We are the Organization for the Collection of Antibody Serum for the Treatment of COVID-19. It is our mission to collect convalescent plasma from donors who have survived COVID-19 and use it as a treatment for new and existing cases. Convalescent serum (antibody rich blood plasma) is an FDA approved treatment for COVID-19. When delivered early in the course of illness, it has been shown to improve prognosis and recovery rates when administered [1,2].
On August 23, 2020 the FDA for the first time approved convalescent serum for emergency use in treatment of COVID-19 . Prior to this emergency use authorization (EUA), convalescent serum was only available under emergency access protocols, which required FDA authorization on an individual basis, and was intended primarily for patients with critical symptoms.
Because it is created in the bodies of recovered patients, antibody serum is in theory the most immediately available treatment for current patients. Unfortunately, this is not the case in practice, as serum supply for COVID-19 treatment is critically short .
OCAST believes that a straightforward solution to the shortage is to create a market for plasma donation. Creating a market naturally solves the problem by offering an adequate financial incentive for donors. In this system, patients would purchase plasma directly from donors via an online marketplace. Plasma would be sent to a clinic of the patient's discretion for application.
A single plasma donation can provide treatment for up to three patients . If half of all recovered patients donated plasma, there would be more than enough serum for all current sick patients.
What does OCAST offer recipients? Because of convalescent serum shortages, serum is still being reserved largely for the sickest patients. This is counterproductive, because by late stages of illness, antibody serum is apparently less effective [1,2]. The primary intent of OCAST is not only to create a way to eliminate supply shortages, but to allow ALL COVID-19 patients direct access to serum therapy. Patients who have only recently become sick are encouraged to immediately seek convalescent serum treatment, in order to help avoid development of critical symptoms. OCAST puts serum collection and dissemination under one roof in a direct-to-patient system, so that patients can immediately obtain access to serum rather than hoping that it will be available at the hospital.
BUSINESS PROCESS AND WEBSITE FUNCTIONALITY
To demonstrate how the direct- to - patient system and website marketplace will work, we will show an example using Mary and Bob as the donor and recipient, respectively.
Mary goes to a donation center owned by or partnered with OCAST. Her plasma has a high titer (COVID antibody content) and her donation produces enough plasma for three patients. OCAST will pay her a little less than market price for the first unit of plasma. OCAST will then sell the first unit on its own marketplace, using the money gained from the sale to help fund and expand OCAST operations.
The sale of the second unit of plasma Mary will have the option to participate in herself. From her account in the online marketplace, she can sell directly to a donor, establishing her own price. Donors will see the titer of her plasma, her location, and her price, as well as shipping costs from her location to theirs. Donors will purchase directly from her, and she will keep the profit. If she wants, Mary can specify a state or city for the plasma to be used, or even allocate for use by a specific person.
The third unit of plasma will be used to meet OCAST's voucher obligations (such as those issued as crowdfunding perks), and if those have been met, it will be donated to a hospital. If Mary doesn't want to use the online marketplace for any reason, she can opt out and be paid twice the amount at the time of her donation (assuming that she has donated enough plasma at sufficient titer for at least two full units).
To be a donor, Mary must pass the same basic health exams as other plasma donors. She must be free of blood-based infections such as HIV (these will be tested for at the time of screening); she must be at least 18 years old and weigh at least 110 lbs. . In addition, she must test positive for COVID-19 antibodies, have a sufficient titer for these antibodies, and be free of the coronavirus .
Bob has recently tested positive for COVID-19. He talks to his primary care doctor about serum therapy and his doctor agrees to administer it to Bob. Bob qualifies for OCAST registration by providing a doctor's note or lab test result in order to demonstrate his diagnosis for COVID 19. Bob obtains an OCAST account and purchases Mary's serum. It is sent to his doctor within one day after purchase. He is able to receive treatment quickly and avoid the worst of his possible symptoms.
HIGH LEVEL OPERATIONAL PLAN
Our path moving forward depends on the level of funding we receive through our fundraising efforts. Ideally, OCAST will receive enough to fund a handful of collection and shipping centers in the United States after which OCAST will form plans to expand abroad. It will likely be possible to partner with existing companies specializing in collection of blood products such as IBBI Incorporated. Without information on the amount of capital, it will be possible to raise we don’t at this time have a plan budget for OCAST however in this section we will provide our general plans for moving forward.
Phase I: Completion of the website including recipient and patient portals and construction of the marketplace system will accompany continuing fund raising efforts. Plans for the first set of donation centers will be formed: brick - and - mortar sites will be chosen in locations with the highest concentration of recovered patients. Local advertising in these areas will be used to attract prospective donors. OCAST will seek partnerships with other blood product collection companies to maximize our accessibility to donors.
OCAST will utilize ViveST technology which provides a novel method for enabling the shipment of blood plasma at room temperature.  The common conventional practice for shipping blood plasma serum is to freeze it, pack it with dry ice, and overnighted. However, this has some level of risk, due to the possibility of increased shipping times. Serum can melt, becoming unviable. Alternatively, plasma can be shipped in refrigerated containers at below-freezing temperatures. This is an expensive practice and is only appropriate for bulk orders. By utilizing ViveST technology, OCAST will be able to accommodate small orders quickly and inexpensively at no risk of degradation of plasma viability.
As OCAST expands internationally, it will partition the marketplace into regions to accommodate plasma pricing differences between these regions. This segregation will allow different market prices to be established in each region to maximize affordability and availability of plasma for all prospective recipients.
During Phase I, all earned revenue from OCAST activities will be retained and reinvested to grow the company quickly in order to prevent as many fatalities as possible. Phase I will last until the COVID 19 epidemic is no longer considered a global pandemic.
Phase II Part I: As the COVID 19 epidemic draws to a close in some regions, OCAST will pivot its operation in these regions to provide (1) conventional blood products using its established donation sites and (2) continue to specialize in market base provision of antibody serum for diseases such as the flu and any additional cases of COVID 19. COVID 19, like the flu, may never fully go away as new strains are formed. Maintaining a permanent presence will allow OCAST to continue to serve these new cases. Additionally, OCAST early adoption of ViveST technology will allow OCAST to be particularly competitive in the blood products market.
Phase II Part II: In addition to the provision of blood products, OCAST intends to develop a general solution to future pandemics. One may notice that COVID-19 is but one of a string of novel viruses which have appeared over the course of the past couple of decades. First there was SARS in 2002 then Swine Flu in 2009, MERS in 2012. Ebola in 2014 and now COVID-19. This doesn't seem to be a coincidence; each new virus seems to validate a trend with a particular conclusion: that we have reached a new age of viral epidemics. Globalization and increasing population densities -- consumption of wild animals -- whatever the cause, it is evident that there is a new major problem that doesn't end with COVID-19. Imagine a viral epidemic featuring a fatality rate like Ebola's (90%), with a transmission rate like that of COVID-19, and a long incubation period with contagiousness that begins before symptoms appear. If we don't find a solution to this problem, the incidence of such a virus may be just a matter of time.
So what can we do? OCAST, in phase 2, plans to investigate the possibility of using rapidly modulated electromagnetic fields (like those from an MRI machine) to vibrate viruses to a point of thermal or mechanical failure. This would not require a lengthy development phase or new clinical trials with each new virus, like a vaccine or drug treatment. Once a new pathogen is isolated, a cure could be found within a few days. Curing a patient could be done quickly during an outpatient procedure.
This type of technology has been proposed before, but a major problem is finding the way to modulate fields to destroy pathogens and not harm human tissue. Previous attempts at similar technologies appeared to rely on a brute force search on real tissue to find suitable frequencies at which to attack pathogens, rather than trying machine learning and simulation. Such a search process can be extremely time intensive and therefore infeasible. OCAST plans a straightforward technique:
1) Scan and then model vulnerable parts of the pathogen, such as the capsid, in a molecular dynamics simulator such as GROMACS
2) Simulate the effects of electromagnetic fields (EMFs) on the pathogen within the molecular dynamics simulator
3) Apply a machine learning method search for a suitable pattern of EMF fluctuations within the simulation which destroys the pathogen due to thermal or mechanical excitation but leaves normal tissue unharmed
Such a search, aided by the speed of a supercomputer, could be performed fairly quickly. Once a suitable EMF fluctuation pattern is found, the field modulation program could be used in MRI machines or similar hardware to destroy the pathogen within patients quickly.
Other pathogens, such as drug-resistant bacterial strains, might be treatable with this method. Most bacteria species utilize cell walls which, like viral capsids, do not exist in normal human tissue, and therefore should be safe to target using this technology.
There may be applications in cancer treatment as well using this technology. Cancer however may be more difficult due to its similarity to normal tissue.
Q: Don't we have a vaccine? Is OCAST even needed anymore?
A: A vaccine is finally out, but it will take a lot of time for it to be distributed to everyone in the United States. Even after everyone in the U.S. is vaccinated, there will be other places where the vaccine will take longer to reach. OCAST will remain in operation through the U.S. vaccination and plans to expand operations internationally as well, to help where it is most needed and useful.
Q: Why have a marketplace at all? Won't it allow donors to charge high prices to recipients?
Markets, according to basic macroeconomic theory, provide a natural incentive for suppliers (antibody plasma donors in this case) to generate enough to meet demand. That is why a market is ideal for solving the problem of plasma shortage. The truth is, it might raise the cost of serum therapy, but this cost will fortunately be largely passed on to insurance providers. Furthermore, successful treatment offsets the costs of extensive care for patients who otherwise might have ended up in the hospital due to their illness. The cost of one person's hospital stay would equal many serum treatments, so costs even to insurance providers may be less overall.
Q: Can Phase 2 run concurrently with Phase 1?
A: Yes! If this becomes the case, the two projects would be financially separated. This will hopefully be addressed in a future fundraising campaign. The Round One campaign is for the COVID-19 marketplace only. The success of both phases of OCAST's plan fully depends on your support.