As we face the prospect of a third COVID winter with only a vaccinate & mask response, a needed third leg is missing: effective early treatment, especially measures that mitigate transmission associated with nasal/upper respiratory viral replication of the type that can occur in the noses of both vaccinated and unvaccinated persons. [To see a 2:45 min. video on why SARS-CoV-2 replication in the nasopharynx is a problem, click here.] While new oral antiviral drugs from Merck and Pfizer may be of use, we need to improve and keep improving, our ability to intervene early by designing effective cocktails even as we deploy what we already have available, and by doing good science in the nasal spray category. The following three steps, taken immediately, might really help:
Encourage participation in the COVID-OUT clinical trial <NCT04510194>, and in the ACTIV-6 clinical trial once COVID-OUT is fully enrolled. COVID-OUT is run by a group out of University of Minnesota that includes the United Health Group, part of a network of Minnesota-based companies that includes the United Health Care insurance company. This multi-drug trial includes five combinations of three agents:
metformin,
ivermectin,
fluvoxamine,
fluvoxamine + metformin,
ivermectin + metformin,
and, of course, a placebo group. Medicine is provided by the study and taken at home. Participants are paid $400. When completed, this will be the first phase 3 outpatient clinical trial of these repurposed COVID-19 treatments in the U.S. Some have criticized some of the associated protocols but the fact that these repurposed drugs are under study continues to progress.
There are nasal sprays that may be helpful at fighting the spread of SaARS-CoV-2 available in other nations, but not in the United States. We are hearing from U.S. doctors about one in particular, SaNOtize from Israel, that is safe and should be made available to U.S. doctors and their patients without delay. Click here to read a full Trial Site News article concerning SaNOtize Nasal Spray. If the product is available in Israel pharmacies, why could that be explored in the United States and elsewhere?
Still more exciting are monoclonal antibody nasal sprays in development. Such products might be of particular use in outbreak containment situations such as the one occurring now in South Africa. As scientists rush to determine whether current vaccines are effective against the Omicron Variant, we suggest they also test the IgM-14 antibody in investigational nasal spray IGM-6268. Why this one when there are plenty other exciting developments in the monoclonal antibody space? For the same reason NIH Director Francis Collins blogged about it in June; because this antibody is active in mucus, and there’s no need to report to an infusion center if it can be developed as a nasal spray. This type of delivery could boost access with favorable economics.
Each new SARS-CoV-2 variant that exhibits a fitness advantage does so, in part, by leveraging speed – especially the window of time it takes a host to produce mucosal antibodies. To meet the challenge, we must respond with alacrity and focus, yet with flexibility and respect for one another. Take-home readiness kits that include self-administered COVID tests, a fingertip pulse oximeter, and COVID treatments, are now possible.
Even when we are not each on the same page, we can find ways to work together that unite us. Let’s strive to do that. While there isn’t enough data yet to determine the severity of Omicron, and in fact some early reports evidence possibly higher transmissibility yet milder infection, we must be prepared for the worst.