SCREENING COVID-19 Post-exposure Prophylaxis/Preemptive Treatment Study Screening |
This trial is seeking research volunteers who are:
1) Healthcare workers or household/communal living contacts with known exposure to someone with COVID-19 within the last 4 days and who are currently asymptomatic; OR
2) People who are symptomatic with confirmed PCR+ COVID-19 diagnosis within the first 4 days of symptoms starting; OR
3) Household/communal living contact or Healthcare worker with compatible COVID-19 symptoms with exposure to known PCR+ COVID-19 case within 14 days AND compatible symptoms of fever, cough, or shortness of breath and no available testing or pending testing.
This trial will assign volunteers randomly to either hydroxychloroquine or vitamin (50% chance of either). We ask that all persons answer honestly during the screening survey.
This research trial has certain exclusion criteria which are important for safety. The investigational study medicine may cause harm to certain groups of people who are excluded from research participation.
Second, the inclusion criteria are meant to maximize the success of the trial, so that the trial can be completed as quickly as possible and demonstrate a possible benefit based on people with high-risk exposures.
If you have not truly met the criteria for exposure, your participation in this trial will skew the results of this trial, with the risk that the results will show that hydroxychloroquine has no benefit when in fact, it actually may. If this unfortunate event were to happen, the possibility of finding a drug that could potentially help thousands of people who have been exposed to coronavirus from getting sick is lost. This is why it is of utmost importance that only if you have truly met our exposure criteria, do you sign up for this trial.
We will ask you for your contact with diagnosed COVID-19 disease, so that this may be verified.
Study Definitions
Contact - a person with confirmed COVID-19 disease (aka someone who has tested positive)
Note, for Symptomatic Healthcare Workers, a contact can be a person who is either:
1. Diagnosed with COVID-10 disease with a positive test
OR
2. Clinically diagnosed or is a person under investigation for COVID-19 disease and has any of the following symptoms; fever, cough, difficulty breathing, or myalgias and either unable to obtain a test or has a test pending.
Exposure - period of time being near a person with COVID-19 disease
Household/Communcal Living contact - A person you share a residence with who was diagnosed with COVID-19 disease. This can include a home, dormitory, etc.
Close contact - exposure to the person with COVID-19 disease was closer than 6 feet (< 6 feet) and for longer than 10 minutes all at once (>10 minutes)
Non-close contact - exposure to the person with COVID-19 disease was farther away than 6 feet (>6 feet) or for a time that was shorter than 10 minutes (< 10 minutes)