On Jan. 14, 2021, the National Institutes of Health (NIH) stepped back from its statement last year that Ivermectin, an anti-parasitic drug approved for that use by the U.S. Food and Drug Administration (FDA), is not effective in treating COVID-19. The new statement said more data was needed to make that determination.
While studies continue, some doctors are using Ivermectin with other medicines for the off-label use of treating COVID early outside of a hospital — and are reporting success.
But due to the lack of accepted standard of care for early treatment, many doctors don’t treat COVID-19 before it escalates, meaning many patients may find access to a potentially effective treatment blocked. Most people who test positive for COVID-19 are not given any early treatment recommendations; many who get sick will receive no treatment until they are admitted to the hospital.
LACK OF EARLY TREATMENT
An ever-growing contingent of doctors and medical researchers have been demanding that government officials raise a level of effort for early treatment approval to that seen for vaccine development, with the aim of developing a standard approach for early in-home treatment for those who test positive. But their calls have so far mostly fallen on deaf ears.
As a result, some physicians have chosen to forge ahead independently.
Hazan is one of a growing group of doctors across the country who are treating patients with success and speaking out. She has so far treated hundreds of patients from across the U.S. who tested positive for COVID-19 and were too sick to meet the inclusion protocol of her active clinical trials or because the patients themselves wanted to receive the medicine. The clinical trials are double blind randomized – meaning participants may receive the medicines, or be given a placebo and no one will know until the trial concludes.
The Ventura County Reporter previously reported on Hazan’s work and her active FDA-authorized clinical trials for testing the efficacy of treatments and preventative measures for COVID-19 . Early results in one of those ongoing trials took nearly six months to be peer reviewed and published (1). Hazan says the seriousness of this virus amplifies the importance of funding clinical trials and that local doctors should be supporting clinical trials in their region by informing and referring their patients.
CMH CHIEF TREATED AT HOME
Dr. Stanley Frochtzwajg, who is over 65 years old, is the chief medical officer with Community Memorial Health System that operates Community Memorial Hospital in Ventura, Ojai Valley Hospital and numerous clinics across the county. He has been practicing medicine in Ventura County for over 40 years.
Last month, when he tested positive for coronavirus after feeling a few mild symptoms, he did what many of the general public would do: He stopped going to work, rested, waited and did some online research.
“Physicians are notorious for not taking the best care of themselves,” he said with a small chuckle. But he says he strives to work out, eats an anti-inflammatory diet and “try to do all the right things. Nevertheless, after the first five days [after symptoms started] it felt like I was not getting better and I was concerned.”
He recalled a report (2) he read coalescing existing published reports from medical professionals representing 57 facilities in the U.S., Germany, Australia, Canada, Brazil, and India. In the report, the published writings and data of Hazan, Dr. Peter McCullough, an internist and cardiologist in Dallas and others are cited in support of a treatment protocol that includes an array of medications that the authors say is successfully reducing hospitalization and fatality rates of those with COVID-19. McCullough states that his opinions are his own and not those of the institutions and medical facilities he’s associated with in Texas.
Frochtzwajg studied the potential side effects of the medications listed in the protocol, including hydroxychloroquine and ivermectin. “I knew Dr. Hazan was deeply involved in this. I contacted her and said ‘I probably should have called you a few days ago.’” He said he had “weigh[ed] the risks and benefits of the treatment,” and that he would like to “go ahead” with the treatment “if she was willing to treat” him.
Overall he describes a fairly mild case of COVID-19. “Initially I was feeling some symptoms, then I tested positive and from there it was a two-week experience of fatigue, fever, mild cough, and I did lose my taste and my smell for one week,” said Frochtzwajg, speaking with the Ventura County Reporter on Tuesday, Feb. 2. He had tested positive just over two weeks prior. He also had “very little appetite,” during the course of his illness and one aspect of him having COVID that was “reinforced, not that I needed it, is how incredibly precious and valuable my wife is…she was like Florence Nightingale for me.”
He said he now was at about 60% of his normal energy level. While ill he continued to attend hospital meetings virtually and publish his newsletter every Monday. “I was able to keep up on those kinds of things. I just realized my energy levels were unrecognizably very, very low.”
CONFUSION OVER STUDY IMPLICATIONS
One key aspect of the in-home treatment is a drug that has been used for decades to treat multiple conditions and illnesses, but which is not yet FDA-approved for COVID-19 treatment.
Hydroxychloroquine, long used to treat malaria, lupus and arthritis, recently became the center of a political hail storm around the federal government’s pandemic response. In March 2020, when it was initially touted as an effective treatment for COVID-19 — with, at the time, limited evidence on top of a slew of concerning side effects — it was easy to discredit the drug.
Many physicians, however, considered this a rush to judgment.
McCullough, in collaboration with physicians from Italy, first began work on an early treatment regimen for COVID in July 2020. He and others continue to ask why the U.S. government response to the pandemic fails to address all of the four pillars to combat an infectious pandemic. Those four pillars are: contagion spread, early treatment, late-term treatment and vaccination. (3) Even today, these questions and the call for an early treatment standard of care are being met with claims that it is “misinformation.”
On Nov. 19 before the Senate committee on Homeland Security and Governmental Affairs, McCullough and two other physicians provided sworn testimony that studies suggesting hydroxychloroquine and ivermectin were not effective against COVID failed to meet several basic aspects of what he and others were proposing. In those studies, the drugs were not given within the first five days of symptoms, and they were used alone rather than in conjunction with other medications. McCullough and his colleagues emphasized that any effective treatment of viral infections such as COVID required a multifaceted approach. In addition, those initial studies were based in a hospital setting — suggesting that study participants were already far sicker than patients for whom an early in-home protocol would be meant.
TIMING, ADAPTATION IMPROVE EFFICACY
The suggested treatment protocol ideally begins when someone first tests positive for COVID-19. Patients are started on a daily “nutraceutical bundle” of zinc sulfate (220 mg), Vitamin D (5000 IU), Vitamin C (3000 mg), and a flavonoid called quercetin (500 mg), found in several fruits and vegetables, which reduces viral replication. (2) All are available over the counter.
For those 50 years or older with one or more comorbidities, an intravenous infusion of monoclonal antibodies is suggested. In addition, the patient is immediately started on an array of anti-infective agents, which includes hydroxychloroquine, ivermectin, azithromycin, doxycycline, and favipiravir. Some patients are started on a steroid like prednisone, and some are given an anticoagulant. (2)
This treatment protocol is a roadmap for a standard of care to begin with, but doctors adapt it to the individual. “I will tell you, it is very critical with illness to not ‘shotgun’ people, but rather to individualize care,” Frochtzwajg emphasized. “The best caregivers and physicians do this routinely anyway with patients. I treat no two people the same because no two people are the same…different needs, genetics, variations in lifestyle, really require individualized care and that is precisely what Dr. Hazan did, she made a few modifications during my treatment regiment.” He confirmed hydroxychloroquine was a part of his treatment.
When asked about the controversy around outpatient treatment protocols that are not FDA-approved, he responded, “We live in a very strange time with COVID and no way in God’s Earth prior to this last year would we ever have allowed a vaccine to be introduced after a few months of research. Vaccines typically take years before they’re released. But with COVID . . . we’ve made all sorts of variances in the way we treat people.”
“In fact at the hospital when we treat COVID patients we’ve tried a whole array of treatments, some of which we’ve continued and refined,” Frochtzwajg continued. “But we’ve also abandoned treatments that we henceforth did not feel played out in the way we expected. We are living in very dynamic times that force us to consider treatment regiments that we would have prior never considered without well-controlled double-blind studies. And yet we’re using all kinds of treatments including monoclonal antibodies, which are extremely controversial . . . because the urgency and the severity of the illness requires us to think differently.”
CHANGING THE COMPLEXION OF THE PANDEMIC
McCullough understands the strong pushback against moving forward with treatment protocols using drugs off-label.
“I think two tiers of doctors have emerged,” offered McCullough. “One tier is engaging with patients, treating patients in that pre-hospital phase, markedly reducing hospitalization and deaths. The other tier just don’t feel comfortable doing it.”
McCullough said hydroxychloroquine is “one of four [drugs] that is never used alone,” in the COVID early at home treatment protocol. “It’s been on the market for 65 years, available over the counter in many countries. The doctors who are familiar with it consider it safe and very effective. Those not familiar [with it] may not be so comfortable.”
McCullough and his wife were diagnosed with COVID late last year and were treated with hydroxychloroquine, and azythromycin, an antibiotic that works “inside cells.”
“We underwent strict cardiac and pulmonary oxygenation monitoring. Followup swabs indicated we cleared the virus quickly and had the minimum time in quarantine and away from work,” said McCullough. “Because we were treated in the home, we completed all contact tracing and the viral spread terminated in our house. If this was done with all Americans over age 50 from the beginning, the estimates are that 85% of hospitalizations and deaths would have been avoided and so many families would remain together at this time.
The failure to treat COVID-19 early is the greatest American tragedy and public health blunder in history.” (4)
The standard suggested protocol also includes steroids and drugs that he referred to as “broadlayer intracellular” medicine and “anti-infectives.” Those medicines are then followed by blood thinners.
According to McCullough, doctors using this protocol and adapting it to their patients are already having a “huge impact on mortality” rates by keeping people out of the hospital. The protocol reduces the infection in the body, allowing a person to recover at home.
McCullough said timing is key — the protocol is most effective in the early stages of the disease. One issue complicating treatment is that most people think it’s just a mild cold.
“It starts out as the mildest illness,” he explained. “By the time they get sick they are already many days behind. If we treat [COVID when it’s] a mild illness it doesn’t become severe [for most people]. When someone gets a positive COVID test, [they should] get treated right away.” This is particularly important for those over 50, or who have serious existing medical issues.
McCullough expressed concern that “the whole medical community is just not responsive to the idea of early treatment.” He said when someone gets a positive test result they should be given an info sheet of what to do, but instead they are basically just told “good luck…Our health care delivery system has a long way to go to be responsive.”
If a person’s doctor is not comfortable with the in-home treatment, McCullough recommends that they “ask for a referral to a doctor that would do it…they can engage with doctors [anywhere] over telemedicine.”
McCullough also recommended a “layer of early preventive nutraceuticals,” including zinc, Vitamin D, Vitamin C and quercetin, taken daily.
“None are curative,” he explained. “But it is true that those who are just a little deficient end up with a more severe case. I definitely recommend these daily through the pandemic.”
“There are no drugs that cure the illness,” added McCullough, but having an adopted “sequenced multi-drug approach would change the entire complexion of the pandemic.”
“WE’RE NOT OUT OF THE WOODS YET”
Following Hazan’s protocol, Frochtzwajg says he was treated for 10 days. “I definitely started to show improvements in my fatigue, my fever resolved . . . Taste and smell returned about a week after starting treatment.”
“She was unbelievably attentive, concerned and supportive,” he said of Hazan. “It was truly amazing, one of the most compassionate and attentive physicians I have ever dealt with. I can’t speak highly enough of her attentive care or passion . . . I received four or five phone calls a day from her, checking in on me and my status.”
In addition, Frochtzwajg was self-monitoring oxygen saturation using an oximeter, and taking his temperature three to four times a day.
He did experience “mildly decreased oxygen” and says he was “fortunate” in that his levels never got “concernedly low.” He had brought an oxygen tank home but he never needed to use it. The day he was interviewed he said his oxygen levels were “near normal.”
He has started to take walks around the block and hopes he’ll be back seeing patients this week. “Technically a person is no longer considered infectious starting 10 days after onset of symptoms and at least 24 hours without a fever. Technically I could return already, but I’m trying to be smart about it, and taking time to recuperate.”
As for whether he recommends the in-home treatment protocol to his patients, he said, “I offer patients a referral to Dr. Hazan after I’ve had a chance to assess their history and have given them an overview of her treatment approach.”
McCullough is well aware of Hazan’s approach, saying“I strongly support it.” He says a national, and indeed global standard of care for early treatment is needed because the “vast majority of deaths occur in the hospital.” With doctors correctly using the early protocols, McCullough said they are finding an “85% reduction in hospitalizations.” (4)
Each component of the suggested protocols are “currently available and have a proven safety track record.”
McCullough added that even with vaccines being rolled out, the administration of the doses is too slow to save the thousands that will continue to get sick and require hospitalization, without early treatment. “It is our only hope of reducing the risk of hospitalization and death.”
Frochtzwajg emphasized that everyone should continue to follow safety precautions. “I will be doing absolutely everything that we should all be doing, wearing my N95 [mask], wearing a face shield when working with patients — and I think that we’re all going to need to do that going forward to deal with this virus and the new higher contagious variant and variants. We’re not out of the woods yet by a long shot.”
“But it’s hard to convince people to do some of the basics,” said Frochtzwajg. “I was watching a rally the other day [on television], no one was wearing masks in Montana and I thought, we are not going to be over this for a very, very long time.
In terms of the long road and continuing to be better equipped to combat the virus, Frochtzwajg said, “I think Dr. Hazan has the real answer, which is to fortify our intestinal microbiome so that we are much less susceptible . . . our immune system really originates in our microbiome and she is doing the incredible groundbreaking work that is elucidating that more and more. That is my greatest hope.”
Papoutsis, A., Borody, T., Dolai, S. et al. Detection of SARS-CoV-2 from patient fecal samples by whole genome sequencing. Gut Pathog13, 7 (2021). https://doi.org/10.1186/s13099-021-00398-5: Online at: gutpathogens.biomedcentral.com/articles/10.1186/s13099-021-00398-5
Report from published information of 57 medical professionals including Dr. Peter A. McCullough and Dr. Sabine Hazan: WEB Multifaceted highly targeted sequential multidrug treatment of early ambulatory high-risk SARS-CoV-2 infection (COVID-19)-2.
Nov. 19, 2021 Senate hearing of the Committee on Homeland Security and Governmental Affairs: www.hsgac.senate.gov/hearings/early-outpatient-treatment-an-essential-part-of-a-covid-19-solution.
Brian C. Procter, Casey Ross, Vanessa Pickard, Erica Smith, Cortney Hanson, Peter A. McCullough. Clinical outcomes after early ambulatory multidrug therapy for high-risk SARS-CoV-2 (COVID-19) infection. Reviews in Cardiovascular Medicine, 2020, 21(4): 611-614 doi:10.31083/j.rcm.2020.04.260. Online at: rcm.imrpress.com/article/2020/2153-8174/RCM2020260.shtml
Those who have tested positive for COVID-19 and are interested in joining a local COVID-19 clinical trial can contact Ventura Clinical Trials at: 805-339-0221 or visit www.venturaclinicaltrials.com/contact-us/.
For information on the three active clinical trials related to early treatment of COVID visit the links below at www.clinicaltrials.gov:
Trial testing hydroxychloraquine, azithromycin with Vitamin C, Vitamin D and Zinc: https://clinicaltrials.gov/ct2/show/NCT04334512
Trial testing hydroxychloraquine, Vitamin C, Vitamin D and Zinc: https://clinicaltrials.gov/ct2/show/NCT04335084?term=ProgenaBiome&recrs=ab&draw=7&rank=37
Trial testing ivermectin, hydroxychloraquine, doxycycline and Vitamin C, Vitamin D and Zinc: https://clinicaltrials.gov/ct2/show/NCT04482686?term=ProgenaBiome&recrs=ab&draw=7&rank=39