NCT05142306 is a Phase 1 clinical trial of COVID-HIG in SARS-CoV-2 Infection, sponsored by Emergent BioSolutions.

Who is sponsoring NCT05142306?

NCT05142306 is sponsored by Emergent BioSolutions.

What drugs are being tested in NCT05142306?

Interventions in NCT05142306: COVID-HIG.

What condition does NCT05142306 study?

NCT05142306 studies SARS-CoV-2 Infection.

Is NCT05142306 still recruiting?

NCT05142306 is currently completed. Last updated 8 June 2025.

Are results published for NCT05142306?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-06-08 · How we verify

NCT05142306

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Results posted Last updated 8 June 2025

What this trial tests

Phase 1 trial testing COVID-HIG in SARS-CoV-2 Infection in 23 participants. Completed in 31 May 2022.

Timeline

7 December 2021

Primary endpoint
28 March 2022

31 May 2022

Quick facts

Lead sponsor	Emergent BioSolutions
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	7 December 2021
Primary completion	28 March 2022
Estimated completion	31 May 2022
Sites	2 locations across United States

Drugs / interventions tested

COVID-HIG — full drug profile →

Conditions studied

SARS-CoV-2 Infection — all drugs for SARS-CoV-2 Infection →

Sponsor

Emergent BioSolutions — full company profile →

Who can join

Adults 18 to 59, any sex, with SARS-CoV-2 Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Participants With Adverse Events (AEs) up to 72 Hours Post-dosing Primary · 72 hours

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

Group	Value	95% CI
COVID-HIG Intramuscular (IM)	2
COVID-HIG Subcutaneous (SC)	1
COVID-HIG Intravenous (IV)	2

Participants With Adverse Events That Led to Discontinuation or Temporary Suspension of Study Treatment Primary · Day 1

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

Group	Value	95% CI
COVID-HIG Intramuscular (IM)	0
COVID-HIG Subcutaneous (SC)	0
COVID-HIG Intravenous (IV)	0

Participants With AEs and SAEs After Study Treatment Primary · 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.

Number of participants with any AE

Group	Value	95% CI
COVID-HIG Intramuscular (IM)	6
COVID-HIG Subcutaneous (SC)	3
COVID-HIG Intravenous (IV)	4

Number of participants with any SAE

Group	Value	95% CI
COVID-HIG Intramuscular (IM)	0
COVID-HIG Subcutaneous (SC)	0
COVID-HIG Intravenous (IV)	0

Total Number of AEs and SAEs After Study Treatment Primary · 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.

Total number of adverse events (AEs) for all participants reporting AEs

Group	Value	95% CI
COVID-HIG Intramuscular (IM)	9
COVID-HIG Subcutaneous (SC)	5
COVID-HIG Intravenous (IV)	9

Total number of SAEs for all participants reporting SAEs

Group	Value	95% CI
COVID-HIG Intramuscular (IM)	0
COVID-HIG Subcutaneous (SC)	0
COVID-HIG Intravenous (IV)	0

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 Primary · 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.

Group	Value	95% CI
COVID-HIG Intramuscular (IM)	6435.44	1889.47 – 21918.78
COVID-HIG Subcutaneous (SC)	9560.60	3382.99 – 27018.99
COVID-HIG Intravenous (IV)	11883.46	6891.36 – 20491.83

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

Group	Value	95% CI
COVID-HIG Intramuscular (IM)	8042.38	2561.73 – 25248.55
COVID-HIG Subcutaneous (SC)	6875.52	5521.48 – 8561.60
COVID-HIG Intravenous (IV)	19212.18	7569.07 – 48765.28

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

Group	Value	95% CI
COVID-HIG Intramuscular (IM)	17.02	8.00 – 36.24
COVID-HIG Subcutaneous (SC)	16.24	7.62 – 34.65
COVID-HIG Intravenous (IV)	56.88	30.41 – 106.39

Pharmacokinetics Parameter of Time at Which Cmax Occurs After Dose of COVID-HIG Primary · 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.

Group	Value	95% CI
COVID-HIG Intramuscular (IM)	174.71	± 221.13
COVID-HIG Subcutaneous (SC)	201.01	± 213.76
COVID-HIG Intravenous (IV)	1.53	± 0.53

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

Group	Value	95% CI
COVID-HIG Intramuscular (IM)	3.67	0.00 – 15928.95
COVID-HIG Subcutaneous (SC)	7.55	2.36 – 24.19
COVID-HIG Intravenous (IV)	8.15	5.58 – 11.91

Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to 28 Days (AUC0-28d) After Dose of COVID-HIG. Secondary · Day 1 to Day 29

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.

Group	Value	95% CI
COVID-HIG Intramuscular (IM)	14610.82	3072.14 – 69487.73
COVID-HIG Subcutaneous (SC)	14624.92	4470.66 – 47842.64
COVID-HIG Intravenous (IV)	12182.14	6935.59 – 21397.55

Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to 14 Days After Dose of COVID-HIG Secondary · Day 1 to Day 15

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.

Group	Value	95% CI
COVID-HIG Intramuscular (IM)	12057.04	3700.79 – 39281.36
COVID-HIG Subcutaneous (SC)	11118.31	3465.31 – 35672.65
COVID-HIG Intravenous (IV)	11883.46	6891.36 – 20491.83

Pharmacokinetics Parameter of Apparent Terminal Elimination Half-life (T1/2) After Dose of COVID-HIG Secondary · Day 1 to Day 57

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.

Group	Value	95% CI
COVID-HIG Intramuscular (IM)	505.50	± 128.13
COVID-HIG Subcutaneous (SC)	535.70	± 61.09
COVID-HIG Intravenous (IV)	673.90	± 356.02

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from Day 1 (Dosing Day) through Day 57 or early withdrawal.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

COVID-HIG Intramuscular (IM)

Serious: 0/7 (0%)

Deaths: 0/7

COVID-HIG Subcutaneous (SC)

Serious: 0/8 (0%)

Deaths: 0/8

COVID-HIG Intravenous (IV)

Serious: 0/7 (0%)

Deaths: 0/7

Other adverse events (15 terms — click to expand)

Reaction	System	COVID-HIG Intramuscular (IM)	COVID-HIG Subcutaneous (SC)	COVID-HIG Intravenous (IV)
Asymptomatic COVID-19	Infections and infestations	—	—	—
Visual Impairment	Eye disorders	—	—	—
Food Poisoning	Gastrointestinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Bacterial Vulvovaginitis	Infections and infestations	—	—	—
COVID-19	Infections and infestations	—	—	—
Dizziness	Nervous system disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—
Hot flush	Vascular disorders	—	—	—
Phlebitis	Vascular disorders	—	—	—

Data from ClinicalTrials.gov NCT05142306 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other Emergent BioSolutions trials

Trials by the same sponsor.

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NCT04661839 — A COVID-19 Study to Evaluate Safety and Pharmacokinetics of COVID-HIGIV Administered in Healthy Adults · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05142306 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Emergent BioSolutions
Last refreshed: 8 June 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05142306.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing