George C. Fareed, MD

Michael M. Jacobs, MD, MPH


Donald C. Pompan, MD

September 2020

The United States is more than 6 months into the COVID-19 pandemic, and we know a lot more now than we did in March. Individuals 65 and older and those with certain comorbidities are considered high-risk for devastating complications of COVID-19 infection. Children and young adults overwhelmingly do well with uncomplicated or asymptomatic infections, and account for very few hospitalizations and rare deaths. COVID-19 infection presents with a typical sequence of symptoms including fever, body-aches, cough, shortness of breath, loss of smell and altered taste, and may include gastrointestinal symptoms (e.g., diarrhea). The infection can progress to a hyper-inflammatory/hyperimmune state called cytokine storm, with respiratory compromise, blood-clotting disorders, and multiorgan damage. There is evidence of long-term and perhaps permanent sequelae after clearance of the COVID-19 infection.

The current approach to individuals with symptomatic COVID-19 infection is to “wait and see” if they improve with supportive care at home. Individuals who test positive or those who are suspected of having the disease are isolated, especially from individuals in their home. When patients with high-risk comorbidities deteriorate, they are hospitalized. Patients with high-risk comorbidities can deteriorate precipitously and some succumb to the disease.

Because of the potential virulence of COVID-19 infection and high transmissibility, the strategy is generally avoidance of infection; strict hand washing, barrier protection with gloves, masks, gowns, face shields, and social distancing. In some states, businesses considered high-risk are closed, and tragically, classrooms.

The emphasis on reducing the number of deaths in hospitalized patients instead of prioritizing early outpatient intervention to disrupt viral replication is emerging as unjustifiable when weighed against destructive societal consequences: worsening mental health (increases in suicides, depression, drug addiction), neglect of chronic medical conditions and preventive health screenings, economic impact on small businesses and their workers, and devasting consequences for children by restricting in-person education.

What is so disturbing is that all along there has been a readily accessible, safe, inexpensive, and dramatically effective solution, one that has been utilized by countries with considerably less resources than the United States. This solution is early outpatient treatment of symptomatic COVID-19 patients, especially those deemed high-risk, with hydroxychloroquine, zinc, and an antibiotic, azithromycin or doxycycline (as described in the “Zelenko Protocol”). The evidence for early intervention is discussed authoritatively by Yale epidemiologist Dr. Harvey Risch in the American Journal of Epidemiology (27 May 2020) and summarized beautifully in a Newsweek article (23 July 2020), titled “The Key to Defeating COVID-19 Already Exists. We Need to Start Using It.”

Dr. Peter McCullough at Baylor University, in an article published in the American Journal of Medicine (SEP 2020), delineates pharmacologic mechanisms by which components of the HCQ cocktail exert antiviral effects. The article, moreover, provides a treatment algorithm that, if widely implemented, would confidently be a game-changer in the national approach to COVID-19 morbidity and outcomes. Early treatment with the HCQ cocktail will permit our society to resume a semblance of normality and economic vitality.

A safe and effective outpatient treatment for COVID-19 will reduce disruptive and destructive fear. There would be no rationale to shut down schools. It will allow children to conduct themselves normally, and teachers with high-risk morbidities can protect themselves with PPE and, if desired, take the medication prophylactically. Indeed, it will be a game-changer; parents would be more comfortable sending their children to school knowing a readily available outpatient treatment exists if they were to develop a symptomatic COVID-19 infection. On-line schooling options could be implemented where the risks are perceived to be too high. The recurring theme is to protect the most vulnerable, while allowing the rest of society to get on with their lives.

There is no compelling reason to shut down businesses if a safe, effective treatment were readily available for high-risk individuals who develop symptomatic COVID-19 infections. While arguably the vast majority of businesses should be open now even without such treatment, there would be no sound rationale for lockdowns with an outpatient treatment protocol. The agonizing predicament in which our healthcare systems find themselves is the result of an abject failure to acknowledge and implement an existing safe and effective outpatient treatment protocol for symptomatic COVID-19 infections. Relying on an imperfect vaccine is wishful thinking and misplaced optimism at this point.

In most cases, it makes little sense to obtain a COVID-19 test unless one is going to do something with the result. A test can be negative one day and positive the next. It is not practical to test individuals on a daily basis. High-risk individuals (older than 60 and those with comorbidities) with well-recognized COVID-19 symptoms can be treated as early as possible with the hydroxychloroquine cocktail [HCQ + zinc + azithromycin/doxycycline]. A confirmatory test can be obtained prior to treatment without waiting for the result, as the test outcome should not alter the minimal duration of the HCQ cocktail, which can be as short as 5 days.

An available safe and effective outpatient treatment fosters a renewed focus on good judgment and best public-health practices (handwashing and social distancing), especially for the elderly and those with comorbidities. Masks may be helpful when indoors in close proximity to others. A safe, effective, accessible, evidence-based, science-based solution exists that can inspire confidence and mitigate fear.

The FDA/Dr. Hahn is the principle obstacle to implementation of a hydroxychloroquine-based outpatient treatment, falsely labelling the drug as “dangerous.” Moreover, Dr. Fauci falsely characterizes hydroxychloroquine as “ineffective.” These twin falsehoods must be confronted and dismantled. Overwhelming evidence demonstrates that hydroxychloroquine is safe and dramatically effective when used in a cocktail with zinc and an antibiotic, either azithromycin or doxycycline, in the first 5 to 7 days of symptomatic COVID-19 infection. The imperative is to treat high-risk patients early to prevent progression to cytokine storm and hospitalization with consumption of limited human and material resources. It is incumbent on our national medical leadership to implement outpatient treatment with the HCQ cocktail, as an evidence-based, best-practices approach to the SARS-CoV-2/ COVID-19 pandemic.

Equally as startling as the disregard of an effective outpatient treatment is the omission of questioning national medical leadership about the treatment of symptomatic SARS-CoV-2/COVID-19 infection. Central to a National Plan are probing questions for medical leadership, as this has been woefully insufficient. In mid-August, we authored an “Open Letter to Dr. Anthony Fauci Regarding the Use of Hydroxychloroquine for Treating COVID-19.” The mere designation of “expert” does not render Dr. Fauci’s declarations incontestably correct; he has not faced scrutiny about his opinions that are simply not supported by scientific evidence.

Similarly, FDA Director Dr. Hahn has avoided public questioning. As long as these two medical leaders obstruct the best solution to the pandemic, the early use of the HCQ cocktail, the nation is left with periodic lockdowns and awaits an imperfect vaccine. We offer a dramatically effective, safe, inexpensive, readily available, evidence-based intervention.


General Outline

  1. Protect the vulnerable (e.g. nursing home residents, elderly, those with chronic illnesses)
  2. No jurisdiction (local, state, or federal) can lockdown public schools, businesses, places of worship, etc.
  3. Low virulence and morbidity in children and young adults preclude mass isolation and lockdowns of public schools and college Campus support staff can wear PPE and have confidence in prophylaxis and/or rapid treatment for concerning symptoms
  4. Diagnosis of COVID-19 based on symptoms with confirmatory testing after initiating treatment with HCG cocktail, especially for high-risk patients
  5. Emphasis on outpatient treatment initiated immediately on high-risk patients based on well-established characteristic symptoms
  6. Treatment with HCQ cocktail is most effective when prescribed within the first 5 days of symptoms
  7. Disrupt viral replication with the HCQ cocktail to prevent disease progression, hospitalization, and consumption of human and material resources
  8. Establish community clinics for public access to early treatment of symptomatic COVID- 19 infections
  9. Massive education program to emphasize early diagnosis and treatment, independent of test results
  10. Federal fiscal support for outpatient treatment of symptomatic COVID-19 patients
  11. Educate primary care providers on outpatient treatment protocol for symptomatic COVID-19 infections
  12. Vulnerable teachers can wear PPE, use prophylaxis, or provide distant teaching option
  13. On-line schooling is an option for those unable to participate in in-person learning
  14. Vulnerable individuals need to exercise caution with attendance at public events
  15. Masks are encouraged, especially for indoor spaces with compromised social distancing