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Brief Timeline
• 2019
– Dec 12: Cluster of cases from Wuhan
– Dec 31: WHO - Huanan Seafood Market
• 2020
– Jan 5: Chinese public health officials share the
genetic sequence virus online
– Jan 7: Novel coronavirus isolated; 2019-nCOV
• Countries start reporting: Thailand, Japan
– Jan 20: First case in the USA
Brief Timeline
• 2020
– Jan 31: SARS-CoV-2 virus a public health
emergency
– Feb 11: WHO announces the official name for the
disease: COVID-19
– Feb 23: Italy ‘locks down’
– Mar 11: WHO finally calls it a “Pandemic”
– Mar 15: States begin to ‘shut down’
– Mar 17: Moderna’s first human trials
Brief Timeline
• 2020
– Mar 31: FDA issues Emergency Use Authorization
(EUA) for hydroxychloroquine
– Apr 10: U.S. surpasses Italy as
for deaths (23,036 deaths)
– Apr 30: Trump launches Operation Warp Speed
– May 1: EUA for antiviral drug remdesivir
– May 9: U.S. unemployment rate at 14.7%, the
worst since the Great Depression
Brief Timeline
• 2020
– May 28: US death toll tops 100,000
– Sept 22: Death toll tops 200,000
– Dec 11: FDA issues EUA for Pfizer vaccine
– Dec 18: Then, Moderna vaccine
– Dec 30: UK variant found in the US
Recent Updates on COVID-19
Brief Timeline
• 2021
– Jan 18: Death toll passes 400,000
– Jan 25: Brazilian variant (Gamma) arrived in US
– Jan 28: S. African variant (Beta) arrived in US
– Feb 21: Death toll passes 500,000
– Feb 27: J&J vaccine EUA from FDA
– Mar 13: 100,000,000 vaccinated
– Apr 21: 200,000,000 vaccinated
Brief Timeline
• 2021
– June 1: Delta variant starts to wreak havoc in USA
– July 30: Vaccinated CAN STILL have virus
– Oct 21: Booster shots recommended 65+, others
– Oct 29: Vaccine better than disease for immunity
– Nov 2: Pfizer vaccine down to age 5
Brief Timeline
• 2021
– Nov 26: Omicron identified
– Nov 29: CDC recommends ’18+’ get mRNA booster
• 2022
– Jan 24: Estimated about 57% of the world has
been infected by COVID-19
– March 6: Death count over 6 million
79,778,889 cases on 3/22/22 with 972,634 deaths https://coronavirus.jhu.edu/us-map
COVID-19 in the United States: TOTAL
https://www.nytimes.com/interactive/2021/us/covid-cases.html
COVID-19 Hot Spots
https://www.nytimes.com/interactive/2020/us/coronavirus-us-cases.html
New Cases
Could New Variants Arise?
• New Variant of Concern (VOC)
– Very large viral burden globally
– Mutating, mutating, mutating
• Omicron: Highly mutated
around the Spike protein
– 43 spike protein mutations,
compared to 18 for Delta
variant
Will Vaccines Cover for the Next Variant?
• A surge of protective
antibodies after a
booster shot, helps to
prevent severe illness
– Dr. Fauci
• Pfizer, Moderna: Have
modified vaccine
Vaccines Have Worked!
https://www.nytimes.com
Vaccine uptake USA
https://www.nytimes.com
Therapeutics
Anti-Virals - Game Changers?!
• Pfizer: Paxlovid
– strongly effective in preventing severe
COVID when given to high-risk
unvaccinated patients soon after they
started showing symptoms
• Merck: Molnupiravir (Lagevrio)
– inhibits virus replication
Paxlovid
• Paxlovid (PF-07321332 + ritonavir)
– SARS-CoV-2 protease inhibitor
– Take at first sign of infection or
awareness of an exposure
– Help avoid severe illness
– 89 percent if started within 3 days of
symptoms
• Fourth or fifth day, the pill reduced the risk
of hospitalization or death by 85 percent
Supporting each other
Trusted Resources
• Johns Hopkins
https://coronavirus.jhu.edu/map.html
• CDC
https://www.cdc.gov/coronavirus/2019-ncov/index.html
https://emergency.cdc.gov/coca/calls/2020/
• WHO:
https://www.who.int/emergencies/diseases/novel-coronavirus-2019
• Others
https://www.nytimes.com/interactive/2021/us/covid-cases.html
https://www.thelancet.com/coronavirus
https://covidactnow.org/
March 23, 2022
Marwan Haddad MD, MPH (he/him)
Veena Channamsetty, MD, FAAFP (she/her)
Current Available COVID-19 Treatments in
the U.S.
For high risk, non-hospitalized patients (in order of recommendation):
• Ritonavir-boosted Nirmatrelvir (Brand name Paxlovid in U.S.)
• 88% relative reduction of hospitalization or death compared
to placebo.
• Sotrovimab
• 85% relative reduction.
• Remdesivir
• 87% relative reduction.
• Molnupiravir
• 30% relative reduction.
• ONLY if other 3 options are not available or cannot be used.
CDC Risk Factors for Severe COVID Disease
• Cancer
• Cerebrovascular disease
• Children with certain
underlying conditions
• Chronic kidney disease
• Chronic lung disease
• Chronic liver disease
• Diabetes mellitus, type 1
and type 2
• Down syndrome
• Heart conditions
• HIV
• Mental health disorders
• Neurologic conditions
• BMI > 25
• Pregnancy or recent
pregnancy
• Smoking (current and former)
• Sickle cell disease or
thalassemia
• Solid organ or blood stem cell
transplantation
• Substance use disorders
• Tuberculosis
• Moderate to severe
immunocompromised due to
a medical condition or the
use of corticosteroids or
other immunosuppressive
medications
NIH Prioritization of Treatment
(if logistical or supply constraints)
• Statement on Patient
Prioritization for
Outpatient Therapies |
COVID-19 Treatment
Guidelines (nih.gov)
Nirmatrelvir/Ritonavir (Paxlovid)
• FDA issued EUA for outpatient oral treatment of mild-moderate
COVID-19.
• For patients ≥12 years, weighing ≥40 kg
• At risk for severe COVID-19, including hospitalization or death.
• Started ASAP after diagnosis AND within 5 days of symptom onset.
• EUA based on EPIC-HR, RCT, placebo-controlled trial.
• N=2,246
• Mean age 46
• 51% male
• 72% White, 5% Black, 14% Asian, 45% Hispanic/Latino/a
• Eligibility: 18+ with at least 1 of the following:
• DM, BMI>25, chronic lung disease including asthma, chronic kidney disease,
current smoker, immunosuppressive disease or treatment, CVD, HTN, sickle cell,
neurodevelopmental disorders, active cancer, or ≥60 years.
• Excluded if prior history of COVID infection or vaccination.
Paxlovid HCP FS 02232022 (fda.gov)
Dosing & Side Effects
• Nirmatrelvir 300mg (two 150-
mg capsules) AND 100 mg
ritonavir (one 100 mg tablet)
orally twice a day for 5 days
(three tablets taken together
twice daily for 5 days).
• Can be taken with or without
food.
• Side Effects: Impaired sense
of taste 6%; diarrhea 3%;
hypertension 1%; myalgia 1%
Paxlovid HCP FS 02232022 (fda.gov)
Clinical Considerations
• Pregnancy:
– Trial excluded pregnant and lactating individuals.
– Ritonavir used during pregnancy in HIV care
• Suggests acceptable safety profile.
– Mechanisms of action and available animal data suggest treatment can
be used in pregnancy if potential benefits outweigh risks.
• Shared decision-making.
– Pregnancy is high risk for severe COVID-19 illness.
• Lactation:
– Can be used if potential benefits outweigh risks.
• Shared decision-making.
• Pediatric population:
– Authorized in ≥ 12 y.o. and ≥ 40 kg.
– Safety and efficacy not established in trials.
Paxlovid HCP FS 02232022 (fda.gov)
Dosing Considerations & Usage
– Renal Impairment
• Mild (eGFR 60-90 mL/min)- No
adjustment needed.
• Moderate (eGFR 30-60 mL/min)-
Nirmatrelvir 150mg (one 150-mg
capsules) AND 100 mg ritonavir
(one 100 mg tablet) orally twice a
day for 5 days (two tablets taken
together twice daily for 5 days).
• Severe (eGFR <30 mL/min)-
currently NOT recommended.
– Hepatic Impairment
• Mild-Moderate(Child-Pugh Class
A/B)- No adjustment needed.
• Severe (Child-Pugh Class C)- NOT
recommended.
Paxlovid HCP FS 02232022 (fda.gov)
Contraindications
• History of clinically significant hypersensitivity reactions to its
active ingredients (nirmatrelvir or ritonavir) or any other
components.
Warnings
• Hepatotoxicity:
• Caution in patients with pre-existing liver diseases, liver enzyme
abnormalities, or hepatitis.
• Hepatic transaminase elevations, clinical hepatitis, and jaundice have
occurred in patients receiving ritonavir.
• Risk of HIV-1 resistance:
• In individuals with uncontrolled or undiagnosed HIV, there may be a risk of
developing resistance to HIV protease inhibitors because nirmatrelvir is co-
administered with ritonavir.
Paxlovid HCP FS 02232022 (fda.gov)
Drug Interactions
• Prescribed and over the counter medications MUST be checked for
interactions before prescribing nirmatrelvir/ritonavir.
• https://www.covid19-druginteractions.org/checker.
• Management of potential drug interactions can include
• Not prescribing, if serious/life threatening interactions expected.
• Holding medication that interacts with nirmatrelvir/ritonavir
during the 5-day therapy, if can be done safely.
• Monitoring for interactions/side effects.
Sotrovimab
• Monoclonal Antibody Treatment
• COMET-ICE trial (N=1057): RCT, placebo-controlled, ≥18 with at least one
co-morbidity or ≥55 y.o. and started within 5 days of symptoms onset.
• Median age 53; 46% male
• 87% White, 8% Black, 4% Asian, 65% Hispanic/Latino/a
• Common side effects: rash (1%) and diarrhea (2%)
• Remains active against Omicron
• Other monoclonal antibody treatments did not maintain effectiveness against
Omicron (e.g. bamlanivimab + etesevimab and casirivimab + imdevimab)
• Single intravenous (IV) infusion of 500 mg sotrovimab in ≥12 yrs and ≥40
kg.
• Treatment should be done ASAP and within 10 days of symptom onset.
• Monitoring during and for at least one hour post infusion in a setting that
can that can manage severe hypersensitivity reactions
SOTROVIMAB-EUA.PDF (gskpro.com)
Nonhospitalized Adults: Therapeutic Management | COVID-19 Treatment Guidelines (nih.gov)
Remdesivir
• PINETREE trial (N=562) RCT, placebo-controlled, ≥12 y.o. with at least one co-
morbidity or ≥60 y.o., treatment started within 5 days of symptom onset.
• Mean age 50 (only 8 were under 18), 52.1% male,
• 80.4% White, 7.5% Black, 2.5% Asian, 41.8% Hispanic or Latino/a
• Common side effects: nausea, headache, cough
• 3 Day Treatment: Once daily Remdesivir 200 mg IV on Day 1 and then 100
mg IV on Days 2 and 3, in ≥12+ and ≥40 kg.
• Treatment started ASAP and within 7 days of symptom onset.
• Monitoring during and at least one hour after infusion in a setting where
severe hypersensitivity reactions can be managed.
• NB: Use of dexamethasone 6 mg daily for up to 10 days can be given ONLY if person
should be hospitalized but cannot be. Remdesivir given for 5 days in this scenario.
• May have logistical constraints given three days of IV infusion.
Gottlieb RL, Vaca CE, Paredes R, et al. Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients. N
Engl J Med. 2022;386(4):305-315. doi:10.1056/NEJMoa2116846
Nonhospitalized Adults: Therapeutic Management | COVID-19 Treatment Guidelines (nih.gov)
Molnupiravir
• MOVe-OUT trial (N=1,433), RCT, placebo-controlled, ≥18 y.o. with at least one
co-morbidity or ≥60 y.o., treatment started within 5 days of symptom onset.
• Median age 43, 49% male
• 57% White, 5% Black, 3% Asian, 50% Hispanic or Latino/a
• Common side effects: diarrhea (2%), nausea (1%), and dizziness (1%)
• Molnupiravir 800 mg (four 200 mg capsules) po twice daily for 5 days.
• Use in ≥18 y.o. only (due to bone and cartilage toxicity in animal studies)
• ONLY as last resort, if the other treatments not available or unable to use.
FACT SHEET FOR HEALTHCARE PROVIDERS:
EMERGENCY USE AUTHORIZATION FOR
MOLNUPIRAVIR (fda.gov)
Nonhospitalized Adults: Therapeutic Management
| COVID-19 Treatment Guidelines (nih.gov)
Molnupiravir
• Pregnancy:
• Not recommended in pregnancy due to concerns about
instances of fetal toxicity observed during animal studies.
• May consider if high risk for severe infection and no other
treatments available; especially if past time of
embryogenesis (>10 wks gestation).
• Patients on molnupiravir should avoid pregnancy and
use contraception during and following molnupiravir.
• Women of childbearing age: during and for 4 days after
treatment.
• Men: avoid getting partner pregnant during and up to 3
months after treatment.
• Avoid feeding infant breast milk during and for 4 days
after treatment.
FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE AUTHORIZATION FOR MOLNUPIRAVIR (fda.gov)
Nonhospitalized Adults: Therapeutic Management | COVID-19 Treatment Guidelines (nih.gov)
CHC’s Paxlovid Policy & Procedure
Prescribing & Dispensing
• Inputting an EUA Medication into the Electronic Health Record
• Custom Medication
• Medication Interaction Data Bases
• Define the procedure to Prescribe
• Train to adding the medication to the note
• Define the procedure to Dispense
• Rapid Testing during visit
• PCR Testing
• At Home Rapid Test- results are per patient
• Train to the documentation-E.H.R Templates and dispensation
• Inventory updates to ensure exact count of regimen on site
Challenges & Opportunities
• Under Utilizations of Medications
• At home testing
• Patient awareness and education
• Provider education
• Limited time window (ex. 5 days)
• Limited availability at pharmacies and health centers
• Community Education
• Health Departments and educational campaigns
• Patient facing websites
• Patient Texts when testing positive
• Phone system updates
eCW Template: Paxlovid Treatment for COVID-19
• HPI:
• Complete Symptoms, Timeline, Risk Factors,
• Population Group, and Treatment Considerations
Post-Acute Sequelae of COVID PASC
(Long COVID)
Post-Acute Sequelae of COVID PASC (Long COVID)
• Various names:
• Post COVID Condition; Long COVID; Post-Acute Sequelae of COVID (PASC)
• Patients with condition: Long Haulers
• No agreed upon case definition.
• Persistent symptoms and/or organ dysfunction after acute COVID infection.
• CDC: recently defined as sequelae present > 4 weeks after initial infection.
• Other definitions: Ongoing symptomatic COVID (4-12 wks) and post-COVID-19
syndrome (>12 wks)
• Data still emerging and large NIH trial ongoing.
• Common findings include fatigue, joint pain, chest pain, palpitations,
shortness of breath, cognitive impairment, and worsened quality of life.
• Incidence rates vary widely from about 10% in some reports to one cohort
study in which 87% reported at least one persistent symptom.
• No specific treatments; only general management strategies.
main.pdf (nih.gov)
Clinical Spectrum | COVID-19 Treatment Guidelines (nih.gov)
Common Symptoms of Long COVID
• Respiratory symptoms
• Breathlessness; Cough
• Cardiovascular symptoms
• Chest tightness, Chest pain, Palpitations
• Generalized symptoms
• Fatigue, Fever, Pain
• Neurological symptoms
• Cognitive impairment (‘brain fog’, loss of
concentration or memory issues),
Headache, Sleep disturbance, Peripheral
neuropathy symptoms (pins and needles
and numbness), Dizziness, Delirium (in
older populations), Mobility impairment,
Visual disturbance.
• Gastrointestinal symptoms
• Abdominal pain, Nausea and vomiting,
Diarrhea, Weight loss and reduced
appetite
• Musculoskeletal symptoms
• Joint pain, Muscle pain
• Ear, nose and throat symptoms
• Tinnitus, Earache, Sore throat,
Dizziness, Loss of taste and/or smell,
Nasal congestion
• Dermatological symptoms
• Skin rashes, Hair loss
• Psychological/psychiatric symptoms
• Symptoms of depression, Symptoms of
anxiety, Symptoms of post-traumatic
stress disorder
• The following symptoms and signs are less
commonly reported in children and young
people than in adults
• Shortness of breath, Persistent cough,
Pain on breathing, Palpitations,
Variations in heart rate, Chest pain
main.pdf (nih.gov)
Clinical Spectrum | COVID-19 Treatment Guidelines (nih.gov)
Long COVID Studies
• CDC telephone survey study:
• N=292 adult outpatients
• 274 symptomatic, of which 35% reported not having returned to normal 2
weeks or more after testing.
• 26% of 18-34 y.o., 32% of 35-49, and 47% of 50+.
• 50+ and presence of 3+ chronic medical conditions associated with not
returning to usual health within 14-21 days.
• 1 in 5 people 18-34 who did not have a medical condition had not
returned to baseline health at a median of 16 days post testing date.
• Wuhan, China:
• N=1733 people, evaluated at median 186 days after symptom onset.
• Most common symptoms were fatigue or muscle weakness (63%) and
sleep difficulties (26%).
• Anxiety or depression reported among 23% of patients.
main.pdf (nih.gov)
Clinical Spectrum | COVID-19 Treatment Guidelines (nih.gov)
Long COVID Studies
• University of Washington:
• N=177
• Questionnaire completed between 3-9 months after illness onset.
• 91% were outpatients with 150 having mild illness and 11 with no symptoms.
• 9% had mod to severe disease that required hospitalization.
• 33% of outpatient and 31% of hospitalized patients reported at least one
persistent symptom.
• Persistent symptoms in 27% of 18-39 y.o; 30% of 40-64; and 43% of 65+.
• Most common: loss of sense of smell or taste and fatigue.
• Pregnancy: persistent symptoms have been reported.
• Children: case reports suggest may experience long term effects similar to
adults.
main.pdf (nih.gov)
Clinical Spectrum | COVID-19 Treatment Guidelines (nih.gov)
Long COVID Studies
• Fatigue:
• Irish study: N=128; 52.3% reported persistent fatigue at a median of 10
weeks. No association between illness severity and fatigue.
• Italy: N=143; 87% persistent symptoms for a mean of 60 days. Most
common was fatigue.
• Cardiopulmonary:
• UK: N=100 hospitalized patients (32 of which were ICU); 72% of ICU and
60% of ward patients experienced fatigue and breathlessness at 4-8 weeks
after discharge.
• China: retrospective study, N=57; pulm function by spirometry was still
impaired 1 month after discharge in 54.4%.
• Germany: N=100; cardiac MRI done a median of 71 days after diagnosis
showed cardiac involvement in 78% and ongoing myocardial inflammation
in 60%. main.pdf (nih.gov)
Clinical Spectrum | COVID-19 Treatment Guidelines (nih.gov)
Long COVID Studies
• Neuropsychiatric Symptoms:
• Anxiety and depression reported in high rates by self report scales.
• Younger patients reported more psych symptoms than those 60+.
• Patients may continue to experience for up to 3 months after:
• Headaches, vision changes, hearing loss, loss of taste and smell, impaired
mobility, numbness in extremities, and tremors, myalgia, memory loss,
cognitive impairment, and mood changes.
• One study in UK:
• Cognitive tests to 84,285 people after COVID.
• Performances worse across multiple domains expected for same ages and
demographic profiles.
• Observed in those also who were not hospitalized.
• Limitation: not reported when test done in relation to diagnosis.
main.pdf (nih.gov)
Clinical Spectrum | COVID-19 Treatment Guidelines (nih.gov)
Treatment for Long COVID
• Provide advice and information on self management.
• Managing symptoms.
• Setting realistic goals.
• Who to contact if worried about condition or need support.
• Sources of support, e.g. support groups, online forums, social care,
housing, employment, financial, and info about condition to share.
• Support with schools/employers about returning with paced return.
• Use a multidisciplinary approach to guide rehabilitation.
• Physical, psychological, and psychiatric.
• Develop a personalized rehabilitation and management plan.
• Include areas of rehab, goals, symptom monitoring and management
(including fluctuating symptoms and returning/changing symptoms)
main.pdf (nih.gov)
Clinical Spectrum | COVID-19 Treatment Guidelines (nih.gov)
Treatment for Long COVID
• Encourage patient to record recovery goals and any changes in
symptoms.
• Provide additional support for people who may be vulnerable such as
older people with complex needs.
• May include short term care packages, advance care planning, and
support with social isolation, loneliness, and bereavement, if relevant.
• Consider referral for specialist advice for children.
• Shared decision making.
• Follow up, monitoring, which healthcare professionals to involve.
• Be alert to symptoms developing that could mean referral or
investigation is needed.
main.pdf (nih.gov)
Clinical Spectrum | COVID-19 Treatment Guidelines (nih.gov)
THANK YOU!

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Recent Updates on COVID-19

  • 1. 23 March 2022 www.hospitaldaluz.pt
  • 2. Brief Timeline • 2019 – Dec 12: Cluster of cases from Wuhan – Dec 31: WHO - Huanan Seafood Market • 2020 – Jan 5: Chinese public health officials share the genetic sequence virus online – Jan 7: Novel coronavirus isolated; 2019-nCOV • Countries start reporting: Thailand, Japan – Jan 20: First case in the USA
  • 3. Brief Timeline • 2020 – Jan 31: SARS-CoV-2 virus a public health emergency – Feb 11: WHO announces the official name for the disease: COVID-19 – Feb 23: Italy ‘locks down’ – Mar 11: WHO finally calls it a “Pandemic” – Mar 15: States begin to ‘shut down’ – Mar 17: Moderna’s first human trials
  • 4. Brief Timeline • 2020 – Mar 31: FDA issues Emergency Use Authorization (EUA) for hydroxychloroquine – Apr 10: U.S. surpasses Italy as for deaths (23,036 deaths) – Apr 30: Trump launches Operation Warp Speed – May 1: EUA for antiviral drug remdesivir – May 9: U.S. unemployment rate at 14.7%, the worst since the Great Depression
  • 5. Brief Timeline • 2020 – May 28: US death toll tops 100,000 – Sept 22: Death toll tops 200,000 – Dec 11: FDA issues EUA for Pfizer vaccine – Dec 18: Then, Moderna vaccine – Dec 30: UK variant found in the US
  • 7. Brief Timeline • 2021 – Jan 18: Death toll passes 400,000 – Jan 25: Brazilian variant (Gamma) arrived in US – Jan 28: S. African variant (Beta) arrived in US – Feb 21: Death toll passes 500,000 – Feb 27: J&J vaccine EUA from FDA – Mar 13: 100,000,000 vaccinated – Apr 21: 200,000,000 vaccinated
  • 8. Brief Timeline • 2021 – June 1: Delta variant starts to wreak havoc in USA – July 30: Vaccinated CAN STILL have virus – Oct 21: Booster shots recommended 65+, others – Oct 29: Vaccine better than disease for immunity – Nov 2: Pfizer vaccine down to age 5
  • 9. Brief Timeline • 2021 – Nov 26: Omicron identified – Nov 29: CDC recommends ’18+’ get mRNA booster • 2022 – Jan 24: Estimated about 57% of the world has been infected by COVID-19 – March 6: Death count over 6 million
  • 10. 79,778,889 cases on 3/22/22 with 972,634 deaths https://coronavirus.jhu.edu/us-map COVID-19 in the United States: TOTAL
  • 13. Could New Variants Arise? • New Variant of Concern (VOC) – Very large viral burden globally – Mutating, mutating, mutating • Omicron: Highly mutated around the Spike protein – 43 spike protein mutations, compared to 18 for Delta variant
  • 14. Will Vaccines Cover for the Next Variant? • A surge of protective antibodies after a booster shot, helps to prevent severe illness – Dr. Fauci • Pfizer, Moderna: Have modified vaccine
  • 18. Anti-Virals - Game Changers?! • Pfizer: Paxlovid – strongly effective in preventing severe COVID when given to high-risk unvaccinated patients soon after they started showing symptoms • Merck: Molnupiravir (Lagevrio) – inhibits virus replication
  • 19. Paxlovid • Paxlovid (PF-07321332 + ritonavir) – SARS-CoV-2 protease inhibitor – Take at first sign of infection or awareness of an exposure – Help avoid severe illness – 89 percent if started within 3 days of symptoms • Fourth or fifth day, the pill reduced the risk of hospitalization or death by 85 percent
  • 21. Trusted Resources • Johns Hopkins https://coronavirus.jhu.edu/map.html • CDC https://www.cdc.gov/coronavirus/2019-ncov/index.html https://emergency.cdc.gov/coca/calls/2020/ • WHO: https://www.who.int/emergencies/diseases/novel-coronavirus-2019 • Others https://www.nytimes.com/interactive/2021/us/covid-cases.html https://www.thelancet.com/coronavirus https://covidactnow.org/
  • 22. March 23, 2022 Marwan Haddad MD, MPH (he/him) Veena Channamsetty, MD, FAAFP (she/her)
  • 23. Current Available COVID-19 Treatments in the U.S. For high risk, non-hospitalized patients (in order of recommendation): • Ritonavir-boosted Nirmatrelvir (Brand name Paxlovid in U.S.) • 88% relative reduction of hospitalization or death compared to placebo. • Sotrovimab • 85% relative reduction. • Remdesivir • 87% relative reduction. • Molnupiravir • 30% relative reduction. • ONLY if other 3 options are not available or cannot be used.
  • 24. CDC Risk Factors for Severe COVID Disease • Cancer • Cerebrovascular disease • Children with certain underlying conditions • Chronic kidney disease • Chronic lung disease • Chronic liver disease • Diabetes mellitus, type 1 and type 2 • Down syndrome • Heart conditions • HIV • Mental health disorders • Neurologic conditions • BMI > 25 • Pregnancy or recent pregnancy • Smoking (current and former) • Sickle cell disease or thalassemia • Solid organ or blood stem cell transplantation • Substance use disorders • Tuberculosis • Moderate to severe immunocompromised due to a medical condition or the use of corticosteroids or other immunosuppressive medications
  • 25. NIH Prioritization of Treatment (if logistical or supply constraints) • Statement on Patient Prioritization for Outpatient Therapies | COVID-19 Treatment Guidelines (nih.gov)
  • 26. Nirmatrelvir/Ritonavir (Paxlovid) • FDA issued EUA for outpatient oral treatment of mild-moderate COVID-19. • For patients ≥12 years, weighing ≥40 kg • At risk for severe COVID-19, including hospitalization or death. • Started ASAP after diagnosis AND within 5 days of symptom onset. • EUA based on EPIC-HR, RCT, placebo-controlled trial. • N=2,246 • Mean age 46 • 51% male • 72% White, 5% Black, 14% Asian, 45% Hispanic/Latino/a • Eligibility: 18+ with at least 1 of the following: • DM, BMI>25, chronic lung disease including asthma, chronic kidney disease, current smoker, immunosuppressive disease or treatment, CVD, HTN, sickle cell, neurodevelopmental disorders, active cancer, or ≥60 years. • Excluded if prior history of COVID infection or vaccination. Paxlovid HCP FS 02232022 (fda.gov)
  • 27. Dosing & Side Effects • Nirmatrelvir 300mg (two 150- mg capsules) AND 100 mg ritonavir (one 100 mg tablet) orally twice a day for 5 days (three tablets taken together twice daily for 5 days). • Can be taken with or without food. • Side Effects: Impaired sense of taste 6%; diarrhea 3%; hypertension 1%; myalgia 1% Paxlovid HCP FS 02232022 (fda.gov)
  • 28. Clinical Considerations • Pregnancy: – Trial excluded pregnant and lactating individuals. – Ritonavir used during pregnancy in HIV care • Suggests acceptable safety profile. – Mechanisms of action and available animal data suggest treatment can be used in pregnancy if potential benefits outweigh risks. • Shared decision-making. – Pregnancy is high risk for severe COVID-19 illness. • Lactation: – Can be used if potential benefits outweigh risks. • Shared decision-making. • Pediatric population: – Authorized in ≥ 12 y.o. and ≥ 40 kg. – Safety and efficacy not established in trials. Paxlovid HCP FS 02232022 (fda.gov)
  • 29. Dosing Considerations & Usage – Renal Impairment • Mild (eGFR 60-90 mL/min)- No adjustment needed. • Moderate (eGFR 30-60 mL/min)- Nirmatrelvir 150mg (one 150-mg capsules) AND 100 mg ritonavir (one 100 mg tablet) orally twice a day for 5 days (two tablets taken together twice daily for 5 days). • Severe (eGFR <30 mL/min)- currently NOT recommended. – Hepatic Impairment • Mild-Moderate(Child-Pugh Class A/B)- No adjustment needed. • Severe (Child-Pugh Class C)- NOT recommended. Paxlovid HCP FS 02232022 (fda.gov)
  • 30. Contraindications • History of clinically significant hypersensitivity reactions to its active ingredients (nirmatrelvir or ritonavir) or any other components. Warnings • Hepatotoxicity: • Caution in patients with pre-existing liver diseases, liver enzyme abnormalities, or hepatitis. • Hepatic transaminase elevations, clinical hepatitis, and jaundice have occurred in patients receiving ritonavir. • Risk of HIV-1 resistance: • In individuals with uncontrolled or undiagnosed HIV, there may be a risk of developing resistance to HIV protease inhibitors because nirmatrelvir is co- administered with ritonavir. Paxlovid HCP FS 02232022 (fda.gov)
  • 31. Drug Interactions • Prescribed and over the counter medications MUST be checked for interactions before prescribing nirmatrelvir/ritonavir. • https://www.covid19-druginteractions.org/checker. • Management of potential drug interactions can include • Not prescribing, if serious/life threatening interactions expected. • Holding medication that interacts with nirmatrelvir/ritonavir during the 5-day therapy, if can be done safely. • Monitoring for interactions/side effects.
  • 32. Sotrovimab • Monoclonal Antibody Treatment • COMET-ICE trial (N=1057): RCT, placebo-controlled, ≥18 with at least one co-morbidity or ≥55 y.o. and started within 5 days of symptoms onset. • Median age 53; 46% male • 87% White, 8% Black, 4% Asian, 65% Hispanic/Latino/a • Common side effects: rash (1%) and diarrhea (2%) • Remains active against Omicron • Other monoclonal antibody treatments did not maintain effectiveness against Omicron (e.g. bamlanivimab + etesevimab and casirivimab + imdevimab) • Single intravenous (IV) infusion of 500 mg sotrovimab in ≥12 yrs and ≥40 kg. • Treatment should be done ASAP and within 10 days of symptom onset. • Monitoring during and for at least one hour post infusion in a setting that can that can manage severe hypersensitivity reactions SOTROVIMAB-EUA.PDF (gskpro.com) Nonhospitalized Adults: Therapeutic Management | COVID-19 Treatment Guidelines (nih.gov)
  • 33. Remdesivir • PINETREE trial (N=562) RCT, placebo-controlled, ≥12 y.o. with at least one co- morbidity or ≥60 y.o., treatment started within 5 days of symptom onset. • Mean age 50 (only 8 were under 18), 52.1% male, • 80.4% White, 7.5% Black, 2.5% Asian, 41.8% Hispanic or Latino/a • Common side effects: nausea, headache, cough • 3 Day Treatment: Once daily Remdesivir 200 mg IV on Day 1 and then 100 mg IV on Days 2 and 3, in ≥12+ and ≥40 kg. • Treatment started ASAP and within 7 days of symptom onset. • Monitoring during and at least one hour after infusion in a setting where severe hypersensitivity reactions can be managed. • NB: Use of dexamethasone 6 mg daily for up to 10 days can be given ONLY if person should be hospitalized but cannot be. Remdesivir given for 5 days in this scenario. • May have logistical constraints given three days of IV infusion. Gottlieb RL, Vaca CE, Paredes R, et al. Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients. N Engl J Med. 2022;386(4):305-315. doi:10.1056/NEJMoa2116846 Nonhospitalized Adults: Therapeutic Management | COVID-19 Treatment Guidelines (nih.gov)
  • 34. Molnupiravir • MOVe-OUT trial (N=1,433), RCT, placebo-controlled, ≥18 y.o. with at least one co-morbidity or ≥60 y.o., treatment started within 5 days of symptom onset. • Median age 43, 49% male • 57% White, 5% Black, 3% Asian, 50% Hispanic or Latino/a • Common side effects: diarrhea (2%), nausea (1%), and dizziness (1%) • Molnupiravir 800 mg (four 200 mg capsules) po twice daily for 5 days. • Use in ≥18 y.o. only (due to bone and cartilage toxicity in animal studies) • ONLY as last resort, if the other treatments not available or unable to use. FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE AUTHORIZATION FOR MOLNUPIRAVIR (fda.gov) Nonhospitalized Adults: Therapeutic Management | COVID-19 Treatment Guidelines (nih.gov)
  • 35. Molnupiravir • Pregnancy: • Not recommended in pregnancy due to concerns about instances of fetal toxicity observed during animal studies. • May consider if high risk for severe infection and no other treatments available; especially if past time of embryogenesis (>10 wks gestation). • Patients on molnupiravir should avoid pregnancy and use contraception during and following molnupiravir. • Women of childbearing age: during and for 4 days after treatment. • Men: avoid getting partner pregnant during and up to 3 months after treatment. • Avoid feeding infant breast milk during and for 4 days after treatment. FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE AUTHORIZATION FOR MOLNUPIRAVIR (fda.gov) Nonhospitalized Adults: Therapeutic Management | COVID-19 Treatment Guidelines (nih.gov)
  • 36. CHC’s Paxlovid Policy & Procedure
  • 37. Prescribing & Dispensing • Inputting an EUA Medication into the Electronic Health Record • Custom Medication • Medication Interaction Data Bases • Define the procedure to Prescribe • Train to adding the medication to the note • Define the procedure to Dispense • Rapid Testing during visit • PCR Testing • At Home Rapid Test- results are per patient • Train to the documentation-E.H.R Templates and dispensation • Inventory updates to ensure exact count of regimen on site
  • 38. Challenges & Opportunities • Under Utilizations of Medications • At home testing • Patient awareness and education • Provider education • Limited time window (ex. 5 days) • Limited availability at pharmacies and health centers • Community Education • Health Departments and educational campaigns • Patient facing websites • Patient Texts when testing positive • Phone system updates
  • 39. eCW Template: Paxlovid Treatment for COVID-19 • HPI: • Complete Symptoms, Timeline, Risk Factors, • Population Group, and Treatment Considerations
  • 40. Post-Acute Sequelae of COVID PASC (Long COVID)
  • 41. Post-Acute Sequelae of COVID PASC (Long COVID) • Various names: • Post COVID Condition; Long COVID; Post-Acute Sequelae of COVID (PASC) • Patients with condition: Long Haulers • No agreed upon case definition. • Persistent symptoms and/or organ dysfunction after acute COVID infection. • CDC: recently defined as sequelae present > 4 weeks after initial infection. • Other definitions: Ongoing symptomatic COVID (4-12 wks) and post-COVID-19 syndrome (>12 wks) • Data still emerging and large NIH trial ongoing. • Common findings include fatigue, joint pain, chest pain, palpitations, shortness of breath, cognitive impairment, and worsened quality of life. • Incidence rates vary widely from about 10% in some reports to one cohort study in which 87% reported at least one persistent symptom. • No specific treatments; only general management strategies. main.pdf (nih.gov) Clinical Spectrum | COVID-19 Treatment Guidelines (nih.gov)
  • 42. Common Symptoms of Long COVID • Respiratory symptoms • Breathlessness; Cough • Cardiovascular symptoms • Chest tightness, Chest pain, Palpitations • Generalized symptoms • Fatigue, Fever, Pain • Neurological symptoms • Cognitive impairment (‘brain fog’, loss of concentration or memory issues), Headache, Sleep disturbance, Peripheral neuropathy symptoms (pins and needles and numbness), Dizziness, Delirium (in older populations), Mobility impairment, Visual disturbance. • Gastrointestinal symptoms • Abdominal pain, Nausea and vomiting, Diarrhea, Weight loss and reduced appetite • Musculoskeletal symptoms • Joint pain, Muscle pain • Ear, nose and throat symptoms • Tinnitus, Earache, Sore throat, Dizziness, Loss of taste and/or smell, Nasal congestion • Dermatological symptoms • Skin rashes, Hair loss • Psychological/psychiatric symptoms • Symptoms of depression, Symptoms of anxiety, Symptoms of post-traumatic stress disorder • The following symptoms and signs are less commonly reported in children and young people than in adults • Shortness of breath, Persistent cough, Pain on breathing, Palpitations, Variations in heart rate, Chest pain main.pdf (nih.gov) Clinical Spectrum | COVID-19 Treatment Guidelines (nih.gov)
  • 43. Long COVID Studies • CDC telephone survey study: • N=292 adult outpatients • 274 symptomatic, of which 35% reported not having returned to normal 2 weeks or more after testing. • 26% of 18-34 y.o., 32% of 35-49, and 47% of 50+. • 50+ and presence of 3+ chronic medical conditions associated with not returning to usual health within 14-21 days. • 1 in 5 people 18-34 who did not have a medical condition had not returned to baseline health at a median of 16 days post testing date. • Wuhan, China: • N=1733 people, evaluated at median 186 days after symptom onset. • Most common symptoms were fatigue or muscle weakness (63%) and sleep difficulties (26%). • Anxiety or depression reported among 23% of patients. main.pdf (nih.gov) Clinical Spectrum | COVID-19 Treatment Guidelines (nih.gov)
  • 44. Long COVID Studies • University of Washington: • N=177 • Questionnaire completed between 3-9 months after illness onset. • 91% were outpatients with 150 having mild illness and 11 with no symptoms. • 9% had mod to severe disease that required hospitalization. • 33% of outpatient and 31% of hospitalized patients reported at least one persistent symptom. • Persistent symptoms in 27% of 18-39 y.o; 30% of 40-64; and 43% of 65+. • Most common: loss of sense of smell or taste and fatigue. • Pregnancy: persistent symptoms have been reported. • Children: case reports suggest may experience long term effects similar to adults. main.pdf (nih.gov) Clinical Spectrum | COVID-19 Treatment Guidelines (nih.gov)
  • 45. Long COVID Studies • Fatigue: • Irish study: N=128; 52.3% reported persistent fatigue at a median of 10 weeks. No association between illness severity and fatigue. • Italy: N=143; 87% persistent symptoms for a mean of 60 days. Most common was fatigue. • Cardiopulmonary: • UK: N=100 hospitalized patients (32 of which were ICU); 72% of ICU and 60% of ward patients experienced fatigue and breathlessness at 4-8 weeks after discharge. • China: retrospective study, N=57; pulm function by spirometry was still impaired 1 month after discharge in 54.4%. • Germany: N=100; cardiac MRI done a median of 71 days after diagnosis showed cardiac involvement in 78% and ongoing myocardial inflammation in 60%. main.pdf (nih.gov) Clinical Spectrum | COVID-19 Treatment Guidelines (nih.gov)
  • 46. Long COVID Studies • Neuropsychiatric Symptoms: • Anxiety and depression reported in high rates by self report scales. • Younger patients reported more psych symptoms than those 60+. • Patients may continue to experience for up to 3 months after: • Headaches, vision changes, hearing loss, loss of taste and smell, impaired mobility, numbness in extremities, and tremors, myalgia, memory loss, cognitive impairment, and mood changes. • One study in UK: • Cognitive tests to 84,285 people after COVID. • Performances worse across multiple domains expected for same ages and demographic profiles. • Observed in those also who were not hospitalized. • Limitation: not reported when test done in relation to diagnosis. main.pdf (nih.gov) Clinical Spectrum | COVID-19 Treatment Guidelines (nih.gov)
  • 47. Treatment for Long COVID • Provide advice and information on self management. • Managing symptoms. • Setting realistic goals. • Who to contact if worried about condition or need support. • Sources of support, e.g. support groups, online forums, social care, housing, employment, financial, and info about condition to share. • Support with schools/employers about returning with paced return. • Use a multidisciplinary approach to guide rehabilitation. • Physical, psychological, and psychiatric. • Develop a personalized rehabilitation and management plan. • Include areas of rehab, goals, symptom monitoring and management (including fluctuating symptoms and returning/changing symptoms) main.pdf (nih.gov) Clinical Spectrum | COVID-19 Treatment Guidelines (nih.gov)
  • 48. Treatment for Long COVID • Encourage patient to record recovery goals and any changes in symptoms. • Provide additional support for people who may be vulnerable such as older people with complex needs. • May include short term care packages, advance care planning, and support with social isolation, loneliness, and bereavement, if relevant. • Consider referral for specialist advice for children. • Shared decision making. • Follow up, monitoring, which healthcare professionals to involve. • Be alert to symptoms developing that could mean referral or investigation is needed. main.pdf (nih.gov) Clinical Spectrum | COVID-19 Treatment Guidelines (nih.gov)

Editor's Notes

  1. Scholand - 11/17: Welcome everyone – today’s topic is Community Engagement…
  2. 11/30/21 28-Day: 2,315,007 | 30,148 Totals: 48,454,229 | 778,870
  3. Intro: Here you can see from the map the ‘hot spots’ occurring around the country. The Darker colors mean more active infections
  4. 11/30: Resistance to the decline we saw…
  5. Molnupiravir: nucleoside derivative N4-hydroxycytidine (also called EIDD[4]-1931), and exerts its antiviral action through introduction of copying errors during viral RNA replication incorporates NHC-TP into newly made RNA instead of using real cytidine
  6. ritonavir helps slow the metabolism, or breakdown, of PF-07321332 in order for it to remain active in the body for longer periods of time at higher concentrations Phase 2/3 EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) to evaluate efficacy and safety in adults exposed to SARS-CoV-2 by a household member.
  7. End of Scholand’s slides
  8. 12/1: Welcome everyone – today’s topic is Supporting Staff During COVID-19
  9. Veena and Marwan’s own updates on COVID-19 and/or info on how to best kick off this series
  10. Dispense follows sample policy
  11. Providers call is experiment, many phamr don’t dispense. If they do, still need a prescription from a provider who is aware and comfortable.