- ACTIV-6 Study
- Epic Orders
- Epic SmartPhrase
- DOH Medication/Treatment Locator
- Other supportive care treatment options
ACTIV-6 Outpatient Study for Repurposed Medications
- Enroll at ACTIV6STUDY.ORG
- The purpose of the ACTIV-6 research study is to test medications that are already approved for other diseases to see if they can help people with mild to moderate COVID-19 feel better faster and stay out of the hospital. ACTIV-6 is part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program.
- Patients are able to self-enroll in ACTIV-6 at activ6study.org
- Patients that enroll in ACTIV-6 can still receive other outpatient therapies including Mabs, remdesvir, Paxlovid, and MolnupiravirACTIV-6 includes arms for fluvoaxmine, fluticasone, ivermectin, placebo
- adults, Covid+ last 10 days, do not have to come in, do not have to have been seen at TGH/USF
- There is a .ACTIV6 smart phrase with text from an IRB approved recruitment flier under the Epic User Name Wilson, Jason . That can be included in the AVS for the patient and used for reference
- Paxlovid can be found in Epic but requires you to search the database. Below are some screenshots for locating Paxlovid.
- You can add it to your favorites when you order the medicine the first time.
- You should then be able to find it easier the next time
Paxlovid CrCl > 60 ml/min
Paxlovid CrCl 31-60 ml/min
- You can select the pharmacy during the ePrescribe process by clicking on the current pharmacy name (this example has TGH Outpatient Pharmacy).
- TGH Outpatient Pharmacy does not have Paxlovid.
- Only retail pharmacies have been supplied medication.
To find a pharmacy with Paxlovid, use this website:
HHS/DOH COVID TREATMENT LOCATOR (Monoclonals, Paxlovid, Other)
Information about Nirmatrelvir+Ritonavir [Paxlovid]
- nirmatrelvir is a protease inhibitor that inhibits mPRO and stops viral replication EPIC-HR Trial (n=2,246).
- 28 day hospitalization in Paxlovid arm 0.8% (n=8), 6.3% in placebo arm (n=66). Relative Risk Reduction = 88%, Absolute Risk Reduction = 5.5%, Number Needed to Treat to prevent 1 hospitalization on Paxlovid = 18
- All cause 28 day mortality Paxlovid arm 0%, placebo arm 1.1% (n=12). RRR = 100%, ARR = 1.1%
- Number needed to Treat to prevent 1 death on Paxlovid = 91
- The EUA for Paxlovid can be found at this link
- EUA allows for outpatient treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg)
- no for PrEP or PEPstart within 5 days of symptom onset
- RX: Take 3 pills in the morning (2 X 150mg nirmatrelvir, 1 X 100mg ritonavir) and 3 Pills in the evening (2 X 150mg nirmatrelvir, 1 X 100mg ritonavir)
- 30 total pills dispensed in a dose pack for CrCl > 60 ml/min
- If CrCl 31- 60 ml/min, there is decreased dosing (take 1 nirmatrelvir 150mg tablet in morning and night instead of 2) -> 20 total pills in CrCl 31-60
- Avoid in patients with CrCl < 30 ml/min and hepatic impairment with Child-Pugh C
- May want to avoid in patients with HIV
- Caution if patient on drugs that reliant on CYP3A4 metabolism, especially if patient has decreased CrCl.Caution if on: statins, NOACs, warfarin, calcium channel blockers, anti-arrhythmics, HCV Direct Acting Antivirals, sofosbuvir, alfuzosin, pethidine, piroxicam, propoxyphene, ranolazine, amiodarone, dronderone, flecainide, propafenone, quinidine, cholchicine, lurasidone, pimozide, clozapine, dihydroergotamine, ergotamine, methylergonvine, sildafinil, triazolam, midazolam, apalutamide, carbamezapine, phenobarbital, phenytoin, rifampin, St. John’s Wort, bupropion, trazodone, voriconazole, isavuconazonium, itraconazole, ketoconazole, rifampin, clarithomycin, erythromycin, amlodipine, diltiazem, felodipine, nicardipine, nifedpine, digoxin, salmetrolsome
- suggest avoiding concomitant use of Paxlovid and Systemic Corticosteroids
- No available data in pregnant women or those that are breastfeeding
- Not authorized in those younger than 12 years of age
- no cost to patient, $530 cost to US Government
Molnupiravir can be found in Epic
Information about Molnupiravir [Lagevrio]
- nucleoside analog that leads to viral lethal mutagenesis
- MOVe-OUT Trial (n=1,433), 709 received molnupiravir, 699 patients received placebo.
- 29 day combined hospitalization or death for molnupiravir group was 6.8% and 9.7% in placebo arm. RRR = 30%, ARR = 2.9%.
- Number needed to treat to prevent 1 hospitalization or death on molnupiravir = 35
- 29 day mortality in molnupiravir arm was 0.1% and 1.3% in placebo arm. RRR = 92%, ARR = 1.2%
- Number needed to treat to prevent 1 death on molnupiravir = 83
- EUA for molnupiravir can be found here
- must be 18 years oldstart within 5 days of symptom onsetRx: 800mg BID X 5 days (40 pills)200mg pills, 4 pills each dose (comes in a 40 pill bottle)
- Do NOT take if pregnant (embryo toxicity); bone/cartilage toxicity (no peds)
- No known drug interactions
- no cost to patient, $712 cost to US Government
To find a pharmacy with Molnupiravir, use this website (as of 1/28/22, Port Charlotte is closest location):
HHS/DOH COVID TREATMENT LOCATOR (Monoclonals, Paxlovid, Other)
- Non-pregnant, adult patients can potentially receive Fluvoxamine as part of ACTIV-6. However, if patient does not want to join research study or definitively wants/needs Fluvoxamine, this is reasonable given clinical data to prescribe.
- The data for use of Fluvoxamine is found on the USF Emergency Medicine Blog
- Clinical trial dosing was 100mg PO BID X 10 days (this is moderately large dose and can be associated with nausea; consider giving ondansteron RX with Fluvoxamine RX
- Possible drug interactions (from the prescribing information which can be found at this link) with BZD, clozapine, methadone, mexiltine, antipsychotics, ramelton, theophyline, warfarin, NOACs, carbamazepine, sumatriptan, TCAs, tacrine, tryptophan, diltiazem, propranolol, metoprolol
Sotrivimab and Remdesvir
- There is limited effectiveness of Eli-Lilly and Regeneron monoclonal antibody infusions for Omicron based on lab based studies.
- Sotrovimab does have effectiveness against Omicron but there is very limited availability of the medication and requires high risk/immunocompromised conditions to access.
- remdesvir is also available as outpatient but also requires high risk features and 3 days of return encounters.
- Sotrovimab and remdesvir can be given in the GEDI at TGH to very high risk patients.
- Patients and community providers can complete the referral form themselves.
- TGH emergency medicine providers/TGH providers can utilize the AMB REFERRAL TO COVID 19 FOLLOW UP.
- GEDI LINK: The patient and community provider link to GEDI Infusion for Sotrovimab and Remdesvir is here and can be completed by patient or provider
- Sotrovimab and remdesvir referrals to GEDI from TGH/USF System can be made using the AMB Referral to Covid-19 Follow Up Patients must be high risk for sotrovimab or remdesvir infusion.
Epic Smart Phrase For All Outpatient Treatments and Risk Score for Mabs/Infusions
Other Outpatient Covid Treatment Options(USF Medicine, NIH, Collected Guidelines)
- Vitamin D 5,000 units daily
- encourage hydration
- recommend prone positioning at home every 1 hour every 4 hours
- Can still be offered Vitamin D
- Can be offered inhaled budesonide
- Should not be prescribed fluvoxamine, molnupiravir, or paxlovid and are not eligible for ACTIV-6
- Should not be advised to prone at home
- TGH GEDI referral for patients/community providers for infusions (mab, remdesvir)
- ACTIV-6 enrollment form
- HHS/DOH COVID Treatment Locator (Monoclonals, Paxlovid, Other)
- Fluvoxamine Prescribing Information
- USF Emergency Medicine Fluvoxamine Blog Post
- Fluxoxamine Lancet Study
- Paxlovid EUA
- Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab
- Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients
- Molnupiravir EUA
- Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients. NEJM.
- Remdesvir Graphical NEJM Explainer
- Sotrovimab NEJM Quick Take Video