LIVINGDRUG: A REAL-TIME DRUG TO CURE, IMMUNIZE AND PREVENT CORONAVIRUS. A PROBABLE SOLUTION TO END COVID-19 CRISIS IN 60 DAYS.

Abstract:

We are trying to sanitize the whole world but the real problem is our immune system is failing to sanitize our body from inside.

Root cause to this problem, our body is failing to produce a vital antibody in presence of Coronavirus or Coronavirus is not letting our immune system to produce a vital antibody.

1ml of LivingDrug delivers that vital antibody resulting in cure from Coronavirus infection.

Key Words: Cure Coronavirus infection, Vaccine for coronavirus infection, prevent coronavirus infection, coronavirus reinfection, Coronavirus plasma therapy, coronavirus monoclonal antibody, coronavirus recurrence.

Introduction:

“Prevention is better than Cure” remained the core of the Epidemic outbreak management systems currently in place. Gradually it became only prevention and vaccines helped us achieving that. In COVID-19 scenario we need to wait till vaccine becomes available as vaccines involve indirect method of testing.

But we can’t afford to wait even for 6 months, COVID-19 is progressing exponentially and by the time vaccine is available we may be looking at more than 1 million deaths. 

Cure is the absolute truth, which can take us out of this COVID-19 crisis, Vaccine should be based upon the principle of cure.

Theory:

A battle is going on between coronavirus and our body, we are studying the defence mechanism of our body but we are failing to understand the defence mechanism deployed by coronavirus.

Figure 1: Turtle Defence Model

Turtle Defence Model:

A turtle has 2 distinct forms. In adverse times it goes into a shell and comes out during favourable time. Immune system can only see the shell as it is adverse time and immune system can only produce antibodies against the shell not the complete organism.

Immune System can destroy anything that it can see, Coronavirus is only showing indestructible shell and keeping its identity hidden, and the resulting fight is a stale mate. Which is advantage Coronavirus.

But the Virus defence model doesn’t explain the 82% survival rate, for that we need to understand human defence model.

Figure 2: COVID-19 closed cases as on 4^th May 2020

Our Immune System has three layers of Defence. For better understanding let’s assume our body is Troy City.

1. Epithelial tissue or Troy City wall acts like Physical Barrier. Once Microbe crosses this layer, patient is potentially exposed to the Virus.
2. Non-Specific (Innate) Immune System or Troy City Guards. It provides immediate response to the microbial attack but it lacks the capability to identify the microbe with precision, it uses Brute force method to destroy the Microbe and in the process it also cause damage to the nearby cells which are in proximity to the infection area.
3. Specific (Adaptive) Immune System or Troy City Army, is specialized in identifying the microbe by synthesizing a specific antibody to catch the microbe, it takes a minimum of 14 to 21 days to produce right antibody for a new microbe. In coronavirus scenario, Turtle defence model is preventing the synthesis of right antibody hence failing to identify the microbe.

As Specific Immune system is failing to fulfil its duty, burden is falling upon Non-Specific Immune System to defend the body from unknown virus.

When the infection is below a critical level brute force method is able to defend.

Figure 3: Survived Patient Still Remaining vulnerable

Note: To prove that 82% of the survived cases are because of the non-specific immune system, we can check that recovered patients are equally susceptible to future infection on exposure to coronavirus as the rest of us. Because they don’t have immune memory. But when infection crosses a critical level and infection spreads sufficiently, Damage caused by Non-Specific Immune system is more than the earlier scenario and as the day’s progress, immune system self-destruction results into cytokine storm, ARDA and organs failure. Leading to the death of the patient which explains the rest 18% cases.

Figure 4: Infected patient exhibiting symptoms

Root cause to this problem, Non-Specific Immune system is failing to perform its duty, to fix that, we need to understand Achilles Heel.  

Figure 5: Depiction of Achilles Heal

Achilles was the greatest of all the Greek Warriors, and he is known for his invulnerable body and legendary shield. He can take any number of hits on his shield and he can march forward.
To break his defence, Apollo had to intervene and guide an arrow to the Achilles heel resulting in his death.

In the same way we have to introduce a new antibody which our immune system can’t synthesize on its own, because it can’t see the corresponding antigen. But when we introduce that antibody, it disables a coronavirus and immune system gets to catch that virus and creates an immune memory.

From now on immune system knows the identity of coronavirus. And Specific immune system will launch a dedicated well organised attack to clear the known virus present inside the system.

Right Antibody for Coronavirus treatment:

Proof of this theory is dependent on one antibody.

Figure 6: Venn diagram of antibody search area

Let’s say there are N number of antibodies that human body can produce, there are X number of antigens that are present on Coronavirus and H number of targets are hidden. Immune system can only produce antibodies in the space X-H but the antibody that we are looking for our purpose lies in the subset of H, which our immune system can never see and hence will not produce antibody for that target. We have to supply that antibody from outside but in real-life there is no methodology to differentiate antibodies like we did in this Venn diagram, so we have to search complete set of N to find that antibody. Which is nothing but one antibody in a trillion possible antibodies.

One benefit, we don’t have to study about the Coronavirus we just need to explore human immune system, Our 25 year’s long research is only concentrated on finding such antibodies and we are successful in it.

Coronavirus is not required for production of this antibody. In 30 days we can setup monoclonal antibody cultures to produce LivingDrug as per global requirement, and complete In-Vitro, In-Vivo Tests to get FDA Approval for the commencement of clinical trial.

Cure: When we deliver 1ml LivingDrug to a coronavirus infected patient, his immune system creates immune memory for the Coronavirus and it launches a coordinated attack to clear the virus from the system leading to complete cure in 1 to 2 weeks’ time.

Figure 7: Patient cured using LivingDrug
Patients recovered are immune to corona virus as they have immune memory and any further exposure to the same virus, immune system will actively defend and disease is never going to manifest.

Figure 8: Active Defence of a Cured/Immunized PatientVaccine:
We have already created a real-time vaccine inside an infected person, if we treat coronavirus with LivingDrug outside our body coronavirus gets inactivated and it is the ideal vaccine candidate, which can be given to a vulnerable host to create immune memory.

Figure 9: Vaccine – Coronavirus LivingDrug Complex

Vaccine produced in this method is one of its kind ever produced till today. It can also be given to infected person to cure, we can get approval for this vaccine based upon performance of its drug counterpart.

Immune Memory Creation, basis for Epidemic management:

Simultaneous presence of three ingredients, namely immune system of host, Coronavirus and LivingDrug are required to create Immune memory.

Figure 10: LivingDrug use for Cure, Immunization and prevention

Cure, Immunize and Prevent are the three pillars of Epidemic management and for the first time LivingDrug connects all the three pillars, Creating Immune memory remains the basis for all three pillars.

A probable Solution to solve COVID-19 Crisis:

Assuming that LivingDrug is approved today by FDA and is available globally for clinical use. Let’s try to solve active cases of COVID-19 available from today.

Figure 11: COVID-19 active cases as on 4^th May 2020

Serious or Critical Cases:

As critical patients exhibit conclusive evidence that coronavirus is present in the system. We can safely give 1ml LivingDrug to start recovery process.

30 Days test Data for vaccine:

First day is a very tricky day as the patients are at different levels of infection rate. All the patients having a survival chance of a minimum 4 days will recover completely. At this point of time, it is very difficult to predict outcome for the patients who have less than 4 days survival chance. If Non-Specific Immune System has already done irreversible damage it is going to be a difficult task to predict the outcome.
From day two onwards, we are only going to have fresh cases and all the new patients are most likely get admitted at similar levels of infection. Every patient should recover from coronavirus.

From Day 7 onwards, global daily deaths due to Coronavirus should start coming down towards zero, hence fulfilling our primary objective. LivingDrug continues to save critical cases until vaccine is available globally.

By day 30 we will have results of all the cases which were treated from day 1 to day 15, which concludes the effectiveness of LivingDrug.

As the vaccine is also based on same principle, we can obtain FDA approval for Vaccine based on effectiveness of Drug counterpart.

Mild Condition Cases:

We need to make sure that Coronavirus is present inside the system before administering LivingDrug, as LivingDrug requires Coronavirus in the system to create immune memory. A simple antibody test is not a conclusive enough evidence and further evidences are required to confirm the presence of Coronavirus.

But we can use vaccine to immunize all these patients, as vaccine creates immune memory by its own. They get cured, if they contain Coronavirus in the system.

Side Effects and precautions:

1. Both LivingDrug and its vaccine counterpart should not have side effects.
2. Immune suppression medicines shouldn’t be used with this therapy. 

While Vaccine form of LivingDrug only creates Immune memory for Coronavirus, LivingDrug in the drug form has following unintended benefits.

1. If patient have any other infection, immune system will start clearing those infections also.
2. If the patient has a benign tumour, immune system will clear the tumour completely, as if a surgery is performed to a cellular precision.
3. If the patient has a malignant tumour, immune system will clear the tumour, but it may regrow in future, further research is in progress to fix this.

Discussion:

LivingDrug only contains antibody, till today it is not being discovered in any other study, reason for that, selecting a search area is the first step of any research. And we are already taking a wrong search area.

1. For antibody selection, we are injecting the microbe to a host and collecting the antibodies produced by Immune system. Antibody that we are searching is always absent in this search area.
2. For vaccines first step is to kill the microbe chemically which results in loss of information, that immune system needs to handle the real microbe.
   
   

In CAR-T cell therapy (published in 2018), in our point of view, cells were taken from a cancer patient and genetically reengineered and again reintroduced in the patient, now reengineered cells can produce antibodies that are not produced by Immune system otherwise and they have reasonable success in this method. Only challenges are, drug produced in this method is patient specific and it costs $1 million per patient. But this study provides a basis that it is possible to cure cancer with one dosage of medicine.

Dr Ashok Kumar Anem (1957 – 2004), my father conducted cancer research from 1985 to 2004. He was working on identifying antibodies that our body fails to produce but when given to the body, cures cancer. Clinical trials started in 1995 and he produced reasonable progress. Drug produced in this method can be given to any cancer patient and it costed less than $100(in 1995) to manufacture in small quantities.  Due to his sudden death in 2004, most of his research remained unpublished.

This manuscript is just an application of the knowledge gained from the research work conducted by Dr Ashok Kumar Anem.

Conclusion:

While vaccines remained the best strategy to Immunize complete population against deadly microbes, traditional vaccines lack the capacity to cure an already infected Patient. COVID-19 crisis created a unique situation where cure is even more important to stop deaths caused by Coronavirus.
LivingDrug concept discussed in this manuscript is addressing the lacuna in traditional vaccines by delivering a drug and vaccine combo for Coronavirus and greatly reduce the time period required to confirm the effectiveness of the vaccine. With this new methodology it is possible to stop COVID-19 crisis under half a million deaths.

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