Hydroxychloroquine as Chemoprevention for COVID-19 for High Risk Healthcare Workers
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      The study proposes to conduct an open-label Phase II trial to evaluate the feasibility,
      safety and early efficacy of hydroxychloroquine (HCQ) administration in reduction of
      transmission of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and development
      of Corona Virus Disease 2019 (COVID-19) in high-risk, healthy acute care provider
      participants exposed, directly or indirectly, to COVID-19 patients. There is a more than 50
      years track record of safety of HCQ for treatment and prevention of various disease states.
      Early data on use of HCQ for COVID treatment suggests anti-viral activity and
      immunomodulatory properties for reducing inflammation associated with COVID-19.
    

Detailed description: 
      Given the lack of data regarding use of HCQ for COVID-19 prevention in healthy participants
      in midst of pandemic crisis, this study proposes an expedited feasibility study focusing on
      safety and early efficacy.

      Prior to HCQ administration, baseline SARS-CoV-2 and other baseline biomarker testing will be
      conducted. During the 4-week study period, participants will be monitored for drug related
      adverse events and assessed for development of COVID. SARS-CoV-2 assay and biomarker testing
      will be repeated at the end of four-week study. Safety outcomes will be assessed by the
      number of adverse events (AEs) and their severity; and early efficacy as the number of
      participants who tested positive at the end of the 4-week period comparing to data collected
      by occupational Health regarding the total number of high-risk healthcare workers that were
      tested positive during the same period and historical controls from known high risk infection
      rates. An exploratory analysis of inflammatory regulation and immunomodulatory markers by HCQ
      and its effect on possible disease modification based on previously studied
      pathophysiological mechanism of COVID-19.

      The broader aim of this study is to set a precedent to facilitate a large-scale emergent
      public health intervention. Purpose would be to mitigate, or abort further transmission of
      COVID-19. Given that COVID-19 transmission has occurred prior to initiation of this study,
      the rationale for this intervention is based on prior epidemiological evidence.
      Post-infectious or vaccination-induced immunity in at least 30% of population at-risk has
      been shown to mitigate or abort propagation of a local epidemics and global pandemic. This
      would help flatten the curve of the disease progression, until such time that a vaccine may
      become available. Data from this study will be used to design and implement a
      population-based phase IIb/III randomized clinical trial.
    

Intervention name(s): Hydroxychloroquine Sulfate (HCQ)
Intervention type(s): Drug
Intervention description(s): Open-label, consecutive at-risk subjects allocation with chemoprophylaxis with HCQ.
Intervention MeSH terms: Hydroxychloroquine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: covid19; workers; prevention