A Lady physician preparing an injectable medicine or drug that suits best for CoViD19 patient.
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In the midst of one of the world’s most worst pandemic of the modern times, multiple large drug manufacturing companies are in the race against time to produce an effective, safe and best drug/s for the treatment of Covid19 infection. The Covid19 pandemic started from Wuhan China in late December of 2019. It belongs to a group of the old respiratory coronavirus but it was found out to be a new strain, so it is labeled as a novel virus or SARS COV2.The virus originated from bats then transmitted to humans from pangolins as an intermediate host as many experts believe. The mode of transmission of the virus is by droplet form from sneezing, coughing of sick and infected person and by fine and ultrafine aerosol thru talking and respiration. Likewise it is also observed that the contaminated ultrafine aerosols can remain airborne for hours suspended in air. The virus thrive’s best in cool, humid, dark and windy environment. The common signs and symptoms presented by the sick individual/s are cough, fever, sneezing, rhinorrhea, body malaise, itchy throat, difficulty of breathing, joint pains and uncommonly gastrointestinal symptoms but new studies revealed that profound loss of smell and loss of taste are more pathognomonic of the disease.
And new studies from Cambridge University revealed that COVID19 mutated into three distinct strains or variant types; Type A- can be found in the United States of America, Wuhan China and Australia. Type B- also spreads in China, east Asia and is derived from type A then Type C strain is a daughter of Type B strain and widely spread to Europe, England, France, Italy, Sweden, Germany, Singapore, Hongkong and South Korea. And because of the above mentioned ” new ” characteristics of the virus, it infects millions and killed hundreds of thousands all over the world. Known health authorities such as The Centers for Disease Control and Prevention USA and the World Health Organization (WHO) advocated several preventive health policies and strategies to prevent and control the viral spread all over the world. But as of the present time the pandemic continue to take its toll and is increasing by the numbers as the hands of time continue ticking.
Since no known drug or medicine that is approved by the Food and Drug Authority to treat COVID19 or SARS COV2 infection, several big multinational drug companies are in a rush to manufacture drugs/medicines or vaccines that can offer cure to patients with COVID19 infection. And several of this well known drug manufacturing companies are funded or financed by many wealthy countries from all over the world for the purpose of coming up a safe and effective drug for COVID19 pandemic treatment. Recently the only treatment authorized by US-FDA to be use in COVID19 infected patients is blood plasma product recovered and donated to hospitals from patients who survived COVID19 infection, hoping to offer immunity to other patients after receiving the recovered/donated blood plasma.
Best Drug Review for COVID19 infection: waiting FDA approval
Anti-malarial drug preparations.
Anti-malarial Drugs: Directly Targets The Virus.
1, ) Chloroquine and hydrochloroquine- It blocks the entry of Covid19 into the cell as observed in a small in-vitro study by french investigator.It directly targets the virus.
a. cost-relatively cheap but it will increase if combined with an antibiotic drug azithromycin.
b. availability-easily available, not over the counter drug, needs doctors prescription, and present supply is limited or not enough to be distributed worldwide for the treatment of COVID19 infected patients.
c, preparation- oral form( tab )
d. Indication -anti-malarial treatment but repurposed for COVID19 infected patients.
e. efficacy and safety profile- uncertain and still under investigational study. But many doctors in develop countries are skeptical with regards to the efficacy of the anti-malarial drugs in the off-labelling treatment of CoviD19 infected patients, it seems that it didn’t work with CoviD19 infected patients based from their clinical practice experienced.
f. common side effects=blurring of vision, skin rashes, dizziness, nausea, vomiting, light headedness, pallor, pruritus or body itchiness, neuropsychiatric effect, irregular heart beat and hyperglycemia.
g. precautions-careful in giving to patients with liver, kidney and heart problems.
h. FDA approval-not yet approve due to pending results of clinical trials but reports of ” off-label ” used by many doctors in the US was noted and it caused shortage of anti-malarial drugs in the country. The drugs are vehemently touted and supported by US president Donald Trump, fox news and TESLA owner Elon Musk. But many experts all over the world are skeptical in using the drug to patients infected with Covid19 because their initial clinical experience of the drug failed to give good results and even showed to be fatal to the majority of patients with severe Covid19 disease.
i. more than a dozen ongoing clinical studies as of today. And results will be available 1 to 2 months from now.
1. ) Remdesivir-directly targets the virus.
a. cost- higher price compared to anti-malarial drugs.
b. availability-not easily available to consumer, not over the counter drug…needs doctors prescription, and the supply is more limited compared to anti-malarial drugs.
c. preparation-injectable liquid form in a vial. Given intravenous route.
d. Indication-initially tested in west Africa last 2014 for ebola but not working well, it was also tested for SARS, MERS, RSV and hepatitis-C, So it is now repurposed for COVID19 infected patients.
e. efficacy and safety profile-uncertain and still under investigational study and latest partial/incomplete data from an ongoing clinical trial is promising for CoVID19 treatment but it is not yet conclusive.
f. common side effect-nausea, rash, headache, dizziness and varied gastrointestinal symptoms(diarrhea).
g. precaution-pregnancy, existing liver problem, history of allergy to its component, existing kidney disease
h. US-FDA approval- not yet approve for COVID19 treatment but clinical trial results will be available before this month of april ends. The University of Chicago medicine study sample size used in the clinical trials are small in numbers and remdesivir was given daily to moderately and severely infected patients admitted at the intensive care unit, the drug remdesivir is produced by Gilead Sciences and is now testing remdesivir to 2,400 patients with severe COVID19 symptoms in 152 trial sites and giving remdesivir to 1,600 patients with moderate COVID19 symptoms at 169 hospitals including clinics around the world. Initial 10 day clinical trials in remdesivir done by Gilead Sciences is promising, it involved 53 severely Covid19 infected patients admitted in the intensive care unit with ventilator support. And 68% showed clinical improvement and 47% were discharged before the trial ends and 13% died of the disease, thus the result was published in The New England Journal of Medicine. It is also important to note that china has two ongoing trial of the drug remdesivir and will be publishing the results within this month.
i. type of clinical trial-adaptive randomized, double-blind, placebo-controlled trial( phase III trials).Clinical trial results will be available 1 to 2 months from now.
2.Lopinavir/Ritonavir combination (KALITRA)-ABBVIE.-is an anti-viral combination for HIV prophylaxis and treatment.
HIV or AIDS Symbol
a. cost-higher costing than anti-malarial drugs.
b. availability-easy to manufacture, needs doctors prescription and limited supply for COVID19 infected patients.
c. indication-for HIV prophylaxis and treatment for HIV infected patients. But repurposed for COVID19 infected patients.
d. common side effects-nausea, dizziness, diarrhea, hyperglycemia, pancreatitis and elevated liver function test.
e. type of clinical trial-randomized controlled trial in Wuhan China published in March 2020. Kalitra plus bismuth potassium citrate combination given to 199 patients with COVID19 infection which helped some of the patients to recovery. And an ongoing 20 clinical trials around the world for post exposure prophylaxis and treatment of people with high risk close contact with a confirmed COVID19 positive patient/s. The clinical trial results will be publish on the month of May 2020.
Anti-Rheumatoid Arthritis Drugs: It targets the immune system of patient with COVID19 infection.
1. Tocilizumab ( actemra )- ROCHE. -is a humanized monoclonal antibody directed against interleukin-6( IL-6 ) receptor, IL-6 is a pro-inflammatory cytokine that plays a big factor in the formation of ” cytokine storm ” in patients infected with COVID19. Cytokine storm is an excessive systemic immune response that contributes to the respiratory, kidney and heart failure 0f COVID19 infected patients.
Old man walking with two canes due arthritis.
a. cost-higher price compared to anti-malarial drugs.
b. preparation-liquid form to be given by intravenous infusion.
c. indication-for rheumatoid arthritis treatment but repurposed for moderate to severe COVID19 infected patients.
d. efficacy and safety profile- effective to control ” cytokine storm “, but clinical trials are underway in big centers in the United States, Europe and China. And results will be available 1 to 2 months from now.
e. common side effects-infusion site reaction, headache, hypertension, liver enzyme elevation, cholesterol elevation and neutropenia, gastrointestinal side effects, hypersensitivity reactions, thrombocytopenia , hypertension, and blood abnormality.
f. precautions-reactivation of latent tuberculosis, upper respiratory tract infection and increase risk of infection.
g. availability-easily available but may have short supply.
2.Sarilumab ( KEVZARA )-SANOFI ,REGENERON PHARMACEUTICALS.-
a. cost-more expensive than the anti-malarial drugs.
b. indication-is a monoclonal antibody and an interleukin-6 inhibitor (IL-6) for rheumatoid arthritis treatment but repurposed for COVID19 infected patients.
c. common side effects-liver enzyme elevation cholesterol and blood abnormality.
d. efficacy and safety profile-ongoing clinical studies as of the present to control excessive immune response or ” cytokine storm” of patients infected by COVID19. Study results will be available 1 to 2 months from now.
e. precautions-reactivation of latent tuberculosis and increase risk of infection.
f. availability-short supply but easy to produce for consumer distribution.
g. common side effects is almost the same with tocilizumab.
Angiotensin Converting Enzyme-2 Receptor Inhibitor:
1.RHACE2 APNO1-APEIRON BIOLOGICS.-is a recombinant human angiotensin converting enzyme-2 (ACE-2) inhibitor and a synthetic human protein undergoing its phase-II clinical trial in patients with acute lung injury (ALI) and pulmonary arterial hypertension(PAH) in Austria. The clinical trial will reveal if the drug can stop or block the entry of the virus into human cells and hinder its replication inside the cells of patients with COVID19 infections, since ACE-2 is receptor in the human airway where coronaviruses use to get entry inside the human body. Likewise the study will also reveal if the drug can decrease mortality and need of ventilator support in COVID19 infected patients.
a.RHACE2 APNO1-.is an experimental drug targeting ACE-2 receptors in humans.
b. cost-not yet known but most probably higher than remdesivir and anti-malarial drug preparations.
c. efficacy and safety profile-probably the best drug for prevention and treatment for COVID19 infected patients because its functions is for disease prevention and at the same time it prevent serious complications such as respiratory failure and maybe decrease the need of ventilator support in patients infected with the virus.
d. clinical trial result will be available in the month of September 2020.
2.NKG2G-ACE2 CAR-NK-CELLS-is a small multicenter clinical trials from Chongqing Public Health and Medical Center and Chongqing Sidemu Biotechnology Technology in China. The proposed therapy if given to humans will prevent the entry of COVID19 to human host and it will hinder viral multiplication and it indirectly targets the virus. The result of the experimental study will be publish 1-2 months from now.
Anti-inflammatory, Autoimmune Disease and Anti-leukemia Drugs:
anti-leukemia, anti-inflammatory and anti-autoimmune drug preparations.
1.Ruxolitinib (JAKAVI)-NOVARTIS and INCYTE.-it targets the human body’s immune defense during the viral infection.
a. indication- for anti-inflammatory and autoimmune disease but repurposed for COVID19 infected patients.
b. cost-not yet revealed but probably more than anti-malarial drug preparation.
c. efficacy and safety profile-theoritically safe because the drug was already been tested and used by humans.
d. common side effects-nausea, diarrhea, skin rashes, muscle cramps, fluid retention and rarely myelosuppression. It also decreases the ability of the patient’s immune system to ward-off the viral infection
e. availability-readily available but with a limited supply.
f. clinical study-ongoing trials to COVID19 infected patients with severe respiratory symptoms associated with ” cytokine storm ” and overwhelming immune response. Clinical trial sites are in Canada and Mexico. Preliminary results of the study will be release in June 2020.
2.Acalabrutinib ( CALQUENCE) – AstraZeneca.-is a Bruton’s tyrosine kinase inhibitor ( BTK’s ), BTK is an enzyme that is needed to activate a series of immune reaction that will result to massive inflammatory process cause by the patient’s own white blood B cells reaction towards coronavirus that will contribute to cytokine storm formation which will result to multi-organ failure. Thus the drug targets the body’s immune system response towards COVID19 infection. Likewise it is also a known drug for the treatment of chronic lymphocytic leukemia with anti-arthritis effect and is tested now for severe COVID19 infected patients who are on respirator and admitted in the intensive care unit.
a.cost-more costly than the anti-malarial drugs in the market now.
b. indication-treatment for chronic lymphocytic leukemias but repurposed for the treatment of covid19 infected patients.
c. availability-easily available but the supply is limited since it is also needed to treat patients with leukemia.
d. efficacy and safety profile-safe and effective because it has already been tested and used by patients with leukemias.
e. side effects-nausea, diarrhea, muscle cramps and skin rashes and rarely myelosuppression. It also decreases the ability of the immune system to fight against the viral infection.
f. clinical studies- using a randomized, controlled clinical trial and is done under the supervision of the U.S federal government’s National Cancer Institute and the site of the study is located at the Walter Reed Army Medical Center Hospital where an off-label used of the drug to COVID19 patients infected patients with lung failure and hook on ventilator.
h. preparation-capsule form to be given via nasogastric tube mix with an acidic liquid (coca-cola) for good absorption.
3. Ibrutinib (IMBRUVICA)-J&J’s Janssen.-is also a Bruton’s tyrosine kinase inhibitor and function like acalabrutinib (Calquence) of AstraZeneca.The drug is easily available but limited supply for COVID19 infected patients because it is only repurposed for the treatment of the virus and there will be less available to patients with leukemia. The safety and efficacy can be predicted since the drug was already been tested and approved for leukemia treatment in humans. It will also undergo a randomized controlled clinical trial but initial clinical trials of the drug conducted in 2018 at the University of Texas Health Science Center at Tyler using influenza infected mice as a subject revealed very promising results. And the cost is more than that of chloroquine or hydrochloroquine tablet. The common side effects are almost the same with Ibrutinib and Acalabrutinib or other known drugs of its class.
A healthcare professional is preparing antibodies for injection to the patient.
Monoclonal Antibodies or Immunosuppressive Agent:
1.IFX-InFLARX-is a monoclonal antibody that blocks the compliment activation product C5a which is a chemoattractant substance that attracts more polymorphonuclear cells at the site of the infection. Thus blocking the inflammatory response of the body. So it targets the body’s reaction during the viral infection.
a. cost-not yet announce but most probably costlier than anti-malarial drugs.
b. efficacy and safety profile-probably safe and effective for CoVID19 infected patients.
c. common side effects-possible liver function test abnormality, cholesterol elevation and blood count abnormality.
d. clinical trials done in COVID19 patients with severe pulmonary symptoms in Netherland, as an experimental drug and result will be release probably this coming October 2020.
e. availability-not easily available and it is not yet produce because it is a novel drug.
Anti-platelet Activation/Aggregation( Aspirin and Clopidogrel ), Anti-thrombin or Anti- Factor Xa ( Rivaroxaban ), Anti-Cholesterol drug(Atorvastatin ) and Proton-pump Inhibitor( omeprazole ) Drug Combinations: Cardioprotection
Heart of hope!!!
1.Aspirin+clopidogrel+Rivaroxaban+Atorvastatin+Omeprazole combinations are being tested for COVID19 infected patients as a cardio-protective drugs against the effect of cytokine storm which had a direct effect to the cardiac musculature of COVID19 patients.
a. cost-understandably higher costing than anti-malarial plus azithromycin tablet treatment.
b. efficacy and safety profile-the above drug combinations are safe and had proven efficacy due to the fact that it is already been used as a cardiovascular drug.
c. common side effects-gastric irritations, upper gastrointestinal ulcerations and bleeding of perforated ulcers.
d. availability-can be easily produce and readily available if needed.
e. ongoing clinical trials in the United Kingdom and study result will be available less than a year from now.
A patient in the hospital is transfused with convalescent plasma.
1.BLOOD PLASMA-this product is coming or harvested from the person/s blood who survived from COVID19 infected patients and is given to severely infected COVID19 patients because on the premise that the plasma already contains an antibody that can decrease the viral load and or totally destroys the virus. The process of plasma transfusion existed more than a hundred years ago and it is not 100% safe because the process can also transmit other viruses such as hepatitis-B, C, HIV, west Nile virus and syphilis organism. The giving of convalescent plasma is targeting directly the COVID19 .
a. cost-higher cost compared to anti-malarial drug tablet.
b. preparation-blood plasma
c. availability-can be easily harvested from sources especially during emergency situation,but the supply is limited.
d. efficacy and safety profile-very promising results and practically effective and safe as long as patient must be monitored carefully for transfusion reaction.
f. common side effects-body rash or itchiness and volume overload during the giving of the plasma to the patient.
g. clinical trials-undergoing small controlled trials in the United States of America, China and Europe.
Novel Coronavirus vaccine.
1.BACILLE CALMETTE-GUERIN ( BCG )-the vaccine was advocated by health authorities worldwide and given to millions of recipients since the 1920’s to fight against tuberculosis, BCG vaccine is a live but weakened tubercle bacteria( immunologic priming ) and is injected to the recipient and after sometime the recipient can develop antibody towards the virus and further boost a broad innate immune system, thus will protect the recipient from the viral infection in the future due to immunologic memory.
a. cost-cheaper and affordable but also has a limited supply because the vaccine is intended for children’s immunization against tuberculosis as of the moment, but can easily be produce as the need arises.
b. indication-the vaccine is used against tuberculosis and also can be a repurposed vaccine to be use for high risk patient such as the elderly people with comorbidities and healthcare workers.
c. efficacy and safety profile-safe and effective since already been used to humans but remains to be seen if it can offer help to prevent COVID19 infection to humans if given in a mass immunization.
d. common side effects-pain and redness of the injection site, body rashes, itchiness and fever.
e. Ongoing large trials in Germany, Netherlands, and Australia. And the result swill be publish 3-5 months from now.
VACCINES THAT USES VIRAL VECTORS:
Viral vectors in the test tube.
It is a Novel therapeutic tools to use other viruses ( recombinant adenovirus, AAV, retroviruses, poxvirus and influenza viruses ) for experimental purposes in order to make a bio-therapeutic agents or new vaccines. This technique are used for the expression of cytokines that can enhance immunity against coronavirus and maybe can increase the coronavirus sensitivity to anti-viral treatment by expression of proteins, likewise scientists are using non-replicating viruses in many clinical trials to improved safety. But one potential adverse events associated with virus mediated gene transfer is induction of inflammatory and anti-viral immune response and in using retrovirus as viral vectors can induced human malignancies in retroviral gene therapy vectors.
1.NVX-COV2373-NOVAVAX-is a Novel coronavirus vaccine that will enhance immune response by making the body’s immune system to develop antibody against coronavirus.
a. cost-probably more than anti-malarial drug tablet.
b. efficacy and safety profile-remains to be seen after clinical trial results but as long as the vaccine is tested properly and the benefits outweighs the risk of using the vaccine, then the vaccine is good to go for distribution as the crisis needs it badly.
c. common side effects-pain and swelling in the injection site, possible rashes and body itchiness or maybe fever.
d. the vaccine is undergoing experimental trial and will release result maybe 2 months from now.
2.CHADOXI-UNIVERSITY OF OXFORD: it uses a non-replicating ape adenovirus vector, viral vectors are used for experiments to produce safety results and can enhance immunity against coronavirus and tested on subjects aged between 18-55 years old at four sites in the United Kingdom.
a. cost-maybe higher than remdesivir and anti-malarial drug medications.
b. common side effects-pain and redness in the site of injection, rashes and itchiness in the injection site.
c. availability-the supply is limited due to a possible high demand.
d. clinical experimental trials is ongoing and result of the study can be available a year from now.
The clinical trial that started last march 2020 used a non-replicating adenovirus as a viral vector to produce a recombinant vaccine in-order to enhance immune system response against coronavirus and its safety in using the novel vaccine. The phase I trial includes more than a hundred subjects ages from 18 -60 years old in Wuhan, Hubei, China and will have its result publish in late month of December 2020. Then in April 12, 2020 a phase II randomized controlled clinical trial was started with 500 participants to test different doses of the vaccine against placebo and will have its result publish on January of 2021.
A glimpse of hope still lurks inside the hearts of everyone of us, especially nowadays that we are facing one of the worst pandemic of the modern times…experts all over the world is giving their best shots to come up with a drug in just a short period of time that can offer cure and control against COVID19 infection, it is a race against time and humans is resilient enough to survive…
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Laertes B. Amihan MD
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