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Guidelines’ to prevent COVID-19 patent approved in United States


Munawar Naqvi

ISLAMABAD: The United States of America has approved the patent of Pakistan Allergy Asthma and Immunology guidelines for the prevention and treatment of COVD-19 on Sunday, April 17, 2020, disclosed Dr. Shahid Abbas, Consultant Allergy & Immunology and President PAAIS (Pakistan Allergy Asthma and Immunology Society).
The edited version of the detailed document is reproduced below:
Save the life and don’t wait for randomized clinical trials which will come after one year – Hydroxychoroquine and Super-Immuno IV Combination in the absence of randomized control are scientifically proven to be affective and evidence based studies.
Pandemic of coronavirus is huge and the number of deaths daily all over the world are still high. World scientists are unable to develop and have consensus on the prevention and treatment medicines or vaccines for prevention and treatment. The vaccines will be preventive, but it may take more than one year to come to the market.
Lack of Seriousness: Can we just wait and let the precious lives be lost waiting for the vaccines and discuss controversies about medicines which can be effective? We cannot just keep writing articles of some favoring and some criticizing the medicines which can be effective. We have to save the lives and quick decisions have to be taken by the concerned authorities otherwise the consequences are going to be dire. There is lack of seriousness about this despite the death toll all over the world.
Evidence-based medicine: We must re-visit our Lockdown policies and re-evaluate ‘Evidence-based medicine’. Most of scientists are talking about Randomized Trials before starting simple effective medicines which can save life. The Observational studies proving the effectiveness of medicines like Hydroxychloroquine without rigorous reviews and recommend suspected studies just because these happened to be randomized trials. We must understand that time is passing fast and we are losing precious lives and we cannot wait for months for those luxury randomized trials. We need to act fast and use the data we have; we must understand what Evidence Based medicine is. Evidence-based medicine is the integration of individual clinical expertise with the best available research evidence from systematic research and the patient’s values and expectations. The efficient approach to finding the best evidence is to identify a systematic review or evidence-based clinical practice guidelines.
It’s integrating each study into the body of existing data, combining the best available science, reaching defensible conclusions and prescribing the medicines which can be effective.
Let me explain more that with evidence-based medicine approach we can know the ‘Pre randomized Trial Probability of Success’. It means how likely this drug will be effective before we get the data from the randomized scientific trials. In the example of Hydroxychloroquine, half of the world is supporting the use and another half is opposing the use as prophylactic and therapeutic use for corona virus infections.
Hydroxychloroquine has long history of use as antimalarial, antibiotic and antiviral. It has shown to be effective in vitro to inhibit corona virus by changing the structure of the receptors and preventing the attachment of the virus to the receptors on the target cells or in scientific words inhibits viral entry and replication via intracellular alkalinization, interferes w/maturation of viral particles through impaired glycosylation which are the indirect immunomodulatory effects.
Even if we consider that the chances to be affective are 50:50 but still we must use since there is no other alternative and that too in the light of following studies.
1-Efficacy of hydroxychloroquine in patients with COVID-19: results of a randomized clinical trial by Zhaowei Chen etall (BMJ Yale) (https://www.medrxiv.org/content/10.1101/2020.03.22.20040758v3)
Results of a Randomized Clinical Trial: 62 hospitalized pts (mean age, 45 yo) w/ mild dz (SAO2 >93%) due to confirmed COVID-19 randomized to HCQ 200 mg bid x5 days or placebo, plus standard of care.
HCQ-treated pts had shorter duration of cough (2.0 days vs 3.1 days) and fever (2.2 days vs 3.2 days), and higher rates of pneumonia improvement (80.6% vs 54.8%); 4 pts in placebo arm progressed to severe dz; 2 pts in HCQ arm developed mild ADRs.
2-Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open label non-randomized clinical trial Philippe Gautret P, https://www.ncbi.nlm.nih.gov/pubmed/32205204
Thirty-six patients in France with COVID-19 were examined. Twenty of them got hydroxychloroquine and 16 were controls. But this was not randomized; treated patients were different from those not receiving treatment. The researchers looked at viral carriage over time in the two groups.
This appears to be a dramatic reduction in coronavirus carriage in those treated with hydroxychloroquine. It’s not randomized, but when we need to make decisions fast, we have to make decisions in larger interest of nation we have to act fast considering evidence based medicine and pre-study probability of success. So my prediction of 50:50 could be considered by the relevant authorities and try Hydroxychloroquine for prevention and treatment of corona virus infections.
Concerns about taking hydroxychloroquine: Some people consider hydroxychloroquine to be dangerous since it causes prolongation of QT Interval but they should consider that most of the medicines being used daily like Azithromycin, Erythromycin, Clarithromycin, Levofloxacin, Moxifloxacin, Fluconazole, Ketoconazole, Metronidazole(Flagyl), adrenaline used for treatment of anaphylaxis, antipsychotic and anti-depressants. So, Chloroquine and these medicines do not prolong the QT Interval of every person. American College of Cardiology has given guidelines for the heart diseases patients susceptible to developing prolongation of qt interval and Ventricular Arrythmias. Anyone can calculate the Risk Score and if he thinks it can cause Ventricular Arrythmias according to Risk Factor Score he can avoid it.
Recommendations of American College of Cardiology (ACC) for use of Hydroxychloroquine and Azithromycin in cardiac patients to develop prolongation of qt interval and risk of developing Ventricular Arrhythmia.
You have to calculate your Risk Score for drug-Associated QTc prolongation by consulting the table and adding the Risk factor Points.
Protocol for COVID Patients and as Preventive to Boost the Immune System High dose of Vitamin C (Prof. Fowler VCU-USA or our (SuperImmuno-COVID-19 Drip):
Intramuscular: Vitamin D3 100000-150000 IU Intramuscularly once a day.
Inhalers: Salbutamol inhaler 200mcg 2 puffs six hourly.
Prevent corona infection: After extensive research Immuno-Nutrition experts of PAAIS recommends One Tablet of Hydroxychloroquine 400 or 200mg daily; 2 Grams of Vitamin C or Detoxvit Tablet (containing Vitamin C 500mg, Magnesium 200mg and 10mg Zinc). 3-4 tablets daily should be taken daily to prevent the Corona Virus Infections; Vitamin D 5000IU daily for 2 weeks and then 2000 IU daily; Selenium 55ug daily.
PAAIS will be sending protocols for prevention and treatment of patients suffering from infection due to corona virus. The treatment of the patients in ICU with high dose of Vitamin C has amazing results in USA and China, these protocols ae highly recommended. In the end CPVD-19 infection must be taken seriously and public must start 200 or 400mg Hydroxychloroquine weekly with 2 Grams of Vitamin C daily along with Zinc, Magnesium, Vitamin D to prepare the Immune system to fight with corona virus infection.
The guidelines are posted on webpage www.allergypaais.org and www.allergycenter.info and can be downloaded without any hesitation and permission, Dr. Shahid Abbas said.