Abstractor: Stephen V. Cantrill, MD, FACEP
This information has been abstracted from the NIH’s “COVID-19 Treatment Guidelines,” last accessed July 24, 2020. Full details and references are available at the NIH website.
General Drug Treatment Statements
Currently, no FDA-approved drugs exist to specifically treat patients with COVID-19.
- Because remdesivir supplies are limited, it is recommended remdesivir be prioritized for use in hospitalized patients with COVID-19 who require supplemental oxygen but who are not on high flow oxygen (through a high flow device), noninvasive ventilation, mechanical ventilation or ECMO (BI1).
- For patients with COVID-19 on supplemental oxygen but not requiring high flow oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO), remdesivir is recommended for 5 days (AI1).
- For patients with COVID-19 who require high flow oxygen, noninvasive ventilation, mechanical ventilation or ECMO, there is uncertainty regarding whether starting remdesivir confers clinical benefit in these groups of patients, therefore a recommendation for or against starting remdesivir cannot be made.
- Remdesivir is not approved by the Food and Drug Administration (FDA); however, it is available through an FDA Emergency Use Authorization (EUA) for the treatment of hospitalized adults and children with COVID-19. Remdesivir is also being investigated in clinical trials, and it is available through an emergency access program for children and pregnant patients.
- Chloroquine and hydroxychloroquine:
- Chloroquine or hydroxychloroquine are recommended against in the treatment of COVID-19, except in a clinical trial (AII1).
- In nonhospitalized patients, the Panel recommends against the use of chloroquine or hydroxychloroquine for the treatment of COVID-19, except in a clinical trial (AI1).
- Dexamethasone is recommended against in the treatment of COVID-19 in patients who do not require supplemental oxygen (AI1).
- For Hospitalized Patients with COVID-19 Who Require Supplemental Oxygen but Who Do Not Require Delivery of Oxygen Through a High-Flow Device, Noninvasive Ventilation, Invasive Mechanical Ventilation, or Extracorporeal Membrane Oxygenation:
- A combination of remdesivir (dose and duration as above) plus dexamethasone 6 mg IV or orally for up to 10 days or until hospital discharge (BIII1) is recommended; or
- If remdesivir cannot be used, dexamethasone may be used instead (BIII1).
- 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
- A combination of dexamethasone plus remdesivir at the doses and durations discussed above is recommended (AIII1); or
- Dexamethasone alone at the dose and duration discussed above (AI1).
- For Hospitalized Patients with COVID-19 Who Require Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation
- Dexamethasone at the dose and duration discussed above is recommended (AI1); or
- Dexamethasone plus remdesivir for patients who have recently been intubated at the doses and durations discussed above (CIII1).
- If dexamethasone is not available, the Panel recommends using alternative glucocorticoids such as prednisone, methylprednisolone, or hydrocortisone (AIII1). See Corticosteroids for dosing recommendations.
- Ivermectin is recommended against for the treatment of COVID-19, except in a clinical trial (AIII1).
Definition of COVID-19 Disease Severity
- Mild: A variety of symptoms (eg, fever, cough, sore throat, malaise, headache, muscle pain, malaise) without shortness of breath/dyspnea or abnormal chest imaging (if obtained).
- Moderate: Evidence of lower respiratory disease by clinical assessment or imaging with SaO2 >94% on room air (sea level).
- Severe: Having a SaO2 <94% on room air (sea level), respiratory frequency >30 breaths/minute, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <300, or lung infiltrates >50%.
- Critical: Individuals who have respiratory failure, septic shock, and/or multiple organ dysfunction.
- In pediatric patients, radiographic abnormalities are common and, for the most part, should not be used as the sole criteria to define COVID-19 illness category. Normal values for respiratory rate also vary with age in children, thus hypoxia should be the primary criteria to define severe illness, especially in younger children.
Pre- or Post-Exposure Prophylaxis
- Currently no agents are recommended for pre- or post-exposure prophylaxis
Asymptomatic/Presymptomatic COVID-19 Disease
- No additional laboratory testing or specific treatment is recommended for patients who test positive for SARS-CoV-2 but are asymptomatic.
- These patients should self-isolate. If they remain asymptomatic for 10 days after the test, they may resume normal activity. If they become symptomatic, they should contact their primary care provider for further guidance.
Mild COVID-19 Disease
- Most cases can be managed in an ambulatory setting or at home through telemedicine or remote visits.
- Routine antipyretic, hydration and rest instructions should be provided.
- These patients should be in self-isolation until the following:
- If no test is to be done: the patient has been afebrile for at least 72 hours without the use of antipyretics AND other symptoms have improved AND at least 7 days have elapsed since symptoms have appeared.
- If a test can be performed: the patient is afebrile for at least 72 hours without the use of antipyretics AND other symptoms have improved AND there are two negative tests results in a row, 24 hours apart.
- Currently, there are insufficient data to recommend either for or against any antiviral or immune-based therapy in patients with mild disease (AIII1).
- These patients, especially those with risk factors for severe disease, should be closely monitored as the clinical course may rapidly worsen.
- Additional patient information is available at the CDC Resource on What to Do If You Are Sick.
Moderate COVID-19 Disease
- Since patients with moderate COVID-19 infection can rapidly deteriorate, most of these individuals should be admitted to a health care facility for close monitoring.
- If bacterial pneumonia or sepsis is suspected, appropriate empiric antibiotic treatment should be initiated.
- Currently, there are insufficient data to recommend either for or against any antiviral or immune-based therapy in patients with moderate disease (AIII1).
- It is not recommended to use of dexamethasone (AI1) or other corticosteroids for the treatment of COVID-19 (AIII1) unless a patient has another clinical indication for corticosteroid therapy.
- Other therapeutic options under investigation for COVID-19 are presented with clinical data at the NIH’s COVID-19 Treatment Guidelines.
Severe COVID-19 Disease
- Since patients with severe COVID-19 infection can rapidly deteriorate, these individuals should be admitted to a health care facility for close monitoring to a single-person negative-pressure room.
- If bacterial pneumonia or sepsis is suspected, appropriate empiric antibiotic treatment should be initiated.
- Oxygen therapy should be instituted with a target O2 saturation of >94% (sea level).
- Treatment with remdesivir: see “General Drug Treatment Statements” above.
- Treatment with dexamethasone: see “General Drug Treatment Statements” above.
- Other therapeutic options under investigation for COVID-19 are presented with clinical data at the NIH’s COVID-19 Treatment Guidelines.
- See below under “Critical COVID-19 Disease” for other recommendations that may apply.
Critical COVID-19 Disease
- Currently, there is no information to suggest that the critical care management of patients with COVID-19 should differ substantially from the management of other critically ill patients.
- Special caution about environmental contamination by SARS-CoV-2 is warranted.
- Infection control:
- For health care workers performing aerosol-generating procedures on patients with COVID-19, using fit tested respirator masks (N-95 respirators) or powered air-purifying respirators (PAPRs) is recommended rather than surgical masks, in addition to other personal protective equipment (PPE) (ie, gloves, gown, and eye protection such as a face shield or safety goggles). (AIII1) These patients should be placed in airborne infection isolation rooms when available.
- Endotracheal intubation for patients with COVID-19 should be done by health care providers with extensive airway management experience, if possible. (AIII1). Intubation should be achieved via video laryngoscopy, if possible. (CIII1)
- Hemodynamic support:
- For adults with COVID-19 and shock, dynamic parameters, skin temperature, capillary refilling time, and/or lactate are recommended to be used rather than static parameters to assess fluid responsiveness (BII1).
- For the acute resuscitation of adults with COVID-19 and shock, buffered/balanced crystalloids are preferred over unbalanced crystalloids (BII1).
- Norepinephrine is recommended as the first-choice vasopressor. (AII1) Either vasopressin (up to 0.03 U/min) (BII1) or epinephrine (CII1) should be added to norepinephrine to raise mean arterial pressure to target, or adding vasopressin (up to 0.03 U/min) (CII1) to decrease norepinephrine dosage.
- Dobutamine is recommended in patients who show evidence of persistent hypoperfusion despite adequate fluid loading and the use of vasopressor agents. (BII1)
- When norepinephrine is available, using dopamine is recommended against for patients with COVID-19 and shock (AI1).
- Low-dose dopamine for renal protection (BII1) is recommended against.
- For adults with COVID-19 and refractory shock, using low-dose corticosteroid therapy (“shock-reversal”) is suggested over no corticosteroid. (BII1)
- Ventilatory support:
- Low tidal volume (Vt) ventilation (Vt 4-8 mL/kg of predicted body weight) over higher tidal volumes (Vt>8 mL/kg) is recommended. (AI1)
- Targeting plateau pressures of <30 cm H2O is recommended (AII1).
- A conservative fluid strategy over a liberal fluid strategy (BII1) is recommended.
- The routine use of inhaled nitric oxide is recommended against (AI).
- For adults with COVID-19 and acute hypoxemic respiratory failure despite conventional oxygen therapy, high-flow nasal cannula (HFNC) oxygen is recommended over noninvasive positive pressure ventilation (NIPPV). (BI1)
- For adults with COVID-19 and acute hypoxemic respiratory failure for whom HFNC is not available, in the absence of an indication for endotracheal intubation, a closely monitored trial of NIPPV is recommended. (BIII1)
- For adults with COVID-19 who are receiving supplemental oxygen, close monitoring for worsening respiratory status is recommended with early intubation by an experienced practitioner in a controlled setting. (Alll1)
- For patients with persistent hypoxemia despite increasing supplemental oxygen requirements in whom endotracheal intubation is not otherwise indicated, a trial of awake prone positioning to improve oxygenation (CIII1) should be considered.
- Awake prone positioning is recommended against as a rescue therapy for refractory hypoxemia to avoid intubation in patients who otherwise require intubation and mechanical ventilation (AIII1).
- In ventilated adults with COVID-19 and ARDS:
- For mechanically ventilated adults with COVID-19 and refractory hypoxemia despite optimizing ventilation, prone ventilation for 12 to 16 hours per day is recommended, over no prone ventilation (BII1).
- If necessary, a trial of inhaled pulmonary vasodilator as a rescue therapy is recommended; if no rapid improvement in oxygenation is observed, the patient should be tapered off treatment. (CIII1)
- There are insufficient data to recommend either for or against the routine use of ECMO for patients with COVID-19 and refractory hypoxemia. (BIII1)
- Drug therapy:
- Treatment with remdesivir: See “General Drug Treatment Statements”, above
- Treatment with dexamethasone: See “General Drug Treatment Statements”, above
- There are insufficient data to recommend either for or against any immunomodulatory therapy in patients with severe COVID-19 disease (AIII1).
- There are insufficient data to recommend either for or against routine broad-spectrum antimicrobial therapy to treat COVID-19 patients with severe or critical illness. (AIII1)
- As described elsewhere: there are insufficient data to recommend for or against the use of IL-6 antagonists (such as sarilumab, siltuximab, or tocilizumab) for the treatment of COVID-19 (AIII1).
Convalescent Plasma for the Treatment of COVID-19
The FDA has issued an EUA to permit the emergency use of the unapproved product COVID-19 convalescent plasma to treat hospitalized patients with COVID-19 (FDA Fact sheet for Healthcare Providers). Based on the available evidence, the NIH COVID-19 Treatment Guidelines have determined the following:
- There are insufficient data to recommend either for or against the use of convalescent plasma for the treatment of COVID-19.
- Available data suggest that serious adverse reactions following the administration of COVID-19 convalescent plasma are infrequent and consistent with the risks associated with plasma infusions for other indications. The long-term risks of treatment with COVID-19 convalescent plasma and whether its use attenuates the immune response to SARS-CoV-2, making patients more susceptible to reinfection, have not been evaluated.
- Convalescent plasma should not be considered the standard of care for the treatment of patients with COVID-19.
- Prospective, well-controlled, adequately powered randomized trials are needed to determine whether convalescent plasma is effective and safe for the treatment of COVID-19. Members of the public and health care providers are encouraged to participate in these prospective clinical trials.
Antithrombotic Therapy in Patients with COVID-19
- In nonhospitalized patients with COVID-19, there are currently no data to support the measurement of coagulation markers (eg, D-dimers, prothrombin time, platelet count, fibrinogen) (AIII1).
- In hospitalized patients with COVID-19, hematologic and coagulation parameters are commonly measured, although there are currently insufficient data to recommend for or against using this data to guide management decisions (BIII1).
Chronic Anticoagulant and Antiplatelet Therapy
- Patients who are receiving anticoagulant or antiplatelet therapies for underlying conditions should continue these medications if they receive a diagnosis of COVID-19 (AIII1).
Venous Thromboembolism Prophylaxis and Screening
- For nonhospitalized patients with COVID-19, anticoagulants and antiplatelet therapy should not be initiated for prevention of venous thromboembolism (VTE) or arterial thrombosis unless there are other indications (AIII1).
- Hospitalized adults with COVID-19 should receive VTE prophylaxis per the standard of care for other hospitalized adults (AIII1).
- A diagnosis of COVID-19 should not influence a pediatrician’s recommendations about VTE prophylaxis in hospitalized children (BIII1).
- Anticoagulant or antiplatelet therapy should not be used to prevent arterial thrombosis outside of the usual standard of care for patients without COVID-19 (AIII1).
- There are currently insufficient data to recommend for or against the use of thrombolytics or increasing anticoagulant doses for VTE prophylaxis in hospitalized COVID-19 patients outside the setting of a clinical trial (BIII1)
- Hospitalized patients with COVID-19 should not routinely be discharged on VTE prophylaxis (AIII1).
- Using FDA-approved regimens, extended VTE prophylaxis can be considered in patients who are at low risk for bleeding and high risk for VTE as per protocols for patients without COVID-19 (BI1).
- There are currently insufficient data to recommend for or against routine deep vein thrombosis screening in COVID-19 patients without signs or symptoms of VTE, regardless of the status of their coagulation markers (BIII1).
- For hospitalized COVID-19 patients, the possibility of thromboembolic disease should be evaluated in the event of rapid deterioration of pulmonary, cardiac, or neurological function, or of sudden, localized loss of peripheral perfusion (AIII1).
- Patients with COVID-19 who experience an incident thromboembolic event, or who are highly suspected to have thromboembolic disease at a time when imaging is not possible, should be managed with therapeutic doses of anticoagulant therapy as per the standard of care for patients without COVID-19 (AIII1).
- Patients with COVID-19 who require ECMO or continuous renal replacement therapy, or who have thrombosis of catheters or extracorporeal filters, should be treated with antithrombotic therapy per the standard institutional protocols for those without COVID-19 (AIII1).
Special Considerations During Pregnancy and Lactation
- Management of anticoagulation therapy during labor and delivery requires specialized care and planning and should be managed similarly in pregnant patients with COVID-19 as other conditions that require anticoagulation in pregnancy (AIII1).
- Unfractionated heparin, low molecular weight heparin, and warfarin do not accumulate in breast milk and do not induce an anticoagulant effect in the newborn; therefore, they can be used in breastfeeding women with or without COVID-19 who require VTE prophylaxis or treatment (AIII1).
- Direct-acting oral anticoagulants are not routinely recommended because of a lack of safety data (AIII1).
Additional information can be found on the NIH’s COVID-19 website.
Considerations for certain concomitant medications in patients with COVID-19
The following medications, if prescribed for the treatment of comorbid conditions or prevention of disease should be continued (AIII1) (details at the NIH’s COVID-19 website):
- ACE inhibitors, angiotensin receptor blockers
Acute Kidney Injury and Renal Replacement Therapy
- For critically ill patients with COVID-19 who have acute kidney injury (AKI) and who develop indications for renal replacement therapy (RRT), continuous renal replacement therapy (CRRT) is recommended, if available (BIII1).
- If CRRT is not available or not possible due to limited resources, prolonged intermittent renal replacement therapy (PIRRT) rather than intermittent hemodialysis (IHD) is recommended (BIII1).
Therapeutic options for COVID-19 currently under investigation (not covered above)
Summary: At present, no drug has been proven to be safe and effective for treating COVID-19. There are no FDA-approved drugs to specifically treat patients with COVID-19. While reports have appeared in the medical literature and the lay press claiming successful treatment of patients with COVID-19 with a variety of agents, definitive randomized clinical trial data are needed to identify optimal treatment for this disease. Recommended clinical management of these patients includes infection prevention and control measures and supportive care, including supplementary oxygen and mechanical ventilatory support when indicated. As always, treatment decisions ultimately reside with the patient and their health care provider.
- Lopinavir/ritonavir (AI1) or other HIV protease inhibitors (AIII1), are not recommended because of unfavorable pharmacodynamics and negative clinical trials data.
- Host Modifiers
- There are insufficient data to recommend for or against the use of convalescent plasma or hyperimmune immunoglobulin for the treatment of COVID-19 (AIII1).
- There are insufficient data to recommend for or against the use of the following agents for the treatment of COVID-19 (AIII1).
- IL-6 receptor antagonists (such as sarilumab, siltuximab, or tocilizumab)
- IL-1 inhibitors (such as anakinra)
- The use of other immunomodulators is recommended against, except in a clinical trial, such as:
- Interferons (AIII1), because of lack of efficacy in SARS and MERS and toxicity.
- JAK inhibitors (such as baricitinib) (AIII1), because of their broad immunosuppressive effects
Other therapeutic options under investigation for COVID-19 are presented with clinical data at the NIH’s “COVID-19 Treatment Guidelines.”
Table 10.1 Recommendation rating scheme.
For more information, see the NIH’s “COVID-19 Treatment Guidelines.”
Also refer to the “Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19” published on April 11, 2020.
The FDA has issued an EUA for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients.
- Bamlanivimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells.
- Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are ≥12 years of age and weighing ≥40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization (Table 10.2). This includes those who are ≥65 years of age, or who have certain chronic medical conditions.
- While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.
- Bamlanivimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.
- A benefit of bamlanivimab treatment has not been shown in patients hospitalized due to COVID-19.
- Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.
Table 10.2 Bamlanivimab (Eli Lilly) EUA — High-Risk Criteria.
Link to BMI Calculator
NIH Summary Recommendations
- At this time, there are insufficient data to recommend either for or against the use of bamlanivimab for the treatment of outpatients with mild to moderate COVID-19.
- Bamlanivimab should not be considered the standard of care for the treatment of patients with COVID-19.
- An interim analysis of the BLAZE-1 study, a Phase 2, randomized, placebo-controlled trial, suggested a potential clinical benefit of bamlanivimab for outpatients with mild to moderate COVID-19. However, the relatively small number of participants and the low number of hospitalizations or emergency department visits make it difficult to draw definitive conclusions about the clinical benefit of bamlanivimab.
- More data are needed to assess the impact of bamlanivimab on the disease course of COVID-19 and to identify those people who are most likely to benefit from the drug. Health care providers are encouraged to discuss participation in bamlanivimab clinical trials with their patients.
- Given the possibility of a limited supply of bamlanivimab, as well as challenges distributing and administering the drug, patients at highest risk for COVID-19 progression should be prioritized for use of the drug through the EUA. In addition, efforts should be made to ensure that communities most affected by COVID-19 have equitable access to bamlanivimab.
- Bamlanivimab should not be withheld from a pregnant individual who has a condition that poses a high risk of progression to severe COVID-19, and the clinician thinks that the potential benefit of the drug outweighs potential risk (see the criteria for EUA use of bamlanivimab below).
- Patients who are hospitalized for COVID-19 should not receive bamlanivimab outside of a clinical trial.
More information can be found on The COVID-19 Treatment Guidelines Panel’s Statement on the Emergency Use Authorization of Bamlanivimab for the Treatment of COVID-19.
EUA authorizes use of Bamlanivimab for treatment of high risk (Table 10.3) COVID 19 outpatients (ages ≥12 years, weight ≥40 kg) with mild to moderate symptoms at risk for progressing to severe disease/hospitalization.
Key Summary Steps:
- Direct SARS-CoV-2 test (eg, PCR, rapid antigen test) must be positive
- Administered as soon as possible after positive test result and within 10 days of symptom onset
- Provider to review EUA fact sheet
- Patient/caregiver to be provided with EUA fact sheet
- Administered in a setting where health care providers have direct access to medications to manage severe reactions
Table 10.3 Dosing and requirements.
Recently, the FDA authorized revised preparation and administration instructions in the Fact Sheet for Healthcare Providers for bamlanivimab. As seen below, these changes include shortened infusion times, ranging from 16-60 minutes, depending on the size of IV bag used.
These changes were made in response to feedback received from front-line healthcare professionals administering these infusions and are aimed at reducing the burden on the healthcare system.\
- 250 mL 0.9% NaCl
- IV Insertion Supplies
- IV Infusion Tubing
- 0.2/0.22 µm Filter
- 20 mL Syringe x2
- 18 g Sterile Needle x2
- Alcohol Wipes
Readiness Checklist: Administration of Outpatient mAbs under EUA
- Allocate dedicated space and develop plan to manage patient flow
- Clear process for patients that are coming to clinical site including scheduling requirements
- Admission process for COVID-19 positive patients designed to minimize risk of spread per facility requirements/directions/guidelines
- Dedicated room available for treatment
- Ensure dedicated source of supplies; which may be difficult to procure
- Needed infusion components obtained
- Example: IV kits, infusion chair, IV pole, vital sign monitoring equipment, emergency medications
- Assign sufficient personnel to meet expected demand
- Sufficient staffing plans in place for Nurse/IV tech, Physician, Pharmacist
- Likely need dedicated team to treat patients
- Prepare for drug administration process
- Pre-visit: Clear treatment and monitoring plan developed for during infusion
- Treatment: 1-hour treatment and up 1-hour post-treatment observation
- Emergency protocol defined for addressing potential infusion reactions or complications
- Post-treatment: Clear process for patient follow-up defined using telemedicine as possible
- Ensure process for reimbursement in place (non-drug administrative costs)
- Prepare for reporting needs for adverse events and record keeping
Available for download:
Additional Information and Resources
EUA, Fact Sheets, Lilly Playbook, and FDA Resources
Allocation and Distribution
CMS and Reimbursement
Casirivimab Plus Imdevimab
The FDA has issued an EUA to permit the emergency use of the unapproved products casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (≥12 years of age and weighing ≥ 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
NIH Summary Recommendations
- At this time, there are insufficient data to recommend either for or against the use of casirivimab plus imdevimab for the treatment of outpatients with mild to moderate COVID-19.
- The casirivimab plus imdevimab combination should not be considered the standard of care for the treatment of patients with COVID-19.
- Health care providers are encouraged to discuss participation in severe acute respiratory syndrome coronavirus 2 neutralizing antibody clinical trials with patients who have mild to moderate COVID-19.
- Given the possibility of a limited supply of the casirivimab plus imdevimab combination, as well as challenges distributing and administering the drugs, patients at highest risk for COVID-19 progression should be prioritized for use of the drugs through the EUA. In addition, efforts should be made to ensure that the communities that are most affected by COVID-19 have equitable access to casirivimab plus imdevimab.
- Casirivimab plus imdevimab should not be withheld from a pregnant individual who has a condition that poses a high risk of progression to severe COVID-19, if the clinician thinks that the potential benefit of the drugs outweighs the potential risk.
- Patients who are hospitalized for COVID-19 should not receive casirivimab plus imdevimab outside of a clinical trial.
- There are currently no comparative data to determine whether there are differences in clinical efficacy or safety between casirivimab plus imdevimab and bamlanivimab.
High-Risk Criteria for Emergency Use Authorization of the Casirivimab Plus Imdevimab Combination
The FDA EUA allows for the use of casirivimab plus imdevimab for the treatment of COVID-19 in nonhospitalized adults and children aged ≥12 years and weighing ≥40 kg who are at high risk for progressing to severe COVID-19 and/or hospitalization. High-risk individuals specified in the EUA are those who meet at least one of the following criteria:
- Body mass index (BMI) ≥35
- Chronic kidney disease
- Diabetes mellitus
- Immunocompromising condition
- Currently receiving immunosuppressive treatment
- Aged ≥65 years
- Aged ≥55 years and have:
- Cardiovascular disease, or
- Hypertension, or
- Chronic obstructive pulmonary disease/other chronic respiratory disease
- Aged 12 to 17 years and have:
- BMI ≥85th percentile for their age and gender based on the Centers for Disease Control and Prevention growth charts; or
- Sickle cell disease; or
- Congenital or acquired heart disease; or
- Neurodevelopmental disorders, for example, cerebral palsy; or
- A medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19); or
- Asthma or a reactive airway or other chronic respiratory disease that requires daily medication for control
Casirivimab and imdevimab are not authorized for use in patients:
- Who are hospitalized due to COVID-19; or
- Who require oxygen therapy due to COVID-19; or
- Who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to an underlying non-COVID-19 related-comorbidity.
Benefit of treatment with casirivimab plus imdevimab has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 who require high-flow oxygen or mechanical ventilation.