GIGA-2050 / Grifols 
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  • ||||||||||  GIGA-2050 / Grifols
    Journal:  GMP Manufacturing and IND-Enabling Studies of a Recombinant Hyperimmune Globulin Targeting SARS-CoV-2. (Pubmed Central) -  Jul 29, 2022   
    These results supported a successful investigational new drug application for GIGA-2050. This study demonstrates that a new class of drugs, recombinant hyperimmune globulins, can be manufactured consistently at the clinical scale and presents a new approach to treating infectious diseases that targets multiple epitopes of a virus.
  • ||||||||||  GIGA-2050 / Grifols
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  Recombinant Hyperimmune Polyclonal Antibody (GIGA-2050) in COVID-19 Patients (clinicaltrials.gov) -  Jan 26, 2022   
    P1,  N=3, Terminated, 
    This study demonstrates that a new class of drugs, recombinant hyperimmune globulins, can be manufactured consistently at the clinical scale and presents a new approach to treating infectious diseases that targets multiple epitopes of a virus. N=18 --> 3 | Trial completion date: Aug 2021 --> Jan 2022 | Recruiting --> Terminated | Trial primary completion date: Aug 2021 --> Jan 2022; Study stopped for commercial reasons.
  • ||||||||||  GIGA-2050 / Grifols
    Enrollment open:  Recombinant Hyperimmune Polyclonal Antibody (GIGA-2050) in COVID-19 Patients (clinicaltrials.gov) -  Jun 7, 2021   
    P1,  N=18, Recruiting, 
    N=18 --> 3 | Trial completion date: Aug 2021 --> Jan 2022 | Recruiting --> Terminated | Trial primary completion date: Aug 2021 --> Jan 2022; Study stopped for commercial reasons. Not yet recruiting --> Recruiting