SARS-CoV-2 InfectionPhase 1NCT05142306
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
A Phase 1 study testing COVID-HIG in people with SARS-CoV-2 Infection, run by Emergent BioSolutions at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- COVID-HIG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Dec 2021to 31 May 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- 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
- Women of childbearing potential who are not planning to be pregnant during the study period who meet all of criteria i-iii:
- 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).
- 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.
Who cannot join
- 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.
- Screening clinical laboratory test result greater than the laboratory's upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), random glucose, total and/or direct bilirubin, blood urea nitrogen (BUN), or creatinine. Other serum chemistry parameters that are not within the reference range will not be considered exclusionary unless deemed clinically significant by the principal investigator.
- Positive laboratory evidence of current infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV). Note: Positive anti-HCV antibody result along with a negative HCV PCR would NOT be exclusionary.
- History of allergy or hypersensitivity to blood or plasma products or to COVID-HIG excipients (proline, PS80).
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- 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.
- Other condition which may place participant at increased risk due to participation in the study or may impact study compliance as determined by the investigator.
- An opinion of the investigator (or designee) that it would not be in the best interest of the individual to participate in the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Qps-Mra, Llc
Miami, Florida, 33143
Bio-Kinetic Clinical Applications, LLC
Springfield, Missouri, 65802
About this study
Official title: A Phase 1, Open-Label, Randomized Study to Evaluate Safety and Pharmacokinetics of Anti-SARS-CoV-2 Immunoglobulin (Human) Investigational Product (COVID-HIG) Administered Through Intramuscular, Subcutaneous or Intravenous Routes as a Single Dose Regimen to SARS-CoV-2 Uninfected Adults
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.
Read the detailed description
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.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- COVID-HIG
- Keywords
- COVID-19, Coronavirus disease 2019, Severe acute respiratory syndrome coronavirus 2, immunoglobulins, intravenous, subcutaneous, intramuscular
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-HIGBiological
Also called NP-028
Anti-SARS-CoV-2 Immunoglobulin (Human) [COVID-HIG] is a purified liquid immunoglobulin G (IgG) preparation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Biological: COVID-HIG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start7 Dec 2021
- Primary completion28 Mar 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants in two cohorts will be enrolled and assigned equally to one of three study arms.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergent BioSolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Gideon Akintunde, MD, Study director, Emergent BioSolutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142306
- Sponsor's protocol ID
- EBS-CVH-006
- Status last verified
- May 2025
- First submitted
- 30 Nov 2021
- Last updated
- 8 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Randomized Study to Evaluate Safety and Pharmacokinetics of Anti-SARS-CoV-2 Immunoglobulin (Human) Investigational Product (COVID-HIG) Administered Through Intramuscular, Subcutaneous or Intravenous Routes as a Single Dose Regimen to SARS-CoV-2 Uninfected Adults
- ClinicalTrials.gov ID
- NCT05142306
- Acronym / sponsor ID
- EBS-CVH-006
- Conditions
- SARS-CoV-2 Infection
- Keywords
- COVID-19, Coronavirus disease 2019, Severe acute respiratory syndrome coronavirus 2, immunoglobulins, intravenous, subcutaneous, intramuscular
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Emergent BioSolutionsIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Posted 20 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants in two cohorts will be enrolled and assigned equally to one of three study arms.
| Arm | Type | Receives |
|---|---|---|
| COVID-HIG Intramuscular | Experimental | Biological: COVID-HIGEligible 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 | Biological: COVID-HIGEligible 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 | Biological: COVID-HIGEligible 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
- Screening clinical laboratory test result greater than the laboratory's upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), random glucose, total and/or direct bilirubin, blood urea nitrogen (BUN), or creatinine. Other serum chemistry parameters that are not within the reference range will not be considered exclusionary unless deemed clinically significant by the principal investigator.
- Positive laboratory evidence of current infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV). Note: Positive anti-HCV antibody result along with a negative HCV PCR would NOT be exclusionary.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-HIGAlso: NP-028Anti-SARS-CoV-2 Immunoglobulin (Human) [COVID-HIG] is a purified liquid immunoglobulin G (IgG) preparation | Biological | COVID-HIG Intramuscular, COVID-HIG Intravenous, COVID-HIG Subcutaneous |
Primary outcome
Participants With Adverse Events (AEs) up to 72 Hours Post-dosing
Time frame: 72 hours
Number of participants with AEs and severity of AEs up to 72 hours post-dosing.
Participants With Adverse Events That Led to Discontinuation or Temporary Suspension of Study Treatment
Time frame: Day 1
Number of participants and severity of AEs that led to discontinuation or temporary suspension of study treatment.
Participants With AEs and SAEs After Study Treatment
Time frame: Day 0 to Day 57
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.
Total Number of AEs and SAEs After Study Treatment
Time frame: Day 0 to Day 57
Number of adverse events (AEs) and serious adverse events (SAEs) in all participants reporting AEs/SAEs up to 56 days post-dosing.
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
Time frame: Day 1 to Day 57
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.
Pharmacokinetics Parameter of Area Under the Concentration-time (AUC) From Time 0 to Infinity (AUC0-inf) After Dose of COVID-HIGIV
Time frame: Day 1 to Day 57
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.
Pharmacokinetics Parameter of Maximum Observed Concentration (Cmax) of SARS-CoV-2 Antibodies Observed After Dose of COVID-HIG
Time frame: Day 1 to Day 57
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.
Pharmacokinetics Parameter of Time at Which Cmax Occurs After Dose of COVID-HIG
Time frame: Day 1 to Day 57
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.
Pharmacokinetics Parameter of Trough Concentration of SARS-CoV-2 Antibodies Observed 28 Days After Dose (Cmin28d) of COVID-HIG
Time frame: Day 1 to Day 29
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.
5 secondary outcomes
Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to 28 Days (AUC0-28d) After Dose of COVID-HIG.
Time frame: 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
Time frame: Day 1 to Day 15
Pharmacokinetics Parameter of Apparent Terminal Elimination Half-life (T1/2) After Dose of COVID-HIG
Time frame: Day 1 to Day 57
Pharmacokinetics Parameter of Systemic Clearance (CL) After Dose of COVID-HIG
Time frame: Day 1 to Day 57
Pharmacokinetic Parameter of Volume of Distribution (Vz) After Dose of COVID-HIG
Time frame: Day 1 to Day 57
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gideon Akintunde, MD study director
Emergent BioSolutions
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing COVID-HIG in people with SARS-CoV-2 Infection, run by Emergent BioSolutions at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants With Adverse Events (AEs) up to 72 Hours Post-dosing (time frame: 72 hours). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.