Sanford Health, the largest provider of rural health care in the country, will lead a comprehensive clinical trial investigating the anti-malarial drug hydroxychloroquine, to understand its role in treating and potentially preventing COVID-19. The controlled study initially will include 2,000 outpatient individuals exposed to COVID-19, including frontline health care workers and other high-risk patients.
There are no drugs or therapeutics approved by the U.S. Food and Drug Administration to prevent or treat COVID-19. Current clinical management includes infection prevention and supportive care. Hydroxychloroquine is one of the therapeutics that is under investigation in clinical trials for treatment of patients with mild, moderate and severe COVID-19.
“Our goal is to meaningfully advance the science around COVID-19 so physicians can be better prepared to respond to and treat this novel virus in the future, especially for our populations most at-risk,” said Allison Suttle, M.D., chief medical officer for Sanford Health. “Taking care of patients with an illness for which there are no treatments is very difficult for a physician and concerning for patients and families. By doing clinical trials during this pandemic, we are trying to find treatments and, thereby, hope.”
Sanford currently has clinical guidelines in place to prescribe hydroxychloroquine to hospitalized COVID-19 positive patients. Sanford has developed this new randomized placebo-controlled research study to investigate prescribing hydroxychloroquine prophylactically to health care workers and high-risk populations who have been exposed to the novel coronavirus. The prophylactic treatment trial is designed to determine whether the medication can prevent the illness or minimize symptoms in these individuals.
Up to 100,000 patients could be treated
Researchers hypothesize that hydroxychloroquine could help an individual’s immune system as it works to fight off the disease. The medication may slow the replication process of the virus in the human body and allow the patient’s own immune system to get a better start in fighting the illness.
All individuals who meet the study criteria will provide voluntary informed consent before participating and will be screened to make sure they don’t have medical conditions that would make hydroxychloroquine less safe for them.
Sanford has had the benefit of time to prepare for this pandemic and has been able to procure an adequate supply of hydroxychloroquine for treatment of COVID-19 positive patients while ensuring the medication remains available for patients taking it for other conditions. The health system will also access the drug from an inventory secured by the state of South Dakota from the Strategic National Stockpile. Up to 100,000 patients could be treated.
“We look forward to learning more about the effectiveness of this treatment for COVID-19,” said Susan Hoover, M.D., Ph.D., Sanford Health infectious disease doctor and principal investigator of the study. “While this drug has been widely administered in the hope that it can help people, without controlled research studies we aren’t able to say for sure that it really works. Conducting this study allows us to do everything we can to help our patients now, and at the same time gather critical information that will help patients in the coming months and years.”
“I applaud the leadership of Sanford Health for bringing their expertise and innovation to the table to help drive new and better treatments for this virus,” said South Dakota Gov. Kristi Noem. “I’m proud of the way our state’s health care leaders have collaborated with my administration to respond to this unprecedented challenge.”
More about hydroxychloroquine
The CDC describes hydroxychloroquine, which has been used for 75 years, as a relatively well-tolerated medicine. The most common adverse reactions reported are stomach pain, nausea, vomiting, and headache. These side effects can often be lessened by taking hydroxychloroquine with food. Hydroxychloroquine may also cause itching in some people. Minor side effects such as nausea, occasional vomiting, or diarrhea usually do not require stopping the anti-malarial drug. Although rare, serious side effects can occur while taking this medication.
Sanford launched an earlier COVID-19 study in January, opening a registry to collect data from patients with the virus. This study has since been expanded to include data and specimen collection from COVID-19 positive patients and COVID-19 recovered patients to enable Sanford’s researchers to track the progression of the disease and the recovery process for up to five years. The study will aim to answer important questions around the disease process, the development of immunity, the possibility of reinfection and long-term health complications from COVID-19.
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