Reasons for hope: the drugs, tests and tactics that may conquer coronavirus – Reuters

(Reuters) - With much of the world living in lockdown, the spread of the new coronavirus, SARS-CoV-2, that was first detected in China late last year is beginning to slow in some places. As of April 12, 1.8 million had been infected and 115,000 killed by COVID-19, the disease caused by the virus.

FILE PHOTO: Scientist Linqi Zhang shows a tube with a solution containing COVID-19 antibodies in his lab where he works on research into novel coronavirus disease (COVID-19) antibodies for possible use in a drug at Tsinghua University's Research Center for Public Health in Beijing, China, March 30, 2020. REUTERS/Thomas Peter

While a safe, effective vaccine is still more than a year away, researchers are rushing to repurpose existing drugs and non-drug therapies as well as testing promising experimental drugs that were already in clinical trials.

Even moderately effective therapies or combinations could dramatically reduce the crushing demand on hospitals and intensive care units, changing the nature of the risk the new pathogen represents to populations and healthcare systems. New drugs, together with new diagnostics, antibody tests, patient- and contact-tracing technologies, disease surveillance and other early-warning tools, mean the anticipated next wave of the global pandemic does not have to be nearly as bad the first.

More than 70 vaccine candidates are also in development around the world, with at least five in preliminary testing in people. Here are some of the drugs, vaccines and other therapies in development:

REMDESIVIR - GILEAD SCIENCES

Antiviral drug, originally developed to combat RNA viruses including respiratory syncytial virus. At least 13 trials underway in China, Europe and the U.S. with preliminary results from two Chinese trials expected as soon as April 2020. A February assessment by the WHO flagged this candidate as the most promising for battling COVID-19.

CAVEATS: Initial data are expected to come from studies of patients with relatively severe COVID-19. Because antivirals work best when patients are healthier, those results may show limited effectiveness.

STATUS: Repurposed Experimental

EARLY RESULTS: 0-3 months

Gilead starts two late-stage studies to test drug for coronavirus

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Investors await data on coronavirus drugs as market rally builds

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Gilead asks FDA to revoke orphan drug status for potential coronavirus drug

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Clinical Trials

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New England Journal of Medicine, April 2020

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Malaria drug also believed to have antiviral activity. Blocked SARS-CoV-2 entry into cells in an in-vitro experiment. In one small French study, some COVID-19 patients showed improvements but there was no way to know if the drug was the reason. Results published in April from another study in France and one in China found no benefit in patients treated with the drug. Dozens more clinical studies are underway around the world.

STATUS: Repurposed

EARLY RESULTS: 0-3 months

Special Report: Doctors embrace drug touted by Trump for COVID-19, without hard evidence it works

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Coronavirus drug hopefuls are cheap to make but may be in short supply

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Clinical Trials

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Journal of Zhejiang Univ (Med Sci), March 2020

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Mdecine et Maladies Infectieuses, March 2020

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Nature, February 2020

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ACTEMRA (TOCILIZUMAB) - ROCHE

Monoclonal antibody approved for rheumatoid arthritis and also for treating the cytokine storm immune overresponse in cancer patients. Fifteen registered trials in China, Europe and the U.S. are testing it on COVID-19 patients, alone or in comparison to other therapies. One French trial is looking at 28-day effects on COVID-19 in patients with advanced or metastatic cancer.

STATUS: Repurposed

EARLY RESULTS: 0-3 months

Coronavirus drug hopefuls are cheap to make but may be in short supply

Link: here

Clinical Trials

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KEVZARA (SARILUMAB) - SANOFI, REGENERON PHARMACEUTICALS

Monoclonal antibody approved for inflammatory arthritis, and in trials targeting the cytokine storm immune response in severely ill COVID-19 patients. Regenerons chief scientific officer has said initial data on effectiveness could come by late April.

STATUS: Repurposed

EARLY RESULTS: 0-3 months

Data on arthritis drug to treat coronavirus could come within weeks, according to Regeneron executive

Link: here

Exclusive: Sanofi can produce millions of doses of potential coronavirus drug - CEO

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Sanofi, Regeneron expand testing of potential coronavirus treatment

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Clinical Trials

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JAKAVI (RUXOLITINIB) - NOVARTIS, INCYTE

Developed to treat inflammatory and autoimmune diseases, and in late-stage development as a cream for atopic dermatitis. One trial each in Canada and Mexico will test the drug in COVID-19 patients with severe respiratory symptoms associated with the cytokine storm immune response, with preliminary results expected by June 2020. In the United States, Novartis established a managed access program for use in severe/very severe COVID-19 illness on April 7.

STATUS: Repurposed

EARLY RESULTS: 0-3 months

Novartis, Incyte join repurposing wave to give Jakavi a trial run in COVID-19

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Clinical Trials

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KALETRA (LOPINAVIR/RITONAVIR) - ABBVIE

Antiviral combination used to treat and prevent HIV infections. More than twenty trials around the world are testing the drug as a COVID-19 treatment or post-exposure prophylaxis for people with high-risk close contact with a confirmed case. Initial results expected as soon as May 2020.

CAVEATS: One randomized controlled trial in China published results in March showing no differences in viral load or 28-day mortality among 199 patients. Median time to clinical improvement was one day shorter in patients taking the drug. However the same investigators, doctors at Jinyintan Hospital in Wuhan, said in April that they believe Kaletra, as well as a second drug, bismuth potassium citrate, helped some of the COVID-19 patients they treated.

STATUS: Repurposed

EARLY RESULTS: 0-3 months

Key China coronavirus hospital says HIV drug beneficial to patients

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Mylan waives exclusive U.S. distribution rights for potential COVID-19 therapy

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Clinical Trials

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New England Journal of Medicine, March 2020

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RHACE2 APN01 - APEIRON BIOLOGICS

A recombinant human angiotensin converting enzyme 2 (rhACE2) under Phase-2 clinical development in ALI (Acute Lung Injury) and PAH (Pulmonal arterial hypertension). This synthetic version of the human protein that the novel coronavirus uses to enter cells is being tested in Austria to see if it can block viral entry and decrease viral replication in COVID-19 patients, reducing deaths or need for mechanical ventilation. Preliminary results from the trial that was announced on April 2 are expected in September 2020.

STATUS: Experimental

EARLY RESULTS: 3-6 months

Clinical Trial

Link: here

CAMOSTAT MESYLATE - UNIVERSITY OF AARHUS, DENMARK

Protease inhibitor licensed in Japan and South Korea to treat chronic pancreatitis. In vitro experiments found it blocks a mechanism SARS-Cov-2 uses to enter human cells. As of early April, an estimated 180 COVID-19 patients aged 18-110 were being recruited at nine locations in Denmark for a phase 2a trial that will examine 30-day changes in disease severity and mortality, with results expected by December 2020. The University of Tokyo also announced plans for a trial of camostat mesylate and a related drug, nafamostat mesylate, starting as early as April 2020.

STATUS: Repurposed

EARLY RESULTS: 6-12 months

IFX-1 - INFLARX

Monoclonal antibody targeting complement activation product C5a. Designed to block a mechanism of inflammation, the drug is also in clinical trials for Hidradenitis Suppurativa, ANCA-associated vasculitis and Pyoderma Gangraenosum. In early April, a trial in the Netherlands launched to test IFX-1 in patients with severe COVID-19 pneumonia, with preliminary results expected in late October 2020.

STATUS: Experimental

EARLY RESULTS: 6-12 months

ASPIRIN, CLOPIDOGREL, RIVAROXABAN, ATORVASTATIN, OMEPRAZOLE - IMPERIAL COLLEGE LONDON

Trial of cardioprotective drugs to prevent direct damage to the heart muscle that appears to drive the severity of COVID-19 in certain patients as well as their likelihood of needing invasive critical care. The trial will include more than 3,000 patients in the UK, with a completion date of March 30, 2021.

EARLY RESULTS: 9-12 months

MRNA 1273 - MODERNA/NIAID

RNA vaccine made with messenger-RNA (mRNA) encoding the spike protein of SARS-CoV-2 encapsulated in a lipid nanoparticle. The phase 1 trial with 45 subjects aged 18-55 at three locations in the U.S. will evaluate the vaccines safety and provide early data on the immune response it induces. Trial completion is anticipated to be June 1, 2020.

STATUS: Experimental

EARLY RESULTS: 0-3 months

J&J, Moderna sign deals with U.S. to produce huge quantity of possible coronavirus vaccines

Link: here

Clinical Trial

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Reasons for hope: the drugs, tests and tactics that may conquer coronavirus - Reuters