The Royal Road to Recovery from COVID

The president of the United States and the former governor of New Jersey sailed through their bouts with COVID-19. Both would be considered high-risk patients: the president because of his age and weight, and the governor because of his weight. According to newspaper reports, both were hospitalized, despite not having severe symptoms, and treated, first with an infusion of monoclonal antibodies and then with remdesivir for 5 days. The president also received dexamethasone when he developed changes in his lung scans. Aside from dexamethasone, which is ubiquitous and inexpensive, how available are these drugs for other high-risk patients?

Three combinations of monoclonal antibodies are under development by Eli Lilly, Regeneron, and AstraZeneca. All 3 contain 2 antibodies directed against different regions of the SARS-CoV-2 spike protein. President Trump received the Regeneron product. Eli Lilly and Regeneron have submitted requests to the FDA for emergency use authorization. No results from Phase 3 trials are available for any of these products.

Remdesivir has now been approved by the FDA for treatment of hospitalized patients ≥12 years old with COVID-19. It has been effective in shortening recovery time, but to date has not demonstrated a significant effect on mortality. Most recently, the authors of the multicenter, poorly controlled, open-label WHO Solidarity trial reported that remdesivir did not reduce mortality, the need for ventilation, or the duration of hospitalization in patients with COVID-19. But the drug is not being used optimally. Many or most of the patients in clinical trials have started treatment with remdesivir, which inhibits viral replication, near or after the end of the time when the virus is still replicating.

It seems logical, given their mechanisms of action, that both remdesivir and monoclonal antibodies would be most effective when started early in the illness, as they were for President Trump and Governor Christie. Outside the rarefied world of the VIP, that presents some logistical problems. Most patients with COVID-19 do well without treatment, so the selection of patients to be treated with these expensive drugs is likely to be contentious. Then there is the difficulty of obtaining a timely diagnosis. Antigen tests are helpful if they are positive, but false-negative results are common and require follow-up tests. Molecular PCR tests are reliable, but until new rapid PCR tests become widely available, it may take a week or more to get a result. The infusion rooms of most hospitals, where outpatients go to receive IV drugs, are often populated by immunosuppressed patients, who hardly need exposure to SARS-CoV-2. And it would not be easy to scale up the production and distribution of monoclonal antibodies, if they prove to be effective in phase 3 trials, to accommodate the large number of high-risk patients who have early symptoms and test positive.

Some of these problems could be solved with infusions of money and organizational competence. For now, though, it appears that power and influence determine the rules of the road.

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