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CORONAVIRUS RESEARCH: 500 More Clinicals! Hope On the Way!

Brian Turner

Posted on April 10 2020

By Steve Blechman

 

On April 1, my article entitled: “Coronavirus War! Attack It Now: Potential Drugs & Treatments” (Advanced Molecular Labs.com), I mentioned the preliminary results of the China study published March 17, 2020 in the International Journal of Anti-Microbial Agents. The results of the study found that 100% of the patients were cured by day six by using anti-malarial drug hydroxychloroquine in combination with azithromycin (brand name: Z-Pak), which is prescribed for upper respiratory tract infections. 57.1% of patients are just treated hydroxychloroquine alone.

A small human study was recently reported by French researchers that looked at 80 hospitalized coronavirus patients receiving the drug combo after eight days of treatment. 93% of patients tested negative for the virus. On March 29, 2020 the FDA fast-tracked with emergency approval and more widespread availability of hydroxychloroquine to clinical research centers and hospitals and most recently allowed physicians to prescribe an off-label to their patients under medical supervision.

The drug companies Novartis donated 30 million doses of hydroxychloroquine and Bayer contributed 1 million doses to the federal government and those most in need. Novartis CEO Vas Narasimhan told a Swiss newspaper that its malaria drug hydroxychloroquine is the drug maker’s biggest hope against COVID-19.

According to recent survey of 6,200 doctors, hydroxychloroquine was listed as one of the top treatments. No surprise because no legal options for physicians are available right now through prescriptions to treat their sickened patients. There are no proven miracle cures or treatments but hydroxychloroquine or its combo provide hope that they may lower the infection rate and spread of the virus until we have a vaccine in hopefully 12-15 months.

What’s needed are gold standard, double-blind randomized clinical trials to prove safety and efficacy of hydroxychloroquine alone or combined with azithromycin (Z-Pak). Unfortunately, these stringent types of clinical trials will take months. We need something now. People are dying! Hope is on the way. A new 62-patient randomized clinical trial was most recently completed in China to treat coronavirus patients with a five-day hydroxychloroquine regimen, which was found to be effective. The new study has not been peer-reviewed or published yet in a reputable medical journal. Another clinical trial is now underway in 1,500 coronavirus patients at Columbia University Medical Center to measure risks and benefits. Also, the University of Pennsylvania has started a double-blind clinically controlled trial with hydroxychloroquine.

According to the Friday, April 10, issue of The Wall Street Journal, “dozens of companies and universities, researchers have been hustling to develop therapies or vaccines against the virus. More than 140 are in development worldwide, most in the early stages, including about a dozen already in clinical trials according to Pharma Intelligence.” Drug makers such a Pfizer (Xeljanz), Roche Holding AG (Actemra), Regeneron Pharmaceuticals (Kevzara), Gilead Sciences (Remdesivir) and CytoDyn (Leronlimab) just some of the drug companies working on anti-viral, anti-inflammatory, cytokine blockers and immunomodulators for the potential treatment of the coronavirus. 260 monoclonal antibodies have shown a strong ability to bind with coronavirus proteins and block viral entry into the cell. San Francisco doctor Jacob Glanville, who was highlighted in the Netflix documentary “Pandemic,” has acknowledged that he and his company Distributed Bio are working on a monoclonalantibody therapy to block the coronavirus from infecting human cells.

Cytel Inc. has launched an open-access global COVID-19 clinical trial tracker. It was recently reported by Drug Discovery Technology Networks (April 9, 2020) “in the short time, since the outbreak occurred, around 500 trials have already commenced -- a number that is growing daily.” The Cytel Inc. COVID-19 clinical trial tracker was developed “to help facilitate greater collaboration between researchers, policy makers, clinicians, journalists, philanthropists, and other critical stakeholders who need to understand the complex dynamics of the global response to find a solution to COVID-19 outbreak.”

In my last article, I mentioned half a dozen biotech companies are working on antibody treatments against COVID-19. Blood is collected from coronavirus-recovered patients who carry antibodies to COVID-19 and then would donate the plasma to someone who is seriously ill with the virus. Known as convalescent plasma treatment, which I mentioned in my last article, and has very promising results that were recently published in the Journal of the American Medical Association (JAMA, March 27, 2020).

An exciting new pilot study on convalescent plasma (CP) therapy for treating 10 COVID-19 patients was most recently reported by Biopharma from Technology Networks (April 8, 2020). The study was published most recently in the April 6, 2020 Proceedings of the National Academy of Sciences of the United States of America (PNAS) and reported: “within three days of CP transfusion, clinical symptoms, such as fever, cough, shortness of breath and chest pain, significantly improved, and patients exhibited increased lymphocyte counts, improved liver and lung function, and reduced inflammation.”

This is a very exciting preliminary study and suggests that convalescent plasma therapy might be a safe and effective treatment for coronavirus treatments. Hopefully, in the near future controlled randomized clinical trials will further support these findings.

We are at war with the coronavirus. This article further reviews and provides the most recent update on the latest drugs and treatments being tested now to attack the coronavirus. In an editorial by Binh Nᴳᴼ and Stephen Ditmore in the Friday, April 10, 2020 issue of The Wall Street Journal, past FDA director Scott Gottleib in “Bet Big on Treatments for Coronavirus” in the Wall Street Journal (op-ed April 6, 2020) said that we cannot rely solely on isolation and social distancing and urged the FDA to accelerate approval of covid-19 drugs. The FDA recently approved biotech company Cellex under “emergency use authorization” which allow for its new antibody tests to be used prior to gaining full approval! Abbott Labs new rapid 5- and 15-minute tests that had recently been approved by FDA for testing of coronavirus are vital and urgently needs to be more widespread -- even in asymptomatic people. I can’t emphasize this enough if we are going to control the spread of infection! 

Even though cases of coronavirus are going down, we cannot take our foot off of the pedal! More testing, effective treatments and therapeutics and randomized controlled trials need to continue so we can establish safety and efficacy. We can win the war with the coronavirus with the help with all of our wonderful heroic health care workers and leading pharmaceutical and research centers. We can recover, control and kill the virus! “Can’t” isn’t in my vocabulary -- only can is!

 

Hope is on the way!

 

Sources:

  1. Centers for Disease Control and Prevention (CDC)
  2. National Institutes of Health (NIH)
  3. Johns Hopkins Center for Health Security

 

References:

 

  1. Gautret et al. (2020) Hydroxychloroquine and azithromycin as a treatment of COVID‐19: results of an open‐label non‐randomized clinical trial. International Journal of Antimicrobial Agents – In Press 17 March 2020 – DOI: 10.1016/j.ijantimicag.2020.105949       
  2. French study finds anti-malarial and antibiotic combo could reduce COVID-19 duration. Darrell Etherington@etherington/March 19, 2020.           
  3. Shen C, Wang Z, Zhao F, et al. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. Published online March 27, 2020. doi:10.1001/jama.2020.4783
  4. Roback JD, Guarner J. Convalescent Plasma to Treat COVID-19: Possibilities and Challenges. JAMA. Published online March 27, 2020. doi:10.1001/jama.2020.4940
  5. Arturo Casadevall, Liise-anne Pirofski. The convalescent sera option for containing COVID-19. Published April 1, 2020; First published March 13, 2020. Citation Information: J Clin Invest. 2020;130(4):1545-1548. https://doi.org/10.1172/JCI138003. 
  6. Global COVID-19 Clinical Trial Tracker Launched NEWS Apr 09, 2020 | Original story from Cytel Technology Networks.com https://www.technologynetworks.com/drug-discovery/news/global-covid-19-clinical-trial-tracker-launched-333234
  7. Pilot Study Suggests the Feasibility of Convalescent Plasma Therapy for COVID-19 NEWS Apr 08, 2020 | Original story from PNAS https://www.technologynetworks.com/biopharma/news/pilot-study-suggests-the-feasibility-of-convalescent-plasma-therapy-for-covid-19-333225
  8. Effectiveness of convalescent plasma therapy in severe COVID-19 patients

Kai Duan, et al. Proceedings of the National Academy of Sciences Apr 6 2020, 202004168; DOI: 10.1073/pnas.2004168117

  1. Pfizer PinPoints An Early Drug Candidate. Wall Street Journal. Jared S. Hopkins. April 10, 2020
  2. On Developing New Drugs to Treat Covid-19. Binh Nᴳᴼ & Stephen Ditmore. Friday, April 10, 2020 Wall Street Journal.
  3. Eric J. Rubin, M.D., Ph.D., Lindsey R. Baden, M.D., and Stephen Morrissey, Ph.D. Audio Interview: New Research on Possible Treatments for Covid-19. March 19, 2020. N Engl J Med 2020; 382:e30. DOI: 10.1056/NEJMe2005759      
  4. COVID-19 treatment might already exist. Nevan Krogan - Professor and Director of Quantitative Biosciences Institute, University of California, San Francisco. March 26, 2020. Live Science.    
  5. Anthony S. Fauci, M.D. et al. Covid-19 - Navigating the Uncharted. March 26, 2020 N Engl J Med 2020; 382:1268-1269 DOI: 10.1056/NEJMe2002387