COVID-19 PRACTICE GUIDE

1 of 23 COVID-19 PRACTICE GUIDE

Compliments American Medical Association

2 of 23 Guiding Principles:

• We follow CDC guidelines • We belong to the FLCCC Alliance, led by Dr. Paul Marik • We add the wisdom we’ve gained from caring for Covid-19 patients • We remember that SARS-Cov2 is a novel virus and disease and adapt our guidelines as new insights become available. There is no perfect plan. • COVID-19 is primarily a clinical diagnosis • Testing is used to guide social distancing, quarantine schedules, and presence of immunity.

Who is at the highest risk? (CDC) • Cancer • Chronic kidney disease • COPD (chronic obstructive pulmonary disease) • Heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies • Immunocompromised state (weakened immune system) from solid organ transplant • Obesity (body mass index [BMI] of 30 kg/m2 or higher but < 40 kg/m2) • Severe Obesity (BMI ≥ 40 kg/m2) • Pregnancy • Sickle cell disease • Smoking • Type 2 diabetes mellitus

• Asthma, Type 1 diabetes and Hypertension are likely high risk also according to the CDC • 80 % of deaths have been in patients over 65 years.

3 of 23 Limiting Spread ::::

According to CDC and OSHA, our office is considered “High Exposure Risk” because we handle specimens that may have SARS Cov-2 (saliva, nasal swabs). We do not however perform procedures that aerosolize saliva, which lowers our risk profile. (versus an ENT office for example.) https://www.osha.gov/Publications/OSHA3990.pdf

Pracitioner Schedules We restrict each of our three medical providers to separate days in office

Social Distancing We keep 6 feet between people when in-office as much as possible

Masks • N95 are worn at all times in office by both patients and staff • When N95 are not available then 3-layer cotton or 2-3 layer surgical masks at all times in office • Although the CDC says the effectiveness of “gaiters” is still unknown we discourage use (see Duke Study) • Cloth masks with 2-3 layers of fabric are acceptable for COVID-negative patients • Behind a closed door in the consult room a patient should maintain their mask Duke Study : https://hartfordhealthcare.org/about-us/news-press/news-detail?articleid=27691&publicId=395 CDC : https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care.html

Gowns

Disposable gowns (and gloves) are worn with any symptomatic patient, and patients with known contact or positive test

Face Shields

Shields should be worn with any symptomatic patient who is within 10 days since testing positive.

4 of 23 Ofce Barriers

Symptomatic patients or those with positive tests who are within the frst 10 days should remain behind a closed door with a room air flter at all times while in our ofce. Our front desk staf function as medical assistants also therefore we do not have pexiglass barriers at our front desk

Ofce Hygiene

All surfaces in treatment rooms are disinfected in between patient encounters as is the bathroom if a patient visits the bathroom

Air Purifers

Symptomatic patients and patients known to be COVID-positive are only seen in our Treatment Room, which has a continuously running HEPA flter portable air purifer.

How Long Are Patients Infectious?

CDC: • Mild to Moderate COVID-19 patients remain infectious for 10 days after symptom onset • A large contact tracing study demonstrated that high-risk household and hospital contacts did not develop infection if their exposure to a case patient started 6 days or more after the case patient’s illness onset (Cheng et al., 2020). • Patients should be assumed infectious 2 days prior to the onset of symptoms (and can contact trace based on that timeline)

5 of 23 When to End Isolation and Precautions?

Asymptomatic: 10 days after the first postive PCR test

Mild-Moderate Symptoms: 10 days after symptoms started and 24 hours after patient’s temperature is normal without medication.

CDC: https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration- isolation.html#:~:text=Available%20data%20indicate%20that%20persons,days%20after%20symptom%20onset.

How Long Are Patients Immune to Reinfection?

Most likely, 3 months. For persons recovered from SARS-CoV-2 infection, a positive PCR without new symptoms during the 90 days after illness onset more likely represents persistent shedding of viral RNA than reinfection.

CDC: https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration- isolation.html#:~:text=Available%20data%20indicate%20that%20persons,days%20after%20symptom%20onset

6 of 23 Testing Notes ::::

Nasal Swabs:

The likelihood of recovering replication-competent virus declines after onset of symptoms.

For patients with mild to moderate COVID-19, replication-competent virus has not been recovered after 10 days following symptom onset (CDC, unpublished data, 2020; Wölfel et al., 2020; Arons et al., 2020; Bullard et al., 2020; Lu et al., 2020; personal communication with Young et al., 2020; Korea CDC, 2020).

Nasal Swabs - False Positives

Although replication-competent virus was not isolated 3 weeks after symptom onset, recovered patients can continue to have SARS-CoV-2 RNA detected in their upper respiratory specimens for up to 3 months (Korea CDC, 2020; Li et al., 2020; Xiao et al, 2020).

Investigation of 285 “persistently positive” persons, which included 126 persons who had developed recurrent symptoms, found no secondary infections among 790 contacts attributable to contact with these case patients. Efforts to isolate replication-competent virus from 108 of these case patients were unsuccessful (Korea CDC, 2020).

When the language “some patients may be contagious for up to 20 days” is used it is in reference to a study that showed that 88% at 10 days and 95% at 15 days had no replicating virus and that many of the patients in the study were immunocompromised. (van Kampen et al., 2020 and CDC)

The True Accuracy of Tests for COVID-19 is Uncertain

Unfortunately, it’s not clear exactly how accurate any of these tests are. There are several reasons for this:

7 of 23 • We don’t have precise measures of accuracy for these tests — just some commonly quoted figures for false negatives or false positives, such as those reported above. False negative tests (2-37%) provide false reassurance, and could lead to delayed treatment and relaxed restrictions despite being contagious. False positives, which are much less likely, can cause unwarranted anxiety and require people to quarantine unnecessarily. • How carefully a specimen is collected and stored may affect accuracy. • None of these tests is officially approved by the FDA. They are available because the FDA has granted their makers emergency use authorization. And that means the usual rigorous testing and vetting has not happened, and accuracy results have not been widely published. • A large and growing number of laboratories and companies offer these tests, so accuracy may vary. At the date of this posting, more than 170 molecular tests, two antigen tests, and 37 antibody tests are available. • All of these tests are new because the virus is new. Without a long track record, assessments of accuracy can only be approximate. • We don’t have a definitive “gold standard” test with which to compare them.

Source : https://www.health.harvard.edu/blog/which-test-is-best-for-covid-19-2020081020734

Time-of-Appointment Policy for Patient Care During the Pandemic ::::

Telemedicine Pre-Screening

All patients at the time of scheduling will be asked about COVID symptoms, COVID exposures, and prior COVID tests. Patients will be encouraged to take their temperature at home prior to departing for our office.

Entry to Ofce for Appointment

All patients will have their temperature checked prior to entering the office. Anyone with a temperature of 100 F or higher will not be permitted to the office and will be recommended to have a COVID test either by our staff (outside the office) or will be directed to a rapid test center. Afebrile patients will enter the office and go directly to the Treatment Room or the Consult Room. Restrooms are available as usual for patients, but will be cleaned between patients.

8 of 23 Patients who are atleast 14 days after either the start of symptoms or their first positive COVID test that have documented antibodies against SARS Cov-2 and are afebrile will be treated as a non-COVID patient if they are less than 90 days since the presence of antibodies was established.

Exiting the Ofce After Appointment

Covid-positive patients who are within 10 days since testing positive and symptomatic patients (with unknown COVID status) will have payment information collected prior to arriving at the office. All other patients will follow a normal check-out process at ARISE MD.

Visitors

We make every effort to limit the number of non-patient visitors to our practice during the pandemic. Patients are encouraged to come alone to their appointments. They are permitted to bring one relative (who is a member of their household) with them to the appointment if needed.

Exposure Procedure

If a staff member has a known exposure he or she will have a rapid COVID test and a PCR COVID test done as soon as possible and will go into quarantine until the rapid test results are back. If the patient’s rapid test is negative and he or she is not symptomatic then the staff member will take 12mg of Ivermectin and be observed for 24 hours after taking Ivermectin. He or she will also be encouraged to do hydrogen peroxide nebulizer treatments 3 times per day for the first 24 hours. If the person remains asymptomatic 24 hours after taking Ivermectin he or she may return to work following all COVID care precautions listed in this document. The person will take a second dose of Ivermectin 3 days after the first dose. If the person’s PCR test comes back positive the person will have an antibody test drawn at our office and go into quarantine for 7 days. If antibodies are present the person will come back to work. If the antibody test is negative the staff member will remain in quarantine for 10 total days from the day of the PCR testing, which may only be a few days at that point.

All staff members and practitioners in our office space will be alerted about a positive test and estimated quarantine period for an afflicted staff member.

9 of 23 Testing ::::

PCR Nasal Swab

We ofer PCR Nasal Swabs through HealthLab (Northwestern University) with a 2-3 day turnaround.

When we do a swab the staf is in disposable N95 mask, gown and gloves. The room air flter is on and the room is sprayed down with a disinfectant after the procedure. Whenever possible the swab will be done in a drive-up fashion.

We do not ofer Rapid Tests for SARS-Cov2.

False negatives are thought to be around 15%

False positive tests should be less than 5%, however in a recovered patient it is well documented that most patients do not have replication-competent virus after 10 days of symptoms and yet the viral debris (proteins) can trigger a positive nasal swab up to 3 months after the patient has recovered.

Antibody Testing

We ofer Antibody (against SARS-Cov2) Testing for our patients with a 1-2 day turnaround. The antibody test we ofer is run on the highly accurate (98%) and highly specifc (97%) Roche machine at HealthLab/Northwestern University.

10 of 23 Treatment Guide for COVID-19 ::::

There is no one agreed upon protocol for preventing or treating COVID-19. One thing most parties agree upon is timing is everything. The sooner one starts therapy the less likely they are to have long-term complications (lung scarring, chronic fatigue). This means you need to be prepared to act “if” you get COVID-19. Therefore we say preparation is everything.

Preparation (Home Planning)

Team:

• Determine a family member who will be the COVID Quarterback • Talk to your Doctor about testing for and managing COVID (do they believe in Ivermectin ? Hydroxychloroquine?) • If your PCP and your husband’s PCP don’t agree on approaches to care then pick one or default to ARISE MD. • Are you open to Intravenous Vitamin C and glutathione if you become sick? Where will you get this done? • Which Emergency Room are you most comfortable going to? • What is your insurance company’s posture towards COVID care?

Self-monitoring: We ask all our patients to have these items at home

• Automated blood pressure cuf (OMRON-10) • Pulse oximeter (JN Pulse Oximeter) • Thermometer (Kinsa) • Netti-pot • Telemedicine capabilities (preferably not on their phone) • Nebulizer is also good to have at home. (Mayluck) • Kardia ECG device • Extra batteries • Oxygen generator is an option. We have (2) pathways to help our patients: INOGEN Oxygen and through our ofce. Both pathways will require 30 minutes of admin. time for paperwork and coordination.

11 of 23 Preferred Lab Sites:

Blood draws > We ask our patients to have one blood lab (hospital, Labcorp, Quest) that is convenient to them in addition to our

COVID testing > We want our patients to have a list of rapid test and PCR test sites

Home Apothecary:

We expect our patients to have the following items at home ready if / when needed:

Biocidin throat spray (1) spray in the morning and evening, especially before exercise Vitamin C (3) grams per day (Perque bufered C) Zinc (30) mg per day (Perque Chewables) Vit D3 with vitamin K2 (3,000) iu of D3 per day (Orthomolecular drops) Multi-vitamin (4) per day (Mitocore - Orthomolecular) Aspirin (81) mg daily unless contraindicated Tylenol brand Acetaminophen Melatonin (1) mg nightly of Intelligent Melatonin Magnesium (Mg Guard) Probiotic (Orthobiotic by Orthomolecular) Hydrus Hydration Formula (Hydrus Corporation) Quercetin 1 gram / day (Repair Guard by Perque) Tumeric 1 gram / day in the Pulmonary Phase until CRP is normalized (Turiva by Orthomolecular) Anti-anxiety tools like Calming Powder, CBD/Hemp or KAVA Epsom salts for bathing or foot soaks

12 of 23 Nasonex OTC nasal steroid spray Quick Access to Ivermectin 0.2mg/ kg for 3 doses A nutrient dense medical food for blending smoothies (Metagenics GI Replenish, Infamm X or Fit Food Vegan Xymogen)

Prevention (Prophylaxis) General Recommendations ::::

Biocidin throat spray in the morning and evening (Study showed increased antibodies) Vitamin C (3) grams per day (Perque bufered C) Zinc (30) mg per day (Perque Chewables) Vit D3 (3,000) iu per day with vitamin K2 (Orthomolecular drops) Multi-vitamin (4) per day (Mitocore - Orthomolecular) Aspirin (81) mg daily unless contraindicated Melatonin (1) mg nightly

Sleep 7-9 hours per night Hydrate 2 litres H20 per day and 2 servings of Hydrus daily Diet - dairy free, peanut free, low sugar, low gluten Exercise 150 mins. of moderate intensity weekly= Dental Hygiene - reduce oral infammation by brushing twice per day, fossing 1x/day

After a known exposure

• We recommend patients take Ivermectin 0.2 mg/kg on day 1 and day 3, then one dose weekly for 10 weeks followed by one dose every 2 weeks * updated FLCCC guidelines December, 2020 • We will help patients review the contraindication list for Ivermectin to make sure it is safe • We recommend patients do Hydrogen Peroxide (H202) nebulizer treatments once daily until test results are back • 4 cc of normal saline mixed with 1 cc of 3% food-grade H202 • Saline link • H202 link

13 of 23 • Nebulizer link • Reference 1 for hydrogen peroxide • Reference 2 for hydrogen peroxide

Vaccination Guide ::::

Key Considerations:

1. The FDA has never approved an mRNA virus (both Pfzer and Moderna’s are mRNA) 2. This is the fastest (by far) a vaccine has ever come to market 3. It will still be months before the vaccine is widely available to citizens 4. The vaccination takes two injections 3 weeks apart 5. Other 2-injection vaccines show that people frequently skip the second dose 6. It’s common for drugs to be rejected during Phase 3 trials 7. The Pfzer and Moderna vaccines are still in Phase 3 trials 8. The federal government paid Pfzer $2 Billion for the vaccine 9. Pfzer and Moderna’s vaccines showed roughly 95% efectiveness at preventing COVID19 10. 5-10% of participants in the Pfzer vaccine study already had COVID 19

(WSJ article) Vaccine Notes:

Many vaccines that show promise in early testing fail during the final round.

Trials involving two of the top-runners, developed by AstraZeneca and Johnson & Johnson, were paused or halted because of illness in study subjects—developments that aren’t unusual in large clinical trials—but the studies have resumed. While final-stage testing may stretch for months or even years to continue to track safety and the durability of protection, positive interim results from Phase 3 can be enough for a vaccine to start getting regulatory approval for mass

14 of 23 production and distribution in the meantime. Some of the leading vaccine candidates have released interim results, and more are expected in the coming weeks or months.

The Moderna vaccine also uses a gene-based technology to provoke an immune response, though the code it delivers takes the form of messenger RNA. Those molecules, commonly referred to as mRNA, are the body’s molecular couriers ferrying DNA instructions for making proteins. The vaccine delivers to cells mRNA for making the coronavirus’s spike protein…. It was the first candidate to enter human testing in the U.S. The vaccine produced an immune response in early-stage testing and was generally well-tolerated, with minor side effects observed in test subjects. 30,000 person trial is ongoing.

An mRNA vaccine has never been approved for any disease.

The vaccine developed by Pfizer and German partner BioNTech SE also uses mRNA. Phase 3 testing began in the U.S. in July and expanded overseas to include about 120 sites. The study enrolled 44,000 people. The vaccine reached a development milestone in early November, proving to be more effective than expected at protecting people from Covid-19. In the U.K., the two-shot vaccine began to be rolled out in December after having won regulatory approval. The vaccine will go into distribution in December, though it will take months for the companies to make enough doses for the general population.

• The U.S. government has agreed to pay Pfizer and BioNTech nearly $2 billion for 100 million doses…

• Russia, China and UAE are already vaccinating through State Programs prior to finishing clinical trials.

• Concerns about influencing fertility in child-bearing-age women have yet to be validated.

Also see this article : “What you need to know as the frst COVID-19 Vaccine Heads Our Way”

The decision to have a vaccine ultimatley lies with the individual.

15 of 23 Treatment at ARISE MD - Final Notes ::::

We follow the FLCCC guidelines for teating COVID-19.

We treat COVID + symptomatic patients with heavy emphasis on anti-virals (especially Ivermectin and Lysine and Vitamin C, and Biocidin) during the viral phase (days 0-10). We caution patients against the overuse of anti- infammatories during the viral phase.

In the pulmonary phase (days 11-28) we emphasize anti-infammatories (like methylprednisolone and Tumeric ) and anti-coagulants (like Eliquis). Ivermectin may have a role as an anti-infammatory in symptomatic patients who have entered the pulmonary phase.

We use Intravenous Vitamin C (see I-MATH and I-MASK Protocols from FLCCC) for our patients in both the Viral and Pulmonary Phases of COVID-19 and in preventing infections of all kinds. BMJ Reference

Although research-based evidence is weak at this time we believe ozone, hydrogen peroxide and Biocidin LSF may each play a powerful role in helping certain patients in their recovery from COVID-19.

We believe that quercetin at 1 gram per day can help in the viral phase and 2-3 grams per day can help during the pulmonary phase

We believe that aspirin is important for both the viral and pulmonary phases. 325mg tablets are recommended unless a known contraindication exists (bleeding concerns.) If a prescription blood thinner is needed then aspirin should be stopped.

Hydroxychloroquine (HCQ), an anti-malarial often used in Lupus and Rheumatoid arthritis was not efective in sick hospitalized patients. The W.H.O does not endorse HCQ for moderate to severe disease. A November 2020 article in The Lancet Rheumatology concluded that HCQ does not reduce risk or treat COVID-19. Regarding Hydroxychloroquine, The FLCC concluded: Not recommended: Hydroxychloroquine (HCQ). The use of HCQ is extremely controversial.[97] The best scientifc evidence to date suggests that HCQ has no proven beneft for post exposure prophylaxis, for the early symptomatic phase and in hospitalized patients. [98–115] Considering the unique pharmacokinetics of HCQ, it is unlikely that HCQ would be of beneft in patients with COVID-19 infection (it takes 5–10 days to achieve adequate plasma and lung

16 of 23 concentrations).[107,116–118] Finally, it should be recognized that those studies which are widely promoted to support the use of HCQ are severely methodologically fawed.[119–122]

We tell our patients that there is no one perfect treatment plan for every COVID-19 patient. Therefore we require patients have an evaluation by Dr. Miller prior to initiating treatment. And we prepare patients for frequent follow ups until the patient is well again.

All recommendations within this document MUST be reviewed by a patient’s Primary Care Physician prior to initiating any of our recommendations.

This document, ARISE Covid Practice Guide, is intended for internal circulation and reference by ARISE MD, Ltd. staf only.

VISUAL REFERNCES WE USE IN COVID CARE AT ARISE MD ::::

(next page) compliments of Dr. Paul Marik and The FLCCC ALLIANCE

17 of 23 Fig 1. Timing is everything. This is a phased disease. Viral Phase and Pulmonary Phase have distinct treatments.

18 of 23 Fig 2. Timing is everything. This is a phased disease. Viral Phase and Pulmonary Phase have distinct treatments.

19 of 23 Fig 3. As many as 30% of COVID Patients have Post-COVID Syndrome

20 of 23 Fig 4. Vitamin C (Ascorbic Acid) is a part of the prevention, viral and pulmonary phases of treatment for these reasons

21 of 23 Fig 5. Orthomolecular Corp. Study of 32 patients showing Complete Tumeric (Turiva) lowered hs-CRP, an important fnding for those in the pulmonary phase trying to reduce infammation and risk for lung scarring.

22 of 23 All Rights Reserved.

Dr. Adam Miller ARISE MD, Ltd. 414-386-2600 [email protected] www.arisemd.com

No reproduction or distribution without expressed written consent

December, 2020

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