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A novel coronavirus (2019-nCoV) originating in Wuhan, China presents a potential respiratory viral pandemic to the world population. Current efforts are focused on containment and quarantine of infected individuals. Ultimately, the outbreak could be controlled with a protective vaccine to prevent 2019-nCoV infection. While vaccine research should be pursued intensely, there exists today no therapy to treat 2019-nCoV upon infection, despite an urgent need to find options to help these patients and preclude potential death. Herein, I review the potential options to treat 2019-nCoV in patients, with an emphasis on the necessity for speed and timeliness in developing new and effective therapies in this outbreak. I consider the options of drug repurposing, developing neutralizing monoclonal antibody therapy, and an oligonucleotide strategy targeting the viral RNA genome, emphasizing the promise and pitfalls of these approaches. Finally, I advocate for the fastest strategy to develop a treatment now, which could be resistant to any mutations the virus may have in the future. The proposal is a biologic that blocks 2019-nCoV entry using a soluble version of the viral receptor, angiotensin-converting enzyme 2 (ACE2), fused to an immunoglobulin Fc domain (ACE2-Fc), providing a neutralizing antibody with maximal breath to avoid any viral escape, while also helping to recruit the immune system to build lasting immunity. The ACE2-Fc therapy would also supplement decreased ACE2 levels in the lungs during infection, thereby directly treating acute respiratory distress pathophysiology as a third mechanism of action. The sequence of the ACE2-Fc protein is provided to investigators, allowing its possible use in recombinant protein expression systems to start producing drug today to treat patients under compassionate use, while formal clinical trials are later undertaken. Such a treatment could help infected patients before a protective vaccine is developed and widely available in the coming months to year(s).
Accepted 2020 Feb 4; Collection date 2020.
In the updated version of the manuscript, the use of recombinant ACE2 is highlighted as a treatment for acute respiratory distress syndrome (ARDS), including several studies exploring its use to treat ARDS during RSV and H5N1 infection. Importantly, two clinical trials employing recombinant ACE2 are described, which provides important data for the safety of translating the ACE2-Fc approach into human patients in an expedited manner. Given the potential for ACE2-Fc to have this third mechanism of action, the focus was shifted toward using the wild type ACE2 sequence rather than abolishing peptidase activity. Overall, this additional evidence increases the potential for ACE2-Fc to have a positive therapeutic benefit in patients infected with 2019-nCoV.
A mysterious illness causing pneumonia in December 2019 in Wuhan, China is now growing into a potential pandemic. These pneumonia cases were eventually characterized to be caused by a novel coronavirus (2019-nCoV)
The novel coronavirus, 2019-nCoV, is now quickly spreading across the world after originating in Wuhan
These efforts resemble not only what happened with SARS in 2002–2003, but also the Ebola virus outbreak in 2014–2015. During those outbreaks, special protocols were put in place to quarantine any infected individuals and identify patient contacts at risk
The dire situations facing patients in outbreak scenarios demand quick responses by the healthcare community and the biotech industry. Unfortunately, many of the traditional options that guide drug development are inadequate for outbreaks; a process that takes years can’t help patients who are dying today, and economies that are being halted. In these situations, studies have often been conducted on compassionate use, and clinical trial approvals expedited. This was most recently seen in the 2014–2015 Ebola outbreak, where a variety of clinical trial candidates were studied. Many of these therapies failed, but ultimately a vaccine did emerge that was fully protective against the virus
In this article, I will outline different potential treatment options that could be pursued as a therapy for 2019-nCoV virus, keeping the focus on agents that could be rapidly tested in patients today and broadly effective in spite of limited knowledge of the biology of 2019-nCoV. Simply stated, there is limited time for basic studies of 2019-nCoV in research labs, while patients need effective therapies today. I finally propose the best potential treatment option in my opinion, along with instructions on how to manufacture the therapy for testing in patients today.
Coronavirus entry starts with the S protein binding to a target receptor on the cell surface, where after fusion is mediated at the cell membrane, delivering the viral nucleocapsid inside the cell for subsequent replication
A neutralizing antibody targeting the S protein on the surface of 2019-nCoV is likely the first therapy contemplated by biomedical researchers in academia and industry, providing passive immunity to disease
An alternative strategy of generating neutralizing antibodies against 2019-nCoV S protein would be to immunize large animals (sheep, goat, cow) with the 2019-nCoV S protein, and then purifying polyclonal antibodies from the animals
Beyond targeting the surface proteins of 2019-nCoV, one could also target the RNA genome itself for degradation. This RNA genome sequence of 2019-nCoV was recently published (GenBank:
Ideal agents to fight 2019-nCoV would be approved small molecule drugs that could inhibit different aspects of the viral life cycle, ultimately inhibiting replication. Two classes of potential targets are viral polymerases
A simple but potentially very effective tool that can be used in infectious outbreaks is to use the serum of patients who have recovered from the virus to treat patients who contract the virus in the future
Patients with resolved cases of 2019-nCoV can simply donate plasma, and then this plasma can be transfused into infected patients
As the outbreak continues, more patients who survived infection will become available to serve as donors to make antisera for 2019-nCoV, and a sizeable stock of antisera could be developed to serve as a treatment for the sickest patients. Unfortunately, the exponential growth of the outbreak would work against this strategy, since the growing number of cases would likely outstrip the ability of previous patients to provide donor plasma as treatment. Moreover, convalescent patient sera would have significant variability in the potency of antiviral effect, making it less ideal