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because d.z. is on azithromycin, what interventions need to be included in his plan of care?

Written By Tuesday, April 12, 2022 Add Comment Edit

Abstract

Approximately 9 months of the severe acute respiratory syndrome coronavius-2 (SARS-CoV-2 [COVID-nineteen]) spreading across the globe has led to widespread COVID-19 astute hospitalizations and death. The rapidity and highly communicable nature of the SARS-CoV-two outbreak has hampered the design and execution of definitive randomized, controlled trials of therapy outside of the clinic or hospital. In the absence of clinical trial results, physicians must use what has been learned about the pathophysiology of SARS-CoV-2 infection in determining early outpatient treatment of the illness with the aim of preventing hospitalization or decease. This article outlines fundamental pathophysiological principles that relate to the patient with early infection treated at dwelling house. Therapeutic approaches based on these principles include one) reduction of reinoculation, 2) combination antiviral therapy, 3) immunomodulation, iv) antiplatelet/antithrombotic therapy, and 5) administration of oxygen, monitoring, and telemedicine. Future randomized trials testing the principles and agents discussed will undoubtedly refine and clarify their individual roles; however, we emphasize the immediate need for direction guidance in the setting of widespread hospital resource consumption, morbidity, and mortality.

Keywords

  • Ambulatory handling
  • Anticoagulant
  • Anti-inflammatory
  • Antiviral
  • COVID-19
  • Critical care
  • Epidemiology
  • Hospitalization
  • Mortality
  • SARS-CoV-two

Clinical Significance

  • •

    COVID-19 hospitalizations and death can be reduced with outpatient treatment.

  • •

    Principles of COVID-19 outpatient care include: one) reduction of reinoculation, 2) combination antiviral therapy, three) immunomodulation, 4) antiplatelet/antithrombotic therapy v) assistants of oxygen, monitoring, and telemedicine.

  • •

    Futurity randomized trials volition undoubtedly refine and clarify ambulatory treatment, nonetheless we emphasize the firsthand need for direction guidance in the current crisis of widespread hospital resource consumption, morbidity, and bloodshed.

The pandemic of severe acute respiratory syndrome coronavius-2 (SARS-CoV-two [COVID-19]) is rapidly expanding beyond the earth with each country and region developing singled-out epidemiologic patterns in terms of frequency, hospitalization, and death. There has been considerable focus on 2 major areas of response to the pandemic: containment of the spread of infection and reducing inpatient bloodshed. These efforts, although well-justified, have not addressed the ambulatory patient with COVID-nineteen who is at risk for hospitalization and decease. The current epidemiology of ascent COVID-19 hospitalizations serves as a strong impetus for an attempt at treatment in the days or weeks before a hospitalization occurs.

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Nearly patients who arrive to the hospital past emergency medical services with COVID-19 do not initially require forms of advanced medical care.

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Once hospitalized, approximately 25% require mechanical ventilation, advanced circulatory back up, or renal replacement therapy. Hence, it is conceivable that some, if not a majority, of hospitalizations could be avoided with a treat-at-home start arroyo with appropriate telemedicine monitoring and admission to oxygen and therapeutics.

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As in all areas of medicine, the big randomized, placebo-controlled, parallel group clinical trial in appropriate patients at risk with meaningful outcomes is the theoretical aureate standard for recommending therapy. These standards are not sufficiently rapid or responsive to the COVID-19 pandemic.

One could argue the results of definitive trials were needed at the outset of the pandemic, and certainly are needed at present with more than than ane 1000000 cases and 500,000 deaths worldwide.

Because COVID-19 is highly communicable, many ambulatory clinics practice not care for patients in contiguous visits, and these patients are normally declined by pharmacies, laboratories, and imaging centers. On May 14, 2020, after about 1 million cases and 90,000 deaths in the United States had already occurred, the National Institutes of Health (NIH) announced it was launching an outpatient trial of hydroxychloroquine (HCQ) and azithromycin in the treatment of COVID-19.

A calendar month afterwards, the agency announced it was endmost the trial because of the lack of enrollment with just xx of 2000 patients recruited.

No rubber concerns were associated with the trial. This effort serves every bit the best electric current working example of the lack of feasibility of outpatient trials for COVID-19. It is also a potent signal that time to come ambulatory trial results are non imminent or likely to report soon enough to have a significant public health impact on clinical outcomes.

If clinical trials are non feasible or will non deliver timely guidance to clinicians or patients, then other scientific information bearing on medication efficacy and prophylactic needs to be examined. Cited in this article are more a dozen studies of diverse designs that accept examined a range of existing medications. Thus, in the context of present knowledge, given the severity of the outcomes and the relative availability, cost, and toxicity of the therapy, each dr. and patient must brand a selection: watchful waiting in self-quarantine or empiric treatment with the aim of reducing hospitalization and decease. Because COVID-19 expresses a wide spectrum of affliction progressing from asymptomatic to symptomatic infection to fulminant adult respiratory distress syndrome and multiorgan organization failure, there is a need to individualize therapy according to what has been learned nigh the pathophysiology of human being SARS-CoV-ii infection.

Information technology is beyond the scope of this article to review every preclinical and retrospective study of proposed COVID-19 therapy. Hence, the agents proposed are those that have appreciable clinical support and are feasible for administration in the ambulatory setting. SARS-CoV-2 as with many infections may be amenable to therapy early in its course simply is probably not responsive to the aforementioned treatments very late in the hospitalized and terminal stages of affliction.

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For the ambulatory patient with recognized early signs and symptoms of COVID-19, oftentimes with nasal real-time contrary transcription or oral antigen testing pending, the following four principles could be deployed in a layered and escalating fashion depending on clinical manifestations of COVID-19-like illness

and confirmed infection: 1) reduction of reinoculation, 2) combination antiviral therapy, 3) immunomodulation, and four) antiplatelet/antithrombotic therapy. Because the results of testing could take up to a week to return, treatment can be started before the results are known. For patients with key features of the syndrome (ie, fever, torso aches, nasal congestion, loss of taste and olfactory property, etc.) and suspected false-negative testing, treatment can be the aforementioned as those with confirmed COVID-19.

Future randomized trials are expected to confirm, reject, refine, and aggrandize these principles. In this article, they are ready forth in emergency response to the growing pandemic equally shown in Effigy one.

Figure 1

Figure 1 Treatment algorithm for COVID-nineteen-like and confirmed COVID-19 illness in convalescent patients at abode in self-quarantine. BMI = trunk mass index; CKD = chronic kidney disease; CVD = cardiovascular disease; DM = diabetes mellitus; Dz = affliction; HCQ = hydroxychloroquine; Mgt = management; Oii = oxygen; Ox = oximetry; Yr = year.

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Command of Contagion

A major goal of self-quarantine is the control of contagion.

Many sources of information suggest the main place of viral transmission occurs in the abode.

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Facial covering for all contacts within the abode as well equally frequent utilise of paw sanitizer and hand washing is mandatory. Sterilizing surfaces such equally countertops, door handles, phones, and other devices is brash. When possible, other close contacts can move out of the domicile and temporarily stay with others not sick with SARS-CoV-ii. Findings from multiple studies bespeak that policies concerning control of the spread of SARS-CoV-two are effective and extension into the domicile every bit the most frequent site of viral transfer is paramount.

Reduction of Self-Reinoculation

It is well-recognized that COVID-xix exists outside the human body in a bioaerosol of airborne particles and droplets. Considering exhaled air in an infected person is considered to be "loaded" with inoculum, each exhalation and inhalation is effectively reinoculation.

In patients who are hospitalized, negative pressure is applied to the room air largely to reduce spread exterior of the room. We propose that fresh air could reduce reinoculation and potentially reduce the severity of affliction and possibly reduce household spread during quarantine. This calls for open windows, fans for aeration, or spending long periods of time outdoors abroad from others with no face covering to disperse and not reinhale the viral bioaerosol.

Combination Antiviral Therapy

Rapid and amplified viral replication is the hallmark of well-nigh acute viral infections. By reducing the rate, quantity, or duration of viral replication, the degree of straight viral injury to the respiratory epithelium, vasculature, and organs may exist lessened.

Additionally, secondary processes that depend on viral stimulation, including the activation of inflammatory cells, cytokines, and coagulation, could potentially be lessened if viral replication is attenuated. Because no grade of readily bachelor medication has been designed specifically to inhibit SARS-CoV-2 replication, 2 or more of the nonspecific agents listed here can be entertained. None of the approaches listed have specific regulatory canonical advertisement labels for their manufacturers; thus all would be appropriately considered acceptable "off-label" utilise.

Zinc Lozenges and Zinc Sulfate

Zinc is a known inhibitor of coronavirus replication. Clinical trials of zinc lozenges in the common common cold have demonstrated modest reductions in the duration and or severity of symptoms.

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By extension, this readily bachelor nontoxic therapy could exist deployed at the first signs of COVID-19.

Zinc lozenges tin be administered 5 times a day for up to five days and extended if needed if symptoms persist. The amount of elemental zinc lozenges is <25% of that in a single 220-mg zinc sulfate daily tablet. This dose of zinc sulfate has been effectively used in combination with antimalarials in early treatment of high-adventure outpatients with COVID-nineteen.

Antimalarials

Hydroxychloroquine (HCQ) is an antimalarial/anti-inflammatory drug that impairs endosomal transfer of virions within human cells. HCQ is also a zinc ionophore that conveys zinc intracellularly to block the SARS-CoV-2 RNA-dependent RNA polymerase, which is the cadre enzyme of the virus replication.

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The currently completed retrospective studies and randomized trials take mostly shown these findings: 1) when started late in the hospital course and for short durations of time, antimalarials announced to be ineffective, 2) when started earlier in the hospital course, for progressively longer durations and in outpatients, antimalarials may reduce the progression of illness, prevent hospitalization, and are associated with reduced mortality.

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,

,

In a retrospective inpatient study of 2541 patients hospitalized with COVID-xix, therapy associated with an adjusted reduction in mortality was HCQ alone (chance ratio [HR] = 0.34, 95% confidence interval [CI] 0.25-0.46, P <0.001) and HCQ with azithromycin (60 minutes = 0.29, 95% CI 0.22-0.xl, P <0.001).

HCQ was canonical by the United states of america Food and Drug Administration in 1955, has been used past hundreds of millions of people worldwide since then, is sold over the counter in many countries, and has a well-characterized safety profile that should not raise undue alert.

,

Although asymptomatic QT prolongation is a well-recognized and infrequent (<1%) complexity of HCQ, it is possible that in the setting of acute disease symptomatic arrhythmias could develop. Data safety and monitoring boards have not alleged safe concerns in any clinical trial published to appointment. Rare patients with a personal or family history of prolonged QT syndrome and those on additional QT prolonging, contraindicated drugs (eg, dofetilide, sotalol) should be treated with caution and a program to monitor the QTc in the ambulatory setting. A typical HCQ regimen is 200 mg bid for 5 days and extended to 30 days for continued symptoms. A minimal sufficient dose of HCQ should be used, because in excessive doses the drug can interfere with early immune response to the virus.

Azithromycin

Azithromycin is a commonly used macrolide antibiotic that has antiviral backdrop mainly attributed to reduced endosomal transfer of virions as well as established anti-inflammatory effects.

It has been usually used in COVID-19 studies initially based on French reports demonstrating markedly reduced durations of viral shedding, fewer hospitalizations, and reduced mortality combination with HCQ every bit compared to those untreated.

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In the big inpatient written report (n = 2451) discussed previously, those who received azithromycin alone had an adjusted HR for mortality of 1.05, 95% CI 0.68-1.62, and P = 0.83.

The combination of HCQ and azithromycin has been used every bit standard of care in other contexts as a standard of care in more than 300,000 older adults with multiple comorbidities.

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This agent is well-tolerated and like HCQ can prolong the QTc in <one% of patients. The same safety precautions for HCQ listed previously could exist extended to azithromycin with or without HCQ. Azithromycin provides additional coverage of bacterial upper respiratory pathogens that could potentially play a role in concurrent or secondary infection. Thus, this agent tin serve equally a safety net for patients with COVID-nineteen against clinical failure of the bacterial component of community-acquired pneumonia.

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The same safety precautions for HCQ could exist extended to azithromycin with or without HCQ. Because both HCQ and azithromycin accept pocket-sized but potentially condiment risks of QTc prolongation, patients with known or suspected arrhythmias or taking contraindicated medications or should have more thorough workup (eg, review of baseline electrocardiogram, imaging studies, etc.) earlier receiving these 2 together. Ane of many dosing schemes is 250 mg po bid for 5 days and may extend to 30 days for persistent symptoms or evidence of bacterial superinfection.

Doxycycline

Doxycycline is another mutual antibiotic with multiple intracellular effects that may reduce viral replication, cellular damage, and expression of inflammatory factors.

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This drug has no effect on cardiac conduction and has the primary caveat of gastrointestinal upset and esophagitis. Equally with azithromycin, doxycycline has the advantage of offer antibacterial coverage for superimposed bacterial infection in the upper respiratory tract. Doxycycline has a high degree of activity against many common respiratory pathogens including Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, anaerobes such as Bacteroides and anaerobic/microaerophilic streptococci and atypical agents similar Legionella, Mycoplasma pneumoniae, and Chlamydia pneumoniae.

One of many dosing schemes is 200 mg po followed by 100 mg po bid for 5 days and may extend to 30 days for persistent symptoms or bear witness of bacterial superinfection. Doxycycline may be useful with HCQ for patients in whom the HCQ-azithromycin combination is non desired.

Favipiravir

Favipiravir, an oral selective inhibitor of RNA-dependent RNA polymerase, is approved for ambulatory use in COVID-xix in Russia, India, and other countries outside of the The states.

Information technology has been previously used for treatment of some life-threatening infections such as Ebola virus, Lassa virus, and rabies. Its therapeutic efficacy has been proven in these diseases.

Like, the antimalarials and antibiotics, favipiravir has no large-scale randomized trials completed at this time, given the short time frame of the pandemic. A dose assistants could exist 1600 mg po bid on twenty-four hour period 1, post-obit by 600 mg po bid for xiv days.

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Immunomodulators

The manifestations of COVID-nineteen that prompt hospitalization and that may well atomic number 82 to multiorgan system failure are attributed to a cytokine storm. The characteristic profile of a patient acutely ill with COVID-nineteen includes leukocytosis with a relative neutropenia. These patients have higher serum level of cytokines (ie, TNF-α, IFN-γ, IL-1β, IL-two, IL-four, IL-6, and IL-x) and C-reactive protein than control individuals. Among patients with COVID-nineteen, serum IL-6 and IL-10 levels appear even more elevated in the critically ill.

As with any acute inflammatory land, early on treatment with immunomodulators is expected to impart greater benefit. In COVID-19, some of the offset respiratory findings are nasal congestion, cough, and wheezing. These features are due to excess inflammation and cytokine activation. Early utilise of corticosteroids is a rational intervention for patients with COVID-19 with these features as they would exist in acute asthma or reactive airways affliction.

,

The RECOVERY trial randomized 6425 hospitalized patients with COVID-19 in a two:1 ratio to dexamethasone half-dozen mg po/Four daily for up to 10 days and plant dexamethasone reduced bloodshed (Hr = 0.65, 95% CI 0.51-0.82, P <0.001).

One potential dosing scheme for outpatients starting on day 5 or the onset of respiratory symptoms is prednisone 1 mg/kg given daily for 5 days with or without a subsequent taper.

Colchicine

Colchicine is a nonsteroidal antimitotic drug that blocks metaphase by binding to the ends of microtubules to prevent the elongation of the microtubule polymer. This agent has proven useful in gout and idiopathic recurrent pericarditis. The GRECCO-xix randomized open-label trial in 105 hospitalized patients with COVID-19 institute that colchicine was associated with a reduction in D-dimer levels and improved clinical outcomes.

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The clinical principal finish betoken (ii-point change in World Health Organization ordinal calibration) occurred in fourteen.0% in the control group (vii of fifty patients) and ane.eight% in the colchicine group (1 of 55 patients) (odds ratio, 0.11; 95% CI, 0.01-0.96; P = 0.02).

Because the short-term safety profile is well understood, it is reasonable to consider this agent along with corticosteroids in an attempt to reduce the effects of cytokine storm. A dosing scheme of ane.2 mg po, followed past 0.6 mg po bid for three weeks tin be considered.

Antiplatelet Agents and Antithrombotics

Multiple studies accept described increased rates of pathological macro- and micro-thrombosis.

,

Patients with COVID-nineteen have described chest heaviness associated with desaturation that suggests the possibility of pulmonary thrombosis.

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Multiple reports have described elevated D-dimer levels in acutely sick patients with COVID-19, which has been consistently associated with increased adventure of deep venous thrombosis and pulmonary embolism.

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Necropsy studies have described pulmonary microthrombosis in COVID-19.

These observations back up the notion that endothelial injury and thrombosis play a role oxygen desaturation, a cardinal reason for hospitalization and supportive care.

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Based on this pathophysiologic rationale, aspirin 81 mg daily can exist administered as an initial antiplatelet and anti-inflammatory agent.

,

Ambulatory patients tin be additionally treated with subcutaneous depression-molecular-weight heparin or with short-acting novel anticoagulant drugs in dosing schemes similar to those use in outpatient thromboprophylaxis. In a retrospective written report of 2773 inpatients with COVID-19, 28% received anticoagulant therapy within 2 days of admission, and despite being used in more than severe cases, anticoagulant administration was associated with a reduction in mortality (Hr = 0.86 per day of therapy, 95% CI: 0.82-0.89; P <0.001). Additional supportive data on the use anticoagulants reducing mortality has been reported in hospitalized patients with elevated D-dimer levels and higher comorbidity scores.

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Many acutely ill outpatients besides accept general indications for venous thromboembolism prophylaxis applicable to COVID-19.

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Delivery of Oxygen and Monitoring

Because ambulatory centers and clinics have been reticent to have face up-to-confront visits with patients with COVID-19, telemedicine is a reasonable platform for monitoring. Clinical impressions can exist gained with audio and video interviews past the medico with the patient. Supplemental information, including vital signs and symptoms, will be important to guide the physician. A significant component of condom outpatient direction is maintenance of arterial oxygen saturation on room air or prescribed home oxygen under straight supervision by daily telemedicine with escalation to hospitalization for assisted ventilation if needed. Cocky-proning could be entertained for confident patients with adept at-home monitoring.

Many of the measures discussed in this commodity could be extended to seniors in COVID-19 treatment units in nursing homes and other nonhospital settings. This would leave the purposes of hospitalization to the assistants of intravenous fluid and parenteral medication, assisted force per unit area or mechanical ventilation, and advanced mechanical circulatory support.

Summary

Acute COVID-19 has a smashing range of clinical severity from asymptomatic to fatal. In the absence of clinical trials and guidelines, with hospitalizations and mortality mounting, it is prudent to deploy treatment for COVID-xix based on pathophysiological principles. Nosotros have proposed an algorithm based on age and comorbidities that allows for a large proportion to be monitored and treated at home during cocky-isolation with the aim of reducing the risks of hospitalization and death.

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Published online: August 06, 2020

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Funding: None.

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