- |||||||||| COVID-HIG / CSL Behring, Emergent Biosolutions, Mount Sinai, ImmunoTek, Takeda, Grifols
P1 data, PK/PD data, Journal: 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. (Pubmed Central) - Mar 20, 2023
The half-life of COVID-HIGIV per dose level was 24 d (583 h), 31 d (753 h), and 26 d (619 h) for the 100?mg/kg, 200?mg/kg, and 400?mg/kg groups, respectively. The safety and pharmacokinetics of COVID-HIGIV support its development as a single-dose regimen for postexposure prophylaxis or treatment of COVID-19.
- |||||||||| COVID-HIG / CSL Behring, Emergent Biosolutions, Mount Sinai, ImmunoTek, Takeda, Grifols
PK/PD data, Preclinical, Journal: Pharmacokinetic and Pharmacodynamic Effects of Polyclonal Antibodies against SARS-CoV2 in Mice. (Pubmed Central) - Jan 22, 2023
AUC increased and mean residence time, T, and Vd reduced in infected animals compared to healthy animals. These data suggest that COVID-HIGIV may be an effective treatment for SARS-CoV-2 infection when given early after exposure.
- |||||||||| VXA-CoV2-1 / Vaxart, Emergent Biosolutions
Preclinical, Journal: Efficacy of COVID-HIGIV in animal models of SARS-CoV-2 infection. (Pubmed Central) - Oct 18, 2022
P3
In hamsters, COVID-HIGIV treatment reduced infection-associated lung pathology including lung inflammation, and pneumocyte hypertrophy in the lungs. These results support ongoing trials for outpatient treatment with COVID-HIGIV for safety and efficacy evaluation (NCT04910269, NCT04546581).
- |||||||||| COVID-HIG / CSL Behring, Emergent Biosolutions, Mount Sinai, ImmunoTek, Takeda, Grifols
Trial completion, Enrollment change: 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) - Jun 21, 2022
P1, N=23, Completed,
These results support ongoing trials for outpatient treatment with COVID-HIGIV for safety and efficacy evaluation (NCT04910269, NCT04546581). Recruiting --> Completed | N=36 --> 23
- |||||||||| COVID-HIG / CSL Behring, Emergent Biosolutions, Mount Sinai, ImmunoTek, Takeda, Grifols
Enrollment open: 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) - Jan 25, 2022
P1, N=36, Recruiting,
Recruiting --> Completed | N=36 --> 23 Not yet recruiting --> Recruiting
- |||||||||| COVID-HIG / CSL Behring, Emergent Biosolutions, Mount Sinai, ImmunoTek, Takeda, Grifols
New P1 trial: 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) - Dec 2, 2021
P1, N=36, Not yet recruiting,
- |||||||||| COVID-HIG / CSL Behring, Emergent Biosolutions, Mount Sinai, ImmunoTek, Takeda, Grifols
Trial completion: A COVID-19 Study to Evaluate Safety and Pharmacokinetics of COVID-HIGIV Administered in Healthy Adults (clinicaltrials.gov) - Aug 17, 2021
P1, N=28, Completed,
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- |||||||||| COVID-HIG / CSL Behring, Emergent Biosolutions, Mount Sinai, ImmunoTek, Takeda, Grifols
Trial completion: Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC) (clinicaltrials.gov) - Aug 11, 2021
P3, N=593, Completed,
Active, not recruiting --> Completed Active, not recruiting --> Completed
- |||||||||| COVID-HIG / CSL Behring, Emergent Biosolutions, Mount Sinai, ImmunoTek, Takeda, Grifols
Enrollment closed, Enrollment change: A COVID-19 Study to Evaluate Safety and Pharmacokinetics of COVID-HIGIV Administered in Healthy Adults (clinicaltrials.gov) - Jun 21, 2021
P1, N=28, Active, not recruiting,
Overall, these studies demonstrate the efficacy of human plasma-derived FLU-IGIV in relevant animal models of influenza virus infection. Recruiting --> Active, not recruiting | N=56 --> 28
- |||||||||| COVID-HIG / CSL Behring, Emergent Biosolutions, Mount Sinai, ImmunoTek, Takeda, Grifols
Enrollment closed: Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC) (clinicaltrials.gov) - Feb 14, 2021
P3, N=593, Active, not recruiting,
Recruiting --> Active, not recruiting | N=56 --> 28 Recruiting --> Active, not recruiting
- |||||||||| COVID-HIG / CSL Behring, Emergent Biosolutions, Mount Sinai, ImmunoTek, Takeda, Grifols
Enrollment open: Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC) (clinicaltrials.gov) - Oct 19, 2020
P3, N=500, Recruiting,
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
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