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CMAAO Coronavirus Facts and Myth Buster 62

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Dr KK Aggarwal    18 April 2020

Coranxiety the Next Pandemic

An article published online April 10 in JAMA Internal Medicine on the mental health consequences of COVID-19, warns of a “pandemic” of behavioral problems and mental illness.

What can happen

The COVID-19 pandemic will possibly cause a considerable rise in anxiety and depression, substance use, loneliness, and domestic violence. With school closures, the possibility of an epidemic of child abuse is also possible.

In COVID era the Guidance states that, prior to and during the work shift for post-positive workers, employers should:

  • Pre-screen andmeasure the employee’s temperature and assess symptoms prior to the employee enters the facility;
  • Regularly Monitor the employee’s temperature and symptoms
  • Have the employeewear a face mask at all times while in the workplace for 14 days after the last exposure;
  • Have the employee maintain social distanceand maintain a 6 feet perimeter as work duties permit in the workplace;
  • Clean and disinfectall areas such as offices, bathrooms, common areas and shared electronic equipment routinely; and
  • Work with facility maintenance to increase air exchangesin the building.

[CDC]

How to minimize patient contact visits

UCSD Hospital Medicine drafted guidelines for the reduction of patient contacts -

Targeting one in-person MD visit per day for stable patients.

Attending reexaminations of patients seen by residents, nurse practitioners, physician assistants, etc., not to be done for billing or teaching purposes, only when clinically necessary.

Using phone or video conferencing for follow-up discussions unless direct patient contact is needed.

Skipping daily exams on patients who do not require them, such as patients awaiting placement or stably receiving long courses of antibiotics. Try to interview them remotely or from the door instead.

Conducting team rounds, patient discussions, and handoffs with all members 6 feet apart or by telephone or video. Avoiding shared work rooms. Substituting video conferences for in-person meetings. Using EMR embedded messaging to limit face-to-face discussions.

Checking if a patient is ready for a visit before donning PPE to avoid waste.

Explaining to patients that distancing is being conducted to protect them.

[The Hospitalist]

Hb in COVID 19

A meta-analysis of four studies revealed that hemoglobin value was significantly lower in COVID-19 patients with severe disease, compared with those with milder forms, stated a letter to the editor of Hematology Transfusion and Cell Therapy by Giuseppe Lippi, MD, of the University of Verona (Italy) and colleague.

The hemoglobin value was significantly lower in COVID-19 patients with severe disease compared to those with milder forms, with a weighted mean difference of −7.1 g/L, with a 95% confidence interval of −8.3 g/L to −5.9 g/L. [The Hospitalist]

PPE side effects in skin

Nearly 75% of doctors and nurses in and around Wuhan, China, have reported skin problems during a single week in early February 2020, revealed a survey of healthcare workers (HCW) caring for COVID-19 patients at five university and five regional hospitals. The most commonly affected areas included hands, cheeks, and the nasal bridge, with skin dryness, maceration, papules, and erythema being the most common problems, suggested the research published in the British Journal of Dermatology. [The Hospitalist]

FDA restricted blood donation guidelines

On April 2, the FDA issued three sets of revised recommendations in order to get more people eligible to donate blood. The revised recommendations will remain effective after the COVID-19 health emergency is declared over.

The first revised recommendation amends the December 2015 guidance.

For male blood donors who would have been deferred for having sex with another male partner, the deferral period was decreased from 12 months to 3 months. The change in the deferral period also applies to female donors who had sex with a man who had sex with another man and also for those with recent tattoos and piercings.

The second recommendation revised guidance from August 2013 and pertains to the risk of transfusion-transmitted malaria.

The new recommendations state that for those who traveled to malaria-endemic areas (and reside in malaria non-endemic countries), deferral period has been decreased from 12 months to 3 months. The FDA also provides notice of an alternate procedure that allows donations without a deferral period given the blood components are pathogen-reduced using an FDA-approved pathogen reduction device.

The third recommendation finalized draft guidance from January that eliminates the deferral period for those who spent time in certain European countries or were on military bases in Europe and were previously considered to have had exposure to a potential risk of transmission of Creutzfeldt-Jakob Disease or Variant Creutzfeldt-Jakob Disease.

[Medscape]

Can X-ray be normal

In a study published in the Journal of Urgent Care Medicine, Michael Weinstock, MD, of Wexner Medical Center at The Ohio State University in Columbus, and colleagues have revealed that among cases of confirmed COVID-19, 58.3% of chest x-rays read as normal, with 89% reading as either normal or mild. [Medpage Today]

Self-collected throat washings

Throat washing is a promising candidate for 2019-nCoV screening due to its safety and reliability. Its utility and efficacy in 2019-nCoV detection have been described in a study, report Dr. Shi-Yue Li of The First Affiliated Hospital of Guangzhou Medical University in China and colleagues.

The WHO recommends both NP swabs and oropharyngeal (OP) swabs. Dr. Li and colleagues noted in Clinical Infectious Diseases that while NP swabs were found to be more effective than OP swabs for diagnosing infection, this approach still puts healthcare workers at risk of infection, with the samples being of inconsistent quality, and the test being uncomfortable for patients.

Dr. Li and colleagues have reported on the performance of throat washing in 11 patients with laboratory-confirmed COVID-19. Subjects gargled with 20 ml of normal saline for 5 to 10 seconds, and then spit in a sterile container.

Twenty-four paired throat washings and NP swabs were obtained from the patients, including five from the five patients who had been discharged, and 19 from the six patients who remained hospitalized. Sample collection was done a median 53 days after symptom onset.

Fourteen of the pairs were negative for 2019-nCoV. Five pairs had inconsistent results, with the throat washing testing positive and the NP swab testing negative.

Using the Chi-squared test, positive testing rate of throat washing was found to be much higher than that of NP swabs (P=0.031).

Contact lenses and COVID 19

Contact lenses are not likely to raise the risk of contracting COVID-19. Contrary to popular belief, glasses may offer little protection from the virus, according to a review article published in Contact Lens and Anterior Eye.

Social distancing - For how long

The United States may need to continue with social distancing measures adopted during the coronavirus outbreak until 2022, state researchers at the Harvard School of Public Health.

Intermittent distancing may be required until 2022 unless critical care capacity is increased to a considerable extent or a treatment or vaccine becomes available, the Harvard researchers said in findings published in the journal Science.

[The Economic Times]

CMAAO Coronavirus Facts and Myth Buster: Plasma Therapy 61

India has started convalescent plasma therapy in COVID 19 patients. ILBS, Kerala, TN and many other centers have started it. Its time -

  1. For a central website of the donors
  2. Indian Red Cross to become the nodal agency
  3. Expedite permissions to hospitals

What is Convalescent plasma 

The Food and Drug Administration (FDA) is accepting investigational new drug applications for use of convalescent plasma for patients with severe or life-threatening COVID-19. Pathways for use through these applications include clinical trials, expanded access programs, and emergency individual use.

Is there any study

One case series has described the administration of plasma from donors who had recovered from COVID-19 to five patients with severe COVID-19 on mechanical ventilation and persistently high viral titers despite investigational antiviral treatment.

The patients were found to have decreased nasopharyngeal viral load, decreased disease severity score, and improved oxygenation by 12 days after transfusion. [Shen C, Wang Z, Zhao F, et al. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA 2020.]

Do these findings establish a causal effect

No.

Will there by any logistic issues

Finding appropriate donors and establishing testing to confirm the neutralizing activity of plasma may pose logistical challenges.

What is the solution addressed by the USA

In the United States, the American Red Cross is facilitating the collection and distribution of convalescent plasma throughout the country.

What is Convalescent plasma

It refers to plasma from an individual who has recovered from an infection. It is a means of antibody transfer to provide passive immunity (neutralizing antibodies against the infectious pathogen) until the individual can develop an active immune response, with the hope that clinical outcomes can be improved in the recipient.

When its use is allowed

Convalescent plasma is not routinely available, nor is it a licensed product. It has been made available for specific agents at times of disease epidemics or pandemics. Once an epidemic has subsided, convalescent plasma is likely to become unavailable.

What are related products

Related products include convalescent serum (contains antibodies but not clotting factors) and hyperimmune globulin (a concentrated product containing a high titer of antibodies).

Monoclonal antibodies with neutralizing potential are another approach, although this requires additional development and manufacturing steps.

What are the indications

Convalescent plasma (or hyperimmune globulin) could be used to improve the clinical course of disease in affected individuals or to reduce the risk of developing a disease (eg, postexposure prophylaxis).

Can it be risky

The risk of transfusion reactions or disease worsening must be considered in the risk-benefit analysis.

Is there any evidence

Prior to SARS-CoV-2 – A 2015 systematic review and meta-analysis of the use of convalescent plasma for treating severe acute respiratory syndromes summarized results from clinical studies (this analysis preceded the emergence of the 2019 novel coronavirus [SARS-CoV-2]). It stated that convalescent plasma may reduce mortality and appears safe.

Mair-Jenkins J, Saavedra-Campos M, Baillie JK, et al. The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis. J Infect Dis 2015; 211:80.

Is there any evidence in SARS

SARS-CoV (2003 SARS epidemic) – There was reduced mortality (7 to 23 percent lower mortality). There was a reduced hospital length of stay, especially when convalescent plasma was administered within two weeks of symptom onset. No major complications were reported.

Is there any evidence in MERS

MERS-CoV (2012 outbreak) – No clinical studies were identified, although animal models suggested there might be a benefit.

Is there any evidence in influenza viruses

H1N1-pdm09 (2009 pandemic) – One study reported an 80 percent reduction in mortality, especially with early treatment. There was a reduced length of intensive care unit (ICU) stay. No major complications were reported.

H5N1 (avian influenza; several outbreaks) – Nonsignificant benefits seen in one study.

H1N1 (1918-1919 flu epidemic) – There was reduced mortality (approximately 20 percent reduction) according to a meta-analysis. These studies used convalescent blood rather than plasma; chills, fever, and sweats were reported following the infusions.

Is the evidence strong

The reviewed studies were generally considered of low quality due to high risk of bias and lack of control groups. The observed lower mortality with convalescent plasma could reflect selection bias (therapy only given to patients who were well enough to be treated) or publication bias (only positive studies reported).

Is it effective in Ebola

A study found no evidence of benefit in Ebola virus disease, although some case reports described good outcomes.

When it is most useful

Convalescent plasma is generally most appropriate for individuals who are severely ill and do not have access to better alternatives.

Criteria for optimal preparation of plasma (or hyperimmune globulin) include -

High enough titer of neutralizing antibody to be effective

Lack of infectious particles (either the target pathogen or others)

Blood type compatible (ABO; Rh in women of reproductive potential)

Evidence for efficacy and lack of harm, ideally from randomized trials or prospective studies

Informed consent with discussion of the risk of disease and risks and benefits of therapy

Mair-Jenkins J, Saavedra-Campos M, Baillie JK, et al. The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral aetiology: a systematic review and exploratory meta-analysis. J Infect Dis 2015; 211:80.

The FDA has released guidance to assist with obtaining convalescent plasma during the SARS-CoV-2 coronavirus pandemic of 2019-2020 for individuals who do not have access to a clinical trial.

How much plasma can be donated

400 ml (for two to three patients)

After how many days plasma can be donated

2 weeks

What is the Mayo clinic protocol

Only hospitalized COVID-19 patients who meet certain criteria and are referred by their healthcare provider can participate in this protocol. Mayo Clinic is serving as the lead institution for the protocol, working collaboratively with industry, academic, and government partners

How many people have donated plasm in the USA

 Thousands of COVID-19 survivors in the US are willing to donate convalescent plasma to leading universities, which are undertaking clinical trials in the race for solutions against the coronavirus pandemic until theres a vaccine available.

 How often can one donate

 A COVID-19 survivor could provide enough plasma in one sitting to treat two or three other patients. If they donate every seven days, one person could donate 10 to 12 units of plasma in a month.

 When should we administer plasma

 Viremia peaks in the first week of infection in most viral illnesses.

The patient develops a primary immune response by days 10–14, followed by virus clearance.

Theoretically, it would be more effective to administer the convalescent plasma at the early stage of the disease.

However, other treatments might affect the relationship between convalescent plasma and antibody level, including antiviral drugs, steroids, and intravenous immunoglobulin.

Dr KK Aggarwal

President CMAAO, HCFI and Past National President IMA

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