Dear Patients:
You must stay home if your job is not considered essential, if you or someone in your home has any symptoms of a respiratory illness, if you are over the age of 65, have a compromised immune system, or a chronic disease. A large percentage of patients infected with COVID-19 show no symptoms and are therefore unaware that they are carrying the virus and can infect someone else. The virus can spread to others by talking, breathing, coughing, sneezing and touching contaminated surfaces. Higher temperatures and humidity does not slow this virus down. Please be prepared for another 1-2 months of continued social distancing, frequent handwashing, avoiding touching your face, disinfecting solid surfaces, wearing masks and staying home.
Do we know any more about who is at increased risk of severe COVID-19 infection?
Risk factors for severe COVID-19 infection include:
- Age greater than 65
- Diabetes or pre-diabetes
- Obesity
- Heart Disease
- Chronic lung disease
- Chemotherapy within the last month
- High blood pressure
- Men appear to be at greater risk than women.
- Healthcare workers who are continually exposed to high doses of the virus.
Are patients with compromised immune systems at increased risk?
Common sense would suggest that a compromised immune system would increase your risk of severe COVID-19 infection. However, the severe lung damage that occurs in mechanically ventilated hospitalized patients is due to an intense immune response. This response is referred to as a cytokine storm. Medications such as Leronlimab or Actemra (tocilizumab) that suppress this immune response have been used successfully in some critically ill COVID-19 patients. A hospital in northern Italy did not find an increased risk of severe COVID-19 infection in their liver transplant patients who are on immunosuppressant medications. More data is needed about the risk of severe COVID-19 infection in patients with compromised immune systems.
Can we better define the symptoms associated with COVID-19 infection?
The most common symptoms of a COVID-19 infection include fever (88%), cough (70%) and fatigue (43%). Loss of sense of smell or taste are rather unique symptoms associated with COVID-19 infection. Progressive chest discomfort or tightness, difficulty breathing and confusion are symptoms of severe COVID-19 infection. I have learned that it is difficult to make a COVID-19 diagnosis based on symptoms alone. This is why testing is so important.
Testing for COVID-19 infection
There are two main forms of testing to determine if you have a COVID-19 infection.
- The most common test performed is a nasal swab or throat swab looking for the genetic material of the virus. Polymerase Chain Reaction (PCR) is the most common and effective way of looking for genetic material of the virus. This is the best way to determine if you have a current infection.
- A serological test is a blood test which detects proteins or antibodies your body makes against the virus. This is the best way to determine if you have had a past infection and whether you are immune from reinfection.
Polymerase Chain Reaction (PCR) Testing.
A PCR test can amplify a small amount of genetic material allowing the detection of the virus even at low levels. The test is very specific, therefore if you test positive you have the disease. A PCR test is the best way to determine if a patient has an active current COVID-19 infection. A recent study showed nasal swab samples obtained by patients to be as accurate as those obtained by healthcare workers.
PCR testing requires special equipment and takes time to perform. PCR testing cannot determine if you had a past infection. The nasal or throat swabs in up to 30% of patients with an active COVID-19 infection have tested falsely negative. The amount of COVID-19 virus in the nose or throat is very high at the onset of infection and then diminishes over several days. Testing patients well into the course of the infection, obtaining an improper nasal, improper transportation of the specimen or using an unreliable lab, are all potential reasons that can lead to a falsely negative test. I have not found any false negative tests using Quest Diagnostic Labs for PCR testing.
Abbott ID NOW COVID-19 Test
The new Abbott ID NOW COVID-19 uses a nasal or throat swab specimen to detect genetic material of the virus. The test can be done in a physician’s office and returns results in 5-15 minutes. Under the direction of the FDA, Abbott plans to first roll these tests out to hospitals and “hotspots” around the country. I am on a waitlist to receive the analyzer once the FDA approves release to physician offices.
What are Antibodies?
Antibodies are proteins made by cells in your immune system directed specifically against a virus or other intruder. Antibodies serve as scouts for your immune system. If that virus re-enters the body, specific antibodies will stick to the virus triggering destruction of the virus by the immune system. Immunity is the presence of specific antibodies providing protection from future infection. For example, measles antibodies protects you only against measles. Immunity can last a lifetime or only for a short period of time. Vaccines work similarly by introducing a harmless yet distinct piece of the virus or germ into your body triggering the formation of antibodies.
Types of Antibodies
IgM antibodies are the first antibodies made against a new infection. The presence of IgM antibodies indicates that the infection is recent. IgM antibodies are present for a short period of time then disappear. IgG antibodies are formed shortly thereafter providing longer term protection from infection by remembering which germs you’ve been exposed.
IgM antibodies to COVID-19 can be found between 3 to 10 days after the onset of symptoms. IgG antibodies to COVID-19 begin to form after IgM antibodies have formed. IgG antibodies to COVID-19 first peak at 21 days after the onset of symptoms. IgG antibodies to other similar coronaviruses lasted 1-2 years. We do not know how long IgG antibodies to COVID-19 will last.
The role of plasma
Plasma is the liquid portion of your blood devoid of cells. It is light yellow in color and contains water, salts, enzymes, nutrients, hormones, proteins and antibodies. When you donate blood, plasma can be isolated and the different components of plasma can be concentrated. If you have had a COVID-19 infection you likely have developed COVID-19 specific IgG neutralizing antibodies. We have found improvement in critically ill COVID-19 patients who are administered convalescent plasma containing neutralizing COVID-19 antibodies. Plasma donations can be done as soon as 21 days after the onset of symptoms. You can donate plasma as often as every 28 days.
Why is testing for COVID-19 antibodies important?
Although antibody testing does not detect an early infection, antibody testing is important for the following reasons:
- It is important to identify who has been infected with COVID-19 and is making protective antibodies.
- It is important to identify who is NOT making antibodies and remains vulnerable to infection.
- 25% of COVID-19 infections are asymptomatic. Antibody testing will identify these patients who have been infected and did not know it.
- 55% of COVID-19 patients develop mild symptoms. Due to lack of PCR testing supplies, we have been unable to test all patients with mild symptoms. Antibody testing will identify these patients who had mild symptoms and past infections.
- Some patients had more moderate symptoms of fever, cough and fatigue suggestive of a COVID-19 infection but recovered at home and were never tested or tested too late. Antibody testing is the best way to determine if they had a past COVID-19 infection.
- The presence of IgG antibodies to COVID-19 will indicate those patients who are immune and therefore should be protected from reinfection. These patients can help others by going back to work and are also potential candidates for plasma donations.
- Healthcare workers deserve to know if they had an asymptomatic or mild infection and whether they now have developed protective antibodies.
- If we know who is making protective antibodies we can more precisely determine the infectivity and mortality rate.
Rapid home testing for IgM and IgG COVID-19 specific antibodies.
Rapid IgM and IgG COVID-19 blood tests can be done safely at home with a fingerstick. Results are available immediately in 10-15 minutes. Although the test has not been reviewed by the FDA it has been approved for emergency use and has been found to be reliable in other countries initially affected by the COVID-19 pandemic. Some of these products have undergone quality control testing in the United States. This week, I was involved in the quality control testing of one manufacturer. My patients were able to perform this test at home following step by step instructions. I found this test to be very reliable in a small sample of patients.
- All four patients with symptoms and a positive COVID-19 PCR nasal swab tested positive for COVID-19 specific antibodies.
- All six patients with symptoms and negative COVID-19 PCR nasal swabs tested negative for COVID-19 specific antibodies.
How can you obtain COVID-19 antibody test?
Early next week, I am scheduled to receive 200 test kits that will detect the presence of COVID-19 specific IgM and IgG antibodies in blood. Once I receive the shipment of the test kits, I will send an email with instructions and a link on how to purchase the antibody test kit. Your test kit will arrive from my office in the mail. Testing will be done at home to avoid any unnecessary exposure. Detailed instructions and all supplies will be included in your test kit. My office will be available to help you with any test performance questions 303-799-8890. I will ask each patient performing the test to email a picture of the completed test cassette to cmiranda@southdenvermedicine.com. I will be available for consultations to help interpret your results.
I can only offer testing to my patients. This test is not covered by health insurance. You are not obligated to do the test. However, I would recommend antibody testing for anyone who has had respiratory symptoms during the month of February and March or been exposed to someone who has been sick during that time. I plan to purchase more test kits in order to do ongoing testing of patients with no symptoms or exposures
Hydroxychloroquine Treatment of COVID-19 infection
The FDA approved the use of Hydroxychloroquine based on continued evidence supporting the potential benefit for COVID-19 infections. In vitro studies show that Hydroxychloroquine has anti-viral properties against COVID-19. A continuation of the French study showed improvement in 78 of 80 patients receiving hydroxychloroquine and azithromycin for COVID-19 infection. A Chinese randomized control study of 62 patients showed patients who took Hydroxychloroquine had faster improvement in fever, cough and pneumonia compared to patients who took no drug. Many of these ongoing studies in the United States are using Hydroxychloroquine late in the course of the illness once patients have developed pneumonia. These studies may not find benefit as I believe that in high risk patients, the sooner you treat with Hydroxychloroquine the better the outcome. I would not recommend waiting until someone develops pneumonia before starting hydroxychloroquine.
Alvesco Inhaler Treatment of COVID-19 infection
Alvesco (ciclesonide) is an inhaled corticosteroid developed for the prevention of asthma. Unlike other inhaled or oral steroids, Alvesco reduces airway inflammation, inhibits replication of the COVID-19 virus and reduces how long the virus remains in your airway. Japan found Alvesco to be beneficial in the treatment of several COVID-19 infected patients of the cruise ship Diamond Princess. Japan has ordered 20,000 vials of Alvesco for a recent clinical trial.
Who should receive treatment for a COVID-19 infection?
- Healthy patients with no symptoms or mild symptoms of short duration and no risk factors do not need medication therapy.
- Healthy patients with moderate or severe symptoms or symptoms of prolonged duration may benefit from therapy.
- Patients with one or more risk factors for severe disease benefit from therapy.
My approach to treatment
I have treated a small number of COVID-19 infected patients with oral hydroxychloroquine and inhaled Alvesco with good results.
- Hydroxychloroquine 200 mg orally twice a day for 5-7 days. I will review your most recent electrocardiogram prior to starting therapy. If a patient has troubles tolerating Hydroxychloroquine due to nausea, diarrhea, headache or ringing in the ears I will reduce the dose to 200 mg daily. Hydroxychloroquine is inexpensive yet remains in short supply.
- Alvesco 160 mcg one inhalation twice a day for 10 days. Alvesco is expensive and needs to be ordered by the pharmacy typically arriving the next day. Health insurance companies have been put on notice that they should cover all COVID-19 related treatments.
- If a patient is not responding, I add Azithromycin 250 mg two tablets on day 1 and one tablet on day 2-5. Azithromycin is readily available and inexpensive. The addition of Azithromycin to Hydroxychloroquine carries the potential risk of abnormal heart rhythms.
- Rather than stockpiling and adding to shortages, I prefer to order treatment at the time you develop symptoms or have a known exposure.
Why do some healthy patients develop severe disease?
This question is gaining more attention among physicians and scientist. We believe that differences in genetic factors regarding the expression of the ACE-2 receptor that the COVID-19 virus uses to gain entry into the lung cell may predispose some patients to more severe lung disease. Genetic differences encoding the proteins that regulate our immune system may also affect how vigorous our immune system responds to a COVID-19 infection.
Do certain blood pressure medications increase your risk of a COVID-19 infection?
High blood pressure is a risk factor for severe COVID-19 infection. I am monitoring very closely ongoing research that potentially implicates the use of a common class of blood pressure medications called angiotensin converting enzyme inhibitors or angiotensin II receptor blockers. The COVID-19 virus gains entry into lung cells via the angiotensin converting enzyme-2 (ACE-2) receptor. Researchers are evaluating how these two common classes of blood pressure medications affect these cellular receptors. We do not yet have an answer. I do not want to make any changes in blood pressure treatments at this time but I wanted to alert you to this potential situation.
Masks reduce the spread of the COVID-19 virus.
Our public health leaders initially told us that masks do not work for the general population. They knew we had a shortage of masks and wanted to maintain adequate supplies for healthcare workers. What they did not recognize is that not using masks increased the number of infections. The virus spreads by respiratory droplets and close contact. Many people are infected and do not know it because they have no symptoms. When you breathe, speak, sneeze or cough droplets come out of your nose or mouth. Masks protect you and others by reducing the spread of respiratory droplets that contain virus. I have always worn a mask whenever I see a patient in the office who has a respiratory infection. Save N95 mask for the healthcare workers. Until supplies of surgical masks are readily available for everyone, cloth masks work just fine preventing the escape of and exposure to large respiratory droplets. Purchase a few and wash them. A bandana or scarf can help as long as you wash it after each use. Remove the mask by the straps. Do not touch the front of the mask. Remember to wash your hands after you remove your mask. Not wearing masks when out in public is one of the biggest mistakes we are currently making.
I am confident in my diagnostic and treatment approach against the COVID-19 virus. My staff and I remain ready and prepared to take care of any healthcare needs you may encounter. I hope that you continue to benefit from these updates as I have always believed that knowledge conquers fear.
Sincerely,
Charles H. Miranda, MD, FACP
South Denver Internal Medicine
Denver Concierge Medicine
10103 RidgeGate Pkwy, Suite 114
Lone Tree, CO 80124
(303) 799-8890
Fax: 303-799-8891