A Las Vegas-based trial site organization called Las Vegas Medical Research Center was selected by the National Institute of Health (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), the public-private partnership overseeing U.S. taxpayer-originated funding of clinical trials targeting a range of investigational vaccines and therapies targeting SARS-CoV-2, the virus behind COVID-19. Here in Las Vegas, Nevada, this trial site is now recruiting up to 220 participants aged 18 and up for an actual outpatient treatment, that is for those people that get diagnosed with COVID-19, the government is now partnering with various private sector pharma companies to introduce advanced experimental therapies, such as monoclonal antibody-based investigational products. Outspoken physician groups such as the Front Line COVID-19 Critical Care Alliance (FLCCC) have been vocal for many months now that treatments are needed for early onset COVID-19, that is the vast majority of cases (nearly 90%) where individuals may suffer from body aches, cold or flu-like symptoms when down with COVID-19. To date, there are no treatments for this stage of the condition (again the majority of cases). While controversy builds around generic, repurposed medicines (e.g. fluvoxamine, ivermectin, colchicine, etc.) in the antiviral area ACTIV has only supported biopharmaceutical-backed experimental therapies. What’s increasingly recognized is the need for a “Tamiflu” for COVID-19 and now Las Vegas Research offers residents in Las Vegas recently infected with SARS-Cov-2 an option backed by the NIH’s ACTIV.
To date, the only drug trial breakthrough in America targeting COVID has been Gilead’s remdesivir. Yet that drug is only for individuals hospitalized and according to a recent study that’s only about 12% of the total COVID-19 patients. For those hospitalized they may be given remdesivir and a monoclonal antibody cocktail or if conditions worsen dexamethasone.
COVID-19 in Las Vegas
The entertainment capital of the world was hit very hard by this pandemic as tourism is the by far the largest economic contributor to this large city. Approaching 2.3 million, the Las Vegas metropolitan area represented one of the fastest growing cities in the country for decades.
The region was hit with essentially three waves of the pandemic first starting in late June and July with over 1,000 cases per day then again a big wave from November into early January where as many as 2,092 cases per day/seven day average were recorded. The case count has declined and is now down to about 205 per day based on last week’s seven day average.
While earlier in the year Clark County faced a shortage of vaccine products, now clinics are full of supply and well-staffed and now complain they need more people to come in and get vaccinated.
The Importance of Therapies for COVID
So what study does Las Vegas Medical Research offer access to? The ACTIV-2 initiative also called “Rise Above COVID.” Sponsored by ACTIV, which again is a public-private partnership led by the NIH, the study investigates various medicines to determine if they are safe and if they can help adults with COVID-19. Critically important because the virus is rapidly spreading worldwide and can cause serious sickness, often with long term effects and of course death.
Although many people falsely think with a vaccine there is no need for therapies this is not true. As explained in the ACTIV-2 website developing both safe and effective vaccines and therapies are absolutely vital in stopping COVID-19.
With vaccines now available, quite a few people won’t be able to have a vaccine whether due to health conditions, weak immune system, a lack of supply in a given area and in some cases some people may opt not to receive one. Therapies that are ultimately deemed safe and efficacious will help give society tools to help those who fall ill to SARS-CoV-2 while the vaccine is under development as well. Moreover, it is not known yet how strong the vaccine protection actually is (they are still emergency authorized and not formally approved) and there is not enough data to know with certainty how long they last).
A Phase 2 clinical trial that can seamlessly expand to a Phase 3, the focus is on adults with COVID-19 who are not hospitalized with an aim to evaluate the safety and efficacy of a few different treatments including monoclonal antibodies and other types of therapeutics. TrialSite includes a table showing the different treatments:
|LY-CoV555: An investigational antibody developed by Eli Lilly in partnership with AbCellera Biologics. This is an monoclonal antibody originally identified with NIAID’s Vaccine Research Center||The therapy was given emergency use authorization (EUA) by the FDA on November 2020, They issued an emergency use authorization for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19.|
Bamlanivimab is authorized for people with positive results of direct SARS-CoV-2 viral testing who are twelve years of age and older weighing at least 40 kilograms (88 lb), and who are at high risk for progressing to severe COVID-19 or hospitalization.
|BRII-196 & BRII-198 developed by a Chinese biotech firm called Brii Biosciences. The company was founded by a prominent pharmaceutical executive and maintains a U.S. headquarters in Research Triangle Park in NC.||Clinical Trials|
|SNG-001—inhalable beta interferon delivered via nebulizer and developed by a biotech called Synairgen||Clinical Trials|
|AZD7442—combination of two monoclonal antibodies (AZD8895 and AZD1061) profiled by TrialSite. Note one is undergoing testing as prophylaxis||Clinical Trials|
|Camostat Mesilate—orally administered serine protease inhibitor developed by Sagent Pharmaceuticals that can possibly block the coronavirus from entering the human cells.||Clinical Trials|
Treatments as a Care Option in Las Vegas
Because the federal regulatory authorities haven’t thus far accepted data from worldwide ivermectin trials, for example, and other studies with positive results such as Colchicine and Fluvoxamine are not yet accepted there are no authorized treatments for early onset COVID-19.
Las Vegas Medical Research investigator, Dr. Bharat Mocherla, shared recently in a local press entry that more research is absolutely essential to combat actual transmission of the coronavirus, its variants in the effort to overcome the pandemic. He reports that having additional treatments ready for COVID-19 would represent big progress in the war against this pathogen.
Participation in ACTIV-2
Dr. Mocherla warns more variants are coming and, “We need to advance the treatments because the treatments that we have today are working that may not work in the future.” The Principal Investigator reports for new treatments volunteers are needed. Hence if someone resides in the Las Vegas area and is tested positive with COVID-19 within 10 days of registering for the trial, they can potentially participate in ACTIV-2.
Importantly, those who have had COVID-19 symptoms for longer than 6 days are not eligible. Moreover, if one is experiencing severe symptoms, they should go to a hospital. Ideally, any individual in Las Vegas that just started with symptoms should consider this study.
The Trial Site Organization
Las Vega Medical Research Center is a dedicated research center collaborating with community doctors and researchers around the globe to provide advanced diagnostic tests and effective treatments for debilitating diseases. This trial site participates in major multi-center trials with worldwide presence. The group is led by Dr. Bharat Mocherla, nuclear medicine specialist.