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OCTOBER BLOG

OCTOBER BLOG

COVID UPDATE

34,227,495 million people worldwide have tested positive for the novel coronavirus and the number is growing quickly. Our healthcare system is increasingly strained and the country is in desperate need of a safe and effective treatment for COVID-19. Scientists around the world are racing against time to find a cure.

The Latest Research on COVID-19 Treatments and Medications in the Pipeline

Key takeaways:

There are no approved coronavirus treatments at this time! The FDA recently created a new emergency program, Coronavirus Treatment Acceleration Program (CTAP), aimed at speeding up research for the development of COVID-19 treatments. CTAP is intended to promote collaboration between FDA, companies, scientists, and doctors to “bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus.”

For now, the treatment for patients with mild symptoms is to self-isolate at home.
Patients who are hospitalized receive supportive care (such as oxygen), enroll in clinical trials, and are given medications off-label based on hospital guidelines and their doctors’ clinical judgement.
The drug that’s furthest along in clinical trials for treating COVID-19 is Remdesivir, a new intravenous antiviral not yet approved the FDA, although an emergency use authorization was granted to make it more accessible.
Researchers are also testing older medications (that are typically used to treat other conditions to see if they are also effective in treating COVID-19.

Over 30,983,958* million people worldwide and 6,764,780 million in the United States have tested positive for the novel coronavirus and the number is quickly growing. Our healthcare system is becoming increasingly strained while we are in desperate need of a safe and effective treatment for COVID-19. World Scientists are racing against time to find a cure.

Hospitals and research labs all over the world are testing many different therapies on coronavirus-positive patients. Listed below are a few medications and treatments that have been making a buzz in the science community in an effort to find a potential COVID-19 treatment.

Remdesivir - an antiviral, given by intravenous (IV) infusion in the hospital. Remdesivir is an antiviral drug that blocks an enzyme, RdRp (RNA- dependent RNA polymerase), that the virus uses to make copies of itself, so there is a decrease in the quantity of coronavirus in the body. For the SARS-CoV-2 virus to make you sick, it has to first infect the cells to make copies of itself, in order to spread throughout the body to make you sick.

This is a brand-new drug not yet approved by the FDA for use on the market yet. Remdesivir is currently at the clinical trial stage of development which is the primary way for patients to access it. Remdesivir is available under the “expanded access” program, which means hospitals or physicians can apply for emergency use for multiple severely ill patients at a time. It was previously shown to have some effect against SARS, MERS, and Ebola in cell and animal models.

Early results from a large study of 1,063 patients, showed hospitalized patients receiving Remdesivir recovered faster than those receiving a placebo - 11 days vs. 15 days, respectively. The death rate in the Remdesivir group, 7%, was also lower than that of the placebo group, 12%. Patients requiring oxygen saw the most benefit.

Dexamethasone - a common corticosteroid, steroid medication, that prevents the release of substances in the body that cause inflammation and is used to treat various health conditions, such as: autoimmune conditions, allergic reactions, ulcerative colitis, arthritis, lupus, psoriasis and breathing disorders. Dexamethasone can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had and can affect growth in children.

A press release reported that there was a lower death rate, 2,104 hospitalized patients with COVID-19 who got a low, daily dose of dexamethasone compared to the 4,321 patients who did not get it. The medication seemed to be most helpful for patients on a ventilator, 35% lower death rate, or needed extra oxygen, 20% lower death rate.

Convalescent plasma - March 24, 2020, the FDA issued an Emergency Investigational New Drug (eIND) application for the use of convalescent plasma to treat people with COVID-19. Antibodies develop in plasma, the liquid part of blood that carries blood cells. It’s light yellow, about 91% water, accounts for 55% of blood and 45% red and white blood cells and platelets. Platelets help blood clot. Convalescent plasma is collected from people who have recovered from COVID-19, then transfused into patients with active coronavirus infection to mount an antibody response, which could prevent a mild case from becoming more severe. It assumed antibodies found in the convalescent plasma can help fight the coronavirus infection.

In China, 10 adults with severe COVID-19 symptoms were given convalescent plasma. Researchers reported that all symptoms such as fever, cough, shortness of breath, and chest pain, had greatly improved within 3 days of receiving the treatment. Compared to a historic control group, a random group of patients previously hospitalized for COVID-19, the group receiving convalescent plasma saw better improvements in their health.

The first convalescent plasma transfusion in the U.S. for COVID-19 was recently done in Texas. A physician can request convalescent plasma on an individual basis by contacting their local blood center, but it’s not widely available since centers have just recently begun collecting it. Over 2,700 hospitals have administered plasma therapy through an expanded-access program led by the Mayo Clinic. The program has delivered plasma to more than 105,000 patients,

Tocilizumab (Actemra) - is a disease-modifying anti-rheumatic drug (DMARD) approved for rheumatoid arthritis and juvenile idiopathic arthritis, both inflammatory diseases. It works by blocking interleukin-6 (IL-6), a protein involved in the natural immune responses, reduces the effects of a substance in the body that can cause inflammation. IL-6 normally signals other cells to activate the immune system, but too much activation can cause issues. An overactive immune system is a cytokine storm, a potentially fatal problem in which the immune system goes haywire and inflammation gets out of control.

By blocking IL-6, tocilizumab helps to calm down the immune system and is believed to also help with managing cytokine storms. A study from France reported people who got tocilizumab were less likely to require ventilation or die. Another study from Italy found those who got tocilizumab had a lower death rate, though ab out the same percentage of patients from both groups needed ventilators. On the other hand, tocilizumab did not help COVID-19 patients with early-stage pneumonia.

Actemra affects the immune system increasing the risk of getting infections more easily, even fatal infections. It may also cause a perforation or tear in the stomach or intestines. Tocilizumab may also cause liver problems.

Other medications that affect the body’s immune response are also being tested for COVID-19 and include:

LAM-002A, Apilimod – has been deemed safe for the treatment of autoimmune diseases and follicular lymphoma and found the most effective in combatting the SARS-CoV-2 virus in lung cells infected with the virus. In another study in the journal Cell, researchers independently showed that LAM-002A could combat SARS-CoV-2 infections in human lung cells.

AI Therapeutics’ unpublished data along with data recently published by the Scripps Research Institute suggest that LAM-002A administered with remdesivir, already approved for treating COVID-19, can boost the effectiveness of the antiviral agent. “LAM-002A holds promise to be a powerful new therapy for COVID-19 patients to prevent progression of disease, hopefully avoiding the need for hospitalization” said Yale’s Murat Gunel, professor of neurosurgery and professor of genetics and neuroscience.

Calquence (acalabrutinib) - blocks the action of certain enzymes in the body, which can interfere with the growth and spread of cancer cells. Calquence is used to treat mantle cell lymphoma, a type of non-Hodgkin lymphoma, in adults. CALQUENCE works by blocking a protein, Bruton tyrosine kinase or BTK, in B cells. This medicine is given after other treatments have failed. Calquence was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, patients responded to this medicine, but further studies are needed.

Xeljanz (tofacitinib) - blocks the activity of certain enzymes in the body that affect immune system functions. Xeljanz is used to treat moderate to severe rheumatoid arthritis or active psoriatic arthritis in adults who have tried methotrexate or other medications without successful treatment of symptoms or sometimes given in combination with methotrexate or other arthritis medicines.

Tofacitinib affects your immune system! You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, cough, trouble breathing, skin sores, diarrhea, weight loss, or burning when you urinate.

Jakafi (ruxolitinib) - works by blocking certain enzymes in the body that affect blood cell production. Jakafi is used in adults to treat myelofibrosis or polycythemia vera, which are bone marrow disorders that that affect your body's ability to produce blood cells. Jakafi is also used to treat acute graft versus host disease (GVHD) in adults and children 12 years of age and older who have taken corticosteroids and they did not work well enough. Jakafi is usually given after other treatments have failed

Olumiant (baricitinib) - blocks the activity of certain enzymes involved in activating inflammation in the body. Olumiant is used to reduce pain, stiffness and swelling in adults with rheumatoid arthritis after other treatments have failed. Olumiant also helps slow the progression of bone and joint damage.

Kineret (anakinra) - reduces the actions of chemicals in the body that are involved in inflammatory and immune responses. Uzara is a plant used in traditional African medicine. The root is used to make medicine. Kineret is used to treat the symptoms of moderate to severe rheumatoid arthritis in adults and may help slow the progress of the disease. Kineret is usually given after other arthritis medications have been tried without successful treatment of symptoms.

Kineret is also used in newborn babies to treat a rare genetic condition called neonatal onset multisystem inflammatory disease (NOMID). NOMID is a form of cryopyrin-associated periodic syndromes, CAPS. This condition causes uncontrolled inflammation in many parts of the body, including the skin, joints and central nervous system.

Ilaris (canakinumab) - is a monoclonal antibody that blocks certain proteins in the body that affect inflammation and other immune responses. Ilaris is used to treat certain types of periodic fever syndromes or auto-inflammatory syndromes. Periodic fever syndromes are rare and often inherited conditions caused by mutations in certain genes. People with a periodic fever syndrome have episodes of fever and inflammation without other causes such as infection or virus.

Otezla (apremilast) - is an enzyme within your immune system that can affect certain cells and contribute to inflammation in the body and to treat active psoriatic arthritis in adults. Otezla is also used to treat moderate to severe plaque psoriasis in adults. Otezla is also used to treat mouth ulcers in adults with Behçet's disease, a disease causing inflammation in blood vessels.

Mavrilimumab - Giant cell arteritis, GCA, is a chronic inflammatory disease of medium-large arteries. According to Kiniksa, blocking GM-CSF signaling, a protein, secreted by cells that carry signals to neighbouring cells, with mavrilimumab may be able to reverse the course of GCA upstream. It targets cell types driving the inflammatory process, a mechanism that is different from currently available therapies.

Accumulating evidence suggests that patients with severe acute COVID-19 pneumonia have a cytokine storm syndrome, or unbalanced hyper-inflammatory response resulting in markedly elevated cytokine and chemokine production. GM-CSF is a cytokine with dual roles as a critical pulmonary hormone and pro-inflammatory properties that can exaggerate tissue inflammation.

Kaletra or lopinavir/ritonavir - is an HIV medication containing a combination of two antivirals, lopinavir and ritonavir, medications that prevent the human immunodeficiency virus, HIV, from multiplying in your body. In vitro and clinical studies, patients previously receiving these antiviral agents, suggest some activity against SARS and MERS, infections caused by other coronaviruses. Kaletra may increase the risk of certain infections or autoimmune disorders by changing the way the immune system works. Symptoms may occur weeks or months after starting treatment.

In one randomized study of 199 people hospitalized with COVID-19, there was no difference between using Kaletra and not using it in terms of how long it took for patients to improve.
Another small study of 127 people with mild COVID-19 symptoms looked at Kaleta alone compared to Kaletra in combination with interferon beta-1b and ribavirin. Results suggest the group who received all three medications improved sooner and cleared the virus faster, 7 days, and those who received only Kaletra, 12 days.

Avigan or favipiravir – an antiviral medication approved in Japan and China for the flu, selectively inhibits RNA polymerase necessary for influenza virus replication. This mechanism of action applies to the coronavirus, which is an RNA virus of the same type as influenza viruses. In vitro studies have shown that high doses of favipiravir were able to prevent human cells from being infected with SARS-CoV-2.

A small study in China looked at 80 patients with mild COVID-19 symptoms and saw that that favipiravir helped clear the virus faster than Kaletra (4 days vs. 11 days, respectively). The patients who took favipiravir also showed greater improvements in their lungs based on chest images. A handful of clinical trials are now ongoing in the United States. The first U.S. clinical trials for favipiravir were recently approved to start in Boston.

Umifenovir or Arbido - is a flu medication used outside the U.S. As mentioned above, Umifenovir was not as good as favipiravir but seems better than Kaletra, in helping patients recover from COVID-19 and clear the virus in a study from China.

Stay safe. Mask. Social distance. Frequent hand washing. Avoid crowds.

ALWAYS CONSULT YOUR PERSONAL HEALTH CARE PROFESSIONAL