A Guide to Outpatient COVID Treatment: Step-By-Step Doctors’ Plan That Could Save Your Life
Recently, Dr. Peter McCullough, MD, of Baylor University Medical Center in Dallas testified to Texas Senate HHS Committee about how mass media and even some government agencies are silencing clinical outpatient evidence for effective treatment of COVID19 and instead push vaccines only (video shown below).
Treatments like those mentioned by Dr. McCullough can be found in sites like https://c19early.com/ but specifically, McCullough refers to the following Appendix to a document published by Association of American Physicians and Surgeons (AAPSonline.org) as an educational resource. It is based on a paper published in American Journal of Medicine (link), by Dr. Peter McCullough and 22 other clinicians (MDs) and researchers (PhDs).
“Seek early treatment and be your own advocate. All of the physicians contributing to this booklet are on the frontlines treating outpatients at the first signs of COVID illness. Studies in the US and many other countries clearly show that patients who are treated within the first 5 days of symptoms have better outcomes using the combination of medications in the algorithm below.”
COVID-19 hospitalizations and death can be reduced with outpatient treatment.
Principles of COVID-19 outpatient care include: 1) reduction of reinoculation, 2) combination antiviral therapy, 3) immunomodulation, 4) antiplatelet/antithrombotic therapy 5) administration of oxygen, monitoring, and telemedicine.
“For the ambulatory patient with recognized early signs and symptoms of COVID-19, often with nasal real-time reverse transcription or oral antigen testing pending, the following 4 principles could be deployed in a layered and escalating manner depending on clinical manifestations of COVID-19-like illness and confirmed infection: 1) reduction of reinoculation, 2) combination antiviral therapy, 3) immunomodulation, and 4) antiplatelet/antithrombotic therapy. Because the results of testing could take up to a week to return, treatment can be started before the results are known. For patients with cardinal features of the syndrome (ie, fever, body aches, nasal congestion, loss of taste and smell, etc.) and suspected false-negative testing, treatment can be the same as those with confirmed COVID-19. Future randomized trials are expected to confirm, reject, refine, and expand these principles. In this article, they are set forth in emergency response to the growing pandemic as shown in Figure 1 .
Treatment algorithm for COVID-19-like and confirmed COVID-19 illness in ambulatory patients at home in self-quarantine. BMI = body mass index; CKD = chronic kidney disease; CVD = cardiovascular disease; DM = diabetes mellitus; Dz = disease; HCQ = hydroxychloroquine; Mgt = management; O2 = oxygen; Ox = oximetry; Yr = year.
The basic groups of prescription medicines and other therapies used in COVID-19:
▪ Combination anti-viral medicines started as soon as symptoms occur ▪ Medicines to decrease inflammation, such as corticosteroids (called immunomodulators)
▪ Anticoagulant therapy to prevent blood-clots that can cause strokes, heart attacks, kidney shut-down, and death.
▪ Non-prescription supportive treatments with zinc, vitamin D, vitamin C, electrolyte drinks such as Pedialyte, and others.
▪ Home-based oxygen support, such as with an oxygen concentrator. These machines are available by physician prescription from home health medical supply businesses and are covered on most medical insurance plans.
I. Antiviral Agents:
These must be started quickly at STAGE I (Days 1-5):
Symptoms include sore throat, nasal stuffiness, fatigue, headaches, body aches, loss of taste and/or smell, loss of appetite, nausea, diarrhea, fever.
These medicines stop the virus from (1) entering the cells and (2) from multiplying once inside the cells, and they reduce bacterial invasion in the sinuses and lung:
▪ *Hydroxychloroquine (HCQ) with azithromycin (AZM) or doxycycline
OR
▪ Ivermectin with azithromycin (AZM) or doxycycline
Either combination above must also include zinc sulfate or gluconate, plus supplemental vitamin D, and vitamin C. Some doctors also recommend adding a B complex vitamin.
Zinc is critical. It helps block the virus from multiplying.
Hydroxychloroquine is the carrier taking zinc INTO the cells to do its job.
An educational resource from The Association of American Physicians and Surgeons (AAPSonline.org) 16
II. Anti-inflammatory Agents - Corticosteroids (“steroids”): Oral and Nebulized.
These are started at STAGE II (Days 3-14) to reduce inflammation, the cause of added damage to the lungs and critical organs. Symptoms include worsening cough, difficulty breathing, chest heaviness/tightness or chest pain.
As inflammation damages the airways interfering with normal oxygen-carbon dioxide exchange, blood oxygen levels drop and people experience loss of focus, drowsiness, confusion, difficulty concentrating, low energy and severe fatigue.
The exaggerated Inflammation response in COVID further increases the risk of blood clots.
Prescription medicines and other support added now to Stage I medicines are: ▪ nebulized budesonide to help penetrate the lungs and reduce inflammation ▪ oral prednisone, methylprednisolone, dexamethasone
▪ colchicine – may also be added to reduce inflammation
▪ full strength adult aspirin 325 mg to reduce inflammation and risk of blood clots ▪ home oxygen concentrator may be needed to improve oxygen levels (requires physician prescription)
III. Prescription Anticoagulants (“blood thinners”):
STAGE III (Day 7 and beyond): Symptoms seen in Stage II intensify. Difficulty breathing becomes extreme, oxygen levels drop sharply, risk of heart attack or stroke increases. At this point, people are critically ill.
The medicines to be added to Stage I and II medicines now include:
▪ Aspirin 325 mg unless told not to take by your doctors
▪ And/or low molecular weight heparin injections (e.g. enoxaparin [Lovenox]) OR
▪ apixaban (Eliquis), or rivaroxaban (Xarelto), or dabigatran (Pradaxa) or
edoxaban (Savaysa) in standard doses for 5 to 30 days
If these added steps do not lead to improvement, or the patient becomes unstable, a 911 call is warranted for ER evaluation and hospital admission so that more aggressive IV medications (such as remdesivir, Regeneron, and others) may be considered, and more intensive ventilation regimens are possible in ICU settings.
IV. Vitamins, Supplements, and Oxygen.
▪ Zinc sulfate, gluconate or citrate. These forms are available in pharmacies, health food stores, and sold online. Zinc sulfate 220 mg provides 50 mg elemental zinc, the recommended anti-viral dose. Zinc in the form of zinc picolinate form is not recommended following reports of liver damage and tumors from studies about 20 years ago. Following these reports, the German Commission E that regulates supplements used in medical practice in Germany banned this form of zinc.
An educational resource from The Association of American Physicians and Surgeons (AAPSonline.org) 17
▪ Vitamin D3, preferable in oil in capsules for better absorption. Recommended doses for anti-viral benefit vary from 5000 IU or more for 5-30 days
▪ Vitamin C with bioflavonoids for antioxidant, anti-inflammatory effects. Dose
recommendations from our contributors vary from 1000 mg (1 gram) once or twice a day up to 4 or more times a day.
▪ A word about quercetin. Some physicians are recommending this supplement to reduce viral illnesses because quercetin acts as a zinc ionophore to improve zinc
uptake into cells. It is much less potent than HCQ as a zinc transporter, and it does
not reach high concentrations in lung cells that HCQ does. Quercetin may help
reduce risk of viral illness if you are basically healthy. But it is not potent enough to replace HCQ for treatment of COVID once you have symptoms, and it does not
adequately get into lung tissue unless you take massive doses (3-5 grams a day),
which cause significant GI side effects such as diarrhea.
Control of Contagion
A major goal of self-quarantine is the control of contagion. Many sources of information suggest the main place of viral transmission occurs in the home. Facial covering for all contacts within the home as well as frequent use of hand sanitizer and hand washing is mandatory. Sterilizing surfaces such as countertops, door handles, phones, and other devices is advised. When possible, other close contacts can move out of the domicile and temporarily stay with others not ill with SARS-CoV-2. Findings from multiple studies indicate that policies concerning control of the spread of SARS-CoV-2 are effective and extension into the home as the most frequent site of viral transfer is paramount.
Reduction of Self-Reinoculation
It is well-recognized that COVID-19 exists outside the human body in a bioaerosol of airborne particles and droplets. Because exhaled air in an infected person is considered to be “loaded” with inoculum, each exhalation and inhalation is effectively reinoculation. In patients who are hospitalized, negative pressure is applied to the room air largely to reduce spread outside of the room. We propose that fresh air could reduce reinoculation and potentially reduce the severity of illness and possibly reduce household spread during quarantine. This calls for open windows, fans for aeration, or spending long periods of time outdoors away from others with no face covering to disperse and not reinhale the viral bioaerosol.
Combination Antiviral Therapy
Rapid and amplified viral replication is the hallmark of most acute viral infections. By reducing the rate, quantity, or duration of viral replication, the degree of direct viral injury to the respiratory epithelium, vasculature, and organs may be lessened. Additionally, secondary processes that depend on viral stimulation, including the activation of inflammatory cells, cytokines, and coagulation, could potentially be lessened if viral replication is attenuated. Because no form of readily available medication has been designed specifically to inhibit SARS-CoV-2 replication, 2 or more of the nonspecific agents listed here can be entertained. None of the approaches listed have specific regulatory approved advertising labels for their manufacturers; thus all would be appropriately considered acceptable “off-label” use.
Zinc Lozenges and Zinc Sulfate
Zinc is a known inhibitor of coronavirus replication. Clinical trials of zinc lozenges in the common cold have demonstrated modest reductions in the duration and or severity of symptoms. By extension, this readily available nontoxic therapy could be deployed at the first signs of COVID-19. Zinc lozenges can be administered 5 times a day for up to 5 days and extended if needed if symptoms persist. The amount of elemental zinc lozenges is <25% of that in a single 220-mg zinc sulfate daily tablet. This dose of zinc sulfate has been effectively used in combination with antimalarials in early treatment of high-risk outpatients with COVID-19.
Antimalarials
Hydroxychloroquine (HCQ) is an antimalarial/anti-inflammatory drug that impairs endosomal transfer of virions within human cells. HCQ is also a zinc ionophore that conveys zinc intracellularly to block the SARS-CoV-2 RNA-dependent RNA polymerase, which is the core enzyme of the virus replication. The currently completed retrospective studies and randomized trials have generally shown these findings: 1) when started late in the hospital course and for short durations of time, antimalarials appear to be ineffective, 2) when started earlier in the hospital course, for progressively longer durations and in outpatients, antimalarials may reduce the progression of disease, prevent hospitalization, and are associated with reduced mortality. In a retrospective inpatient study of 2541 patients hospitalized with COVID-19, therapy associated with an adjusted reduction in mortality was HCQ alone (hazard ratio [HR] = 0.34, 95% confidence interval [CI] 0.25-0.46, P <0.001) and HCQ with azithromycin (HR = 0.29, 95% CI 0.22-0.40, P <0.001). HCQ was approved by the US Food and Drug Administration in 1955, has been used by hundreds of millions of people worldwide since then, is sold over the counter in many countries, and has a well-characterized safety profile that should not raise undue alarm. Although asymptomatic QT prolongation is a well-recognized and infrequent (<1%) complication of HCQ, it is possible that in the setting of acute illness symptomatic arrhythmias could develop. Data safety and monitoring boards have not declared safety concerns in any clinical trial published to date. Rare patients with a personal or family history of prolonged QT syndrome and those on additional QT prolonging, contraindicated drugs (eg, dofetilide, sotalol) should be treated with caution and a plan to monitor the QTc in the ambulatory setting. A typical HCQ regimen is 200 mg bid for 5 days and extended to 30 days for continued symptoms. A minimal sufficient dose of HCQ should be used, because in excessive doses the drug can interfere with early immune response to the virus.
Azithromycin
Azithromycin is a commonly used macrolide antibiotic that has antiviral properties mainly attributed to reduced endosomal transfer of virions as well as established anti-inflammatory effects. It has been commonly used in COVID-19 studies initially based on French reports demonstrating markedly reduced durations of viral shedding, fewer hospitalizations, and reduced mortality combination with HCQ as compared to those untreated. In the large inpatient study (n = 2451) discussed previously, those who received azithromycin alone had an adjusted HR for mortality of 1.05, 95% CI 0.68-1.62, and P = 0.83.23 The combination of HCQ and azithromycin has been used as standard of care in other contexts as a standard of care in more than 300,000 older adults with multiple comorbidities. This agent is well-tolerated and like HCQ can prolong the QTc in <1% of patients. The same safety precautions for HCQ listed previously could be extended to azithromycin with or without HCQ. Azithromycin provides additional coverage of bacterial upper respiratory pathogens that could potentially play a role in concurrent or secondary infection. Thus, this agent can serve as a safety net for patients with COVID-19 against clinical failure of the bacterial component of community-acquired pneumonia. The same safety precautions for HCQ could be extended to azithromycin with or without HCQ. Because both HCQ and azithromycin have small but potentially additive risks of QTc prolongation, patients with known or suspected arrhythmias or taking contraindicated medications or should have more thorough workup (eg, review of baseline electrocardiogram, imaging studies, etc.) before receiving these 2 together. One of many dosing schemes is 250 mg po bid for 5 days and may extend to 30 days for persistent symptoms or evidence of bacterial superinfection.
Doxycycline
Doxycycline is another common antibiotic with multiple intracellular effects that may reduce viral replication, cellular damage, and expression of inflammatory factors. This drug has no effect on cardiac conduction and has the main caveat of gastrointestinal upset and esophagitis. As with azithromycin, doxycycline has the advantage of offering antibacterial coverage for superimposed bacterial infection in the upper respiratory tract. Doxycycline has a high degree of activity against many common respiratory pathogens including Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, anaerobes such as Bacteroides and anaerobic/microaerophilic streptococci and atypical agents like Legionella, Mycoplasma pneumoniae, and Chlamydia pneumoniae. One of many dosing schemes is 200 mg po followed by 100 mg po bid for 5 days and may extend to 30 days for persistent symptoms or evidence of bacterial superinfection. Doxycycline may be useful with HCQ for patients in whom the HCQ-azithromycin combination is not desired.
Favipiravir
Favipiravir, an oral selective inhibitor of RNA-dependent RNA polymerase, is approved for ambulatory use in COVID-19 in Russia, India, and other countries outside of the United States.35 It has been previously used for treatment of some life-threatening infections such as Ebola virus, Lassa virus, and rabies. Its therapeutic efficacy has been proven in these diseases. Like, the antimalarials and antibiotics, favipiravir has no large-scale randomized trials completed at this time, given the short time frame of the pandemic. A dose administration could be 1600 mg po bid on day 1, following by 600 mg po bid for 14 days.
Immunomodulators
The manifestations of COVID-19 that prompt hospitalization and that may well lead to multiorgan system failure are attributed to a cytokine storm. The characteristic profile of a patient acutely ill with COVID-19 includes leukocytosis with a relative neutropenia. These patients have higher serum level of cytokines (ie, TNF-α, IFN-γ, IL-1β, IL-2, IL-4, IL-6, and IL-10) and C-reactive protein than control individuals. Among patients with COVID-19, serum IL-6 and IL-10 levels appear even more elevated in the critically ill. As with any acute inflammatory state, early treatment with immunomodulators is expected to impart greater benefit. In COVID-19, some of the first respiratory findings are nasal congestion, cough, and wheezing. These features are due to excess inflammation and cytokine activation. Early use of corticosteroids is a rational intervention for patients with COVID-19 with these features as they would be in acute asthma or reactive airways disease. The RECOVERY trial randomized 6425 hospitalized patients with COVID-19 in a 2:1 ratio to dexamethasone 6 mg po/IV daily for up to 10 days and found dexamethasone reduced mortality (HR = 0.65, 95% CI 0.51-0.82, P <0.001). One potential dosing scheme for outpatients starting on day 5 or the onset of respiratory symptoms is prednisone 1 mg/kg given daily for 5 days with or without a subsequent taper.
Colchicine
Colchicine is a nonsteroidal antimitotic drug that blocks metaphase by binding to the ends of microtubules to prevent the elongation of the microtubule polymer. This agent has proven useful in gout and idiopathic recurrent pericarditis. The GRECCO-19 randomized open-label trial in 105 hospitalized patients with COVID-19 found that colchicine was associated with a reduction in D-dimer levels and improved clinical outcomes. The clinical primary end point (2-point change in World Health Organization ordinal scale) occurred in 14.0% in the control group (7 of 50 patients) and 1.8% in the colchicine group (1 of 55 patients) (odds ratio, 0.11; 95% CI, 0.01-0.96; P = 0.02). Because the short-term safety profile is well understood, it is reasonable to consider this agent along with corticosteroids in an attempt to reduce the effects of cytokine storm. A dosing scheme of 1.2 mg po, followed by 0.6 mg po bid for 3 weeks can be considered.
Antiplatelet Agents and Antithrombotics
Multiple studies have described increased rates of pathological macro- and micro-thrombosis. Patients with COVID-19 have described chest heaviness associated with desaturation that suggests the possibility of pulmonary thrombosis. Multiple reports have described elevated D-dimer levels in acutely ill patients with COVID-19, which has been consistently associated with increased risk of deep venous thrombosis and pulmonary embolism. Necropsy studies have described pulmonary microthrombosis in COVID-19. These observations support the notion that endothelial injury and thrombosis play a role oxygen desaturation, a cardinal reason for hospitalization and supportive care. Based on this pathophysiologic rationale, aspirin 81 mg daily can be administered as an initial antiplatelet and anti-inflammatory agent. Ambulatory patients can be additionally treated with subcutaneous low-molecular-weight heparin or with short-acting novel anticoagulant drugs in dosing schemes similar to those use in outpatient thromboprophylaxis. In a retrospective study of 2773 inpatients with COVID-19, 28% received anticoagulant therapy within 2 days of admission, and despite being used in more severe cases, anticoagulant administration was associated with a reduction in mortality (HR = 0.86 per day of therapy, 95% CI: 0.82-0.89; P <0.001). Additional supportive data on the use anticoagulants reducing mortality has been reported in hospitalized patients with elevated D-dimer levels and higher comorbidity scores.53 Many acutely ill outpatients also have general indications for venous thromboembolism prophylaxis applicable to COVID-19.
Delivery of Oxygen and Monitoring
Because ambulatory centers and clinics have been reticent to have face-to-face visits with patients with COVID-19, telemedicine is a reasonable platform for monitoring. Clinical impressions can be gained with audio and video interviews by the physician with the patient. Supplemental information, including vital signs and symptoms, will be important to guide the physician. A significant component of safe outpatient management is maintenance of arterial oxygen saturation on room air or prescribed home oxygen under direct supervision by daily telemedicine with escalation to hospitalization for assisted ventilation if needed. Self-proning could be entertained for confident patients with good at-home monitoring.
Many of the measures discussed in this article could be extended to seniors in COVID-19 treatment units in nursing homes and other nonhospital settings. This would leave the purposes of hospitalization to the administration of intravenous fluid and parenteral medication, assisted pressure or mechanical ventilation, and advanced mechanical circulatory support.”
This is the group’s statement on vaccines:
“Vaccines in Development:
Several vaccine models are being investigated for SARS-CoV-2 (COVID-19) including DNA and RNA vaccines. These vaccines take genetic information from other sources that is introduced into the cells. This information includes instructions to produce a SARS2-like viral antigen itself, and the immune system then reacts to it to develop immunity to the virus.
The most important consideration before approving a vaccine for human use is to make sure that the vaccine is safe and effective. Developing safe and controlled infection models for humans normally takes many years of phased testing in the lab and then in humans. Many physicians and scientists have been concerned that vaccine manufacturers, with government support, are speeding up this process in ways that are not allowing adequate time for the usual phased testing leading up to human clinical trials. Two vaccine manufacturers already have voluntarily paused their clinical trials in people due to serious adverse events.
Currently, there are no RNA-based vaccines approved for human use so it would seem prudent to take the time needed to ensure safety. Vaccines for RNA viruses are notoriously challenging and difficult to develop. We still, after all these years since AIDS emerged in the 1980s, do not have a vaccine for the AIDS virus, or the SARS-1 coronavirus that emerged in 2002-2003, and both are RNA viruses.
Several attempts have been made to create vaccines for coronavirus and other respiratory viruses but none of the vaccines have survived the testing phases. The vaccine trials for SARS-1 from 2003, for example, was shut down because it produced autoimmune hypersensitivity reactions when exposed to the natural virus after immunization in animal studies.
Another problem is that the SARS-2 virus has already shown many mutations. Viruses adapt to the environment to survive. Like the flu virus, it is difficult to predict what mutations will occur and circulate around the world each season. A new vaccine must be reformulated to adjust to the changing genetic makeup of the SARS-2 virus.
Even the best vaccines for flu are only about 30-60% effective. Compare that with an effectiveness for improvement ranging from 64% to more than 90% in more than 100 new studies showing early, outpatient treatment with our existing medications described in chapters.
As research on the vaccine continues, safety and effectiveness are of primary concern. The good news is there are very safe and effective early treatments already available as we described in Chapter 3. Clearly, early, home-based treatment has now been so successful and offers so much hope, there is less urgency to have a vaccine.”
You can sign up to receive the full protocol here: https://aapsonline.org/covidpatientguide/ or find the research paper here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7410805/
