High-dose zinc and vitamin C (ascorbic acid) did not significantly affect the course of symptoms in patients with mild COVID-19, a randomized trial found.
With a 50% reduction in symptoms as the primary endpoint, there was no difference in the number of days to reach whether patients were receiving zinc gluconate, ascorbic acid, both medications, or the drug. second, reports Milind Desai, MD, of the Cleveland Clinic, and colleagues. All patients also received routine outpatient care.
In addition, there was no difference in secondary endpoints, including days to symptom resolution, severity of symptoms, hospitalization or death, the authors wrote. in Open JAMA Network.
The early study was discontinued for income following an interim study conducted in which 214 patients were enrolled; the researchers planned to include 520 patients.
“Based on the current study, these adjuvants cannot be recommended to reduce symptom morbidity” in patients with mild COVID-19, Desai and colleagues concluded.
Oral therapies have been suggested “to reduce the duration and depth of viral infection by stimulating an immune response,” said Erin Michos, MD, of Johns Hopkins University School of Medicine in Baltimore, and Miguel Cainzos-Achirica, MD, of Houston Methodist in Texas, in accompanying editorial; Zinc and vitamin D have been reported to be among the treatments President Trump received during his involvement with COVID-19.
“We commend the researchers of the COVID Study A to Z for applying rigorous science by testing their effectiveness and challenging popular beliefs,” the editors wrote. Unfortunately, these two accessories did not live up to their hype. “
They extended the disconnect between “mechanically and / or observational analysis and the final conclusions from randomized controlled trials” well directed. Observational associations between vitamin D and several health outcomes, for example, have never been repeated in placebo-controlled trials.
Michos and Cainzos-Achirica also reported hydroxychloroquine failure in prospective COVID-19 trials.
Desai and his colleagues designed the COVID A to Z Study as an open-label randomized trial at several hospitals in Ohio and Florida from April to October 2020. Patients 18 and older were eligible if they had a new diagnosis of COVID-19, confirmed through RT -PCR test. A primary primary endpoint was the number of days required to reach a 50% reduction in symptoms, including fever, cough, shortness of breath, and fatigue.
Patients were randomized to routine care in addition to either 8,000 mg of ascorbic acid (2-3 times daily with food), 50 mg of zinc gluconate at bedtime, either. Of the 214 patients, 50 were randomized to routine care alone, 48 to ascorbic acid, 58 to zinc, and 58 to both medications in addition to routine care.
The average age of participants was 45, and 62% of women. About a third said they smoke now or before, and about a quarter said they had used vitamins and minerals before.
Patients who received only routine care achieved the main outcome at an average of 6.7 days versus 5.5 days for patients in the ascorbic acid group, 5.9 days in the zinc gluconate group and 5.5 days in both treatment groups. The number of hospitals and deaths did not vary significantly among treatment groups.
But side effects from the medications were not common.
Constraints on the data included the absence of a placebo group and the trial was open, and a series of symptoms by age, sex, race, or duration of symptoms were not taken into account prior to the trial during the trial. analysis. Some potential antagonists, such as vitamin D levels, have also not been studied.
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Thomas did not show any conflict of interest.
Desai showed support from Myokardia and support from Haslam Family Chair in Cardiovascular Medicine.
Other co-authors expressed support from Gilead Sciences.
Michos and Cainzos-Achirica showed no conflict of interest.