Laurie Welton D.O. And Associates
1627 US Highway 1, Suite 208, Sebastian, FL 3295
P. 772-299-7009 F. 772-562-7138
Operation Warp Speed
By Laurie Welton DO
Well, it has been a year for the record books for all of us! I would like to provide an update on outpatient Covid Research and treatment.
Of course, the great news is the vaccine rollout is really starting to progress in fact I was recently informed by the IRCHD that my practice will be receiving 500 doses of the Pfizer vaccine.
The bad news is the virus is mutating at warp speed. That is why vaccine and treatment development has needed to be conducted at Warp Speed.
Through extensive randomized placebo-controlled studies (see references) we have found the antiviral Remdesivir probably improves recovery and reduces serious adverse events and may reduce mortality and time to clinical improvement in hospitalized patients. However, adding a monoclonal antibody to the Remdesivir (LY-CoV555) did not add improvement in efficacy.
So, what about people with mild to moderate disease who are not hospitalized?
Extensive study on Hydroxychloroquine for treatment and prevention has shown no benefit. In fact, the risks of the medication greatly outweigh any benefit. Dexamethasone is used on hospitalized and hypoxic patients, but it has not been tested in outpatients and the immune suppressive effect may cause more harm than good.
Therefore, research on infected people with mild to moderate symptoms is so BADLY needed.
One of the largest studies for treatment in outpatients is the NIH funded multicenter Adaptive Platform Treatment Trial for Outpatients with Covid-19 (Adapt Out Covid). It is a randomized, blinded controlled study that can add or drop agents as they are found to be promising and safe enough for human trials. These study drugs include some of the already emergency use approved monoclonal antibodies (Regen-Cov, Bamlanivimab and Etesevimab) for use in high-risk patients in early disease (best if given within a week of symptoms) as well as other mAbs already tested in healthy volunteers and hospitalized patients. Other drugs being studied include a Mab that can be given IM, an inhaled interferon and an oral medication called Camostat (a protease inhibitor used in Japan since 1985 for acute flares of pancreatitis and is being evaluated in the US also for pancreatitis treatment). There are other studies ongoing by private companies as well.
I am very aware of the Adapt out Covid study trials as my practice has been a study site since December, in my Sebastian office.
Unfortunately, there are many barriers to getting people to take part in the study.
- The study is only open to people who have had symptoms for less than 10 days (preferably less than a week) and have been tested within 10 days. The key to this is to educate physicians and patients who go somewhere to get tested. I feel so sorry for people who get tested somewhere, test positive, and then have no idea what to do next. Do your patients a favor and tell them to call me or any other physician who you know is doing research and treating, ASAP. They can also visit the website RiseAboveCovid.org.
- People think the study drugs being used are truly “investigational” and not studied to be safe. All the human studies are phase 2 or 3, which means the drugs beings studied have already been given to enough healthy volunteers to prove they have not been found to cause severe or unacceptable side effects, and that they look promising in early use.
- People want treatment only. They do not want to take the risk of getting a Placebo. Unfortunately, the only treatment available is the Emergency use monoclonal antibodies which many of the variants are starting to show resistance to. They also are not widely available.
I have been able to acquire a few doses. They are only approved for people who are high risk for severe disease. They are given IV only. All investigators must weigh who can safely get placebo versus who needs hospital care or current EUA medications.
- Mindsets such as: “I will just let it run its course” or “It is just like a cold or a flu”, did not benefit the multitudes of people who have died and the millions who have had the disease and developed long term effects. At least 20% of those infected will develop severe or critical disease. We do not make enough antibody on our own without being vaccinated.
So, what are the benefits to participating in studies like this one or others?
Well, the most important reason is no vaccine or treatment of any kind can be available for use before it is studied to be useful and safe. We currently have these lifesaving vaccines thanks to the thousands of volunteers who participated in a trial. For that matter we have all lifesaving medications and medical devices/equipment thanks to study trial volunteers. I think there is no better feeling than knowing you helped save lives, and boy would I volunteer if I qualified.
Other benefits participants receive are healthcare at no cost to them. Free testing if needed. Free evaluations by physicians and nurses. Free labs. We even call the participants daily so see how they are. So, when did you last get that much attention from your doctor’s office?
Of course, there is also the stipend given to the participants to thank them for being part of a lifesaving study.
Not to mention they may get the active drug that may do many things to include:
- Lessening the severity of the disease to keep them out of the hospital.
- Shortening the duration of their symptoms.
- Greatly lowering the amount of virus, they have so they also have less chance of transmitting it to others.
Many people who have had Covid 19 have developed long term complications. More studies are necessary to prove this but lowering the viral load rapidly may cut down on the “long haul” complications.
Well, that is all I have for now. I know all of us are so sick of Covid, Covid, Covid and unfortunately it is not over yet. Let us do everything we can to stop the spread and the deaths with vaccines and new therapies.
Dr. Laurie Welton
- Activ-3/TICO LY-CoV555 study group, “A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19”, N Engl J Med, March 11,2021, pages 905-914.
- Timothy J Wilt, et al. “Remdesivir for Adults with Covid 19”, Annals of Internal Medicine, February 2021 pages 209-218.
- Peter S Kim MD, Sarah W Read MD “Therapy for Early Covid-19”, JAMA, December 2020, pages 249-250.
- Robert H Goldsein MD, MPH, Rochelle P Watensky, MD MPH” The Challenges Ahead with Monoclonal Antibodies: Prior Authorization to Access”, JAMA, December 1, 2020, pages 2151-2152.
- Ruanne V Barnabas et al, “Hydroxychloroquine as Postexposure Prophylaxis to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 Infection, A randomized trial”, Annals of Internal Medicine. March 2021, pages 344-352.