22 Apr IMPORTANT INFORMATION FOR PROVIDERS: THE COVID-19 PANDEMIC
Unprecedented global collaboration between scientists has greatly accelerated understanding of the COVID-19 virus, the infection it causes, and the testing and development of therapies and vaccines to treat and prevent it. With new therapies and treatments on the market comes with new guidance. Please see below for a comprehensive one-stop resource as you work to keep your communities healthy.
COVID-19 MEDICAL PRODUCTS AND TREATMENTS
What medical products and treatments currently approved under Emergency Use Authorizations (EUAs) by the Food and Drug Administration (FDA)?
EUAs for COVID-19 vaccines include: the Pfizer-BioNTech vaccine, the Moderna vaccine, and the Johnson & Johnson (Janssen) ., that is currently paused as it undergoes additional reviews by the CDC and FDA. While adverse events associated with the Johnson & Johnson (Janssen) vaccine appear to be extremely rare, COVID-19 vaccine safety is a top priority for the healthcare system and its partners. Review processes exist to take all reports of health problems following COVID-19 vaccination to ensure the safety of the vaccine.
EUAs for Drug and Biological Therapeutic Products include: Fresenius Medical, multiFiltrate PRO System and multiBic/multiPlus Solutions, Remdesivir, Fresenius Kabi Propoven 2%, REGIOCIT replacement solution, COVID-19 convalescent plasma, Bamlanivimab, Baricitinib (Olumiant) in Combination with remdesivir (Veklury), REGEN-COV (Casirivimab and Imdevimab), Bamlanivimab and Etesevimab, and Propofol‐Lipuro 1%.
EUAs for medical devices include: Blood Purification Devices, Continuous Renal Replacement Therapy and Hemodialysis Devices, In Vitro Diagnostics, Decontamination Systems, Infusion Pumps, Personal Protective Equipment, Patient Monitoring Devices, Respiratory Assist Devices, and Ventilators and Ventilator Accessories. All other EUAs for medical devices can be found on the FDA’s website here.
Please note, the FDA announced that healthcare personnel and facilities may cut back on the use of strategies for conserving capacity that have been in effect during the COVID-19 crisis, such as decontaminating disposable respirators for reuse. The FDA and CDC believe there is adequate supply of new respirators approved by the CDC and NIOSH to transition away from use of decontamination and bioburden reduction systems. Additional details on this announcement can be found here.
What is the latest news on the Johnson & Johnson (Janssen) vaccine?
The CDC and FDA recommend a pause in the distribution of the Johnson & Johnson (Janssen vaccine out of an abundance of caution due to six cases of a rare and severe blood clots have surfaced in six women 6-13 days after the women received the Johnson & Johnson (Janssen) vaccine, as of April 12, 2021.
What antibody tests and collection kits available are currently available?
The FDA has authorized 235 molecular, 63 antibody, and 11 antigen COVID-19 tests and collection kits. For more information on COVID-19 tests and collection kits, head to the FDA’s Medical Devices website.
When should CT scans be used for COVID-19 patients?
CT scans should be reserved for use on hospitalized symptomatic COVID-19 patients.
What are the current treatment recommendations for clinicians who are caring for patients with COVID-19 with varying severities of disease?
The COVID-19 Treatment Guidelines Panel continues to review the most recent clinical data to provide up-to-date treatment recommendations for clinicians who are caring for patients with COVID-19. Please see below for current recommendations for managing patients with varying severities of disease.
Patients With Mild to Moderate COVID-19 Who Are Not Hospitalized
- There are insufficient data for the Panel to recommend either for or against the use of any specific antiviral or antibody therapy in these patients.
- SARS-CoV-2-neutralizing antibodies (bamlanivimab or casirivimab plus imdevimab) are available through EUAs for outpatients who have a high risk of disease progression. These EUAs do not authorize use in hospitalized patients.
- The Panel recommends against the use of dexamethasone or other corticosteroids (AIII). Patients who are receiving dexamethasone or another corticosteroid for other indications should continue therapy for their underlying conditions as directed by their health care provider.
Patients Who Are Hospitalized With Moderate COVID-19 but Who Do Not Require Supplemental Oxygen
- The Panel recommends against the use of dexamethasone or other corticosteroids (AIIa). Patients who are receiving dexamethasone or another corticosteroid for other indications should continue therapy for their underlying conditions as directed by their health care provider.
- There are insufficient data to recommend either for or against the routine use of remdesivir in these patients. The use of remdesivir may be appropriate in patients who have a high risk of disease progression.
For Hospitalized Patients With COVID-19 Who Require Supplemental Oxygen but Who Do Not Require Oxygen Delivery Through a High-Flow Device, Noninvasive Ventilation, Invasive Mechanical Ventilation, or Extracorporeal Membrane Oxygenation
- One of the following options for these patients:
- Remdesivir (e.g., for patients who require minimal supplemental oxygen) (BIIa);
- Dexamethasone plus remdesivir (e.g., for patients who require increasing amounts of oxygen) (BIII); or
- Dexamethasone (e.g., when combination therapy with remdesivir cannot be used or is not available) (BI).
- If dexamethasone is not available, an alternative corticosteroid such as prednisone, methylprednisolone, or hydrocortisone can be used (BIII). See Corticosteroids for dosing recommendations.
- In the rare circumstances when corticosteroids cannot be used, baricitinib plus remdesivir can be used (BIIa). Baricitinib should not be used without remdesivir.
For Hospitalized Patients With COVID-19 Who Require Delivery of Oxygen Through a High-Flow Device or Noninvasive Ventilation but Not Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation
- One of the following options for these patients:
- Dexamethasone alone (AI); or
- A combination of dexamethasone plus remdesivir (BIII)
For Hospitalized Patients With COVID-19 Who Require Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation
- Recommends the use of dexamethasone in hospitalized patients with COVID-19 who require invasive mechanical ventilation or ECMO (AI).
- If dexamethasone is not available, equivalent doses of alternative corticosteroids such as prednisone, methylprednisolone, or hydrocortisone may be used (BIII).
- For patients who initially received remdesivir monotherapy and progressed to requiring invasive mechanical ventilation or ECMO, dexamethasone should be initiated and remdesivir should be continued until the treatment course is completed.
- The Panel recommends against the use of remdesivir monotherapy (AIIa).
What COVID-19 treatments available are currently available?
The spectrum of medical therapies to treat COVID-19 is growing and evolving rapidly, including both drugs approved by the FDA and drugs made available under FDA EUA. The CDC strongly encourages clinicians, patients and their advocates, and health system administrators to regularly consult the COVID-19 Treatment Guidelines published by the National Institutes of Health (NIH). The treatment and management recommendations in these guidelines are based on scientific evidence and expert opinion and are frequently updated.
Monoclonal antibody treatments are typically used within the first ten days of treatment to prevent severe and hospitalized cases of COVID-19. EUAs have been issued by the FDA for several monoclonal antibody COVID-19 treatments. To obtain a COVID-19 monoclonal antibody treatment for administration, head to the Health and Human Services. Monoclonal antibody treatments are available for persons who are at high-risk of severe COVID-19 symptoms. A patient is eligible for treatment if they:
- are 65 years or older
- are 55 years or older with heart disease, high blood pressure, chronic obstructive pulmonary disease (COPD), or chronic respiratory disease (such as asthma)
- 12 years or older with a weak immune system, obesity, type 1 or 2 diabetes, or chronic kidney disease
- 12 to 17 if they are obese; regularly use medical technology (such as a feeding tube); have a developmental condition (such as cerebral palsy); have sickle cell disease; have heart disease; or have a chronic respiratory problem that requires daily medication
Veklury (remdesivir) is approved by the FDA to treat COVID-19 infections in hospitalized patients 12 years or older weighing at least 40kg. Side effects of Veklury (remdesivir) include hypersensitivity, changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling, rash, nausea, sweating, and shivering. Liver enzyme levels may also increase in liver blood tests. Gilead can be contacted to obtain Veklury (remdesivir) for administration.
What are the current strategies recommended for medical glove conservation?
Reserve sterile gloves for procedures where sterility is necessary. When broad barrier protection isn’t necessary or when there is low risk of transmission, use gloves beyond their manufacturer-declared shelf life. Inspect the gloves before use, and discard if necessary. Do not change gloves between patients who do not have infectious diseases. Clean gloved hands between patients (do not use hand sanitizer, it may degrade the gloves). Replace gloves if damaged. Clean and use radiographic protective gloves or radiation attenuating surgeon’s gloves that protect fluid barriers. Use non-medical gloves using the FDA’s Medical Glove Guidance Manual.
What are the current strategies recommended for medical gown conservation?
Use reusable gowns instead of single-use gowns. Use sterile surgical isolation gowns for surgeries and invasive procedures with medium to high contamination risk. Use non-sterile gowns. Use isolation gowns for patients with confirmed or suspected COVID-19 infection. Remove only used gowns when treating patients with the same infectious disease. Be careful of contamination. Use gowns beyond their manufacturer-declared shelf life for training. In the case of gown shortages, prioritize them for aerosol-generating procedures, activities involving splashes and sprays, and high-contact patient care activities. Use sterile non-surgical isolation gowns for surgeries and procedures with low contamination risk. For more information on medical gowns, visit the FDA’s webpage here.
What are the current strategies recommended for surgical mask conservation?
Wear the same surgical mask when treating patients with the same infectious disease. Be careful of contamination. Prioritize masks based on the type of necessary patient activity. When there is low transmission risk, use surgical masks beyond their manufacturer-declared shelf life. Inspect masks before use, and discard if necessary. When there is low transmission risk, re-use masks between multiple patients.
What’s the latest information on COVID-19 variants?
As genetic variations of COVID-19 continue to evolve, keep up with the CDC’s published SARS-CoV-2 sequences at this webpage here. The B.1.1.7, B.1.351, P.1, B.1.427, and B.1.429 COVID-19 variants have been classified as variants of concern in the United States.
What are the different type of tests available for COVID-19?
The FDA has identified four COVID-19 molecular tests that could be impacted by COVID-19 genetic mutations: 1) Accula SARS-CoV-2 Test, 2) Linea COVID-19 Assay Kit, 3) TaqPath COVID-19 Combo Kit, 4) Xpert Xpress SARS-CoV-2, Xpert Xpress SARS-CoV-2 DoD, Xpert Omni SARS-CoV-2.
Pooled sample testing is recommended by the FDA when there are more negative COVID-19 test results expected than positive results. Pooled sample testing allows for multiple persons’ COVID-19 samples to be tested together, allowing for increases in the number of persons who can be tested with the same amount of resources. However, pooled sample testing increases the risk of false negative COVID-19 test results.
Screening testing searches for individual COVID-19 infections within a group, even when there is no suspicion of infection within the group. For example, a workplace or school may want to perform a screening test before restarting in-person activities.
Diagnostic testing searches for COVID-19 infections within an individual when that person has had potential disease exposure or symptoms of infection.
Note, if a genetic mutation has occurred within a person’s COVID-19 infection, the possibility of a false negative test result can arise. When testing patients for COVID-19, keep in mind persons may be infected with a viral, bacterial, or fungal disease in addition to COVID-19.
GUIDANCE FOR PATIENT INTERACTIONS
What are the timelines associated with COVID-19?
COVID-19’s median incubation period is four to five days with a maximum of about 14 days.
The median time range of illness infection to difficulty breathing among COVID-19 infected persons is five to eight days; the median time range of illness infection to acute respiratory distress syndrome (ARDS) is eight to twelve days; the median time range of illness infection to intensive care unit (ICU) admission is 9.5-12 days.
One week after infection, be prepared for patients’ conditions to rapidly deteriorate.
What are the current symptoms to be aware of with COVID-19?
COVID-19 symptoms to look out for in patients include: Fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, loss of taste or smell, sore throat, congested or runny nose, nausea or vomiting, and diarrhea. Symptoms may vary with the severity of the infection. Shortness of breath is of particular correlation to COVID-19 hospitalizations.
Non-respiratory COVID-19 symptoms (gastrointestinal, physical, and neurologic symptoms) are likely to appear first in COVID-19 infected persons.
Age, cardiovascular disease, diabetes, respiratory disease, and cancer are the highest risk factors for persons infected with COVID-19.
Children may have fewer symptoms than adults infected with COVID-19.
What are the recommended actions to take for patients with underlying health conditions?
Encourage patients to receive their COVID-19 vaccinations as soon as they become available to them. Patients need to keep routine doctors appointments and keep up with their treatments. When accessible to patients, encourage them to schedule online telehealth appointments during this time.
Encourage patients to continue practicing preventative measures like wearing a mask and social distancing. Facilitate access to culturally and linguistically appropriate resources for ethnic and racial minorities.
What are the current recommendations around home isolation?
Persons with COVID-19 infections under home isolation may discontinue their isolation after all of the following conditions have been met:
- At least ten days have passed since the beginning of the patient’s COVID-19 symptoms.
- 24 hours have passed since the presence of a recorded fever without the use of fever-reducing medication.
- Other COVID-19 symptoms have improved.
What is the current research on re-infection of COVID-19?
Data on COVID-19 re-infection is limited, but re-infection is known to be possible.
For communication resources regarding the COVID-19 pandemic, head to the CDC’s webpage.
- Prioritizing Vulnerable & At-Risk Individuals in the New Stage of the COVID-19 Pandemic
- COVID-19 in your first 10 days – There’s a Treatment for That!
- Partnering with the Healthcare Supply Chain During Disasters
- Pandemic Preparedness in the Healthcare Supply Chain
- Disaster Preparedness in the Healthcare Supply Chain
- What is the Healthcare Supply Chain?
- IMPORTANT INFORMATION FOR PROVIDERS: THE COVID-19 PANDEMIC