Background: Actemra is a indicated to treat autoimmune diseases such as rheumatoid arthritis as well as cytokine release syndrome. Research from China has shown Actemra may be an effective treatment for patients with severe cases of COVID-19. Trial…

Background: Revive Therapeutics is testing antirheumatic drug bucillamine in a Phase 3 trial of patients with mild-to-moderate COVID-19. The trial is a randomized, placebo-controlled study of up to 1,000 participants who will receive bucillamine or …

Background: Bamlanivimab is a monoclonal antibody that binds to the spike protein receptor in SARS-CoV-2 and can block viruses from binding to the ACE2 host cell surface receptor. Regulatory Actions: On 9 November, the FDA issued an EUA …

Background: Vir Biotechnology, Inc. and GlaxoSmithKline are evaluating their monoclonal antibody VIR-7831 (GSK4182136) to treat COVID-19. The monoclonal antibody has shown the ability to neutralized SARS-CoV-2 in vitro, according to the companies. T…

Background: The potential treatment is designed to antagonize GM-CSF signaling by binding to the alpha subunit of the GM-CSF receptor (GM-CSFRα). Kiniksa’s lead indication for mavrilimumab is giant cell arteritis. Regulatory Actions: The FDA has ap…

Background: Casirivimab and imdevimab, formerly known as REGN-COV2, are antibodies used as a cocktail to target the spike protein of SARS-CoV-2. Regulatory Actions: FDA issued an emergency use authorization (EUA) for the combination of casirivimab…

Background: BioCryst is testing whether galidesivir, an antiviral drug with demonstrated broad-spectrum activity in vitro against coronaviruses MERS and SARS, is effective in treating patients with COVID-19. The company is enrolling up to 132 partic…

Background: In the Phase 3 ACTIV-4 inpatient protocol, NIH Researchers seek to evaluate if heparin has an effect on reducing clotting events that develop as a result of COVID-19. Patients receive various doses of unfractionated or low-molecular-weig…

Background: Celltrion, based in South Korea, is evaluating the human monoclonal antibody CT-P59 as a potential treatment for COVID-19. The candidate was selected through a screening process where CT-P59 was found to neutralize the SARS-CoV-2 and sev…

Background: Veklury, an intravenous drug that inhibits viral replication, has shown in vitro and in vivo activity against SARS-CoV-2. It was originally developed as a treatment for Ebola. Regulatory actions: As studies of Veklury have shown reduced…

Background: Reports from officials in China have said Avigan is clinically effective against COVID-19. Regulatory Actions: Avigan is approved in Italy to treat COVID-19, and in China as an experimental drug for COVID-19. Avifavir, a generic form of…

Background: PRO 140 is a CCR5 antagonist that blocks the CCR5 co-receptor on the surface of immune cells like CD4 cells. It is believed that PRO 140 can enhance the immune response in patients experiencing cytokine release syndrome from respiratory …

Background: Olumiant (baricitinib), a Janus kinase (JAK) inhibitor developed by Eli Lilly and Company, is being evaluated as a therapeutic for COVID-19 alone and in combination with other therapies. Regulatory Actions: On 19 November, FDA issued an …

Background: Inhaled nitric oxide has been explored as a treatment for COVID-19 patients due to its success in improving arterial oxygenation in patients with ARDS due to SARS-CoV. Results from patients treated with INOpulse under an emergency expand…

Background: Ivermectin is used to treat intestinal strongyloidiasis and onchocerciasis (tablets), lice and rosacea (topical). The drug has been proven effective in vitro of inhibiting SARS-CoV-2 within 48 hours of treatment with a 5,000-fold reducti…

Background: Metformin, an oral medication used to treat type 2 diabetes, is being evaluated as a therapeutic candidate for COVID-19. Early results from Wuhan, China, suggested metformin helped reduce the risk of mortality from COVID-19 in patients w…

Background: MK-4482 (formerly EIDD-2801) is an oral broad-spectrum antiviral that has shown effectiveness against infections such as influenza, chikungunya, Ebola and equine encephalitis. It has a similar mechanism of action to remdesivir and preven…

Background: AstraZeneca is testing AZD7442, a combination of two monoclonal antibodies, AZD8895 and AZD1061, as a prevention and treatment for COVID-19. The monoclonal antibodies were discovered by researchers at Vanderbilt University and licensed t…

Background: Kaletra is indicated in combination with other antiretrovirals to treat HIV-1 infection in adults and in pediatric patients 14 days and older. Kaletra has been effective against SARS, showing in vitro activity against the disease in a 20…

Background: Dexamethasone has been selected as a potential therapy due to its potential for reducing the inflammation associated with cytokine release syndrome in patients with COVID-19. Trials: The drug is currently being evaluated as a treatment …

Background: Colchicine, an anti-inflammatory drug primarily used to treat gout, is being evaluated as a therapeutic candidate for COVID-19. Pre-clinical studies have shown use of colchicine reduces lung injury in patients with ARDS, and could be use…

Background: PTC has said PTC299 has the potential to address the high level of viral replication and inflammatory response associated with COVID-19. Results from a study published in Virus Research indicate the therapeutic is effective at inhibiting…

Background: Lenzilumab has been shown to have a protective effect against cytokine release syndrome associated with CAR-T therapy. It is believed that lenzilumab can aid cytokine-mediated immunopathology of COVID-19 lung injury and ARDS. Regulatory…

Background: RLF-100 is thought by researchers to help decrease mortality and improve oxygenation in the blood for patients with COVID-19 through its anti-inflammatory activity. It currently has an Orphan Drug designation from the FDA and EMA for acu…

Background: Atea Pharmaceuticals, Inc. is developing their oral direct-acting antiviral drug AT-527 as a COVID-19 therapeutics candidate. The company is evaluating up to 190 participants in an international Phase 2 trial where patients 45-80 years o…

Background: Niclosamide, an antiparasitic drug used to manage tapeworm infections, is being investigated by several centers as a COVID-19 therapeutic. It has shown efficacy against SARS-CoV-2 in animal models. Trials: ANA Therapeutics is evaluating …

Background: Convalescent plasma has been studied as passive immunotherapy in other coronaviruses such as MERS and in SARS-CoV-2. Trials: Convalescent plasma is being evaluated against placebos, other treatments, and standard of care…

Background: Pepcid is mainly used to treat peptic ulcer disease, GERD, and Zollinger-Ellison syndrome. Pepcid was identified by computer models as having the potential for inhibiting 3-chymotrypsin-like protease, which controls coronavirus replicati…

Background: Remicade is a tumor necrosis factor inhibitor that been proposed as a potential treatment for cytokine release syndrome associated with COVID-19. Trials: Together with the monoclonal antibody namilumab, Remicade is being tested in patie…

Background: Sorrento Therapeutics is testing a tyrosine kinase inhibitor STI-5656 (abivertinib maleate) in patients hospitalized with COVID-19 related pneumonia. The company recently licensed abivertinib from ACEA Therapeutics for use as a therapy f…

Background: JS106 binds to the spike protein receptor in SARS-CoV-2 and can block viruses from binding to the ACE2 host cell surface receptor. Status: Lilly has announced a Phase 1 trial is underway evaluating JS016 in 40 patients with COVID-19, an…

Background: Kevzara is indicated to treat moderately to severely active rheumatoid arthritis in adults with inadequate response or intolerance to one or more DMARDs. The drug is being evaluated for its potential benefit in reducing the inflammatory …

Background: SACCOVID, formerly known as CD24Fc, was recently part of several trials for the prophylactic treatment of graft-versus-host disease (GVHD) in leukemia patients receiving hematopoietic stem cell transplantation. The recombinant fusion pro…

Background: The University of Oxford is testing whether adalimumab, an anti-tumor necrosis factor drug, helps prevent the progression of COVID-19 to severe disease among patients in community care homes in the United Kingdom. The AVID-CC trial, spon…

Background: Sorrento Therapeutics, Inc. is developing STI-1499, also called COVI-GUARD, a neutralizing antibody that binds to the S1 subunit of the spike protein in SARS-CoV-2. COVI-GUARD is also part of a neutralizing antibody cocktail of three mol…

Background: PhaseBio is evaluating their vasoactive intestinal peptide (VIP) receptor agonist PB1046 in hospitalized patients with COVID-19. Results in animal studies demonstrated PB1046 was effective in preventing acute lung injury and stopping inf…

Background: Pfizer is evaluating its phosphate prodrug PF-07304814, which metabolizes to PF-00835321 and has shown antiviral activity in vitro against SARS-CoV-2. The company has started a Phase 1b study of up to 56 participants who will receive the…

Background: Researchers from NIH have launched NIH ACTIV-4 Outpatient trial, which will evaluate if anticoagulants or antithrombotic therapy has an effect on reducing cardiovascular or pulmonary complications that develop as a result of COVID-19. In…

Background: Japanese pharmaceutical company Takeda is investigating whether lanadelumab, a monoclonal antibody currently being studied as a treatment for patients with hereditary angioedema, is effective in reducing fluid build-up in the lungs of pa…

Background: Hydrocortisone is being evaluated in several trials as a treatment to reduce or prevent lung injury and multisystem organ dysfunction associated with COVID-19. Other glucocorticoids such as dexamethasone have been shown to be effective i…

Background: Ilaris is a monoclonal antibody that targets interleukin (IL)-1β. Two studies published in The Lancet of COVID-19 showed patients had elevated levels of IL-1β and other cytokines during cytokine release syndrome. It is approved to treat…

Background: BLD-2660, an oral small-molecule inhibitor of calpain, is being investigated as a therapeutic candidate for treating pneumonia associated with COVID-19. Its developer, Blade Therapeutics, is performing a Phase 2 randomized, double-blinde…

Background: BioAegis Therapeutics is assessing whether Rhu-pGSN, their recombinant human plasma product, is effective in treating hospitalized patients with COVID-19 who have developed pneumonia. Rhu-pGSN has shown in pre-clinical testing to regulat…

Background: Constant Therapeutics is testing its peptide angiotensin-(1-7) drug TXA127 in a Phase 2 clinical trial. The peptide is a Mas receptor agonist which has demonstrated efficacy in reducing inflammation, stabilizing endothelial and epithelia…

Background: AI Therapeutics and the Yale Center for Clinical Investigation are examining the efficacy of LAM-002A, a PIKfyve kinase inhibitor, in newly diagnosed patients with COVID-19. Preliminary research has shown LAM-002A combats SARS-CoV-2, esp…

Background: Biopharmaceutical company Denali Therapeutics and Sanofi are partnering to test DNL758, a peripherally-restricted small molecule inhibitor of RIPK1, in a Phase 1b study of patients hospitalized with severe COVID-19. DNL758 is thought to …

Background: ABX464 has anti-inflammatory properties through its upregulation of miR-124 micro-RNA, which downregulates chemo- and cytokines causing cytokine release syndrome in patients with COVID-19. The candidate also has antiviral effects against…

Background: Previous research has shown ACE2- mesenchymal stem cells were safe and effective in treating pneumonia associated with COVID-19. Trial: A Phase 2, multicenter, double-blinded study of 200 healthy participants where 100 participants who …

Background: Losmapimod is a p38α/β MAPK inhibitor thought to reduce the inflammatory response associated with disease progression in COVID-19 by reducing inflammatory biomarkers such as C-reactive protein and IL-6. Trials: Fulcrum is launching the …

Background: Mantle cell lymphoma (MCL) for patients who have received at least one prior therapy and chronic lymphocytic leukemia (CLL) in the US. Calquence inhibits the enzyme Bruton’s tyrosine kinase (BTK). The BTK pathway has been implicated in T…

Background: Gimsilumab targets the pro-inflammatory cytokine granulocyte-macrophage colony stimulating factor (GM-CSF), which researchers have seen elevated in the blood of patients with COVID-19 and may be associated with acute respiratory distress…

Background: Otilimab is an anti-GM-CSF antibody developed and currently being evaluated for rheumatoid arthritis. GSK has identified the drug as a potential candidate for COVID-19 treatment in patients who experience cytokine release syndrome. Tria…

Background: Farxiga is primarily used to treat type 2 diabetes by promoting glucosuria. In the DECLARE CV trial, the drug was associated with a lower rate of heart failure resulting in hospitalization and cardiovascular death. Other trials have show…

Background: Ultomiris is C5 complement inhibitor originally engineered from eculizumab to have a longer-lasting half-life and longer intervals between dosing for treatment of paroxysmal nocturnal hemoglobinuria. Preclinical data of animal models pub…