Which immunotherapies are being investigated for the treatment of coronavirus disease 2019 (COVID-19)?

Updated: Jul 02, 2020
  • Author: David J Cennimo, MD, FAAP, FACP, AAHIVS; Chief Editor: Michael Stuart Bronze, MD  more...
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Answer

Table 3. Investigational Immunotherapies for COVID-19 (Open Table in a new window)

Drug Description
CEL-SCI Corporation [286] Preferentially directed immunotherapy using ligand antigen epitope presentation system (LEAPS) peptide technology to reduce COVID-19 viral load and consequent lung damage.
Brilacidin (Innovation Pharmaceuticals) [287, 288] Defensin-mimetic that mimics the immune system and disrupts the pathogen membrane, leading to cell death. It is undergoing clinical-stage testing at a US regional biocontainment laboratory. Also see Table 5 for potential use as a vaccine adjuvant.
Allogeneic natural killer (NK) cells (CYNK-001; Celularity, Inc) [289] FDA-approved investigational new drug for phase 1/2 clinical trial; demonstrates a range of biological activities expected of NK cells, including expression of activating receptors such as NKG2D, DNAM-1, and the natural cytotoxicity receptors NKp30, NKp44, and NKp46, which bind to stress ligands and viral antigens on infected cells.
Autologous, adipose-derived mesenchymal stem cells (HB-adMSCs; Hope Biosciences) [290, 291, 292] Shown to attenuate systemic inflammation in phase 1/2 clinical trial for rheumatoid arthritis. FDA approves phase 2 single-arm, nonrandomized study for COVID-19 in patients ≥50 years with preexisting health conditions or at high exposure risk. Another phase II trial will enroll 100 frontline healthcare workers and first responders. A third clinical trial placebo-controlled study is planned in collaboration with advanced diagnostics healthcare.
MultiStem cell therapy (Athersys) [293] Potential to produce therapeutic factors in response to signals of inflammation and tissue damage. A previous phase 1-2 study assessed therapy in ARDS. The first patient has been enrolled in the phase 2/3 trial—MultiStem Administration for COVID-19 Induced Acute Respiratory Distress Syndrome (MACOVIA) at University Hospital’s Cleveland Medical Center.
CD24Fc (OncoImmune) [294] Biologic that fortifies an innate immune checkpoint against excessive inflammation caused by tissue injuries. Phase 3 testing was initiated April 20, 2020, at the University of Maryland. As of mid-June 2020, 70 patients have been enrolled.
LY3127804 (Eli Lilly Co) [235] Selective monoclonal antibody against angiopoietin 2 (Ang2), which is known to be elevated in patients with ARDS. Trial initiated at several US medical centers to determine if it reduces progression to ARDS or mechanical ventilation.
Bucillamine (Revive Therapeutics) [295] Bucillamine has been shown to significantly attenuate clinical symptoms in respiratory viral infections in humans, primarily via donation of thiols to restore antioxidant and to reduce the activity of cellular glutathione. A phase 3 trial for treatment of mild-to-moderate COVID-19 was approved by the FDA in late April 2020.
Peginterferon lambda (Eiger Biopharmaceuticals; Stanford University) [296] Phase 2 trial initiated in outpatients with mild COVID-19 to evaluate efficacy of reducing viral shedding. Patients receive a single SC dose and are monitored for 28 days. Interferon lambda is thought to target innate immune response against viral pathogens.
Immune globulin IV (Octagam 10%; Octapharma) [297] IND for phase 3 randomized trial accepted by FDA to assess efficacy and safety in patients with severe COVID-19 disease.