time curve from time 0 to the last quantifiable concentration of SARS-CoV-2 binding IgG antibodies after COVID-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85. | The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample). | Posted | Geometric Mean | 95% Confidence Interval | h*Alliance Units (AU)/mL | Day 1 through Day 85 |
|
|
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| 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-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85. | The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample). | Posted | Geometric Mean | 95% Confidence Interval | h*AU/mL | Day 1 through Day 85 |
|
|
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| Primary | Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to 14 Days After Dose of COVID-HIGIV | AUC from time 0 to 14 days (AUC0-14d) of SARS-CoV-2 binding IgG antibodies after COVID-HIGIV. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, and Day 15. | The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample). | Posted | Geometric Mean | 95% Confidence Interval | h*AU/mL | Day 1 through Day 15 |
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| Primary | Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to 28 Days (AUC0-28d) After Dose of COVID-HIGIV | AUC from time 0 to 28 days of SARS-CoV-2 binding IgG antibodies after COVID-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, and Day 29. | The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample). | Posted | Geometric Mean | 95% Confidence Interval | h*AU/mL | Day 1 through Day 29 |
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| Primary | Pharmacokinetics Parameter of Maximum Observed Concentration (Cmax) of SARS-CoV-2 Antibodies Observed After Dose of COVID-HIGIV | The Cmax of SARS-CoV-2 binding IgG antibodies observed after COVID-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85. | The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample). | Posted | Geometric Mean | 95% Confidence Interval | AU/mL | Day 1 through Day 85 |
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| Primary | Pharmacokinetics Parameter of Time at Which Cmax Occurs After Dose of COVID-HIGIV | Time at which Cmax occurs (Tmax) after COVID-HIGIV at each dose level .Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85. | The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample). | Posted | Mean | Standard Deviation | hours | Day 1 through Day 85 |
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| Primary | Pharmacokinetics Parameter of Trough Concentration of SARS-CoV-2 Antibodies Observed 28 Days After Dose (Cmin28d) of COVID-HIGIV | The observed trough concentration of SARS-CoV-2 binding IgG antibodies 28 days after COVID-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, and Day 29. | The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample). | Posted | Geometric Mean | 95% Confidence Interval | AU/mL | Day 1 through Day 29 |
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| Primary | Pharmacokinetics Parameter of Apparent Terminal Elimination Half-life (T1/2) After Dose of COVID-HIGIV | The apparent terminal elimination half-life (T1/2) after dose of COVID-HIGIV. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85. | The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample). | Posted | Mean | Standard Deviation | hours | Day 1 through Day 85 |
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| Primary | Pharmacokinetics Parameter of Systemic Clearance (CL) After Dose of COVID-HIGIV | The systemic clearance (CL) of SARS-CoV-2 binding IgG antibodies after dose of COVID-HIGIV. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85. | The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample). | Posted | Geometric Mean | 95% Confidence Interval | mL/h | Day 1 through Day 85 |
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| Primary | Pharmacokinetics Parameter of Volume of Distribution (Vz) After Dose of COVID-HIGIV | The volume of distribution (Vz) of SARS-CoV-2 binding IgG antibodies after dose of COVID-HIGIV. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85. | The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample). | Posted | Geometric Mean | 95% Confidence Interval | mL | Day 1 through Day 85 |
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| Secondary | Body-weight Normalized Pharmacokinetics Parameter of Maximum Observed Concentration of SARS-CoV-2 Antibodies Observed After Dose of COVID-HIGIV | The body-weight normalized Cmax (CmaxBWN) of SARS-CoV-2 binding antibodies observed after COVID-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85. | The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample). | Posted | Geometric Mean | 95% Confidence Interval | AU/mL/kg | Day 1 through Day 85 |
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| Secondary | Body-weight Normalized 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-HIGIV | The body-weight normalized area under the concentration-time curve from time 0 to the last quantifiable concentration of SARS-CoV-2 binding IgG antibodies after COVID-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85. | The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample). | Posted | Geometric Mean | 95% Confidence Interval | h*AU/mL/kg | Day 1 through Day 85 |
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| Secondary | Body-weight Normalized Pharmacokinetics Parameter of Area Under the Concentration-time (AUC) From Time 0 to the Last Quantifiable Concentration of SARS-CoV-2 Antibodies Plus the Additional Area Extrapolated to Infinity (AUC0-inf) After Dose of COVID-HIGIV | The body-weight normalized 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-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85. | The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample). | Posted | Geometric Mean | 95% Confidence Interval | h*AU/mL/kg | Day 1 through Day 85 |
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| Secondary | Body-weight Normalized Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to 14 Days (AUC0-14d) After Dose of COVID-HIGIV | Body-weight normalized AUC from time 0 to 14 days of SARS-CoV-2 binding IgG antibodies after COVID-HIGIV. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, and Day 15. | The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample). | Posted | Geometric Mean | 95% Confidence Interval | h*AU/mL/kg | Day 1 through Day 15 |
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| Secondary | Body-weight Normalized Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to 28 Days (AUC0-28d) After Dose of COVID-HIGIV | AUC from time 0 to 28 days of SARS-CoV-2 binding IgG antibodies after COVID-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, and Day 29. | The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample). | Posted | Geometric Mean | 95% Confidence Interval | h*AU/mL/kg | Day 1 through Day 29 |
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| Secondary | Body-weight Normalized Pharmacokinetics Parameter of Trough Concentration of SARS-CoV-2 Antibodies Observed 28 Days After Dose (Cmin28d) of COVID-HIGIV | The body-weight normalized observed trough concentration of SARS-CoV-2 binding IgG antibodies 28 days after COVID-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, and Day 29. | The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample). | Posted | Geometric Mean | 95% Confidence Interval | AU/mL/kg | Day 1 through Day 29 |
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| 0 |
| 8 |
| 0 |
| 8 |
| 3 |
| 8 |
| EG001 | COVID-HIGIV Dose Level 2 (200 mg/kg) | Eligible subjects will be randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg). COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion. | 0 | 8 | 0 | 8 | 6 | 8 |
| EG002 | COVID-HIGIV Dose Level 3 (400 mg/kg) | Eligible subjects will be randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg). COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion. | 0 | 7 | 0 | 7 | 6 | 7 |
| EG003 | Dose Placebo (Saline) | Eligible subjects will be randomized to receive a single IV infusion of saline placebo. Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion. | 0 | 4 | 1 | 4 | 3 | 4 |
| Vision blurred | Eye disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Frequent bowel movements | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Chills | General disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Infusion site pain | General disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Xerosis | General disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
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| Helicobacter gastritis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA (23.0) | Non-systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA (23.0) | Non-systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA (23.0) | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Dysaesthesia | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Thrombophlebitis superficial | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
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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 |
| D017670 |
| Sodium Compounds |
| Any TEAE leading to infusion discontinuation |
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| Number of subjects with serious adverse events (SAEs) |
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| Total number of SAEs for all subjects reporting SAEs |
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