Dr K K Aggarwal
President Confederation of Medical Associations of Asia and Oceania, HCFI and Past National President IMA
With regular inputs from Dr Monica Vasudev
731: Amendment of Disease Epidemic Act in India
Violence and discrimination against the fraternity has once again come to the fore during the Coronavirus pandemic.
Healthcare providers are leading from the front. They must be given the highest form of protection in this critical hour.
The decision of the government to amend the disease epidemic act and penalize those who attack healthcare workers is welcome but the same should be further amended to include health caré establishments treating non Covid patients also otherwise it will end up with the police to interpret the situation on case to case basis for inclusion in the disease epidemic act. It would have been easier and better to amend the clinical establishment act and included the same clause.
732: NIH guidelines for COVID-19
The guidelines consider two broad categories of therapies currently in use by healthcare providers for COVID-19: antivirals, and host modifiers and immune-based therapies. The COVID-19 Treatment Guidelines Panel noted that at present, no drug has been proven to be safe and effective for treating COVID-19.
733: What are the summary recommendations of NIH guidelines regarding antivirals
1. There are insufficient clinical data to recommend either for or against using chloroquine or hydroxychloroquine for the treatment of COVID-19 - if chloroquine or hydroxychloroquine is used, clinicians should monitor the patient for adverse effects, especially prolonged QTc interval.
2. There are insufficient clinical data to recommend either for or against using the investigational antiviral drug remdesivir for the treatment of COVID-19.
3. Except in the context of a clinical trial, the Panel recommends against the use of the following drugs for the treatment of COVID-19:
· The combination of hydroxychloroquine plus azithromycin because of the potential for toxicities.
· Lopinavir/ritonavir (AI) or other HIV protease inhibitors because of unfavorable pharmacodynamics and negative clinical trial data.
· There are insufficient clinical data to recommend either for or against the use of convalescent plasma or hyperimmune immunoglobulin for the treatment of COVID-19.
· There are insufficient clinical data to recommend either for or against the use of the following agents for the treatment of COVID-19:
Interleukin-6 inhibitors (e.g., sarilumab, siltuximab, tocilizumab).
Interleukin-1 inhibitors (e.g., anakinra).
734: What are the summary recommendations of NIH guidelines regarding immunomodulators
Except in the context of a clinical trial, the Panel recommends against the use of other immunomodulators, such as:
Interferons because of lack of efficacy in treatment of severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) and toxicity.
Janus kinase inhibitors (e.g., baricitinib) because of their broad immunosuppressive effect.
What are the guidelines concerning the use of concomitant medications
735: ACE Inhibitors AE Blockers
Persons with COVID-19 who are prescribed ACE inhibitors or ARBs for cardiovascular disease (or other indications) should continue these medications.
The Panel recommends against the use of ACE inhibitors or ARBs for the treatment of COVID-19 outside of the setting of a clinical trial.
736 Systemic Oral Steroids
The Panel recommends against the routine use of systemic corticosteroids for the treatment of mechanically ventilated patients with COVID-19 without acute respiratory distress syndrome (ARDS).
For mechanically ventilated patients with ARDS, there is insufficient evidence to recommend for or against the use of systemic corticosteroids.
For adults with COVID-19 and refractory shock, the Panel recommends using low-dose corticosteroid therapy (i.e., shock reversal) over no corticosteroids.
The Panel recommends against the routine use of systemic corticosteroids for the treatment of COVID-19 in hospitalized patients, unless they are in the intensive care unit.
Oral corticosteroid therapy used prior to COVID-19 diagnosis for another underlying condition (e.g., primary or secondary adrenal insufficiency, rheumatological diseases) should not be discontinued. On a case-by-case basis, supplemental or stress-dose steroids may be indicated.
737: Inhaled corticosteroids
Used daily for patients with asthma and chronic obstructive pulmonary disease for control of airway inflammation should not be discontinued in patients with COVID-19.
738: Antenatal steroids
The antenatal corticosteroids betamethasone and dexamethasone are known to cross the placenta and therefore are generally reserved for when administration is required for fetal benefit. Other systemic corticosteroids do not cross the placenta, and pregnancy is not a reason to restrict their use if otherwise indicated.
The American College of Obstetricians and Gynecologists recommends against offering antenatal corticosteroids for fetal benefit in the late preterm period (34 0/7 weeks–36 6/7 weeks) because the benefits of antenatal corticosteroids in the late preterm period are less well established. Modifications to care for these patients may be individualized, weighing the neonatal benefits of antenatal corticosteroid use with the risks of potential harm to the pregnant patient.
Persons with COVID-19 who are prescribed statin therapy for the treatment or prevention of cardiovascular disease should continue these medications.
The Panel recommends against the use of statins for the treatment of COVID-19 outside of the setting of a clinical trial.
Persons with COVID-19 who are taking NSAIDs for a co-morbid condition should continue therapy as previously directed by their physician.
The Panel recommends that there be no difference in the use of antipyretic strategies (e.g., with acetaminophen or NSAIDs) between patients with or without COVID-19.
Myth: 740: We don’t need mass testing to reopen the country.
Actually, we do. Reopening depends on our ability to transition from population-wide mitigation — which is what social distancing does — to individual-level containment.
That means we must identify each individual with covid-19 and then trace and quarantine their contacts. This requires mass testing.
In addition, one of the guidelines for reopening the country is a downward trend in infections. We can’t know that the numbers are going down unless we have an accurate daily count, which can only be obtained through widespread testing.
Mass testing will also provide the reassurance that many need to resume normal activities. Having enough tests to regularly check employees, students and teachers would help provide confidence that we can resume work and school. And imagine if all patients receive a test before they enter the hospital, and those who test negative will then receive care in a separate ward from those who test positive. Patients would not be so frightened to seek care for ongoing medical issues such as cancer, pregnancy or heart disease, and hospital staff could also conserve needed personal protective equipment.
Fear 741: A person could test negative today and contract the virus tomorrow.
That’s true for any infectious disease — or indeed, for any illness. We don’t stop screening people for HIV or diabetes because they could develop the disease later.
At the time of testing, people can be given guidance about limitations of a negative test.
742: Fear: Tests are not 100 percent accurate.
This is true for every test. We need to develop tests that have as high a degree of accuracy of possible, and the government must stop fraudulent tests from coming on the market.
Remember perfect cannot be the enemy of the good. We don’t stop doing tests for other diseases because there is a risk of false positives or negatives.
Fact: 743: It’s not just testing that we need to reopen society.
There are other key components, such as the public health infrastructure to conduct contact tracing and social supports to isolate those are affected. But testing is the linchpin. We must know who is testing positive before we can identify their contacts and quarantine them.
744 Fact: We shouldn’t focus on manufacturing one test because there are other tests being developed.
There are two main types of tests: the PCR swab test that identifies people who are currently infected, and a blood serology test that looks for who has been exposed and, therefore, has antibodies to covid-19.
Both types of tests are needed, but that the most urgent test that must be mass-produced is the PCR test — and ideally one that can produce results within minutes.
The fact that the serology test is also being manufactured doesn’t replace the need for the PCR test; indeed, both should be produced and deployed in large numbers.
745: Myth: In lieu of testing, there are other ways of doing surveillance by looking at the rate of influenza-like illnesses.
Waiting for hospitals to register an increase in the number of visits for flu-like symptoms is acting too late. We must fight any endemic on the grounds and not the hospitals.
Two weeks could pass before a patient who contracts covid-19 ends up in the hospital; the key needs to be prevent the spike in illnesses through early detection.
Most people with covid-19 may never develop symptoms but can still transmit the virus to others. The rate of flu-like illnesses is, at best, a proxy for when mass testing cannot be done, but it does not replace the need for it.
746: Myth: We don’t need to test every single person
Why not? If everyone is at risk for contracting covid-19, everyone should be able to get tested — and not only once, but many times if needed.
We routinely screen people for high blood pressure. We encourage everyone to be tested for sexually transmitted infections. There is no limit to the number of times people receive these screenings. Why shouldn’t everyone have access to covid-19 testing, too, when they want and need it?
747: Why so many dubious tests in the market
To speed up the process, the US FDA made a much-criticized move to allow a free-for-all for developers to begin marketing antibody tests that had not gone through the agency's usual evaluation process.
The result was a flood of more than 90 unapproved tests "that have, frankly, dubious quality.
The FDA, has moved quickly into damage control, conducting evaluations of the tests in an effort to distinguish the potentially useful from the useless.
So far, they have succeeded in issuing emergency use authorizations (EUAs) to only four tests, those marketed by Cellex, Ortho Clinical Diagnostics, Chembio Diagnostic Systems, and the Mount Sinai Laboratory.
748: What about in other countries
People started marketing them that they have been approved in USA and on the trust that test developer has done a good job in validation.
But there are worrying anecdotes. We are seeing fraudulent marketing.
749: Some companies are marketing tests for use in physicians' offices or pharmacies.
Today, there are no serology tests approved for point-of-care settings. We don't know how to interpret the test results, if the presence of antibodies indicates immunity, how long it will last, or what titer might be sufficient.
750: WHO and FDA Uncertainty Emphasized
The FDA emphasized the uncertainty about antibody tests in a statement released on April 18.
Although the tests can identify people who have been exposed and who developed an immune response to the virus, "we don't yet know that just because someone has developed antibodies, that they are fully protected from reinfection, or how long any immunity lasts."
The FDA says that the role of these antibody tests, at present, lies in providing information to "help us track the spread of the virus nationwide and assess the impact of our public health efforts now, while also informing our COVID-19 response as we continue to move forward."
The WHO also emphasized the current uncertainty over antibody tests at a press briefing on April 17. "Nobody is sure about the length of protection that antibodies may give and whether they fully protect against...the disease,"
There is also a concern that such tests may give false assurance or be misused.
"There is still a lot of work that needs to be done to validate these antibody tests,"
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