A clinically validated, broadly active, oral viral superinfection therapy could mitigate symptoms in early-stage COVID-19 patients.

More than 200 viruses infect humans but drugs are available for fewer than ten. To narrow the gap between 'bugs and drugs', a paradigm shift is required. The "one drug, one bug" approach should be supplemented by the "one drug, multiple bugs" strategy such that the host is targeted rather than the virus. The revolutionary viral superinfection therapy (SIT) activates the antiviral interferon gene natural defense system of host cells from within by an attenuated infectious bursal disease virus (IBDV) that releases its double-stranded RNA (dsRNA) cargo inside the cells. An attenuated IBDV vaccine strain has resolved hepatitis A virus infection (HAV) in marmoset monkeys and hepatitis B and C virus infections (HBV/HCV) in 42 patients with acute HBV or HCV. SIT was also safe and effective in four hepatically decompensated, chronically infected HBV and HCV patients. The proof-of-principle of SIT was demonstrated first in a 43-year-old male patient with COVID-19. Three doses of IBDV (3x106 IU) alleviated most of his COVID-19 symptoms, even the sense of smell returned within a week. Two additional COVID-19 patients responded similarly to oral treatment with IBDV. Furthermore, a severe herpes zoster ophthalmicus with orbital edema was healed within few days by combination of acyclovir and 7 doses IBDV (7x106 IU). IBDV is simple to manufacture and will be affordable even in resource limited settings. Acid resistant IBDV can be orally administered in an outpatient setting providing the greatest ease of dosing and the highest chance of patient compliance. Under an Emergency Use Authorization, the broad-based IBDV drug candidate could be tested immediately in clinical trials and rapidly distributed to millions of early-stage patients with COVID-19. The German Paul Ehrlich Institute supports such a phase I safety study for persons acutely infected with SARS‑CoV-2. An expert team of the US National Institutes of Health-sponsored ACTIV public-private partnership came to the conclusion that the IBDV drug candidate shows merit as a potential treatment for COVID-19 and an FDA approved clinical trial is in the pipelines in Los Angeles.