COVID-19 prophylaxis proposal

URGENT PROPOSAL TO STOP COVID-19

US Gov response plan

Radical problems need radical solutions and swift action - chloroquine / hydroxychloroquine in high risk populations or hard hit areas for SARS-cov-2 (COVID-19)

Authors

• Prab R. Tumpati, MD, editor in chief and founder, WikiMD
• Bhanu Gadde, PharmD

Background

The United States and the world currently face an threat to the lives, economy and future of the world due to the challenges faced by the nations to combat the fast spreading pandemic called COVID=19, caused by SARS-Cov-2 virus, a type of coronavirus that initially was reported in Wuhan province of China. Having already affected over 335,000 diagnosed cases as of March 22nd, 2020, with an unknown, potentially much larger proportion of un-diagnosed people. As evidenced by the experience of italy, Iran and other countries where the situation has spinned completely out of control, the window of opportunity is small and nations have very little time to act.

Flatten the curve

Since the problem with COVID-19 is not the disease itself as much as the overwhelming of the healthcare ICU beds, which are in limited supply, any measure aimed at slowing, or stopping the spread of the virus is golden.

The problem with social isolation

The problem with the current strategy is that it is not working and there is no way to enforce it for democratic societies. Also, the population in the West including the United States never experienced something like SARS like the Chinese who acted very quickly and enforced complete shut down for almost two months for them to get the control. The alternative strategy we are proposing assumes that everyone either got exposed or going to be exposed soon and the goal is to slow down the virus enough and break the rapid spread.

Research

Chloroquine

LATEST COMBINATION OF DRUGS FOR SARS-COV-2 (COVID-19): A COMBINATION OF DRUGS - CHLOROQUINE 200 MG THREE TIMES A DAY ALONG WITH AZITHROMYCIN 500 MG FOLLOWED BY 250 MG FOR 4 DAYS HAS BEEN USED IN A SMALL STUDY IN FRANCE WITH THE FOLLOWING PROMISING RESULTS. NEW

SUMMARY OF RESULTS - FRENCH STUDY ON CHLOROQUINE AND AZITHROMYCIN

• 14 Patients with COVID-19 given Hydroxyhloroquine (57.1% cured)
• 6 patients given combination of Hydroxychloroquine and Azithromycin (100% cured)
• 16 patients given neither of the above for 4 days (12.5% cured)

Link to the French Study - Chloroquine and Azithromycin

• Chloroquine and Azithromycin French Study for COVID-19

Proposal*

Put every other person in the country on a 5 day prophylactic course of Chloroquine / Hydroxychloroquine starting with states and or regions most affected fist such as New York in the case of the United States as the likelihood that a large portion of the population are already infected is high.

The median age of the United States population is 38.2 years. Our proposal is that the government consider putting every person who is over 38.2 years of age without a known contra-indication for the use of either of the above drugs, be put on a prophylactic regimen for a period of 5 days starting with hard hit areas such as New York along with other supportive measures such as Vitamin D, and Zinc.

Median age

Countries with a different demographic can use the median age of country and treat those that are above the median age. In the case of the United States, the median age is 38.2 years.

Rationale

Here is the rationale for use of Hydroxychloroquine and or Chloroquine

Flatten the curve

From CDC website: Hydroxychloroquine and chloroquine are oral prescription drugs that have been used for treatment of malaria and certain inflammatory conditions.

Breakthrough

Chloroquine has been used for malaria treatment and chemoprophylaxis, and hydroxychloroquine is used for treatment of rheumatoid arthritis, systemic lupus erythematosus and porphyria cutanea tarda. Both drugs have in-vitro activity against SARS-CoV, SARS-CoV-2, and other coronaviruses, with hydroxychloroquine having relatively higher potency against SARS-CoV-2. A study in China reported that chloroquine treatment of COVID-19 patients had clinical and virologic benefit versus a comparison group, and chloroquine was added as a recommended antiviral for treatment of COVID-19 in China.

Current recommendations

Based upon limited in-vitro and anecdotal data, chloroquine or hydroxychloroquine are currently recommended for treatment of hospitalized COVID-19 patients in several countries.

Our proposal - prophylaxis can flatten the curve

Our proposal goes beyond this and treats every other person or those that are above the median age of the country to slow down or stop the uncontrollable spread of the disease. When there is no herd immunity, the only option we have is to prophylax or to otherwise limit the exposure. Since social distancing, while an effective measure, is hard to enforce and in hard hit areas such as New York City, we need assume a large proportion of the population already got exposed and start treating them empirically, either with or without symptoms. This not only helps limit the more severe form of the disease, but also helps slow down the rate of spread, which is exactly what we are trying to do - flatten the curve. When there is no herd immunity to stop the spread, the only other recourse is to use prophylaxis in addition to social distancing.

Also, add at least 20,000 units of Vitamin 3, see the section below on Vitamin D, written by a pharmD.

Safety profiles

Both chloroquine and hydroxychloroquine have known safety profiles with the main concerns being cardiotoxicity (prolonged QT syndrome) with prolonged use in patients with hepatic or renal dysfunction and immunosuppression but have been reportedly well-tolerated in COVID-19 patients.

Due to higher in-vitro activity against SARS-CoV-2 and its wider availability in the United States compared with chloroquine, hydroxychloroquine has been administered to hospitalized COVID-19 patients on an uncontrolled basis in multiple countries, including in the United States. One small study reported that hydroxychloroquine alone or in combination with azithromycin reduced detection of SARS-CoV-2 RNA in upper respiratory tract specimens compared with a non-randomized control group but did not assess clinical benefit.

Be cautious with adding Azithromycin in community setting

Hydroxychloroquine and azithromycin are associated with QT prolongation and caution is advised when considering these drugs in patients with chronic medical conditions (e.g. renal failure, hepatic disease) or who are receiving medications that might interact to cause arrythmias. However, those that are hospitalized that can be monitored on telemetry, can safely be placed on the combination with Azithromycin with either Chloroquine or Hydroxychloroquine.

Benefits of Hydroxychloroquine

Hydroxychloroquine is currently under investigation in clinical trials for pre-exposure or post-exposure prophylaxis of SARS-CoV-2 infection, and treatment of patients with mild, moderate, and severe COVID-19. In the United States, several clinical trials of hydroxychloroquine for prophylaxis or treatment of SARS-CoV-2 infection are planned or will be enrolling soon. More information on trials can be found at: https://clinicaltrials.gov/external icon.

Azithromycin with Hydroxychloroquine

For those who test positive or have a potential contact, or those with other comorbidities, I propose adding Azithromycin 500 mg daily for 5 days in addition to either Hydroxychloroquine or Chloroquine.

Dosage schedule

Although optimal dosing and duration of hydroxychloroquine for treatment of COVID-19 are unknown, some U.S. clinicians have reported anecdotally different hydroxychloroquine dosing such as:

1. Hydroxychloroquine 400mg BID on day one, Day 2-5 one tablet PO daily for 5 days;^
2. Alternative dosing schedule 1 - Hydroxychloroquine 400 mg BID on day one, then 200mg BID for 4 days;
3. Alternative dosing schedule 2 - Hydroxychloroquine 600 mg BID on day one, then 400mg daily on days 2-5.

Risks of treatment

Most of the risks are for long term use and for a very short course, the risks are lower than that posed by a short course of an antibiotic

Map of coronavirus

Benefits

Potential to stop the uncontrolled spread of the virus leading to overload of the healthcare system as it is projected to affect over 40-60% of the entire population of the United States and possibly population of the world.

Risk benefit ratio

The risk benefit ratio is extremely favourable to a the use of the prophylactic use as the short term us is almost harmless with enormous benefits to the life, economy and wellbeing of the population

Window of opportunity to act

1-2 weeks from 03/22/2020

Coronavirus replication cycle

Healthcare workers prophylaxis

The Indian government, and Indian Medical Association recommend this: The National Task Force for the novel coronavirus constituted by Indian Council of Medical Research (ICMR) has recommended the use of hydroxychloroquine for high-risk cases. According to the Director-General of ICMR, Balram Bhargava, "Hydroxychloroquine is recommended only for a healthcare worker who is treating a COVID-19 patient. Secondly, it's recommended only for persons staying with and caring for a household patient who has been tested positive. They can take that for prophylaxis".

Our recommendation: While larger studies are still pending, given the relatively low risk of the medication, with significant potential benefit, all healthcare workers in the United States taking care of active or suspected COVID-19 patients be on prophylaxis.

Healthcare worker prophylaxis dose for oral hydroxychloroquine: 400 mg twice daily on day 1, then 400 mg once a week for 7 weeks. The same treatment applies for household contacts of active or suspected cases of COVID-19. (The same can be used as prophylaxis for all asymptomatic adults over the median age, without contra-indications, for a short duration as recommended in the prophylaxis for general population in highly infected areas).

The problem - The US government needs to act fast and act now

Unfortunately, the United States government and other governments around the world are not acting fast enough this as the cases double every other to a every third day and if we do not act now, it will be just a matter of a few weeks before our systems so overwhelmed that we will be worse of compared to even Italy.

Vitamin D to reduce risk of COVID-19

The following part is primarily written by a licensed pharmacist as noted below.

Bhanu Gadde, PharmD - author for the following section

Preventing a disaster – Pharmacist recommendations for covid-19

When it comes to the Covid-19 pandemic, the recommendations are numerous. Every one of them focuses on social isolation, physical barriers, washing hands, wearing masks, gloves, etc. There has been so much doubt that this would affect the population of the United States in the same way it affected the people in China and Italy, but all that is quickly changing as we are seeing the infections multiply here in our backyard. Learn more

Our proposal - recommendation

• Every adult in the COVID affected areas must consider starting on at least 20,000 iu/day of vitamin D3 (not D2, which is a vitamin D analog; the same beneficial effects of D3 were not seen in D2 supplementation) whether symptomatic or asymptomatic in consultation with a licensed physician^ for a duration recommended by the physician.
• Also consider 50 to 100 mg of zinc daily^.
• Once symptomatic, (or in high risk areasa, healthcare workers etc as prophylaxis) start on Hydroxychloroquine^ (200 mg 2 to 3 times daily)/Azithromycin 250 mg daily^ combination along with Ritonavir^ 100 mg daily/Oseltamivir^ 75 mg daily.
• Proper hydration with minerals is extremely important throughout the duration of the therapy.
• Optional: Vitamin C and other multivitamins

External links

The government of India actually recommends prophylaxis for higher risk population such as healthcare workers and this article extends the same concept and proposes that even the general population over the median age of the country to take it, especially in high risk areas such as Italy, New York, and Iran etc.

• The Indian Government recommends prophylaxis for healthcare workers

Authors

• Prab R. Tumpati, MD
• Bhanu Gadde, PharmD

References

References for Vitamin D

1. . Antimicrob Agents Chemother . 2004 Mar; 48(3): 783–790.
2. . https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4488782/
3. . https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5331620/
4. . https://www.bmj.com/content/368/bmj.m810
5. . https://thorax.bmj.com/content/70/7/617
6. . https://jlb.onlinelibrary.wiley.com/doi/pdf/10.1189/jlb.1011523
7. . https://www.ncbi.nlm.nih.gov/pubmed/30611908

^Disclaimer:: Please do not take any medication including, but not limited to, any of the above medications, without first consulting with a licensed physician. This proposal is intended as a suggestion for the government and other policy makers to come up with a plan of action. This article, by no means, should be taken as providing medical advise.

COVID vaccine development

WHO preventing coronavirus

Coronavirus: WHO declares COVID 19 a pandemic.

• Prevention
• FAQs on COVID
• Glossary of COVID

Treatments

The monoclonal antibodies treatments Bamlanivimab (made by Eli Lilly and Company) and the therapeutic cocktail Casirivimab/Imdevimab (made by Regeneron) called monoclonal antibodies that can be given to help treat patients with COVID-19.  

List of approved COVID-19 vaccinations in US

The following COVID-19 vaccines have received emergency use authorization from the U.S. Food and Drug Administration for the prevention of COVID-19:

• The Pfizer-BioNTech COVID-19 vaccine for use in persons 16 years of age and older.
• The Moderna COVID-19 vaccine for use in persons 18 years of age and older.
• The Johnson & Johnson (Janssen) COVID-19 vaccine for use in persons 18 years and older.

External links

• US HHS dashboard

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