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.
Sub-Study 1: COVID-19 patients in self-quarantine. Group 1: Hydroxychloroquine 400 mg bid (two 200 mg tablets taken twice a day; totaling 800 mg per day) for two weeks; Group 2: Placebo 2 pills twice a day for two weeks Sub-Study 2: Asymptomatic health care worker prophylaxis. Group 1: Hydroxychloroquine 600 mg once a day (three 200 mg tablets taken once a day) for up to 2 months; Group 2: Placebo 3 pills once a day for up to 2 months; cross-over from placebo to HCQ 600 mg once a day is allowed upon confirmatory diagnosis for COVID-19. PRIMARY OBJECTIVES: Sub-Study 1 (Patients tested for COVID-19 who meet symptomology and age requirements for eligibility): Rate of hospitalization Sub-Study 2 (Health Care Workers): Rate of COVID-19 infection (confirmed by accepted testing methods) at 2 months SECONDARY OBJECTIVES Sub-Study 1: Rate of secondary infection of co-inhabitants, adverse events, and negative for COVID-19 (confirmed by accepted testing methods) at 14 days Sub-Study 2: Number of shifts missed; rate of adverse events, and hospitalization at 2 months
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
39
Enrolled participants randomized in Group 1 receive the HCQ drug
Enrolled participants randomized in Group 2 will receive a placebo drug
ProHealth New York
New York, New York, United States
Substudy 1 - Number of COVID-19+ PCR Patients in Self-quarantine Who Are Hospitalized
Number of COVID-19+ PCR patients in self-quarantine who are hospitalized up to 31 days after beginning HCQ or Placebo
Time frame: Until completion of study, 29 to 31 days after beginning treatment.
Sub Study 2:Number of Health Care Workers Testing Positive at 2 Months
Rate of COVID-19 infection (confirmed by accepted testing methods) at 2 months
Time frame: Until completion of study, 2 months after start of treatment.
Sub Study 1 - Secondary Infection of Co-inhabitants of COVID-19 Positive PCR Patients in Self-quarantine
Co-inhabitants of COVID-19 positive PCR patients in self-quarantine that test positive up to 31 days after patient begins treatment with HCQ or Placebo
Time frame: Until completion of study, 29 to 31 days after beginning treatment.
Sub Study 1 - Rate of Negative Tests at End of Treatment for COVID-19 Positive PCR Patients in Self-quarantine
Rate of negative tests at end of treatment for COVID-19 positive PCR patients in self-quarantine
Time frame: 15-17 days after completion of 14 day treatment
Sub Study 1 - Rate of Negative Tests at End of Treatment for COVID-19 Positive PCR Patients in Self-quarantine
Rate of negative tests at end of treatment for COVID-19 positive PCR patients in self-quarantine
Time frame: 1-3 days after completion of 14 day treatment
Sub Study 2:Health Care Workers:Number of Shifts Missed
Any work time missed because the participant experienced COVID-like symptoms during their active 2 month period
Time frame: up to ~60 days after enrollment
Sub Study 2:Health Care Workers: Assessment of Any Medical Events That Occur During the ~60 Day Active Period
Assessment of any medical events that occur during the \~60 day active period that is felt to be related to receipt of HCQ
Time frame: Until completion of study, 2 months (~60 days) after start of treatment.
Sub Study 2:Health Care Workers:Rate of Hospitalization
if the participant gets COVID and has severe symptoms and hospitalized, end point reached if before the end of the 2 month period
Time frame: Until completion of study, 2 months after start of treatment.
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