Coronavirus Disease 2019 (COVID-19)
Updated: January 24, 2022
[January 19, 2022]
Therapies for High-Risk, Nonhospitalized Patients With Mild to Moderate COVID-19
For nonhospitalized patients with mild to moderate COVID-19 who are at high risk of disease progression NIH Covid-19 Guideline Panelrecommends using 1 of the following therapeutics (listed in order of preference):
- Nirmatrelvir 300 mg with ritonavir 100 mg (Paxlovid) orally twice daily for 5 days, initiated as soon as possible and within 5 days of symptom onset in those aged ≥12 years and weighing ≥40 kg (AIIa).
- Ritonavir-boosted nirmatrelvir (Paxlovid) has significant and complex drug-drug interactions, primarily due to the ritonavir component of the combination.
- Before prescribing ritonavir-boosted nirmatrelvir (Paxlovid), clinicians should carefully review the patient’s concomitant medications, including over-the-counter medications and herbal supplements, to evaluate potential drug-drug interactions. See the Panel’s statement on the drug-drug interactions for ritonavir-boosted nirmatrelvir (Paxlovid) for details.
- Sotrovimab 500 mg as a single IV infusion, administered as soon as possible and within 10 days of symptom onset in those aged ≥12 years and weighing ≥40 kg (AIIa).
- Because Omicron has become the dominant VOC in the United States and real-time testing to identify rare, non-Omicron variants is not routinely available, the Panel recommends against using bamlanivimab plus etesevimab or casirivimab plus imdevimab (AIIa).
- Sotrovimab should be administered in a setting where severe hypersensitivity reactions, such as anaphylaxis, can be managed. Patients should be monitored during the infusion and observed for at least 1 hour after infusion.
- Remdesivir 200 mg IV on Day 1, followed by remdesivir 100 mg IV daily on Days 2 and 3, initiated as soon as possible and within 7 days of symptom onset in those aged ≥12 years and weighing ≥40 kg (BIIa).
- Because remdesivir requires IV infusion for 3 consecutive days, there may be logistical constraints to administering remdesivir in many settings.
- Remdesivir is currently approved by the FDA for use in hospitalized individuals; therefore, outpatient treatment would be an off-label indication.
- Remdesivir should be administered in a setting where severe hypersensitivity reactions, such as anaphylaxis, can be managed. Patients should be monitored during the infusion and observed for at least 1 hour after infusion.
- Molnupiravir 800 mg orally twice daily for 5 days, initiated as soon as possible and within 5 days of symptom onset in those aged ≥18 years ONLY when none of the above options can be used (CIIa).
- The FDA EUA states that molnupiravir is not recommended for use in pregnant patients due to concerns about the instances of fetal toxicity observed during animal studies. However, when other therapies are not available, pregnant people with COVID-19 who are at high risk of progressing to severe disease may reasonably choose molnupiravir therapy after being fully informed of the risks, particularly those who are beyond the time of embryogenesis (i.e., >10 weeks’ gestation). The prescribing clinician should document that a discussion of the risks and benefits occurred and that the patient chose this therapy.
- There are no data on the use of molnupiravir in patients who have received COVID-19 vaccines, and the risk-to-benefit ratio is likely to be less favorable because of the lower efficacy of this drug.
- Detailed statement
[January 5, 2022]
Tixagevimab Plus Cilgavimab (Evusheld) for Pre-Exposure Prophylaxis in Specific Groups
The NIH Covid-19 Guideline Panel recommends using tixagevimab plus cilgavimab as SARS-CoV-2 PrEP for adults and adolescents (aged ≥12 years and weighing ≥40 kg) who do not have SARS-CoV-2 infection, who have not been recently exposed to an individual with SARS-CoV-2 infection, AND who:
- Are moderately to severely immunocompromised and may have an inadequate immune response to COVID-19 vaccination (BIIa); or
- Are not able to be fully vaccinated with any available COVID-19 vaccines due to a documented history of severe reactions to a COVID-19 vaccine or any of its components (AIIa).
- Detailed statement
Anticoagulation in Hospitalized Patients With COVID-19
- Several randomized controlled trials have evaluated the role of therapeutic doses of heparin in reducing venous thromboembolism or mortality in patients hospitalized for COVID-19.
- The NIH Panel recommendations recommendations on the use of anticoagulation therapy in hospitalized, nonpregnant adults with COVID-19 who are receiving supplemental oxygen, presented according to whether the patient is receiving intensive care unit level of care.
Patient Prioritization for Treatment
Priorities for anti-SARS-CoV-2 mAb therapy based on 4 key elements: age, vaccination status, immune status, and clinical risk factors. The groups are listed by tier in descending order of priority.
- In late 2019, a new coronavirus – not seen previously in humans – was identified as the cause of human illness in Wuhan, China and given the name "novel coronavirus" (2019-nCoV).
- By late January 2020, the outbreak was declared a public health emergency of international concern by WHO and US Centers for Disease Control and Prevention (CDC).,
- By mid February 2020, the virus was renamed Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) and the disease it causes was named COVID-19.
- in March 2020, the outbreak was categorized as a pandemic by WHO.
- Spread by human-to-human transmission via respiratory droplets or fomites.
- Median incubation period from exposure to symptoms onset is 4–5 days; ~97% develop symptoms within 12 days from SARS-CoV-2 infection.
- Individuals of all ages are at risk for SARS-CoV-2 infection and severe disease. However, the probability of serious COVID-19 disease is higher in people aged ≥60 years, those living in a nursing home or long-term care facility, and those with chronic medical conditions.
- Spectrum of illness can range from asymptomatic infection to severe pneumonia with acute respiratory distress syndrome and death.
- The NIH COVID-19 Treatment Guidelines Panel recommends the following strategies for managing patients with different severities of disease.
- Details on each therapeutic agent can be found below this section.
RDV 200 mg IV once, then RDV 100 mg IV once daily for 4 days or until hospital discharge.
DEX 6 mg IV or PO once daily for up to 10 days or until hospital discharge.
Baricitinib dose is dependent on eGFR; duration of therapy is up to 14 days or until hospital discharge.
Tofacitinib 10 mg PO twice daily for up to 14 days or until hospital discharge.
Tocilizumab 8 mg/kg actual body weight (up to 800 mg) administered as a single IV dose.
Use the single-dose, prefilled syringe (not the prefilled pen) for SQ injection. Reconstitute sarilumab 400 mg in 100 cc 0.9% NaCl and administer as an IV infusion over 1 hour.
Key: DEX = dexamethasone; eGFR = estimated glomerular filtration rate; IV = intravenous; PO = oral; RDV = remdesivir; SQ = subcutaneous
Strength of Recommendation
Quality of Evidence for Recommendation
| || |
- Care is primarily supportive (see Supportive Therapy below)
- FDA-approved therapies
- Remdesivir [October 22, 2020] – recommended for hospitalized patients who require supplemental oxygen. See below for details.
- Additional therapies recommended by NIH Guidelines Panel
- Dexamethasone – for hospitalized patients only; see below for details
- Baricitinib or tocilizumab: for certain hospitalized patients who require high-flow oxygen or non-invasive ventilation. If neither agent is available or feasible, tofacitinib can be substituted for baricitinib and sarilumab can be substituted for tocilizumab.
- Anti-SARS-CoV-2 monoclonal antibodies: for outpatients with mild to moderate COVID-19 who are at high risk of clinical progression, as defined by the EUA criteria
- Bamlanivimab plus etesevimab; or
- Casirivimab plus imdevimab; or
- Sotrovimab [preferred for regions where the Omicron variant is dominant]
- Therapies NOT approved nor recommended except in a clinical trial
- Hydroxychloroquine and chloroquine with or without azithromycin
- Lopinavir/ritonavir or other HIV protease inhibitors
- Anti-IL-6 monoclonal antibody (siltuximab)
- Bruton’s tyrosine kinase inhibitors (e.g., acalabrutinib, ibrutinib, zanubrutinib)
- Other Janus kinase inhibitors (e.g., ruxolitinib)
- Many other treatments are being investigated in clinical trials
- On October 22, 2020 the U.S. FDA:
- Approved remdesivir (Veklury®) for adults and pediatric patients (12 years and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Under its approval, Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.
- Authorized continued emergency use to treat suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg.
For Hospitalized Adult and Pediatric Patients (Aged ≥12 Years and Weighing ≥40 kg)
Suggested Dose in EUAa for Hospitalized Pediatric Patients Weighing 3.5 kg to < 40 kg or Aged < 12 Years and Weighing ≥3.5 kg
aThe FDA EUA permits the emergency use of RDV for the treatment of suspected COVID-19 or laboratory-confirmed SARS-CoV-2 infection in hospitalized pediatric patients weighing 3.5 kg to < 40 kg or aged < 12 years and weighing ≥3.5 kg.
ALT = alanine transaminase; ECMO = extracorporeal membrane oxygenation; eGFR = estimated glomerular filtration rate; EUA = Emergency Use Authorization; FDA = Food and Drug Administration;
Remdesivir Research Studies
- Broad antiviral activity including against SARS-CoV-2 in vitro.
- Preliminary results of an NIH-sponsored clinical trial (ACTT; NCT04280705) published in NEJM showed remdesivir accelerated recovery from advanced COVID-19.
Median Time to Recovery (Days)
†Preliminary Results from Adaptive COVID-19 Treatment Trial (ACTT).
- NEJM study in patients with severe COVID-19 not requiring mechanical ventilation did not show a significant difference between a 5-day and 10-day course of remdesivir. With no placebo control, the magnitude of benefit of treatment could not be determined.
- The Lancet reported on a RCT (ClinicalTrials.gov NCT04257656) at ten hospitals in Hubei, China. Remdesivir was not associated with statistically significant clinical benefits, although some authors have concluded that the study was underpowered to detect a statistical difference.
- NEJM study of compassionate-use remdesivir in severe COVID-19 showed clinical improvement in 36 of 53 patients (68%). However, no conclusion about true efficacy could be made from this small and non-controlled study.
- Many additional clinical trials are underway.
NIH COVID-19 Treatment Guidelines Panel
Dexamethasone Research Studies
- Preliminary results from the UK RECOVERY trial published in NEJM showed Dexamethasone 6 mg once daily, taken orally or by injection for 10 days reduced the 28 day mortality rate by 17% (0.83 (0.74 to 0.92); P=0.0007) with the greatest benefit among patients needing ventilation (see table below).
Invasive mechanical ventilation
0.64 (0.51 to 0.81)
0.82 (0.72 to 0.94)
No oxygen received
1.19 (0.91 to 1.55)
†Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report.
CI = Confidence Interval
Anti-SARS-CoV-2 Monoclonal Antibodies
NIH COVID-19 Treatment Guidelines Panel
NIH COVID-19 Treatment Guidelines Panel
Convalescent Plasma Research Studies
- PNAS: In an uncontrolled case series of 10 adult patients with severe COVID-19 who were given one dose of convalescent plasma with the neutralizing antibody titers above 1:640, clinical symptoms significantly improved with an increase of oxyhemoglobin saturation within 3 d, accompanied by rapid neutralization of viremia.
- JAMA: In an uncontrolled case series of 5 critically ill patients with COVID-19 and ARDS, administration of convalescent plasma containing neutralizing antibody was followed by improvement in clinical status.
- U.S. FDA has provided guidance for the use of COVID-19 convalescent plasma under an Emergency Investigational New Drug Application
- Other Convalescent Plasma Clinical Trials are underway.
Hydroxychloroquine (HCQ) and Chloroquine (CQ)
NIH COVID-19 Treatment Guidelines Panel
Hydroxychloroquine Research Studies
- Inhibits growth of SARS-CoV-2 in vitro, but no clinical trials have demonstrated conclusively their effectiveness in humans.
- NEJM article reported that HCQ, alone or with azithromycin, did not improve clinical status in patients hospitalized with mild-moderate COVID-19 at 15 days as compared with standard care.
- Annals of Internal Medicine reported on randomized trial of of 491 patients where HCQ given to nonhosptialized adults with early COVID-19 did not substantially reduce symptom severity or improve outcomes
- UK RECOVERY trial: HCQ treatment arm stopped after preliminary analysis showed HCQ did not reduce mortality or improve other outcomes in hospitalized COVID-19 patients.
- NEJM reported a randomized trial showing HCQ did not prevent COVID-19 infection when used as postexposure prophylaxis within 4 days after exposure.
- Observational study published in JAMA showed amongst 1,438 hospitalized COVID-19 patients those receiving hydroxychloroquine, azithromycin, or both had no significant differences in mortality.
- Observational study published in NEJM showed HCQ not associated with either a greatly lowered or an increased risk of the composite end point of intubation or death.
- An increasing number of studies have reported clinically significant QT Interval prolongation from CQ/HCQ +/- azithromycin, with some authors cautioning "first, do no harm."
Other Antiviral Drugs
NIH COVID-19 Treatment Guidelines Panel
Lopinavir-ritonavir (AbbVie; Kaletra, Aluvia)
NIH COVID-19 Treatment Guidelines Panel
Supportive therapy and monitoring
Mild to Moderate Disease
- Patients with a mild clinical presentation (absence of viral pneumonia and hypoxia) can often manage their illness at home.
- Outpatient or inpatient monitoring may be required, depending on:
- Clinical presentation, need for supportive care, risk factors for severe disease, and the ability to self-isolate at home.
- Risk factors for severe illness: these patients should be monitored closely given the possible risk of progression to severe illness in the second week after symptom onset.
- Inpatient management of COVID-19 is supportive and focused on the mmanagement of complications (see below). For details see NEJM review of treatment of severe COVID-19.
- WHO and the Surviving Sepsis Campaign have produced guidelines for inpatient and ICU management of patients with COVID-19:
- For management of children with COVID-19:
For health professionals
- Coronavirus COVID-19 Outbreak | What’s New
- Reporting COVID-19 in the United States
- Epidemic (Epi) Curves for Coronavirus COVID-19
- Specimen Collection and Testing for Coronavirus COVID-19
- PubMed Searches for Coronavirus COVID-19
- VIDEO | Coronavirus: What Nurses Need to Know
For the Public
- COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Available at https://www.covid19treatmentguidelines.nih.gov/. Updated: January 5, 2022.
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