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PHARMACOTHERAPY OF COVID-19
2021-6-12亞東紀念醫院內科加護病房
張厚台
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大綱
Case Sharing , Pathology process of SARS Cov 2, clinical spectrum Pharmacologic intervention in COVID Monoclonal antibody: SARS-CoV-2 Neutralizing Antibody Antiviral agents : Remdesivir ,baricitinib Anti-inflammation agents : corticosteroid , IL-6 antagonist Anticoagulants
Potential pharmacologic strategy for COVID-19 treatment
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Dexamethasone 6mg/d
Remdesivir 200mg, st and 100 mg, qd* 5d
O2NC O2
SM O2NRM
O2 SM
35 y/o female, husband :萬華果菜市場Nasal Swab (5/22) : SARS-Cov-2 RNA (+) Lym: 738 -> 1225 D D dimer: 407CRP: 0.584, PCT:0.05LDH: 228
Risk Factors: Age >65 y/o (-) , BMI>35 (-) , immunocompromise(-), HTN (-) , DM (-)
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Clinical spectrum of SARS-Cov-2 infection
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Classification Asympto-matic
Mild Moderate Severe Critical
Definition NAAT(+) S/S of COVID fever, smell(-)CXR(-)
SpO2>94% ,at RAS/S of LRI,
SpO2 <94% , at RAPaO2/FiO2 <300 mm Hg,RR >30/min, or lung infiltrates >50%.
respiratory failure, septic shock, and/or multiple organ dysfunction.
% 81% 14% 5%
Treatment (I) SARS-Cov neutralizing antibody *bamlanivimab plus etesevimabor *casirivimab plus imdevimab
DexDex +RDV (Incr. O2)RDV
DexDex +TCZ
Treatment (2) Baricitinib +RDV LMWH
NIH guideline 新型冠狀病毒(SARS-CoV-2)感染臨床處置暫行指引
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Pathology process of SARS-CoV-2
ZHOU ET AL. J Med Virol. 2021; 1–11.Eur Respir J 2021; in press
Initial stage: fever , cough…highest viral load in 7 days 2nd stage: dysfunctional host inflammatoryresponse => lung inflammation and lung injury follows
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Risk of progressive to severe COVID• Older age ( ≥65 years of age) • Obesity ( BMI >25 kg/m2, or 12-17y/o: BMI ≥85th )• Pregnancy , Chronic kidney disease , Diabetes ,Immunosuppressive
disease or immunosuppressive treatment , Sickle cell disease Cardiovascular disease (including congenital heart disease) or
hypertension Chronic lung diseases (ex: COPD, asthma [moderate-to-severe],
interstitial lung disease, cystic fibrosis, and pulmonary hypertension) Neurodevelopmental disorders (for example, cerebral palsy) Having a medical-related technological dependence (ex, tracheostomy,
gastrostomy, or positive pressure ventilation [not related to COVID 19]) Defined by EUA2021/6/12 6
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ZHOU ET AL. J Med Virol. 2021;1–11..2021/6/12 7
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Hajjar et al. Ann. Intensive Care (2021) 11:36
Viral cycle
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SARS-COV-2 NEUTRALIZING ANTIBODY
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SARS-CoV-2 neutralzing antibody
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Antibody Therapeutics, 2020, Vol. 3, No. 4 246–256Viruses 2021, 13, 628.
* Targeting spike protein* Neutralize SARS Cov 2• Cocktail strategy - Two nAb
cocktails (casirivimab1200mg/ imdevimab 1200mg and bamlanivimab700mg/etesevimab 1200 mg )
• Mild to moderate , risk (+)• Within 10 days of symptoms
onset, not hospitalized
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台灣專家會議決議
Casirivimab/ imdevimab and bamlanivimab /etesevimab 具以下任一風險因子: 未使用氧氣, 且發病七天內之成人病患
風險因子: (1). 年齡> 65 y/o * 註: 因最近進量限制, 先訂75歲以上且具以下共病者
(2). 年齡> 55 y/o, 且具以下任一情形: 糖尿病、慢性腎病、心血管疾病( 含高血壓) 、慢性肺疾、BMI >30, 或其他影響免疫功能疾病
(3), 懷孕
劑量: 600mg casirivimab +600mg imdevimab ;
700mg Bamlanivimab+1400mg etesevimab2021/6/12 11
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ANTIVIRAL AGENTS Remdesivir
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JAMA. 2020;323(18):1824-1836
virus-induced host immune system response and viral processing within target cells
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Remdesivir
GS-5734, Remdesivir inhibits viral RNA-dependent RNA polymerase, causing premature termination of RNA transcription, inhibit SARS-CoV-1 and MERS -CoV
Dosage: D1: 200mg, Loading; D2-D10 or discharge: 100mg maintenance
Remdesivir is recommended for hospitalized patients with COVID-19 disease
Remdesivir: shorter time to recovery , in the ordinal scale score at day 15 Lower mortality at D15, prevented the progression to more severe respiratory
disease
Remdesivir for the Treatment of Covid-19 — Final Report. N Engl J Med 2020;383:1813-26. DOI: 10.1056/NEJMoa2007764 14
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Recommendation 10: In patients on supplemental oxygen but not on mechanical ventilation or ECMO, the IDSA panel suggests treatment with five days of remdesivir rather than 10 days of remdesivir.• Remark: In patients on mechanical ventilation or ECMO, the duration of treatment is 10 days.
Recommendation 9: In hospitalized patients with severe* COVID-19, the IDSA panel suggests remdesivir over no antiviral treatment. • Remdesivir appears to demonstrate the most benefit in those with severe COVID-19 on supplemental oxygen rather than in patients on mechanical ventilation or ECMO.
http://www.idsociety.org/COVID19guidelines
IDSA guideline1
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Remdesivir for the Treatment of Covid-19 — Final Report
The mortality rate (day 15) was 6.7% (remdesivir): 11.9% (placebo)
Median time to recovery:
10 (remdesivir) vs. 15( placebo)=> Lower mortality and Faster recovery !!
Serious adverse events were reported in 24.6% of remdesivir patients and 31.6% of placebo patients
Remdesivir for the Treatment of Covid-19 — Final Report. N Engl J Med 2020;383:1813-26.
Adaptive Covid-19 Treatment Trial (ACTT-1)
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Remdesivir for the Treatment of Covid-19 — Final Report. N Engl J Med 2020;383:1813-26. 17
International Journal of Infectious Diseases 106 (2021) 71–7774
Real world data: Symptoms onset to RDV Tx <9 days Better survival
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Remdesivir for the Treatment of Covid-19 — Final Report. N Engl J Med 2020;383:1813-26.
Hospitalized+O2 NIV MV/ECMO
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55 y/o FBH:150cm, BH: 86Kg* 5/26 COV(+)* 5/30 喘* Refer from 趣淘檢疫旅館5/31, 1: 37AM 抵達ER , SpO2:74-80% at room air* 3:27AM Dexamethasone6mg, iv st* CRP: 15.1 ,RR: 45/min, SpO2 89-90% under NRM 15L/min* 6:48AM intubation * 7:30AM TCZ , 600mg , ivd* 8:45AM ICU
D4-D6
6/10 拔管
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ANTI-INFLAMMATIONCorticosteroid , tocilizumab (TCZ)
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ARDS
Dexamethasone
SARS-CoV-2Cytokine storm
European Journal of Pharmacology 894 (2021) 173854
IL-6 antagonist
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IDSA guideline2
Recommendation 4: Among hospitalized critically ill patients* with COVID-19, the IDSA guideline panel recommends dexamethasone rather than no dexamethasone. (Strong recommendation, Moderate certainty of evidence)
equivalent : methylprednisolone 32 mg and prednisone 40 mg *Critical illness: Patients on mechanical ventilation and extracorporeal mechanical oxygenation (ECMO). In COVID-19, the most commonly reported form of end organ dysfunction is ARDS
**Severe illness: SpO2 ≤94% on room air, including patients on supplemental oxygen.
http://www.idsociety.org/COVID19guidelines2021/6/12 22
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Systemic Corticosteroids
We recommend systemic corticosteroids for COVID-19 positive patients who are critically ill or require supplemental oxygen
Dosing regimens to consider include:✔ Dexamethasone 6mg IV or PO daily x 10 days✔ Hydrocortisone 50mg IV Q8h x 10 days✔ Methylprednisolone 15mg IV BID x 10 days✔ Prednisone 40mg PO daily x 10 days
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Dexamethasone in Hospitalized Patients with Covid-19 — N Engl J Med 2021;384:693-704
1. IMV at randomization 2. Age-adjusted
mortality reduction :12.3%
29.3% vs 41.4%22.9% vs. 25.7% (p<0.001) 23.3% vs. 26.2%
Age-adjusted mortality reduction : 4.2%
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Dexamethasone in Hospitalized Patients with Covid-19 — N Engl J Med 2021;384:693-7042021/6/12 25
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JAMA. 2020;324(13):1330-1341
Prospective meta-analysis that pooled data from 7 randomized clinical trials that evaluated the efficacy of corticosteroids in 1703 critically ill patients with COVID-19There were 222 deaths randomized to corticosteroids (n=678) and 425 deaths randomized to usual care or placebo (n=1025) (odds ratio 0.66, 95% CI 0.53-0.82, p<0.001)A class effect of steroids (odds ratio 0.70, 95% CI 0.48-1.01,p=0.053)
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JAMA. 2020;324(13):1330-1341
Dexmethasone Hydrocortisone Methylprednisolone
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Association Between Administration of Systemic Corticosteroids and Mortality Among Critically Ill Patients With COVID-19. JAMA. 2020;324(13):1330-1341. 2021/6/12 28
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IL-6 antagonists
IL-6: recombinant humanized monoclonal antibody, directed against both the soluble and the membrane bound IL-6 receptor,
Acute-phase response, released in response to infection, stimulates inflammatory pathways
Tocilizumab and sarilumab Treatment of Rheumatic arthritis and cytokine release syndrome
associated with CAR-T cell therapy Dosage: by BW, infusion>1hr , 2nd dose: 12-24hrs later Harms: risk of infections , 亦容易引起HBV reactivation
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~This article was published on February 25, 2021, at NEJM.org.
• Tocilizumab (TCZ): 353 8mg/kg/d
• Sarilumab (SAR) :48400mg
• Standard care (402)(Control)
• COVID-19 pts , < 24 hrsof organ support in ICU
21d OSFD- OR: 1.65
Improved 90d survival
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• 14 April 2020 and 24 January 2021 2022 TCZ: 2094 usual care 562 pts (14%) IMV, 1686 (41% ) noninvasive resp support
* Median CRP: 143 mg/L, 82% with corticosteroid * 28-d mortality : TCZ: Usual care (UC) =29% vs. 33% ((rate ratio 0·86, p=0.007 )* Discharge from hospital : TCZ: UC= 54% vs. 47% ( rate ratio 1·22 , p<0·0001 )• Receipt of IMV: 33% vs. 38% (RR: 0.85, p=0.0005)=> In COVID+ hypoxia+systemic inflammation , TCZ improved survival
this version posted February 11, 2021. ; https://doi.org/10.1101/2021.02.11.21249258doi: medRxiv preprint 2021/6/12 31
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28-d mortality this version posted February 11, 2021. https://doi.org/10.1101/2021.02.11.21249258doi: medRxiv preprint
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reduced the likelihood of progression to MV
N Engl J Med 2021;384:20-30.
* For critical COVID-19 pneumonia , under HFNC or high level O2 flow ** Early after intubation
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*IDSA Recommendation 7: progressive severe* or critical** COVID-19 who have elevated markers of systemic inflammation, the IDSA guideline panel suggests tocilizumab in addition to standard of care (i.e., steroids)**In the largest trial on the treatment of tocilizumab, criterion for systemic inflammation was defined as CRP ≥75 mg/L.
*ERS:- The patients most likely to benefit are those:o in the first 24 hours after receiving non-invasive or invasive
ventilatory support patients receiving supplementary oxygen and who are progressing despite corticosteroid treatment or who are considered at high risk of future requirement for ventilatory support.
Guidelines about IL-6 antagonists
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NIH guideline (2021-3-5) Tocilizumab ( 8 mg/kg of actual body weight, up to 800 mg) in
combination with dexamethasone (6 mg daily for up to 10 days) in rapid respiratory decompensation due to COVID-19
Ex: (ICU) within the prior 24 hours and who require invasive mechanical ventilation, or high-flow nasal canula (HFNC) oxygen (>0.4 FiO2/30 L/min of oxygen flow)
(not in an ICU) with rapidly increasing oxygen needs who require NIV or HFNC and have significantly increased markers of inflammation (CRP>75mg/L)
Suggestion for IL-6 antagonists2
~ REMAP-CAP preliminary report2021/6/12 34
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Baricitinib
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1. selective, efficient and safe janus kinase 1 (JAK1) and 2 (JAK2) inhibitor approved for usage in rheumatoid arthritis treatment2. inhibits the intracellular signaling pathway of cytokines implicated in severe COVID-19, including IL-2, IL-6,IL-10, IFN-, and granulocyte-macrophage colony-stimulating factor (GM-CSF)3. inhibition of both AP2-associated protein kinase 1 (AAK1) and cyclin G-associated kinase (GAK). Thus, preventing endocytosis and reducing viral assembly 4. Combined with RDV
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Anticoagulant treatment in COVID-19
SARS-CoV-2 induced complement hyperactivation, endothelial dysfunction and cytokine storm have a prothrombotic effect.
COVID 19 patients develop a pro-coagulative state directly related to disease severity.
In COVID 19 critical patients, thrombotic lesions in pulmunarymicrovessels have a prevalence twice higher than critical non-COVID 19 patients. Prevalence of PE among COVID 19 in ICU : 20% Anticoagulant treatment is associated with lower in-hospital
mortality.
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Journal of Thrombosis and Thrombolysis (2021) 51:642–648CCM 2021 online
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Anticoagulants in COVID 19-proposed algorithm
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Journal of Thrombosis and Thrombolysis (2021) 51:642–648
* D dimer: 6 times the upper limit of normal
* ISTH score: PLT, D dimer, PT, fibrinogen
Better results inin patients with
respiratory failure requiring invasive
ventilation.
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Disease Severity Recommendations
NIH guidelines
Rapid resp decompendations: TCZ (8mg/kg)+ Dexamethasone (6mg/d)* 10 d
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Take home message
Pharmacotherapy strategy in different severity and different stages of COVID-19 illness Mild to moderate but high risk : casirivimab/ imdevimab,
bamlanivimab/etesevimab Severe illness : O2 needed to maintain SpO2>94% , hospitalization Remdesivir : organ support D1: 200mg, Loading; D2-D10 or discharge: 100mg maintenance
Critical illness: COVID-19 +end organ damage (ARDS, etc ) Dexamethasone iv/oral , 6mg/day *10 days +/- remdesivir Dexamethasone iv/oral + / followed by Tocilizumab addition
Rapid respiratory decompensation: 新的O2 setting 24 小時內+ CRP>75mg/L Dexamethasone *10 days + Tocilizumab (IL-6 antagonist) 8mg/d*1-2 doses
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THANKS FOR YOUR ATTENTION
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Therapy Recommendations Recommendation Quality of evidence
Corticosteroids
The panel recommends offeringtreatment with corticosteroids forpatients with COVID-19 requiringoxygen, non-invasive ventilation or invasive mechanical ventilation
Strong Moderate
IL-6 receptorantagonistmonoclonalantibody
The panel suggests offering IL-6receptor antagonist monoclonalantibody therapy to hospitalized patients with COVID-19 requiring oxygen or ventilatory support
Conditional Low
Remdesivir No recommendation is maderegarding the use of remdesivir inpatients hospitalised with COVID-19 and not requiring invasive mechanical ventilationThe panel suggests not to offerremdesivir to patients hospitalisedwith COVID-19 infection who require invasive mechanical ventilation
None
Conditional
Moderate
Moderate
A European Respiratory Society living guideline. Eur Respir J 2021; in press2021/6/12 42
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ICU admission criteria
14% developed a severe form of the disease => hospitalization, 5% were critical => ICU admission
Severe: respiratory rates ≥ 30 breaths/min oxygen saturation ≤ 93%, lung infiltrates > 50% at high risk for clinical deterioration and critical illness => ARDS
在hospitalization中有 25% 需要 ICU admission , ICU admission中60-70% 為acute hypoxemic respiratory failure
Risk factors for ARDS: Age>65y/o, T>39C, Lab data abn ( lymphocytopenia, neutrophilia, hepato-renal failure,
inflammatory marker , coagulation abn )Hajjar et al. Ann. Intensive Care (2021) 11:36
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