Outpatient treatments for Covid-19 & ACTIV-6 study
In this post, I’ll share with you information that has been adapted from our department’s, Outpatient Treatment Resource Guide, developed by Dr. Jason Wilson. This information is up to date as of January 2022. It is important to note that new options and information is available every day. This post is not meant to be direct healthcare advice, but rather a resource for our providers and patients.
Before we jump into the Resource Guide, let me acknowledge that Tampa has been hit particularly hard by the omicron virus. Like much of the country, we have experienced record-high numbers of infections during this wave. Luckily, this variant has resulted in less severe infections but unfortunately, the sheer number of infections has resulted in high patient volumes and some patients experiencing severe disease. Our hospital has been inundated and many of our faculty, residents, nurses, and staff have been out sick with Covid. This past week our Department Chair, Dr. Orban, shared his experience with Covid and his message was clear - The omicron variant affects people differently and still causes severe symptoms for some. This is exactly why we need vaccines and medications to reduce the severity and spread of the disease.
“Don’t let anyone tell you it is a benign disease. It is a different disease for different age groups... Elderly people don’t handle it the same as people in their 30s and 40s do.”
Watch the video below to hear more from Dr. Orban about his personal experience with Covid.
Outpatient Treatment Resource Guide
providers trying to locate Covid Treatment Options:
HHS/DOH COVID TREATMENT LOCATOR (Monoclonals, Paxlovid, Other)
Supportive Care Options for Outpatient Treatment
Non-Pregnant Patients
Vitamin D 5,000 units daily
encourage hydration
can offer fluvoxamine (requires prescription)
Recommend prone positioning at home 1 hour every 4 hours
Pregnant Patients
Can still be offered Vitamin D
Can be offered inhaled budesonide
Should not be prescribed fluvoxamine and there is no data for Paxlovid
Should not be advised to prone at home
ACTIV-6, AN OUTPATIENT STUDY FOR REPURPOSED MEDICATIONS
Activ-6 is an NIH-sponsored clinical trial investigating the use of ivermectin, fluvoxamine, and fluticasone against placebo for the treatment of Covid-19. All of these drugs are already approved for the treatment of other conditions and some hypothesize they may be beneficial for the treatment of Covid-19. Patients may enroll themselves at: ACTIV6STUDY.ORG. Patients do not need to be seen in the hospital to enroll in this trial and receive study medication. Simply go online and register. Enter TGH as your local/referring hospital. It is important to note that we do not recommend prescribing ivermectin outside of a clinical research study. The quality studies we have to date have not supported the use of ivermectin for the treatment of Covid-19 but additional data is needed. For a good summary of what we currently know about ivermectin for the treatment of Covid, visit: https://www.emrap.org/episode/emrap202120/theivermectin. ACTIV-6 will likely provide more definitive guidance for the role of ivermectin in the treatment of Covid-19.
Nirmatrelvir+Ritonavir [Paxlovid]
Based on findings from the EPIC-HR Trial, Paxlovid received emergency use authorization (EUA) and was the first oral pill available to treat outpatient mild to moderate covid infection in patients age 12 and up who are at risk for progression to severe disease. It requires a prescription and is unavailable in most pharmacies. Providers can locate Paxlovid at: HHS/DOH COVID TREATMENT LOCATOR (Monoclonals, Paxlovid, Other)
Paxlovid Fast Facts
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)
Start 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). Requires adjustment based on CrCl.
Multiple potential drug interactions.
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 [Lagevrio]
MOVe-OUT Trial
This was a randomized, controlled trial which compared placebo to molnupiravir to evaluate the efficacy and safety of treatment with molnupiravir started within 5 days after the onset of signs or symptoms in nonhospitalized, unvaccinated adults with mild-to-moderate, laboratory-confirmed Covid-19 and at least one risk factor for severe Covid-19 illness. A total of 1,433 patients were included. 709 received molnupiravir & 699 patients received placebo. The 29 day combined hospitalization or death for molnupiravir group was 6.8% versus 9.7% in the placebo arm. The investigators of the trial concluded that the early treatment with molnupiravir reduced the risk of hospitalization or death in at-risk, unvaccinated adults with Covid-19. View the study here.
Molnupiravir Fast Facts
Must be 18 years old
Start within 5 days of symptom onset
Rx: 800mg twice daily for 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 (not safe for kids)
No known drug interactions
No cost to patient, $712 cost to US Government
Fluvoxamine
Fluvoxamine is an SSRI medication previously used to treat conditions such as anxiety and PTSD, but most recently it has gained attention as a potential treatment for Covid-19. A recent article published in Lancet Global Health reported that fluvoxamine reduced the chances of requiring hospitalization for covid in patients with at least one risk factor. The data for use of Fluvoxamine is found on the USF Emergency Medicine Blog.
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.
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
Sotrovimab and Remdesivir
Unfortunately, the monoclonal antibodies that were previously used to treat pre-omicron variants of covid, are not really effective against omicron. 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. In addition, remdesvir is also available as outpatient but also requires high risk features and 3 days of return encounters. Patients must be high risk for sotrovimab or remdesvir infusion.
Sotrovimab for Early Covid 19 NEJM
OTHER covid clinical studies OFFERED THROUGH OUR ED
Propel Zotatifin Covid Study
Zotatifin is an "investigational" antiviral treatment because it has not been approved by any government agency. It has not been given to people for the treatment of COVID-19 prior to this study but has been given to people in ongoing research studies of other diseases. In this research study, we will compare zotatifin to a placebo to see if it works better or is safer than not taking anything at all. The Principal Investigator at the TGH site is Dr. Enola Okonkwo. For more information visit: https://www.yourpropelstudy.com/about-this-study/
About the Author
This post was written by Dr. Enola Okonkwo, MD. The content of this post was adapted from resources developed by Dr. Jason Wilson, MD. Drs. Okonkwo & Wilson are part of the Core Faculty at USF and both conduct Covid-19 research.