This Protocol is adapted from the World Health Organization recommendations and reflects the current expert opinion of staff from Montefiore’s Antimicrobial Stewardship Program, Infectious Diseases Division, and Pharmacy. Clinical efficacies of these agents are still under investigation at this time. Treatments of COVID-19 are evolving as we gain more clinical experiences along with more published data. Supportive care remains the mainstay of treatment. The availability of certain agents may be limited due to supply chain disruptions and backorders. For suspected or confirmed cases requiring treatments listed below, please consult Infectious Diseases and notify Infection Prevention and Control Departments immediately.

1. Coronavirus Disease 2019 (COVID-19) Treatment Protocol
Antimicrobial Stewardship; Revision Date: March 18, 2020
This Protocol is adapted from World Health Organization recommendations and reflects the current expert opinion of staff from
Montefiore’s Antimicrobial Stewardship Program, Infectious Diseases Division and Pharmacy. Clinical efficacies of these agents are
still under investigation at this time. Treatments of COVID-19 are evolving as we gain more clinical experiences along with more
published data. Supportive care remains the mainstay of treatment. Availability of certain agents may be limited due to supply
chain disruptions and back orders. For suspected or confirmed cases requiring treatments listed below, please consult Infectious
Diseases and notify Infection Prevention and Control Departments immediately.
Please Note: 1) Check G6PD status upon initiation of chloroquine and hydroxychloroquine, however, therapy should NOT be delayed
while result is pending. 2) Please also see dosing with renal adjustment and pregnancy category for antivirals for COVID-19 in
Appendix B. 3) At discharge, outpatient treatment is generally not required if there has been steady and significant improvement
in signs and symptoms. Further, the treatments listed may be unavailable from pharmacies due to limited supply. Consult ID if
there are questions about treatment duration.
CONFIRMED SARS-CoV-2 PCR Positive with Lower Respiratory Tract Signs
Highly Suspected COVID-19 with Lower Respiratory Tract Signs
Discontinue antivirals
Continue Chloroquine or
Hydroxychloroquine with supportive care
See Treatment for Confirmed SARS-CoV-2
PCR positive
SARS-CoV-2 PCR Pending
SARS-CoV-2
PCR Negative
SARS-CoV-2 PCR Positive
Start Chloroquine 500mg PO q12h (preferred) or Hydroxychloroquine 400mg PO daily
Severe (requiring ventilator support or ICU care)*: Chloroquine 500mg PO q12h (preferred) or Hydroxychloroquine 400mg
PO daily
Remdesivir IV (investigational drug) 200mg once, then 100mg IV daily.
Please see Appendix A for inclusion/exclusion criteria for Adaptive COVID-19 Treatment Trial or Compassionate Use Trial.
Plus
*Duration for severe disease is up to 10 days; ID consult assistance strongly recommended
Non-severe (not requiring ventilator support or ICU care): Monotherapy Chloroquine 500mg PO q12h (preferred) or
Hydroxychloroquine 400mg PO daily x up to 5 days (in most cases)

2. Appendix A- Clinical Trials
Remdesivir Adaptive COVID-19 Treatment Trial (ACTT)*
Inclusion Criteria Exclusion Criteria
1. Hospitalized male or non-pregnant female adults >18 years
of age.
2. Consent is obtained.
3. Confirmed SARS-CoV-2 by PCR <72 hours prior to
randomization.
4. Illness of any duration with at least one of the following:
 Radiographic infiltrates by imaging
 Evidence of rales/crackles on exam AND SpO2 <94%
on room air
 Requiring supplemental oxygen
 Requiring mechanical ventilation
1. ALT/AST > 5 times the upper limit of normal.
2. eGFR <50 or require dialysis.
3. Pregnancy or breast feeding.
4. Anticipated transfer to another hospital which is not a study
site within 72 hours.
5. Allergy to any study medication.
*Qualified patient can be enrolled in ACTT at Moses and Einstein campuses
Remdesivir Compassionate Use Trial**
Inclusion Criteria Exclusion Criteria
1. Hospitalization
2. Confirmed SARS-CoV-2 by PCR
3. Invasive mechanical ventilation
1. Evidence of Multi-organ failure
2. Pressor requirement to maintain blood pressure
3. ALT levels > 5 X ULN
4. Cr Clearance <30 mL/min or dialysis or Continuous Veno-
Venous Hemofiltration
**Qualified patient can be enrolled in Compassionate Use Trial at all campuses
Appendix B-Antivirals
Medication
Oral Solution
Available?
Currently
studied for
COVID-19?
Proposed Dose for COVID-19
Renal Dosing
(CrCl, ml/min)
Adverse Effect Pregnancy
Chloroquine
No (tablet can be
crushed)
Yes1
500mg PO q12h
CrCl <10: 250mg PO
q12h
QT prolongation,
hypoglycemia,
retinopathy,
hemolysis if G6PD
deficient.
Avoid
Hydroxychloroquine
No (tablet can be
crushed)
Yes1
400mg q24h No data
QT prolongation,
hypoglycemia,
retinopathy,
hemolysis if G6PD
deficient.
Avoid
Lopinavir/ritonavir (Kaletra) Yes Yes9–16
400mg/100mg (2 tablets or
5ml) PO q12h
No adjustment
needed
Hepatoxocity,
pancreatitis, fat
redistribution,
hyperlipidemia,
QT prolongation,
GI intolerance.
Severe CYP450
drug interaction
Do not use with
Remdesivir
Can be used
Lopinavir/ritonavir (Kaletra) +
Ribavirin
Kaletra: Yes
Ribavirin: No (tablet
can’t be crushed)
N/A
Kaletra: 400mg/100mg (2
tablets or 5ml) PO q12h
+
Ribavirin: 2.4g PO once, then
1.2g PO q12h
(or 15-30mg/kg/day divided
in 2-3 doses, round to the
Kaletra: no
adjustment needed
Ribavirin32
:
CrCl 30-50: 200mg
PO q8h
CrCl <30 or HD: 200
Kaletra: see above
Ribavirin: anemia
(monitor Hgb)
Ribavirin: Avoid

3. References:
1. EfficacyandSafetyofHydroxychloroquineforTreatmentofPneumoniaCausedby2019-nCoV(HC-nCoV)-FullTextView-ClinicalTrials.gov.
https://clinicaltrials.gov/ct2/show/NCT04261517?cond=SARS+%28Severe+Acute+Respiratory+Syndrome%29&draw=5 (accessed Feb 14,2020).
2. WangM,CaoR,ZhangL,et al. Remdesivirandchloroquineeffectivelyinhibittherecentlyemergednovelcoronavirus(2019-nCoV)invitro.Cell Res 2020; published online Feb 4.
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RespiratorySyndromeCoronavirusFusion.JVirol2016;90:8924–33.
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nearest 200mg). mg PO daily
Darunavir/cobicistat (Prezcobix)
Or
Darunavir (Prezista) + Ritonavir
Prezcobix: Yes
Prezista: Yes
Ritonavir: Yes
Yes14,22
Prezcobix 800mg/150 mg PO
daily
Or
Prezista 800mg PO daily +
Ritonavir 100mg PO daily
No renal
adjustment needed
Hyperlipidemia,
hyperglycemia,
hepatoxocity
Prezcobix: Avoid
Prezista and
Ritonavir: can be
used
Emtricitabine/tenofovir fumarate
(Truvada)
No (tablet can be
crushed)
Yes11
Dosage in clinical trial not
available
For HIV, 1 tablet PO daily
CrCl 30-49: 1 tablet
PO q48h
CrCl 15-29: 1 tablet
PO q72h
HD: dose
emtricitabine and
tenofovir
separately, adjust
the dose
accordingly.
Nephrotoxicity
and decreased
bone density with
chronic use due to
tenofovir
fumarate
Can be used
Oseltamivir (Tamiflu)
(might not be helpful, more for
influenza)
Yes 75mg PO q12h
CrCl 30-60: 30mg
PO q12h
CrCl 10-29: 30mg
PO daily
CrCl <10 or HD:
30mg after HD
Well tolerated in
general, can cause
delirium in renal
impaired patient
Can be used
Baloxavir marboxil (Xofluza)
Tablet (tablet can’t
be crushed)
Yes
Clinical trial:
Day 1, 4: 80mg
Day 7: 80mg if still necessary.
Maximum 3 doses in total.
CrCl <50: no data Nausea No data
Remdesivir (GS-5734), Investigational. IV Yes
For the NIH - Adaptive COVID-19 Treatment Trial (ACTT)
 Please contact ID consult
For compassionate use of Remdesivir IV
Please contact Antimicrobial Stewardship team to facilitate the process. For compassionate
use, treating physician needs to contact:
 Gilead: https://rdvcu.gilead.com
Recommended dosing: loading dose 200mg IV on day 1, then 100mg IV daily up to 10 days.

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