PATCH 2&3:Prevention & Treatment of COVID-19 (Severe Acute Respiratory Syndrome Coronavirus 2) With Hydroxychloroquine
Condition: Coronavirus; Corona Virus Infection
MeSH terms: Coronavirus Infections
Intervention: Group 1 HCQ; Group 2 Placebo
Intervention description: Enrolled participants randomized in Group 1 receive the HCQ drug; Enrolled participants randomized in Group 2 will receive a placebo drug
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Treatment and prevention study
Masking: Double (Participant, Care Provider)
Masking description: For PATCH 2: participant and care provider are blinded. For PATCH 3: Health care worker is blinded.
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to give informed consent

          -  Subjects meeting the following criteria by Sub-Study:

        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 are defined as
        :

          -  Medical Doctor (MD)

          -  Doctor of Osteopathic Medicine (DO)

          -  Nurse Practitioner (NP)

          -  Physician's Assistant (PA)

          -  Registered Nurse (RN)

          -  other members of the medical care team with significant COVID-19 exposure;

        Health care workers meeting the following criteria:

          -  asymptomatic and presumed negative for COVID-19 (no confirmatory testing conducted);

          -  scheduled for an average of >20 hours per week of clinical care over the next 2
             months.

        Participant must agree to standard clinical guidelines and undergo COVID-19 testing upon
        the presentation of symptoms indicative of an influenza like illness; if a confirmatory
        COVID-19 diagnosis is given, participant will be offered to cross-over to HCQ 600 mg qd.

          -  Willing to report compliance with HCQ in the form of a diary and participate in other
             forms of self-reporting (e.g., symptom tracker and experience log).

          -  Subjects are willing and able to go to designated areas for testing of
             COVID-19/SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).

          -  Participants must be able to swallow and retain oral medication and must not have any
             clinically significant gastrointestinal abnormalities that may alter absorption such
             as malabsorption syndrome or major resection of the stomach or bowels.

          -  Participants must have adequate baseline organ function

        Exclusion Criteria:

          -  Inclusion Criteria

               -  Able to give informed consent

               -  Subjects meeting the following criteria by Sub-Study:

        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 (Medical Doctor, MD; Doctor of
        Osteopathic Medicine, DO; Nurse Practitioner, NP; Physician's Assistant, PA; and Registered
        Nurse, RN or other members of the medical care team with significant COVID-19 exposure);
        asymptomatic and presumed negative for COVID-19 (no confirmatory testing conducted);
        scheduled for an average of >20 hours per week of clinical care over the next 2 months.
        Participant must agree to standard clinical guidelines and undergo COVID-19 testing upon
        the presentation of symptoms indicative of an influenza like illness; if a confirmatory
        COVID-19 diagnosis is given, participant will be offered to cross-over to HCQ 600 mg qd.

          -  Willing to report compliance with HCQ in the form of a diary and participate in other
             forms of self-reporting (e.g., symptom tracker and experience log).

          -  Subjects are willing and able to go to designated areas for testing of
             COVID-19/SARS-CoV-2.

          -  Participant must be able to swallow and retain oral medication and must not have any
             clinically significant gastrointestinal abnormalities that may alter absorption such
             as malabsorption syndrome or major resection of the stomach or bowels.

          -  Participant must have adequate baseline organ function

        Exclusion Criteria

          -  Allergy to hydroxychloroquine

          -  Pregnant or lactating or positive pregnancy test during pre-medication examination

          -  Receiving any trial treatment drug for 2019-ncov within 14 days prior to screening
             evaluation (off label, compassionate use or trial related).

          -  Known retinal disease including but not limited to macular degeneration, retinal vein
             occlusion, visual field defect, diabetic retinopathy

          -  History of interstitial lung disease or chronic pneumonitis unrelated COVID-19.

          -  Due to risk of disease exacerbation, participants with porphyria or psoriasis are
             ineligible unless the disease is well-controlled, and they are under the care of a
             specialist for the disorder who agrees to monitor the Participant for exacerbations.

          -  Participants with serious intercurrent illness that requires active intravenous
             therapy, intense monitoring, or frequent dose adjustments for medication including but
             not limited to infectious disease, cancer, autoimmune disease, cardiovascular disease.

          -  Participants who have undergone major abdominal, thoracic, spine or central nervous
             system (CNS) surgery in the last 2 months, or plan to undergo surgery during study
             participation.

          -  Participants receiving cytochrome P450 enzyme-inducing anticonvulsant drugs (i.e.
             phenytoin, carbamazepine, Phenobarbital, primidone or oxcarbazepine) within 4 weeks of
             the start of the study treatment

          -  Participants currently taking digoxin

          -  History or evidence of increased cardiovascular risk including any of the following:

          -  Left ventricular ejection fraction (LVEF) < institutional lower limit of normal.
             Baseline echocardiogram is not required.

          -  Current clinically significant uncontrolled arrhythmias. Exception: Subjects with
             controlled atrial fibrillation

          -  History of acute coronary syndromes (including myocardial infarction and unstable
             angina), coronary angioplasty, or stenting within 6 months prior to enrollment

          -  Current ≥ Class II congestive heart failure as defined by New York Heart Association.

          -  Deemed unable to participate for medical reasons identified by Co-PI and study staff.