Table 1.
Clinical studies on pooled antibody-directed therapies against SARS-CoV-2
| Format (and example candidates) | Antibody source | Sponsor(s) | ROA | Number of clinical studiesa | Most advanced stage | Example NCTsb |
|---|---|---|---|---|---|---|
| Convalescent plasma | Convalescent patients | Multiple hospitals and medical facilities | IV | 192a | Phase III; US-FDA EUA 8/23/20 | NCT04361253 and many others |
| Specific (hyperimmune) IVIg | Convalescent patients | Green Cross Corp., Emergent Biosolutions, others | IV, SC | 21 | Phase III | NCT04555148 |
| Normal IVIg (e.g., Gamunex-C) | Pooled human donors | Grifols Therapeutics, Emergent BioSolutions, others | IV, SC, IM | 11 | Phase III | NCT04480424, NCT04561115 |
| Hyperimmune equine serac (e.g., INM005) | Immunized horses | Immunova SA; Hospital San Jose Tec de Monterrey; Bharat Serums and Vaccines Ltd; others | IV | 9 | Phase II/III | NCT04514302, NCT04494984, NCT04834908 |
| Non-specific plasma exchange | Pooled non-specific human donors | Multiple hospitals | IV | 6 | NA | NCT04751643 |
| Recombinant purified human IgGs from immunized cows (SAB-185) | Immunized tg cows | SAB Biotherapeutics | IV | 3 | Phase II/III | NCT04468958. NCT04469179, NCT04518410 |
| Bovine IgG (EnteraGam®) | Cows | Entera Health, Inc | Oral | 2 | NA | NCT04682041 |
| Glycoengineered hyperimmune porcine antibodies (XAV-19) | Immunized pigs | Xenothera SAS | IV | 2 | Phase II/III | NCT04453384, NCT04928430 |
| Polyclonal antibody preparation containing IgG (56%), IgA (21%), and IgM (23%) (Trimodulin; BT-588) | Purified from pooled plasma obtained from donors | Biotest AG | IV | 1 | Phase II | NCT04576728 |
| Polyclonal recombinant hyperimmune IgG (GIGA-2050) | Pooled recombinant IgGs | Gigagen | IV | 1 | Phase I | NCT04883138 |
| Polyclonal hyperimmune IgY | Immunized chickens | Stanford University | IN | 1 | Phase I | NCT04567810 |
| Hyperimmune antibodies | Colostrum from immunized cows | Icosagen Cell Factory | IN | 1 | Phase I | NCT04916574 |
EUA emergency use authorization (USA), Ig immunoglobulin, IM intramuscular, IN intranasal, IV intravenous (administration), IVIg intravenous immunoglobulin, NA not applicable (approved for other indication), NCT National Clinical Trial, ROA route of administration, SC subcutaneous (administration), tg transgenic, US-FDA United States Food and Drug Administration
aAt least this number of separate studies registered with NCT; studies registered with EudraCT (European Union Drug Regulating Authorities Clinical Trials Database; ANZCTR (Australian New Zealand Clinical Trials Registry), ChiCTR (Chinese Clinical Trial Registry), or other registries not included. Based on public data available by 9/1/21
bNCT registries can be found using reference [7]
cEither Fab or F(Ab′)2 fragments isolated from the serum of immunized horses