Updated on 3/27
While no specific treatment for coronavirus disease 2019 (COVID-19) is currently available, several therapies are being investigated globally.*
Ampligen: AIM ImmunoTech is developing the broad-spectrum antiviral for COVID-19 in Japan. A significant survival effect was observed in a trial evaluating mice infected with the earlier Severe Acute Respiratory Syndrome (SARS) coronavirus.
Chloroquine: Recent studies have shown that chloroquine can potentially reduce the duration of symptoms and viral shedding in COVID-19 patients. Positive results announced from a small French study that showed treatment was associated with virological cure, particularly when combined with azithromycin.
Danoprevir: A direct-acting antiviral agent being investigated in combination with ritonavir by Ascletis Pharma to treat COVID-19. Danoprevir is currently approved in China for the treatment of chronic hepatitis C infection.
Favipiravir: An antiviral agent produced by Zhejiang Hisun Pharmaceuticals that is currently approved in Japan for influenza treatment. it is now being investigated as a treatment for COVID-19 based on preliminary results from a clinical trial that showed the antiviral alleviated pneumonia symptoms with few adverse reactions.
Lopinavir/ritonavir: AbbVie is collaborating with select health authorities and institutions to determine the antiviral activity of the HIV drug against COVID-19. Recent trial results published in the New England Journal of Medicine showed that the combination therapy was not associated with clinical improvement in patients with confirmed COVID-19.
Remdesivir: The broad-spectrum antiviral agent, developed by Gilead, is being investigated in a double-blinded, placebo-controlled study sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH). In addition, The Company is initiating two phase 3 trials to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19, following a rapid review and acceptance by the Food and Drug Administration (FDA) of the investigational new drug filing for the novel antiviral.
Oxypurinol: XORTX Therapeutics is exploring the use of a new formulation of oxypurinol as a novel treatment for acute kidney and lung injury accompanying COVID-19 infection.
Immunotherapies and Other Investigational Therapies
ACE-MAB: Sorrento Therapeutics is developing a bi-specific fusion protein that binds to the spike protein of coronaviruses, which is expected to block SARS-CoV-2 from binding and infecting respiratory epithelial cells or ACE2-expressing cells.
Aviptadil (RLF-100): Relief Therapeutics is investigating the vasoactive intestinal polypeptide for the treatment of acute respiratory distress syndrome in patients with COVID-19 infection. In animal models, aviptadil has been shown to have potent anti-inflammatory and anti-cytokine activity in the lungs.
Brilacidin: A defensin-mimetic that mimics the human innate immune system and causes disruption of the membrane of pathogens, leading to cell death. It is being developed by Innovation Pharmaceuticals and has already been tested in humans in phase 2 trials for other indications.
Convalescent plasma: Grifols, in collaboration with the US Biomedical Advanced Research Development Authority (BARDA), the FDA and other federal public health agencies will collect plasma from convalescent COVID-19 patients, process the plasma into a hyperimmune globulin and support the necessary preclinical and clinical studies to determine if anti-SARS-CoV-2 hyperimmune globulin therapy can successfully be used to treat COVID-19 disease.
Gimsilumab: A fully human monoclonal antibody targeting granulocyte-macrophage colony stimulating factor (GM-CSF) being developed by Roivant Sciences to treat acute respiratory distress syndrome associated with COVID-19. Gimsilumab has demonstrated a favorable safety and tolerability profile based on data collected to date.
Ifenprodil: An N-methyl-D-aspartate (NDMA) receptor glutamate receptor antagonist being developed by Algernon Pharmaceuticals. The Company is preparing for US trials based on results of an animal study that showed the investigational therapy significantly reduced acute lung injury and improved survivability in H5N1 infected mice.
Inhaled nitric oxide: The FDA has granted emergency expanded access for use of the INOpulse® system (Bellerophon Therapeutics) and the Genosyl DS tankless system (VERO Biotech) for treatment of COVID-19. In a clinical study of patients infected with SARS-CoV, nitric oxide demonstrated improvements in arterial oxygenation.
LEAPS peptides: CEL-SCI is developing an immunotherapy using a patented T cell modulation peptide epitope delivery technology, to stimulate protective cell-mediated T cell responses and reduce viral load.
Multi-antibody cocktail therapy: Regeneron is developing a novel therapy that could potentially be administered as prophylaxis before exposure to SARS-CoV-2 virus or as a treatment for those already infected. It may potentially enter human trials by early summer.
Remestemcel-L: Mesoblast Limited is investigating its allogeneic mesenchymal stem cell (MSC) product candidate, as a treatment for patients with acute respiratory distress syndrome caused by COVID-19. Remestemcel-L, which is composed of culture-expanded MSCs derived from the bone marrow of an unrelated donor, is administered in a series of intravenous infusions and is believed to have immunomodulatory properties to counteract inflammatory processes.
Sargramostim: A yeast-derived recombinant humanized granulocyte-macrophage colony stimulating factor (rhuGM-CSF) being assessed in the SARPAC trial (sargramostim in patients with acute hypoxic respiratory failure due to COVID-19) at University Hospital Ghent to treat patients with respiratory illness associated with COVID-19. Sargramostim is marketed under the brand name Leukine (Partner Therapeutics) in the US.
Sarilumab: Regeneron and Sanofi are evaluating the interleukin-6 (IL-6) receptor antagonist in patients hospitalized with severe COVID-19 infection. The first part of the trial will evaluate the impact of sarilumab on fever and patient’s need for supplemental oxygen, while the second part will evaluate improvement in longer-term outcomes (ie, preventing death, reducing need for mechanical ventilation, supplemental oxygen and/or hospitalization).
Siltuximab: A study has been initiated at the Papa Giovanni XXIII Hospital, Bergamo Italy, to investigate the use of the interleukin (IL)-6 targeted monoclonal antibody for the treatment of patients with COVID-19 who have developed serious respiratory complications (Siltuximab In Serious COVID-19; SISCO study). In the US, siltuximab (Sylvant; EUSA Pharma) is currently approved for multicentric Castleman disease in adults who are HIV negative and human herpesvirus-8 (HHV-8) negative.
Tocilizumab: Genentech is initiating a randomized, double-blind, placebo-controlled phase 3 trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to evaluate the safety and efficacy of the IL-6 receptor antagonist plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia.
TAK-888: An anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-IG) being developed by Takeda for high-risk individuals with COVID-19. Pathogen-specific antibodies from plasma will be collected from recovered patients (or vaccinated donors in the future) and will be transferred to sick patients to improve the immune response to the infection and increase the chance of recovery.
TZLS-501: The investigational therapy, being developed by Tiziana, has been shown to rapidly deplete circulating levels of IL-6 in the blood, a key driver of chronic inflammation. Excessive production of IL-6 is believed to be associated with severe lung damage observed with COVID-19 infections.
Altimmune Inc: Developing a single-dose, intranasal vaccine against COVID-19 using its proprietary NasoVAX technology. The vaccine is moving toward animal testing.
Applied DNA Sciences: Collaborating with Takis Biotech to develop a DNA vaccine candidate using PCR-based DNA (“LinearDNA”) manufacturing systems; preclinical testing in animals is expected to begin in the second quarter of 2020.
Codagenix Inc: Co-developing a live-attenuated vaccine with the Serum Institute of India using viral deoptimization.
GlaxoSmithKline: Collaborating with Clover Biopharmaceuticals to develop a protein-based coronavirus vaccine candidate (COVID-19 S-Trimer) using Clover’s proprietary technology (Timer-Tag©) and combining it with GSK’s pandemic adjuvant system.
Inovio Pharmaceuticals: Developing a DNA vaccine (INO-4800) to address COVID-19; human trials to begin in the US in April.
Johnson & Johnson: Partnering with the Biomedical Advanced Research and Development Authority (BARDA) to develop a vaccine using Janssen’s AdVac® and PER.C6® technology, which provide the ability to rapidly upscale production of an optimal vaccine candidate.
Moderna Inc: Vials of the Company’s mRNA vaccine (mRNA-1273) have been shipped to the National Institute of Allergy and Infectious Diseases to be used in a phase 1 study in the US. The Company is actively preparing for a potential phase 2 trial based on the outcomes of the NIH study.
Novavax: Currently evaluating multiple recombinant nanoparticle vaccine candidates in animal models; initiation of phase 1 testing is expected in late spring of 2020. The COVID-19 vaccine candidates will likely include the saponin-based Matrix-M™ adjuvant to enhance immune responses.
Pfizer and BioNTech: Co-developing a potential first-in-class COVID-19 mRNA-based vaccine candidate (BNT162), which is expected to enter clinical testing by the end of April 2020.
Sanofi: Collaborating with BARDA to develop a vaccine using Sanofi’s recombinant DNA platform. The DNA sequence encoding the antigen will be combined into the DNA of the baculovirus expression platform and used to produce large quantities of the coronavirus antigen which will be formulated to stimulate the immune system to protect against the virus.
Sorrento Therapeutics: developing STI-6991, an I-CellTM COVID-19 cellular vaccine made of replication-deficient human erythroleukemia K562 cells expressing membrane-bound S1 protein of the SARS-CoV-2 virus. The I-Cell vaccine is expected to elicit both T cell and B cell immunities against SARS-CoV-2.