The proposed hypothesis is that high doses of hydroxychloroquine (HCQ) for at least 2 weeks can be effective antiviral medication both as a treatment in ambulatory patients and prophylaxis/treatment in health care workers because it impairs lysosomal function and reorganizes lipid raft (cholesterol and sphingolipid rich microdomains in the plasma membrane) content in cells, which are both critical determinants of Emerging Viral Disease (EVD) infection.
This hypothesis is based on a growing literature linking chloroquine to antiviral activity. It is estimated that enough information exists to launch a clinical trial of hydroxychloroquine for COVID-19.
Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. The virus that causes COVID-19 is a novel coronavirus that was first identified during an investigation into an outbreak in Wuhan, China.
Study type: Interventional (Clinical Trial)
Estimated Enrollment: 850 participants
Official Title: PATCH 2 & 3: (Prevention and Treatment of COVID-19 With Hydroxychloroquine) An Open Label Multi-arm Randomized Trial of Hydroxychloroquine in the Prevention and Treatment of COVID-19
Actual Study Start Date: April 7, 2020
Estimated Study Completion Date: June 15, 2021
Sub-Study 1: 50-75 years of age; self-reporting as having a fever within four days prior to time of enrollment; and not requiring hospitalization. Enrolled individuals will undergo testing for COVID-19 and sent home for self-quarantine. Participant must be willing and able to provide informed consent, agree to testing for COVID-19 at time of enrollment to confirm diagnosis and two weeks at the end of treatment.
Sub-Study 2: Currently employed as a health care worker. Health care workers meeting the following criteria:
Sub-Study 1: COVID-19 patients in self-quarantine.
Sub-Study 2: Asymptomatic health care worker prophylaxis.
Thank you for your interest in advancing COVID-19 treatments.
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