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Penn Launches Trial to Evaluate Hydroxychloroquine to Treat, Prevent COVID-19
They are currently enrolling people, so check the link if you are interested in participating.
https://clinicalresearch.itmat.upenn.edu/clinicaltrial/6407/covid19-a-trial-in-quarantined-subjects-with-covid19/
https://www.pennmedicine.org/news/news-releases/2020/april/penn-launches-trial-to-evaluate-hydroxychloroquine-to-treat-prevent-covid19
PHILADELPHIA – A new trial led by the Perelman School of Medicine at the University of Pennsylvania will evaluate whether the drug hydroxychloroquine (HCQ) can benefit people infected with COVID-19, as well as whether taking the drug preventatively may help people avoid infection altogether. The study, called Prevention and Treatment of COVID-19 with HCQ (PATCH), is currently enrolling patients in three separate sub-studies (NCT04329923).
PATCH sub-study 1 will evaluate HCQ compared to placebo in infected patients who are quarantined at home. PATCH sub-study 2 will evaluate high dose compared to low dose HCQ in hospitalized patients. PATCH sub-study 3 will evealuate HCQ compared to placebo prophylactically in health care workers working with COVID-19 patients to evaluate whether it can prevent infection. Sub-studies 1 and 3 are double-blind placebo controlled studies, meaning neither the patient nor the doctor will know whether they are taking HCQ or placebo until the end of the study. Importantly, if the patient or health care worker starts getting worse, they can be “unblinded”, and the trial allows crossover to HCQ if the patient was assigned placebo.
(snip)
The first sub-study of the trial will test HCQ in patients who are infected and are well enough to go home, but who need to be in quarantine. Quarantine can be prolonged for some people who have a worse case of the illness, and can impose significant economic, emotional, and psychological hardship on the patient and his or her family. Family members living with a quarantined COVID-19 patient are at high risk of getting the disease themselves. In order to be released from quarantine, they must meet certain criteria according to the Centers for Disease Control (CDC): patients must go 72 hours without a fever, see their symptoms improve, and go seven days since their symptoms first appeared. The primary goal of PATCH sub-study 1 is to find out whether the drug reduces the number of days the patient stays quarantined. Researchers were forced to overcome unique logistical hurdles, including arranging for virtual consents from patients and home delivery of HCQ doses.
The second sub-study of the trial will test HCQ in patients who are hospitalized with COVID-19 to see if it can reduce the time to discharge. Patients in this group will also be randomized into a high dose or low dose group. No one will receive a placebo. The correct dose of HCQ for treating COVID-19 is not currently known and this study will provide valuable information to answer that question.
The third sub-study will test whether HCQ can work as a preventative medicine to stop infection in health care workers at risk of exposure to COVID-19. Researchers plan to enroll 200 workers in the sub-study.
more at links
PATCH sub-study 1 will evaluate HCQ compared to placebo in infected patients who are quarantined at home. PATCH sub-study 2 will evaluate high dose compared to low dose HCQ in hospitalized patients. PATCH sub-study 3 will evealuate HCQ compared to placebo prophylactically in health care workers working with COVID-19 patients to evaluate whether it can prevent infection. Sub-studies 1 and 3 are double-blind placebo controlled studies, meaning neither the patient nor the doctor will know whether they are taking HCQ or placebo until the end of the study. Importantly, if the patient or health care worker starts getting worse, they can be “unblinded”, and the trial allows crossover to HCQ if the patient was assigned placebo.
(snip)
The first sub-study of the trial will test HCQ in patients who are infected and are well enough to go home, but who need to be in quarantine. Quarantine can be prolonged for some people who have a worse case of the illness, and can impose significant economic, emotional, and psychological hardship on the patient and his or her family. Family members living with a quarantined COVID-19 patient are at high risk of getting the disease themselves. In order to be released from quarantine, they must meet certain criteria according to the Centers for Disease Control (CDC): patients must go 72 hours without a fever, see their symptoms improve, and go seven days since their symptoms first appeared. The primary goal of PATCH sub-study 1 is to find out whether the drug reduces the number of days the patient stays quarantined. Researchers were forced to overcome unique logistical hurdles, including arranging for virtual consents from patients and home delivery of HCQ doses.
The second sub-study of the trial will test HCQ in patients who are hospitalized with COVID-19 to see if it can reduce the time to discharge. Patients in this group will also be randomized into a high dose or low dose group. No one will receive a placebo. The correct dose of HCQ for treating COVID-19 is not currently known and this study will provide valuable information to answer that question.
The third sub-study will test whether HCQ can work as a preventative medicine to stop infection in health care workers at risk of exposure to COVID-19. Researchers plan to enroll 200 workers in the sub-study.
more at links
