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SARS-CoV-2 and COVID-19 Prevention and Treatment Options
Avoiding exposure to the SARS-CoV-2 virus is the best way to prevent illness. Staying away from individuals who are ill or who may have been exposed to the virus can reduce your risk of contracting the virus.
Washing hands with soap and water or using an alcohol-based hand sanitizer when handwashing facilities are not available can also be effective in reducing infection risk. A study published in the American Journal of Preventive Medicine in December 2022 found that exercise reduced the risk of severe COVID-19 outcomes, with researchers recommending that public health officials “add physical activity to pandemic control strategies.”
While the CDC continues to promote the use of masks as a method to reduce the risk of viral transmission, and report that consistently wearing a well-fitted mask is better than not wearing one, multiple studies, have found that masks show little or no benefit, and may potentially cause harm.
In January 2023, the Cochrane Library published a review on the available literature pertaining to the use of physical interventions to reduce the spread of respiratory viruses. The authors concluded that wearing medical/surgical masks in community settings offered little to no protection against influenza-like illness and COVID-19. Additionally, the authors also found that when compared to surgical/medical masks, N95 and P2 respirators likely offered little to no additional protection against respiratory illness.
There are also several studies finding that there are harms associated with masking, such as exposure to dangerous levels of carbon dioxide, fatigue or drowsiness, headaches, concentration impairments, irritability, malaise, impairments in learning, depressed moods, and a reluctance to attend school.
Individuals who are deficient in vitamin D have been found to be at an increased risk of severe COVID-19 disease. In addition to strengthening teeth and bones, vitamin D supports nervous, brain and immune system health, lung and cardiovascular function and regulates insulin levels.
A 2021 large-scale observational study revealed that high vitamin D levels may be protective against COVID-19 and noted that while the recommended dietary allowance for vitamin D is 600 to 800 international units (IUs) per day, the National Academy of Medicine states that up to 4,000 IUs per day is safe for the majority of people. Another 2021 study found that persons with low vitamin D levels were at higher risk of serious disease, increased intensive care unit stays, and death. Ensuring adequate vitamin D levels may prevent a person from developing serious COVID-19 illness.
A review published in May 2020 stated that while there were no published nutrition studies specific to COVID-19 and SARS-CoV-2, there was evidence from acute respiratory distress syndrome in other clinical settings that demonstrated that n-3 fatty acids EPA and DHA can help control the cytokine storm. Study authors stated that while this therapeutic treatment protocol had not been tried in the treatment of severe COVID-19, it might be something to consider.
The review also stated that in general, vitamins A, B6, B12, C, E, folate and trace minerals such as iron, zinc, selenium, and copper are vital in reducing the risk of infections and supporting immune function. Ensuring a healthy diet containing these essential vitamins and minerals, or supplementing when dietary sources are inadequate, may be helpful in preventing illness. This review also noted that gut health was important in maintaining a healthy immune system and that consuming fermented foods and a diet rich in fiber could help to maintain a healthy gut microbiota.
According to the CDC, most people who become ill with COVID-19 will not require any specific treatment, with over-the-counter fever and pain reducers to relieve aches and pains associated with illness advised. Ensuring adequate hydration and rest are also considered important for recovery.
The CDC also recommends that individuals with one or more underlying health conditions contact a health care provider immediately following a positive COVID-19 test to discuss treatment and intervention options.
FDA Approved Treatments
The FDA has approved Remdesivir for use in COVID-19 patients 28 days of age and older and who weigh at least 3 pounds. Remdesivir, an antiviral medication administered intravenously, must be given in an acute care setting such as a hospital or similar facility. This drug, initially approved for use under EUA in May 2020, received FDA approval for use in SARS-CoV-2 positive hospitalized individuals aged 12 years and older and weighing at least 40 pounds in October 2020. The FDA has since expanded its approval of the drug to include children as young as 28 days of age, and for use in outpatient settings, for the treatment of mild to moderate COVID-19 illness.
Approval for the use of Remdesivir in infants and young children was based on an open label study of only 53 children, with no placebo control. In this study, 72 percent of children suffered adverse events, but 21 percent of these serious adverse events were considered by the investigators to be unrelated to the medication. Three children died during the study, from either COVID-19 or a pre-existing condition.
In 2020, the World Health Organization (WHO) reported that preliminary results of a larger international study found that Remdesivir “appeared to have little or no effect on hospitalized COVID-19.” Additionally, the European Society of Intensive Care Medicine stated in 2020 that Remdesivir should not be used routinely in COVID-19 patients. In 2021, the Journal of the American Medical Association (JAMA) concluded that
“remdesivir treatment was not associated with improved survival but was associated with longer hospital stays. Routine use of remdesivir may be associated with increased use of hospital beds while not being associated with improvements in survival.”
The Lancet similarly concluded later in 2021 that:
“No clinical benefit was observed from the use of remdesivir in patients who were admitted to hospital for COVID-19, were symptomatic for more than 7 days, and required oxygen support.”
In May 2023, the FDA approved Paxlovid, an oral anti-viral medication, for the treatment of mild-to-moderate COVID-19 in adults considered at high risk for developing severe COVID-19 illness. The drug manufactured and packaged under EUA, however, will continue to be made available under EUA to adults and to children aged 12 through 17 years of age not covered by the FDA approval.
Paxlovid, manufactured by Pfizer, initially received approval under EUA for use in SARS-CoV-2 positive children aged 12 years and older considered at high risk for severe disease, to be given as soon as a diagnosis is made and within five days of symptom onset.
Side effects of the medication include diarrhea, impairment of taste, high blood pressure, and muscle aches. One of the components of Paxlovid, Ritonavir, can cause liver damage. This medication may also lead to HIV-1 drug resistance in persons with undiagnosed or uncontrolled HIV-1. The medication is not recommended for use in persons with kidney or liver disease. According to the FDA, an analysis of the medication in 1,039 individuals reported a 0.86 fatality rate in persons who received Paxlovid, compared to the placebo group (1,046 individuals) that reported a 6 percent death rate. Studies on the medication are ongoing. Paxlovid has the potential to cause severe or life-threatening reactions if taken with common medications such as antidepressants, anticoagulants, and statins.
A case study published in September 2022 suggested that individuals treated with Paxlovid may experience COVID-19 rebound infections. This information prompted the CDC in 2022 to issue an emergency alert to health care providers regarding the risk of “rebound” COVID-19 infection in individuals treated with Paxlovid. The alert stated that additional treatment with Paxlovid was not recommended and those experiencing a relapse in symptoms should re-isolate for at least five days and wear a mask for at least ten days. During 2022, several individuals, including Dr. Anthony Fauci, President Joe Biden, and First Lady Jill Biden reported rebound COVID-19 infection after taking Paxlovid.
In late April 2022, Pfizer announced that Paxlovid did not prevent symptomatic COVID-19 illness in household contacts of persons who took the medication.
Emergency Use Authorization (EUA) is a status given to experimental and licensed products by the FDA during a public health emergency, as defined under federal law.
In 2020, the FDA issued EUAs for several monoclonal antibodies to treat COVID-19. Monoclonal antibodies are laboratory produced synthetic versions of antibodies and included the drugs baricitinib, bamlanivimab, casirivimab, imdevimab, etesevimab, sotrovimab, and bebtelovimab. In 2021, Evusheld, a long-acting COVID-19 preventative monoclonal antibody received EUA status by the FDA for persons 12 years and older considered immunocompromised or for those unable to receive a COVID-19 vaccine.
By December 2022, however, health officials reported that monoclonal antibodies were no longer an effective treatment against the circulating SARS-CoV-2 strains found in the U.S. As of August 27, 2023, all EUAs for monoclonal antibodies targeting the SARS-CoV-2 virus have been revoked.
In December 2021, the FDA issued an EUA for Molnupiravir, an oral anti-viral, for the treatment of mild to moderate COVID-19 illness in SARS-CoV-2 positive adults considered at high risk for severe COVID-19 illness, including hospitalization and death when other FDA authorized treatments are not available or appropriate.
Molnupiravir, manufactured by Merck, is authorized for use in adults 18 years and older for the treatment of COVID-19 illness who are positive for SARS-CoV-2 and at risk of severe illness. According to clinical trials, of the 709 individuals who received molnupiravir, 6.8 percent required hospitalization compared to 9.7 percent of the 699 individuals who received the placebo. One person who received molnupiravir died, compared to nine people who received the placebo. This experimental medication is not recommended for use in pregnant women because animal reproductive studies appear to indicate a risk of fetal harm. Reported side effects include diarrhea, nausea, and dizziness.
Some scientists have expressed concern about Molnupiravir because it is capable of mutating RNA and could potentially cause new and possibly deadlier virus variants.
High doses of vitamin C given intravenously (IV) have been used to treat COVID-19. Three clinical trials and several smaller studies reported successful outcomes among patients who received IV vitamin C at doses varying from 50 to 200 milligrams per kilogram of body weight to up to 200 mg per kg per day.
One study published in March 2020 reported:
“High-dose intravenous VC has also been successfully used in the treatment of 50 moderate to severe COVID-19 patients in China. The doses used varied between 10 g and 20 g per day, given over a period of 8–10 h. Additional VC bolus may be required among patients in critical conditions. The oxygenation index was improving in real time and all the patients eventually cured and were discharged.”
The Frontline COVID-19 Critical Care Alliance (FLCCC), a group comprised of highly published critical care experts, created a protocol to treat hospitalized COVID-19 patients. In 2021, the FLCCC’s clinical and scientific rationale on their methylprednisolone, ascorbic acid (vitamin C), thiamine, heparin and co-interventions (MATH+) protocol was peer reviewed and published in Journal of Intensive Care Medicine. The protocol was reported as effective in the treatment of severe COVID-19 illness requiring hospitalization. Additional treatment co-interventions noted in the research article included the use of melatonin, famotidine, atorvastatin, vitamin D3, and the application of therapeutic plasma exchange (a treatment that replaces an individual’s blood plasma).
The article noted that systematic use of MATH+ in two U.S. hospitals demonstrated an absolute mortality risk reduction of more than 75 percent, or 5.1 percent vs. 22.9 percent, when compared to multiple published COVID-19 hospital mortality rates in the U.S. The article concluded:
“It is exceedingly unlikely that a “magic bullet” will be found, or even a medicine which would be effective at multiple stages of the disease. The Math+ treatment protocol instead offers an inexpensive combination of medicines with a well-known safety profile based on strong physiologic rationale and an increasing clinical evidence base which potentially offers a life-saving approach to the management of COVID-19 patients.”
Because the SARS-CoV-2 virus was new, there were no FDA approved drugs specific to this new virus. This resulted in some health care professionals using their clinical experience to treat COVID-19 symptoms using existing FDA approved drugs off-label.
According to the FDA’s website on understanding the use of off label drugs, “once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient.” The FDA’s website also states that the reason for off-label usage of a drug can stem from no approved drug exists to treat the patient’s condition, to drugs that have been approved may not be working for the patient. The U.S. Department of Health and Human Services has stated that off label drug use is very common and that one in five drug prescriptions written are for off-label use.
Hydroxychloroquine and Chloroquine
Controversy over the off-label use of hydroxychloroquine and chloroquine for COVID-19 continues today. These anti-malaria drugs received emergency use authorization from the FDA in March of 2020, based on laboratory studies that showed these medications to be effective against coronaviruses. However, the FDA revoked the EUA for hydroxychloroquine in mid-June 2020, stating that the medication was ineffective against COVID-19 and potentially harmful.
The World Health Organization (WHO) halted their hydroxychloroquine drug trials after May 2020 study reported that hydroxychloroquine was not effective against COVID-19 and was associated with heart arrhythmias and higher death rates. The validity of this study was immediately questioned and when the study data could not be obtained for independent review, study was retracted.
In June 2020, scientists affiliated with the Henry Ford Hospital System published research on hydroxychloroquine that indicated that the drug was effective in reducing the COVID-19 death rate, improved outcomes with early treatment, with no heart-related side effects were reported. These findings, however, have been criticized by health officials including Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID).
Hydroxychloroquine administered in combination with zinc and azithromycin has also been reported to be an effective treatment for hospitalized COVID-19 patients.
A January 2021 published study in the American Journal of Medicine reported that when the medicine was administered early in the treatment stage, it was effective at halting disease progression, preventing hospitalization, and reducing mortality rates. This study also reported the effectiveness of using the hydroxychloroquine in combination with either azithromycin or doxycycline, two commonly prescribed antibiotics.
FDA approved to treat parasites, the drug ivermectin has been found to inhibit SARS-CoV-2, the virus that causes COVID-19, in vitro. Australian gastroenterologist Dr. Thomas Borody, known for developing the first peptic ulcer cure, reported that ivermectin administered in conjunction with zinc and the antibiotic doxycycline could be a ‘potential life-saver.’ A January 2021 published study reported that the use of ivermectin was associated with lower rates of death, especially in patients who had severe pulmonary involvement. A journal study published in April 2021 concluded that:
“Meta-analyses based on 18 randomized controlled treatment trials of ivermectin in COVID-19 have found large, statistically significant reductions in mortality, time to clinical recovery, and time to viral clearance. Furthermore, results from numerous controlled prophylaxis trials report significantly reduced risks of contracting COVID-19 with the regular use of ivermectin. Finally, the many examples of ivermectin distribution campaigns leading to rapid population-wide decreases in morbidity and mortality indicate that an oral agent effective in all phases of COVID-19 has been identified.”
The FDA has not approved the use of ivermectin for SARS-CoV-2. Further, in 2021 the CDC issued a health advisory regarding the use of ivermectin as a treatment option for COVID-19 and noted it was not approved or authorized as a COVID-19 treatment and warned against its use.
Multiple studies have found ivermectin to be effective in treating COVID-19 illness, preventing hospitalization, and reducing mortality.
The corticosteroid Budesonide, commonly used to treat asthma symptoms, has also been successfully used off-label to treat COVID-19 symptoms. A University of Oxford study showed budesonide significantly decreased urgent care visits and hospitalizations, and shorter recovery time and duration of symptoms when used within seven days of symptom onset.
Other FDA Approved Medications
Additional medications used off-label demonstrating effectiveness in the early treatment options for COVID-19 illness include fluvoxamine, a medication typically used to treat depression, and fenofibrate, a medication used to decrease cholesterol.