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Immunoglobulin

COVID-HIG for COVID-19

Phase 1
Waitlist Available
Research Sponsored by Emergent BioSolutions
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 57
Awards & highlights

Study Summary

It is hypothesized that COVID-HIG in all three routes of administration (intramuscular [IM], subcutaneous [SC], and intravenous [IV]) is well-tolerated and that concentrations of SARS-CoV-2 antibodies will be measurable over time, with derived pharmacokinetic (PK) parameters in line with immunoglobulin product class kinetics.

Eligible Conditions
  • COVID-19

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 57
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 57 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse events leading to discontinuation or temporary suspension of study treatment administration
Adverse events up to 56 days post-administration of a single dose
Adverse events within 72 hours post-dosing
+6 more
Secondary outcome measures
Pharmacokinetic parameter of AUC0-14d after COVID-HIG dosing
Pharmacokinetic parameter of AUC0-28d after COVID-HIG dosing
Pharmacokinetic parameter of AUC0-inf ratios (bioavailability) compared between routes for comparable dose levels
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: COVID-HIG SubcutaneousExperimental Treatment1 Intervention
COVID-HIG single dose administered SC
Group II: COVID-HIG IntravenousExperimental Treatment1 Intervention
COVID-HIG single dose administered IV
Group III: COVID-HIG IntramuscularExperimental Treatment1 Intervention
COVID-HIG single dose administered IM
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
COVID-HIG
2021
Completed Phase 1
~30

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Emergent BioSolutionsLead Sponsor
61 Previous Clinical Trials
937,421 Total Patients Enrolled
1 Trials studying COVID-19
28 Patients Enrolled for COVID-19
United States Department of DefenseFED
865 Previous Clinical Trials
327,676 Total Patients Enrolled
19 Trials studying COVID-19
6,952 Patients Enrolled for COVID-19
Gideon Akintunde, MDStudy DirectorEmergent BioSolutions
1 Previous Clinical Trials
3,862 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A COVID-19 Study to Evaluate Safety and PK of COVID-HIG Administered Through IM, SC, or IV Routes as a Single Dose Regimen to SARS-CoV-2 Uninfected Adults
2021. "A COVID-19 Study to Evaluate Safety and PK of COVID-HIG Administered Through IM, SC, or IV Routes as a Single Dose Regimen to SARS-CoV-2 Uninfected Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05142306.
~7 spots leftby Apr 2025
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