Monoclonal Antibody Treatment

For non-hospitalized patients with Covid-19:

On November 9, 2020 FDA granted EUA for 2 Monoclonal Antibody treatments:

• Bamlanivimab – Eli Lilly single monoclonal antibody therapy (BLAZE trial)
• Casirivimab/imdevimab – Regeneron combination monoclonal antibody therapy

These agents are indicated for the NON hospitalized patient with positive Covid-19 PCR or Antigen, with symptoms not requiring oxygen and within 5 days of symptom onset.

Limited clinical trials for the two treatments showed decrease in viral load and decrease in progression of disease. These treatments have NOT been designated as standard of care but show promise. Mount Sinai has developed protocol and infusion site for administration of these agents to patients who meet the eligibility criteria.

Click here for further details of the Treatment Protocol and the Mount Sinai Treatment Guidelines as of 11.30.2020 for Non Hospitalized and Hospitalized Patients

Visit Mount Sinai’s COVID-19 Vaccination Information and Resources webpage to help answer your patients’ vaccination questions.

Refer a patient to the Mount Sinai Protocol for Outpatient Monoclonal Antibody Treatment via email Covidtherapeuticreferrals@mountsinai.org (preferred) or phone at (212) 824-8390 and ask for the "COVID-19 Infusion Center"

Requirements for referral:

• A laboratory-confirmed diagnostic test for COVID-19 (e.g., PCR or antigen test)
• Symptoms with symptom onset within 5 days
• Risk factors for progressing to severe disease
• Not requiring oxygen therapy for COVID-19

Please include the following information:

• Name and contact information of the patient/caregiver
• Name and contact information of the referring provider
• If the Mount Sinai medical record number is known, please include that in the message

Updated 8/26/2020

There have been advances in both Rapid (antigen-based) Point of Care testing and in saliva as an accurate and reliable source of virus for testing:

Rapid Point of Care Testing (15 minute tests)

• 1 PCR based (Abbott ID Now-used at White House); 2 Antigen Based (Qudel Sofia & Becton Dickenson – both recently purchased by multiple states including New York)
• From Nasopharyngeal/Nasal swab - For Symptomatic individuals
• NYS DOH Suggestion: work with smaller local labs – for more rapid turnaround time and also will report positive results to DOH for follow up contact tracing

Saliva Direct (approved for CLIA labs 8/15/20)

• Rutgers saliva test – piloted with practices and the Yale NBA study
• Stable in saliva for 2-25 days, at room temperature
• Efficacy comparable to NP/Nasal swab
• Can collect saliva at home but test conducted in CLIA approved labs
• Opens the door for At-Home Testing & Result - laminar flow technology being developed (similar to home pregnancy test)

Combined Testing for Collection at the Point of Care

• 3 tests with FDA EUA for Covid 19, Influenza A & B
• Collection of Nasopharyngeal or Nasal Swab specimen
• Performed by CLIA approved laboratories – what will the turnaround time be?!

For further details click here.

Updated 8/26/2020

What we know:

• Three vaccines thus far have produced neutralizing antibody & T-cell Stimulation data: Moderna RNA, CanSino Adeno5, & Oxford Astra Zeneca Chimp Adeno
• 8 Vaccines in all are in Phase II/III recruiting
• NOTE: on 9/10/2020 Astra Zeneca halted Phase III testing in the US (continues in the UK) due to one case of transverse myelitis; unclear at this time if vaccine related
• May indicate that a Coronavirus vaccine in humans is possible
• Has been shown to prevent infection in lab animals (some after one dose; others require two)
• Strong neutralizing antibody response in the laboratory

What we don’t know:

• Does this response in a lab test guarantee that the vaccine will prevent disease?
• Minimal viral mutation at this time – more broad based vaccines might offer more protection vs Spike Protein specific vaccines
• Will the mild side effect profile continue when more patients receive the vaccine?
• What will the efficacy be in real world trials? How long does the immune response last?
• Who goes first?
• Ethically cannot deliberately expose healthy people to the virus to determine infection prevention – rely on the ongoing prevalence of CoVid-19 to determine efficacy (since we do not have a TREATMENT for the infection should the person get sick)
• And perhaps MOST IMPORTANTLY- will People agree to GET the vaccine?
  • Recent estimate by UCSF that 50% of people considering declining the vaccine
  • BUT Phase III recruitment trials around the world have already achieved many of the target number of patients

For further details on the different technologies being utilized for vaccine development and what the normal immune response is, click here.

Updated 6/22/20

1. Hydroxychloroquine, zinc, ivermectin and azithromycin are no longer utilized by MSHS
2. MSHS is no longer utilizing Lopinavir/Ritinovir antivirals
3. Remdesivir has been shown to reduce average length of stay from 15 days to 11 days; has not been shown to reduce mortality
4. Tocilizumab (anti-IL6 monoclonal antibody) to reduce cytokine storm syndrome; MSHS clinical trial using Gimsilumab (anti-GM-CSF monoclonal antibody)
5. Convalescent plasma treatment protocols continue
6. Anti coagulation prophylaxis protocols, Heparin for patients on mechanical ventilators; other anticoagulants (enoxaparin) for other moderate to severely ill patients as per MSHS
7. Use of Steroids in the hospital setting: Currently MSHS protocol determines this on a case by case basis

NOTE: On 6/21/2020 the United Kingdom released some of the results from the Dexamethasone arm of their Recovery Study. This arm was terminated early due to clear reductions in mortality of up to 30% for patients on mechanical ventilation and up to 20% reduction in mortality for patients on any oxygen therapy. There is no benefit to patients with milder disease who are not on oxygen. Peer review of this study is pending.

Currently there are NO prophylactic or treatment recommendations for the management of ambulatory patients with Covid-19.

Some guidelines:

1. Hydroxychloroquine is not recommended — benefits have not been shown and there is clear concern for cardiac arrhythmias in the non-supervised outpatient setting
2. No benefit to measuring D-dimer or other clotting factors and no benefit to prescribing aspirin or other anticoagulants on the ambulatory setting in the absence of other established reasons for anticoagulation (DVT, etc)
3. Continue to prescribe ACEs/ARBs for patients with HTN
4. Continue to prescribe NSAIDs if the patient is requiring these medications for other reasons
5. Patients prescribed hydroxychloroquine for preexisting rheumatologic conditions should be continued on their current dose
6. The Lupus Foundation has developed a registry of patients on Plaquenil and tracking their outcomes. At this date, the hydroxychloroquine does not appear to be protective.

View the NIH Treatment Guidelines

At this time, the NYS DOH guidelines for determining ability to transmit the virus after an acute infection are based on clinical criteria. Due to the variable time frame for the development of IgG Antibody to Covid-19, it is not recommended to be used to determine if the patient is still infectious. The NYSDOH recommends the following:

Release of Symptomatic Individuals from Isolation

Symptomatic individuals who were confirmed as having COVID-19 may discontinue home isolation once they meet the following conditions:

At least 3 days (72 hours) have passed since recovery, defined as resolution of fever without the use of fever-reducing medications;
AND of Improvement in respiratory symptoms (e.g., cough, shortness of breath);
AND At least 7 days have passed since symptoms first appeared

This approach will prevent most, but may not prevent all, instances of secondary spread. The risk of transmission after recovery is likely substantially less than that during illness. To further reduce the risk, individuals returning from isolation should continue to practice proper hygiene protocols (e.g., hand washing, covering coughs) and avoid prolonged, close contact with vulnerable persons (e.g. compromised immune system, underlying illness, 70 years of age or older).

Release of Asymptomatic Individuals from Isolation

Asymptomatic individuals who were confirmed as having COVID-19 may discontinue home isolation under the following conditions:

At least 7 days have passed since the date of their first positive COVID-19 diagnostic test; AND the individual has had no subsequent illness

Ensure all staff safety:

Ensure you have adequate PPE. You may purchase PPE through iRemedy

Have patients wear a facemask at all times and have staff wear a facemask at all times for the foreseeable future.

When performing swabs, be sure to wear a gown, glove, N-95 and faceshield. This is a high-risk transmission activity.

Consider testing staff periodically. If they have respiratory or cold like symptoms; ensure they do not come to work and they have a negative test prior to return
 

Perform Onsite Virus testing

if you are willing to accept increased safety risk to you and your staff (click here for suggested protocols and consideration details) – which has shown recently to substantially help drive practice revenue, there are multiple local labs are available to send tests to (does not constitute MSHP endorsement), and obtain Covid 19 PCR test prior to performing procedures.
 

There are currently over 60 RT-PCR tests (Antigen) and Interpretation tests with FDA EUA.

There is no gold standard and Sensitivity and Specificity may be variable. Most RT-PCR based tests have 70%-80% sensitivity.
 

Viral RNA fragments may persist for up to 6 weeks or more

after resolution of symptoms. Recent studies have confirmed that these viral fragments are NOT infectious (see more)

It is unknown at this time if presence of antibody confers immunity against the virus. Serology results should not be used to make staffing decisions or decisions regarding the need for personal protective equipment.

Tests vary in the viral antigen(s) they target, e.g., nucleocapsid (N protein) or spike protein (S protein), or both. It is not yet clear which antibody responses, if any, are protective or sustained. For further details on the state of antibody testing, the Infectious Disease Society is a good source of information.

There are now 18 serology tests with FDA Emergency Use Authorization (EUA) designation. Overall, Specificity for Covid-19 proteins is >95-100% (all but three 98-100%). This link provides this information for all 18 tests with FDA EUA.

Mount Sinai is currently only testing employees for Covid-19 virus and antibody testing. It is currently not offering testing to non-employees. Antibody testing in the context of the Convalescent Plasma donation program is open to anyone.

Pharmacologic Treatment Modalities

Ongoing head-to-head studies have eliminated the use of certain drugs that initially seemed promising early in the pandemic.

Hydroxychloroquine is NOT recommended for pre-exposure and or post-exposure prophylaxis or in patients with a confirmed diagnosis of SARS-CoV-2 infection. There is insufficient data to support any benefit in persons with COVID-19 and potential harms include cardiac arrhythmias and methemoglobinemia. An NIH-funded cohort study from the VA hospitals noted increased mortality in patients treated with hydroxychloroquine.

Zithromycin, zinc, and certain anti-retrovirals (such as lopinavir/ritinovir) are no longer used by Mount Sinai.

Remdesivir showed promise against SARS in Asia and China utilized it quite early in the pandemic. Release of National Institute of Allergy and Infectious Diseases Remdesivir Trial – ACTT Trial (Adaptive Covid-19 Treatment Trial) resulted in FDA EUA on May 1. This expanded ease of access but not FDA Approval.

• 1060 patients, randomized controlled trial versus placebo
• Recovered in 11 days versus 15 days (p=0.001)
• Mortality trended toward better but not statistically significant 8% vs 11%
• Dr. Fauci, Director of the NIAID : “Opens the door to more research on effective therapeutics and lets us know we can treat the virus”
• Not yet published in the peer reviewed literature

Immune Modulators:

The role of Cytokine Storm Syndrome was recognized early and has led to the measurement of immune markers (IL6, etc) and the use of immune modulators Tocilizumab (anti-IL6 monoclonal antibody)/Gimsilumab (an anti-GM-CSF monoclonal antibody) lessen the lethal effect of this excessive immune response.

MSH is also conducting clinical trials utilizing Mesenchymal Stem Cells for ventilated patients. Rationale is that Mesenchymal stem cells have a natural property that dampens excessive immune responses.

Non Pharmacologic Treatment Modalities:

In addition to drug regimens, there are techniques utilized to delay intubation as much as possible. Mount Sinai has been utilizing Proning effectively (placing patients on their abdomen as much as possible to facilitate mechanics of breathing). In recognition of the coordinated effort required to do this effectively, a 6-person Proning Team is called to perform this maneuver.

Mount Sinai is using convalescent plasma as a treatment modality. If you have either tested positive for or have had the symptoms of Covid 19 infection, you can potentially be tested for antibody and be a donor of convalescent serum.   The best time line is at least 21 days after symptoms have resolved. For the Mount Sinai IgG Antibody titer of >50 is considered positive. Antibody titers of >320 are eligible for convalescent plasma protocol.

To start the process access and fill out the survey/form here. One week is a typical wait time. Thousands of patients are being sent in and the surveys are being screened for the highest yield so it’s a matter of getting in the cue Usually within one week, you will be outreached and sent to various places to receive the antibody test. If tested positive, you can proceed to plasma donate plasma and be informed where you can do so. Blood Type and Match processes are followed.

This issue is evolving. Prior to the recent United Kingdom study (more below) the efficacy of steroids in the treatment of Covid 19 presented a mixed picture, and the decision to use them is made on a case by case basis. The initial concern for use of steroids in Covid-19 was based on worsened outcomes that were noted with its use in MERS and SARS.

On 6/21/2020 The United Kingdom released early findings on their Dexamethasone Recovery Trial, showing decreased mortality in hospitalized patients on mechanical ventilators or on oxygen who were given IV or oral Dexamethasone (6mg OD for 10 days). Please note that this study has NOT yet been peer reviewed and many hospitals in the US are awaiting this review before changing their protocols. Click here for more details.

All cause mortality was evaluated at 28 days after randomization:

Mechanically ventilated patients: Dexamethasone treatment reduced mortality by ~33%

Patients on any oxygen support: Dexamethasone treatment reduced mortality by ~20%

No benefit seen in patients with milder disease or not on any oxygen support

Reference

Practice Recommendations to Help Patients Feel Safe & Return for In Person Visits

• As per DOH, assume all patients in the ambulatory setting are potential asymptomatic carriers via airborne and droplet/touch
• Video visits & telephone visits will all continue to be necessary as well

Pre-visit planning is increasingly important to minimize the time patients spend in the office

• Schedule lab draws prior to the visit
• Patients are phone screened for acute symptoms prior to appointment scheduling & possibly upon office arrival
  • Do you have a fever or a cough?
  • Are you short of breath?
  • Have you interacted with anyone with Covid-19?

Best Practices to Minimize Patient Time in Office

• Patients are screened for acute symptoms prior to appointment being scheduled but again upon entry into the office
• Temperatures can be taken upon arrival (Temp =100 is considered a fever)
• Request patients bring face covering or provide all patients with face covering and gloves upon arrival to wear at all times while in the office
• Schedule ALL patients to better allow for socially distancing in the waiting area
• Consider direct-to-rooming process:
  • Patients wait outside or in their cars; receive a call/text when they are ready to be seen
  • No waiting in waiting area
• Limit one additional adult per patient needing support. One adult per child.
• Minimize time spent in the office
  • Limit in-person portion for specific physical exam components or injections that can only be done in person
  • Follow ups can be conducted via video or telephone visits

Ensure you have adequate PPE for Staff and Patients

Some PPE items are available at this time for purchase online through iRemedy. To place an order, click here.

In the New Normal there is an expanded role for Pre-Visit Planning & Information gathering. This strategy can be utilized for both administrative/front desk component as well as for the chief complaint and clinical information gathering components.

Best strategy to minimize the time patients spend in your office is to expand the use of your support staff to obtain much of the information you would normally gather at the time of the patient’s visit PRIOR to the patient’s arrival.

Some key areas that can be completed by support staff via telephone prior to the in-person visit

• Scheduling and registration
• Questions relating to possible Covid-19 symptoms being present
• Requesting reason for the visit
• Reminding the patient to bring any supportive documents
• Completing/updating registration and insurance paperwork prior to the visit

A sample Mount Sinai Department of Pediatrics Patient Flows highlights the key steps in the Patient’s progress: (see more)
The three main patient flows:

• Previsit: Review & Scheduling
• Arrival: no walk ins; minimize/eliminate use of the waiting area
• Patient Experience: conduct all of the interactions with the patient in one room/area

In the same way, much of the clinical components of the visit can also be conducted via telephone or video visit prior to the patient’s arrival:

• Past Medical History
• Medication Review
• Chief Complaint/Review of Systems
• Obtaining any test results or consult reports prior to the visit

Many of you are able to pull lists of patients with chronic conditions out of your EMRs, particularly patients with Diabetes or Hypertension. These patients have been unwilling to come for care during the past few months and would benefit greatly from restarting their care with you. Bringing patients back into care – whether in person or via video/telephone visits – is good for the patient and good for the practice.

Mount Sinai has identified for many of the practices three main categories of patients for outreach. Your PEM has shared with you or can share with you panels of patients with chronic conditions.

1. Major Complex – these include patients with multiple chronic conditions, including CAD, Atrial Fibrillation, etc, as well as DM and HTN
2. Simple Chronic – patients that have one or two chronic conditions identified and who would benefit from outreach
3. Disabled & Frail Elderly – Our Mount Sinai Care Managers have been outreaching these patients for the past few months and share with you their findings and recommendations If you would also like to follow up with these patients, your PEM can share these panels with you as well.

NYSDOH COVID-19 Guidance for Healthcare Providers
American Academy of Pediatrics COVID-19 Clinical Guidance Q&A
American Academy of Family Physicians COVID-19: Guidance for Family Physicians on Preventive and Non-Urgent Care

Updated 8/26/20

Telehealth:

In late July, HHS extended public health emergency (PHE) for another 90 days: through October 23, 2020 (unless Secretary chooses to end sooner or extend again)

HHS and CMS waivers of certain requirements depend on the PHE declaration. Continued changes include:

• Use of non-HIPAA compliant technologies (e.g., FaceTime, Skype)
• Increased Medicare FFS reimbursement for Telemedicine services (video and phone) compared with pre-COVID rates
• Provision of telehealth to Medicare FFS patients in non-rural areas and in the home
• Patient cost-sharing waivers

Some of the telehealth changes require Congressional action to be extended beyond the PHE and Senate Committees have been holding hearings on telehealth. Under PHE, CMS expanded the list of services that can be delivered via telehealth. In recent regulation, CMS proposed to permanently or on an interim basis add some of these services to approved list beyond the PHE.

CARES Act Relief Fund Update - Second Chance to Apply for Funds:

HHS has re-opened application cycle for Provider Relief Funds. You may be eligible if you are a Medicare FFS provider who did not previously receive General Distribution payment totaling approximately 2 percent of annual patient revenue.

Deadline to Apply: August 28, 2020

More information

Reporting Requirements

HHS will be releasing specific reporting requirements for providers who received >$10,000 in Provider Relief Funds.

Some payer-specific information is available here or visit our COVID Payer Updates page

Updated 6/22/20

During this Covid-19 Public Health Emergency, the U.S. Department of Health and Human Services (HHS) and Centers for Medicare & Medicaid Services (CMS) have relaxed or eliminated some of their requirements regulating usage of these virtual communications.

Main changes FFS Medicare and Medicare Advantage Plans:

1. Video communications may be conducted from provider home to patient home, both rural and urban

2. Skype, FaceTime and other “widely available” technologies can be utilized for video communications without incurring HIPAA-related penalties. Although this waiver is still in force, this may not continue permanently. Please take this time to explore platforms compatible with your EMR in the event that there may come a time that you may only perform Video Visits through your EMR.

3. Providers may waive the deductible or coinsurance payments without penalty. All Payers continue to waive costsharing for Covid -19 related services as per PHE. Please be aware that, as of June, some carriers have opted to no longer waive these cost sharing for non covid-related services. Click here to see the most recent updates for some of our CIN Payers

4. For certain Medicare telephonic visits (99441-99443) there are restrictions around the frequency. You cannot bill for telephonic visits originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment. (Please see attached slides for more details)

5. Email communication services are usually reserved for established patients and must be initiated by the patients, but providers can notify patients that these services are available to them. (No audit currently)

6. Most changes effective during Public Health Emergency, extended every 90 days; now in effect till 7/24/2020 with likely extension

Commercial Payers

1. The NYS Telehealth Parity Law requires commercial insurers under the jurisdiction of the NYS Division of Financial Services to provide reimbursement for services delivered via telehealth, if those services would have been covered if delivered in person.

2. Commercial Payers will reimburse for Telemedicine Services for fully insured and group plans

3. However, Employer (or self funded) plans are beyond the reach of the Division of Financial Services and may opt NOT to include these services

4. Video visits are treated the same as a regular office visit and there is no limit to the number of times you can bill for a video telehealth visit. If there is a reason to see the patient face to face within 24 hours ensure the documentation supports the additional visit.

5. Use modifier 25 for a significant, separately identifiable E&M service by the same physician or other qualified health professional on the same day of the procedure or other service.

There are four main telemedicine services. Click here for slides delineating these services, details of requirements and how to code, and some reimbursements.

NOTE: Video Visits require recording the Location of the Patient

During this Public Health Emergency, the need for the clinician to be licensed in the state where the patient might be located was waived. However, this waiver ended June. We sent out communication with links to various states’ licensing websites to help you obtain temporary licensure. You may also want to confirm with your Medical Malpractice carrier that you are covered for services to patients outside of NYS.

Full list of CMS approved telemedicine video visit codes: including approved codes AWV, Preventive by CMS

CMS has approved several telephonic codes (99441-99443 and 98966-98968) for reimbursement by Medicare during the pandemic but none that are specifically mental health codes.

To bill Medicare for psychotherapy and psychiatric diagnostic services, providers must use video. In clarifying telehealth technology requirements during the emergency CMS has advised an “interactive telecommunications system”, means multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner.

Of note, CMS has expanded the list of services that can be provided via telehealth (video) to temporarily include additional behavioral health codes.

Mount Sinai has several resources to assist you in caring for your more complex and vulnerable patients. Usually these patients have both medical and psychosocial needs. Our Care Management support utilizes Social Workers to do the initial assessments and brings in nursing staff as needed to meet the needs of the patient.

Mount Sinai Care Management support for your practice:

1. Telephonic outreach by Social Work and/or Nursing staff as needed to meet the patient’s needs
2. Training and specific focus on helping patients cope with Covid19 and their anxiety
3. Connecting patient to their PCP and encouraging follow up with their PCP; CM communication of goals and issues addressed back to the PCP via encrypted email
4. Data analytics has identified panels of patients for outreach during this pandemic. Most at Risk: Disabled Patients & Frail Elderly – MS CM has been outreaching these patients and communicates with you via encrypted email
5. Major Chronic Conditions and Simple Chronic Conditions – Your PEM has provided you with these panels of your patients with chronic conditions who would most benefit by primary care outreach

TO MAKE A REFERRAL: Call 212-241-7228
Have your Patient contact information and primary reason for your referral
OR Contact your PEM and have them assist you referring to Care Management

Please click here to access an email and phone script to make your patients aware of telehealth services.

For patients in need of home health services, please contact:

MSHP Post-Acute Care Team: Manager, Ruchi Thakkar:Ruchi.thakkar@mountsinai.org or at (347) 835-3254. Email is preferred.
Home Health Utilization RN, Agnes Taylor: Agnes.taylor@mountsinai.org
Home Health Utilization RN, Ramona Padilla: Ramona.padilla@mountsinai.org

They will collaborate with you and refer to certified home health agencies those patients with COVID related symptoms as well as those with other home health needs (e.g. PT, ST, home health aide). Please keep in mind that home health agencies go into the home within 24-48 hours of referral. Therefore, referrals should not be made when patients are in need of immediate attention.

Clinical Updates:

Infection with Covid19 has been reported in all age groups including infants, children and young adults. However, overall they make up less than 2% of total cases worldwide Children are less likely to be infected, tend to have milder disease and are less likely to test positive when tested.

A small number of children have presented critically ill with a post inflammatory, Kawasaki-like syndrome - Multisystem Inflammatory Syndrome in Children (MIS-C) – now thought to be a post inflammatory hyper acute response to Covid 19 (although some children did not test positive for either the virus or the antibody). For more information, see the next question in this section

Pregnant women are now recognized to be at higher risk for COVID-19 but outcomes for mother and infant have been good. It is now recommended that pregnant women be tested for Covid-19 infection during pregnancy.

Breast feeding is encouraged; Transmission of COVID-19 from mother to baby in utero has not been documented and the virus has not been found in Amniotic fluid or Breastmilk. Masking and Hand hygiene is recommended.

Some Key Resources:

1. The American Academy of Pediatrics has posted guidance links on various topics (see more)
2. The National Institutes of Health –LitCovid is a curated literature hub for up to date scientific information on Covid 19

Practice management: Key CDC guidelines

Use telemedicine and other non-direct care when possible

Conduct pre-visit registration, reminders and phone triage and evaluation, including assessment of symptoms ahead of the visit

For Mount Sinai Department of Pediatrics sample Patient Flow click here

All office staff & clinicians wear masks at all times while in the office

All adults (and children as tolerated) should have or be given cloth face mask upon entry into the office, whether they have symptoms or not

Allow only one adult per child (OR consider Family day and see children of the same family at one time)

Conduct as much of the visit as possible remotely

Decrease the face-to-face time to only the necessary components: administration of the vaccines and Height/Weight/HC

Even sick/acute visits can be conducted virtually

Multisystem Inflammatory Syndrome in Children (MIS-C) first appeared in the United Kingdom in early April, 2020. Chief presenting signs and symptoms were fever and marked GI symptoms (abdominal pain, vomiting) and prolonged fever. There were also some Kawasaki like signs like conjunctivitis and rash. All of these children required ICU level of care. The most common complications were cardiovascular with Hypotension, LV dysfunction and some coronary artery dilatation (as seen with Kawasaki disease).

NYC detected its first cases in late April/early May. In Mount Sinai, 50% of children were positive for PCR; ALL at Mount Sinai were antibody positive. Very elevated inflammatory markers were also seen in these children.

There was only one fatality – a 5 year old without any underlying conditions – and this child happened to be at Mount Sinai. This was the only pediatric fatality in the state.

Treatment usually consisted of Immunoglobulin therapy (as for Kawasaki) and immune modulator such as tocilizumab. Anti virals such as remdesivir were not utilized. ECMO was used in some cases successfully.

On 6/2/2020 NYS DOH presented a summary webinar on the experience to that point of NYC with MIS-C (more details in the MIS-C slide deck here).

Some Key information included:

• Geographic distribution — 1/3 in Brooklyn, 1/3 in Queens, 1/3 combined in Bronx, Manhattan, SI
• Age and gender distribution
• Ethnicity — 80% of children were black or Hispanic
• Clinical & Laboratory Case Criteria (see more)
• Not all children had +Antibody

Note: Information on this topic is rapidly evolving. Data current as of July 10, 2020. Source for much of this discussion: Pediatrics July 2020 communication Pediatric Transmission: The Child is not to Blame

Asymptomatic and subclincal transmission is very common with the SARS CoV2 virus. Having said that, higher viral load, more respiratory symptoms and cluster transmission from adult to adult; or adult to adolescent appears to be the most common mode of transmission. Certainly the PREVALENCE of the virus in communities is also thought to contribute to transmission and to transmission to children, who then theoretically can asymptomatically spread the virus to adults However, almost 6 months into this pandemic accumulating evidence and collective experience argue AGAINST children as the principle drivers of transmission. Some studies supporting this view:

• Geneva University hospital study - 3/39 households (8% of households)the child had symptoms prior to the adults
• Qingdao Hospital - of 68 children admitted with Covid-19, 95.6% were from households with previously infected adults
• In France a 9 year old boy was found to have exposed over 80 classmates. Although influenza spread was noted NO secondary contacts became infected with Covid-19
• In New South Wales 9 infected students had close contact with 735 students and 128 adults; only 2 secondary infections were noted ( one by adult staff and one possibly by exposure to 2 students)
• Overall, mild symptoms with weaker and less frequent cough may cause fewer infectious particles to be released in the air
• The SARS CoV2 virus does not behave like Influenza, where the role of child transmission has been clearly delineated

However, evidence or caveat supporting a contrary view:

• In one German study of 47 Covid-19 infected children, the nasopharyngeal viral loads were SIMILAR to those in other age groups, raising concern that children COULD be as infectious as adults
• Also of note: school closures occurred in most locations along with or prior to widespread social distancing

For a better understanding of the interplay between virus and host membranes, read the NIH summary on this topic

Another Summary Article from the United Kingdom Research & Innovation May 2020