by Elizabeth Hofheinz, M.P.H., M.Ed.
What role might zinc and Ascorbic acid (vitamin C) play in the fight against Covid-19? Can a human anti-IL-1β monoclonal antibody pull Covid-19 patients back from the brink of a cardiac crisis? These are just two of the questions being posed by a team of researchers at Cleveland Clinic.
Leading the Covid-19 research efforts at Cleveland Clinic Florida is Carla McWilliams, M.D. of the Department of Infectious Diseases. She told OSN, “In one study we are examining both zinc and vitamin C. We know that zinc may shorten the duration of the common cold…and many colds are caused by coronaviruses. So we set out to determine if zinc could be effective in fighting Covid-19.”
Working in conjunction with Cleveland Clinic in Ohio, Dr. McWilliams is focusing on outpatients with Covid-19 who have come to one of Cleveland Clinic’s drive through testing sites or have been tested in the ER but are out of danger and can safely return home. “We are enrolling patients within 48 hours of diagnosis and then following them every day for at least two weeks. We are using a symptom scale that includes fever, cough, and fatigue.”
“There are four arms to the study: vitamin C alone (8,000 milligrams divided 2-3x per day for ten days); zinc alone (15mg for ten days); vitamin C plus zinc (same dosing as above); or neither vitamin C nor zinc. We are looking to determine if any of these will impact the severity of illness or time to recovery.”
“Our plan is to enroll 520 outpatients with a positive diagnosis for Covid-19 who are greater than 18 years age. Women of childbearing potential who have not had a menstruation cycle for period of thirty days and are not sterilized may also be included. Our exclusion criteria are: inpatients, pregnant women, women who are breastfeeding, those with end stage renal disease, anyone awaiting a liver transplant, and patients with a history of a certain type of kidney stones. While these are high doses of vitamin C and zinc, the risks are low and the biologic plausibility is there.”
In addition to this study, their team is actively enrolling patients in an Expanded Access Convalescent Plasma Treatment, a joint effort with Mayo Clinic. “In this study, we are taking plasma from those who have been sick with Covid-19 and recovered. We are using the liquid portion of the blood products with the cells removed and the liquid may be rich in Coronavirus antibodies. Then we are infusing that into the recipients. The IV-delivered plasma will be dosed at 200-500mL (.5 to 1 pint) and will be given over the course of about one to two hours.”
“This study involves inpatients only, with its own unique inclusion and exclusion criteria. We are looking to see how long these patients must remain in the hospital and the duration of breathing assistance that is required.”
The third Covid-related research project is a proof of study effort that hopes to stop cardiac problems early on in patients who are Covid-positive. Dr. McWilliams told OSN, “Canakinumab is an anti-cytokine agent that we surmise may prevent myocardial damage and heart failure in patients with Covid-19. We know that a certain set of Coronavirus patients are at a higher risk of heart attack, vascular inflammation, and strokes. Our primary objective is to demonstrate that early treatment with Canakinumab may prevent progression to cardiac damage and the need for ventilator support. We plan to enroll 8 patients in this phase 2 single arm trial, an effort which will lead to a Phase III randomized placebo-controlled trial.”
“There is a substantial amount of interest in the investigation of therapeutic agents in general and we have an entire committee across both campuses that meets biweekly to discuss investigational agents. These are all-encompassing meetings where we cover preventative options, outpatient treatment strategies for mild illness, and inpatient treatment strategies—and what population or subpopulation of patients may benefit. We have assigned physicians to review protocols and they use a scoring system to determine whether we think a given study is worthwhile pursing.”