Treatments for COVID-19 are managed by the COVID-19 Treatment Guidelines Panel (the Panel). The Panel works to ensure that the most updated information is disseminated to healthcare providers to support the needs of patients with COVID-19. As of September 15, 2021, the COVID-19 treatment guidelines are outlined below (NIH, 2021b).
The COVID-19 Treatment Guidelines Panel’s Statement on Bamlanivimab Plus Etesevimab for the Treatment of Mild to Moderate COVID-19 in Nonhospitalized Patients:
From June 25, 2021, to September 2, 2021, the distribution of bamlanivimap plus etesevimab was paused due to the spread of the Gamma (P.1) and Beta (B.1.351) SARS-CoV-2 variants. Bamlanivimab plus etesevimab retains activity against the Delta variant (B.1617.2, non-AY.1/AY.2). This treatment distribution and use have been resumed.
The Panel recommends the use of an anti-SARS-CoV-2 mAb regimen in clients with mild to moderate symptoms and who are at high risk of clinical progression. Monoclonal antibodies should be administered as soon as possible and within ten days of symptom onset and after a positive SARS-CoV-2 antigen or nucleic acid amplification test (NAAT) result (NIH, 2021a). Only one of the therapies should be used. The following Anti-SARS-CoV-2 Monoclonal Antibodies have received emergency use authorizations from the Food and Drug Administration (NIH, 2021a):
- Bamlanivimab plus etesevimab
- Dose: Bamlanivimab 700mg plus etesevimab 1,400mg
- Administration: Intravenous infusion
- Casirivimab plus imdevimab
- Dose: Casirivimab 600mg plus imdevimab 600mg
- Administration: Intravenous infusion or subcutaneous injection
- Dose: Sotrovimab 500mg
- Administration: Intravenous infusion
The COVID-19 Treatment Guidelines Panel’s Statement on the Prioritization of Anti-SARS-CoV-2 Monoclonal Antibodies for the Treatment or Prevention of SARS-CoV-2 Infection When There Are Logistical Constraints:
The Panel recommends the use of anti-SARS-CoV-2 mAbs for mild to moderate symptoms of COVID-19 as mentioned above and for post-exposure prophylaxis (PEP) in patients with concern for the development of severe COVID-19. Logistical constraints to mAb administration technicalities and staffing availability can impact the ability to administer mAbs to all eligible patients. Recommendations are limited to ensure that those with the highest chance of benefit from the mAbs receive those first.
Therapeutic Management of Hospitalized Adults With COVID-19:
The Panel recommends that dexamethasone or other corticosteroids be used only in patients with COVID-19 who are hospitalized and require supplemental oxygen. Dexamethasone may be given alone if the combination medication Dexamethasone plus remdesivir is not available or if remdesivir cannot be used. Clients who require high-flow oxygen therapy or noninvasive ventilation may receive either baricitinib or IV tocilizumab along with dexamethasone or dexamethasone plus remdesivir. For clients pending admission to the ICU, dexamethasone plus IV tocilizumab or IV sarilumab (if IV tocilizumab is not available or feasible) should be administered.
Additional Panel recommendations under this update include recommending:
- IV sarilumab can be offered as an alternative to IV tocilizumab
- Tofacitinib can be used as an alternative to baricitinib if baricitinib is not available or feasible to use
The COVID-19 Treatment Guidelines Panel’s Statement on the Emergency Use Authorization of Casirivimab Plus Imdevimab as Post-Exposure Prophylaxis for SARS-CoV-2 Infection:
As of July 30, 2021, the Food and Drug Administration expanded the emergency use authorization for the anti-SARS-CoV-2 monoclonal antibodies casirivimab plus imdevimab to be used for post-exposure prophylaxis (PEP). Casirivimab plus imdevimab is recommended as PEP for people at high risk for progression to severe COVID-19 if infected with SARS-CoV-2 and who have either been incompletely vaccinated or who are fully vaccinated but may not have amounted an appropriate immune response and who have exposure history to COVID-19. Doses of casirivimab plus imdevimab should be administered as soon as possible within seven days of high-risk exposure.
Dosing of casirivimab plus imdevimab includes 600mg of each medication (casirivimab 600mg plus imdevimab 600mg) as four subcutaneous injections, each 2.5ml, at four different sites or as a single IV infusion. Observation of the patient for one hour after the injections or infusion is required in the case of adverse effects.
At this time, there is insufficient evidence to repeat dosing of casirivimab plus imdevimab every four weeks or for those who have repetitive high-risk exposures.
Prior and additional guidance regarding the treatment of SARS-CoV-2 (COVID-19) can be found within the full NIH COVID-19 Treatment Guidelines.