South Dakota launched the nation’s first statewide clinical research study to investigate the anti-malarial drug hydroxychloroquine and understand its role in potentially preventing COVID-19 in certain groups. Gov. Kristi Noem made the announcement April 13.
The trial will enroll roughly 2,000 individuals, and researchers hope to have results on the drug’s effectiveness within six months. This study is a collaboration among Sanford Health, Avera Health and Monument Health led by a team from Sanford Research.
The study team will begin screening participants for study entry on May 14. Call (605) 312-6023 for more information.
In the meantime, the team addressed some commonly asked questions.
What is the hydroxychloroquine clinical trial?
This is a clinical trial looking at whether the drug hydroxychloroquine can help prevent an individual from getting sick after they have been exposed to someone who tested positive for COVID-19.
This trial is not for people who already have COVID-19. Instead, this trial focuses on health care workers or individuals who are considered high-risk, who may have been exposed at work or in the community. People enrolled in the trial will be given either hydroxychloroquine or a placebo.
Although this drug is getting national attention, its effectiveness in preventing or treating COVID-19 is unknown until clinical trials take place.
Who is eligible for this trial?
Participants will include health care workers and high-risk individuals who have been exposed to someone with a confirmed COVID-19 positive test within the past 5 days – either as close contact in the community or as a health care worker. They include:
- Employees of any health care organization in South Dakota,
- Residents of South Dakota, regardless of health care provider
- Any Sanford Health employee, regardless of state
- Any patient or facility resident of Sanford Health, regardless of state
Other requirements include:
- No known COVID-19 symptoms (fever, cough, difficulty breathing, sore throat)
- Must be at least 18 years old
- For non-health-care workers, they must have one or more of the risk factors listed below.
How do you define ‘high risk’?
A study team member will review your medical history to see if you qualify, but risk factors will include:
- Congestive heart failure
- Asthma, COPD, emphysema
- Organ transplant
- Currently on immuno-suppressive drugs such as chemotherapy
- Kidney disease
- Cardiovascular disease such as hypertension
- Smoking or vaping
- High cholesterol
- Over 80 years of age
What about people who have tested positive for COVID-19?
Individuals who have tested positive for COVID-19 should contact their medical provider to discuss their care, including the potential use of hydroxychloroquine.
How do I enroll? Do I need a referral from a provider?
An individual who has been exposed can call (605) 312-6023. You will be asked to provide contact information so the study team can reach out to you with further details and discuss your eligibility. No doctor’s referral is needed. While individuals can call to inquire about the process, the study team will begin screening participants for study entry on May 14.
Where can I get the drug?
Hydroxychloroquine or placebo will be provided free of charge as part of the study for participants. Study drug or placebo will be supplied by the study team. Once enrolled, participants will work with the study team to obtain study drug. Arrangements will be made individually between the study team and the eligible participant.
For South Dakota residents, the medication will come from the South Dakota state supply.
How much does it cost to enroll?
There is no cost to the participant.
What health systems are participating?
This clinical trial is sponsored by the state of South Dakota and led by Sanford Health. This study will be conducted through collaboration among Sanford Health, Avera Health and Monument Health.
What are the potential side effects?
Hydroxychloroquine can have significant side effects including nausea, visual changes and heart rhythm disturbances. Some people should not take hydroxychloroquine. The study team will review all trial details, including possible side effects, with every potential participant. The study’s Safety Committee will review adverse events during the trial and conduct an interim safety analysis.
Do we know if this drug will help patients?
A clinical trial is the way to answer this question. We do not yet know if hydroxychloroquine will prevent COVID-19 infection or illness.
Call (605) 312-6023 for more information.
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