COVID-19 Disease and Interleukin-10

COVID-19 is in coronavirus family and causes immunopathogenic disease. The disease is caused by over produced cytokine storm/tornado during the eradication of invade COVID-19 in no underlying disease individuals or pre-existing conditioned patients. The healthy individuals immune system vigorously respond to continuously stimulate COVID-19 antigens from endless propagation of invaded COVID-19. It leads to generate cytokine storm or further irreversible cytokine tornado to the victims. Cytokine storm is a double edged sword for orchestrating host immune response to eradicate COVID-19 and permanently damage tissue, such as pulmonary fibrosis or even death. Interleukin-10 is a down regulator able to immunomodulate over expressed cytokine storm for further forming cytokine tornado and permanently injuring tissues or death in the acute phase of COVID-19 disease. Under sub-lethal infection, patients usually can heal by themselves. External recombinant and nano technology manipulated interleukin-10 is considered to exert protective function to down-regulate cytokine tornado formation. 

Currently, COVID-19 disease caused global over 400,000 and US over 110,000 deaths up to June 2020. Many patients died of COVID-19 pneumonia and/or other associated clinical symptoms by over produced cytokine storm (or cytokine tornado). Interleukin-10 is a pivotal player capable of down-regulate other pro-inflammatory cytokines formed cytokine tornado especially in the (early) acute phase of clinical symptoms. An example is in the last two slide in my presentation of three imagines with dark brown staining of Interleukin-10 expression on the left handed three sides. Interleukin-10 is transiently and vigorously expressed in the acute to early post acute phases of liver tissues in experimental baboon schistosomasis mansoni with sub-lethal dose infection. Schistosomiasis is another good example of immunopathogenic disease with no effective vaccines for over centuries. Interleukin-10 can ideally and potentially protect tissues for further permanent damages, such as pulmonary fibrosis or deaths in human COVID-19 cases. External recombinant interleukin-10 with nano technology as a biopharmaceutical will be administrated to the lower lungs of COVID-19 pneumonia patients may reduce fibrosis formation, increase the possibility of cure, and shorten recovery time.       

Interleukin-10 can down-regulate pro-inflammatory cytokines to orchestrate over reactive cytokine storm/tornado in immune response against permanent host tissue damages and/or deaths during eradication of COVID-19 pneumonia. Recombinat technology will be used for generation of abundant quantity of expressed interleukin-10 polypeptide via the usage of large capacity of fermentors. Nano technology will be used for protection of recombinant interleukin-10 polypeptide into the disease sites of pulmonary pneumonia in a fast delivery. Nano technology will be conducted for micron-molecules able to penetrate cell membrane pores within the inflammatory organs caused by the disease of COVID-19. Combination of the two high technologies will generate powerful, effective, and safe manner of an interleukin-10 biopharmaceutical.

The interleukin-10 biopharmaceutical product will be directly used in severe COVID-19 severe pneumonia patients and/or other immunopathogenic or specific conditions, such as SARS, MERS, Eborla, AIDS, flu, and/or severely burned patients in fire or war zone. These patients apparently have clinical signs caused by over expressed cytokine storm/tornado from pro-inflammatory cytokines. Interleukin-10 can transiently play a crucial function of down-regulating harmful scenario caused by cytokine tornado. Therefore, the usage of external recombinant interleukin-10 with nano technology will protect the patient from the harmful factors from his or her immune system. Thus, the patients will have opportunities be recovered faster and better with the lowest injuries post recovery.    

COVID-19 pneumonia is an immunopathogenic disease. Many recovered patients have no or almost limited antibodies, which means humoral immunity did not generate specific antibody/antibodies against COVID-19 antigens. COVID-19 can systematically invade host organs by binding to specific cell surface receptors, such as ACE2, DC-SIGN, and L-GN and enter cells for replication. After completion of replication, COVID-19 can break out of cells and infect new cells. During the process, COVID-19 virus and/or antigens can stimulate antigen presenting cells taken-up, process, and presented antigens to host immunity. Cytokine tornado possibly formed during numerous immune eradication. Interleukin-10 can down-regulate cytokine tornado formation.

The current methods used are vaccine development against COVID-19 or developing new drug(s) killing the virus. The vaccines will develop under no specific antigen(s) for target(s), which will sensitize the immune system of host and waste the usage of immune system. Drugs designed to kill COVID-19 will possibly generate cell toxicity during killing the virus and recycling viral antigens into the immune system. The usage of interleukin-10 is a natural product from the standpoint of host immunity. In addition, COVID-19 pneumonia is an immunopathogenic disease from patient over produced cytokine storm/tornado. External addition of recombinant plus nano tech manipulated interleukin-10 transiently can knock down over produced cytokine storm/tornado for host protection. Passing the dangerous cytokine tornado, immune system can continuously exert the function of eradication of COVID-19 without any harmful side-effect. Patients will recover faster without any or very limited tissue injury. It is an innovated method for COVID-19 therapy.   

Recombinant technology and nanotechnology are considered to used for construction of newly expressed interleukin-10 polypeptide with suitable expression vector(s) and delivery vehicle into the sites of lesions. Both high tech are either existing or will be under developing. Fermentors with large capacity will be used for production of large quantity of the product for clinic use. SPF eggs can be used for an alternative method in a large size of quantity if use a different expression vector. The usage of the breakthrough technology will fulfill specification and regulation of efficacy and safety. 

Several of my unpublished studies demonstrated that over produced cytokine storm/tornado blocked immune response. The similar scope is seen in COVID-19 severe pneumonia tissues. Interleukin-10 transiently expressed in the acute to early post acute experimental baboon schistomiasis mansoni with sub-lethal dose infection. External applying interleukin-10 to severe COVID-19 pneumonia patients is considered for over su-blethal dose (or lethal dose) infection or other patients with different severe diseases. The external interleukin-10 treatment may also provide more opportunities to save more lives with reduction of permanent tissue damages.   

The etiology of COVID-19 disease falls into the same disease models, which I have studied for several diseases over two decades. This disease model is in a gray area between vaccine and drug, but COVID-19 is a beautiful and a very standard one of immunopathogenesis. In addition, the publications of interleukin-10 did not catch the right approaches for the usage of interleukin-10 because of the characteristics of this cytokine. Currently, there are limited percentage of pathogens able to develop effective and safe vaccines for prevention based upon my best knowledge and working experience in academic and pharmaceutical industry. Interleukin-10 for therapy has been in my mind since Thanksgiving 1993. This potentially important cytokine, interleukin-10 can make a revolutionary breakthrough in both human and veterinary medicine. 

My solution may work forever on many known and unknown diseases if my proposed solution will meet specification, qualification, and regulation. The numbers will be unlimited if they fall into the categories of diseases of many intracellular pathogens, some extra cellular pathogens, immunopathogenic, burning, and/or severe physical injuries, 

I will start my new journey for the development of innovation of interleukin-10 therapy next year if I will have the chance. This project may last for several years to complete the whole project. This project will be from ground zero to build a skyscraper. I have experience in both academic and industry from upstream to downstream plus regulatory affairs. I need to build a team for this giant solution. 

Funding, man power, facility, timing, and policy are all countable.

Ambition and opportunity can overcome the barriers. It is not a one person project. It is a big project for whole human beings. Need coordination of all who have the same interests and are willing to engage into it. We need to work together based upon my work ethics.

Only myself and my son assists me if he can.

I have been educated and trained in work ethics, animal science, biology, microbiology, veterinary science, virology, molecular biology, cellular and molecular immunology, parasitology, pharmacology, vaccine discovery and development from upstream to downstream, regulatory affairs, civil engineering. I also taught virology and laboratory instructor of human anatomy, human physiology, molecular and cell biology, medical parasitology. I successfully worked on and developed a few veterinary vaccines currently in the market, including one of the biggest annual sale. I also engage myself for many years to study etiology of several diseases. COVID-19 pneumonia is a beautiful disease model fitting into the category f immunopathogensis. Interleukin-10 will be the best choice for potential COVID-19 therapy for severe pneumonia patients and/or other unusual clinical symptoms with different formations.  

I am currently a self-employed consultant and a substitute teacher in a few school districts in Iowa. I will organize a special team for this special interleukin-10 therapy project if I will have an opportunity in the near future. This project will use well-developed platforms and tools from different countries. Therefore, it is a miniature of a special project of united nations.

The business model is in biopharmaceutical industry. It will sever the whole human beings in needs. Key customers will be severe COVID-19 pneumonia patients plus with other unusual clinical signs reported in news, SARS, MERS, Ebola, ehrlichiosis, leishmaniasis, Lyme disease, brucellosis, severe burning, and/or others.

It will run as a new business with all kinds of donations, proposals for grants, IPO as a combination. Once this product will successfully developed, it will have markets worldwide.

I need a FDA and/or EU regulatory certified biopharmaceutical facility to conduct the project. This facility is a lot money for running the project, including advanced equipment, BL3 or BL4 laboratory, disposable medical supplies, and many others. Everything needs money to build into the product.    

Need specific very experienced persons who have business modeling as well as consultant for technology, business team for distribution, IOP in New Stock Exchange, knowledge technicians and managers, advisory members for foreseen market, legal and regulatory team for dealing with any legal issue and government updated regulations, monitoring and evaluation of market needs, marketing, media, and exposure for introducing the product into market, and other unexpected things. It is like the environment when I worked for pharmaceutical industry before.

MIT nano technology team for pharm delivery system, quantum computer team, and some other future potential partners as well.

In my working experience, there are many diseases can not develop vaccines for prevention. Many drugs have side effects on patients. Therefore, safety, efficacy, quality, and specification are always the top priority for vaccine and drug development and usage. Fortunately, it took 14 years of huge data to prove that vaccine is not a good option for prevention of a common infectious disease. Studying etiology of each disease is the most important thing. It is thankful and also sad that COVID-19 pandemic generates such a large amount of unfortunate cases in a few months to support the disease model of immunopathogenesis I studied for two decades. It is time re-classify diseases for more advanced prevention, treatment, or therapy.    

Some COVID-19 patients showed losing the sensory of taste or smell. It may be related to COVID-19 penetrating into cranial nerves through blood barrier influenced by cytokine storm/tornado. Polymannose of COVID-19 may non-specifically stimulate the generation of non-specific antibody for demyelation of nerve sheath of taste buds or smell. Alternatively, COVID-19 proteins may stimulate glial cells for accidentally damage the nerves. The demyelination symptoms have observed in a protozoa disease with the possible evidence associated with stimulated glial cells. Some psychiatric symptoms of COVID-19 patients may highly be associated with over expressed cytokine storm/tornado in their central neural system. However, these are very challenged studied to conduct.

COVID-19 symptoms open new avenues for scientific investigation, such as building new computer and artificial intelligence systems to predict the possible symptoms of patients possibly develop next. Each female patients may have different pre-existing conditions, pregnancy, or complicated hormone regulation with the combination of cytokine storm/tornado. In such complicated conditions, more studies need to conduct on females for providing more secured conditions for women and girls.  

Recombinat and nano technology manipulate interleukin-10 product is a innovated option for therapy for many diseases, which are no effective and safe vaccine for prevention or no drug for treatment. Based upon my years of studies for several non-solved diseases are associated with a standard disease model of immunopathogenesis caused by uncontrollable cytokine storm formed irreversible cytokine tornado. The giant force made from cytokine tornado can easily destroy tissues or even causing deaths from host immune responses. Interleukin-10 can knock down inflammation or tissue injuries caused from pro-inflammatory cytokines regulated immune cells, such as neutrophils, macrophages, T lymphocytes, and B lymphocytes. Interleukin-10 plays a crucial and transient function to down-regulate over reactive pro-inflammatory cytokines for host recovery and protection. The usage of external recombinant interleukin-10 with a novel delivery system of nano technology can reduce mortality and morbidity for many patients with immunopathogenic diseases. Interleukin-10 may provide a hope for many diseases currently without good treatments.