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PATCH 2&3:Prevention & Treatment of COVID-19 (Severe Acute Respiratory Syndrome Coronavirus 2) With Hydroxychloroquine

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ClinicalTrials.gov Identifier: NCT04353037
Recruitment Status : Terminated (As enrollment began external studies called into question the safety and efficacy of hydroxychloroquine as a treatment which resulted in controversy. The timing of the controversy significantly impacted our ability to enroll and retain participants.)
First Posted : April 20, 2020
Last Update Posted : March 12, 2021
Sponsor:
Collaborators:
ProHealth Care Associates
University of Pennsylvania Perelman School of Medicine
Information provided by (Responsible Party):
Dr. Deneen Vojta, UnitedHealth Group

Tracking Information
First Submitted Date  ICMJE April 9, 2020
First Posted Date  ICMJE April 20, 2020
Last Update Posted Date March 12, 2021
Actual Study Start Date  ICMJE April 7, 2020
Actual Primary Completion Date July 11, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2020)
  • Sub Study 1: Patients [ Time Frame: 21 days ]
    Rate of hospitalization
  • Sub Study 2: Health Care Workers [ Time Frame: 2 months ]
    Rate of COVID-19 infection (confirmed by accepted testing methods) at 2 months
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2020)
  • Sub Study 1: Patients: Rate of secondary infection of co-inhabitants [ Time Frame: 14 days after enrollment of the household ]
    any house hold member who has reported symptoms or test positive for COVID 19 during their 14 day active participation
  • Sub Study 1: Patients: Adverse Events [ Time Frame: 14 day active period ]
    Assessment of any medical events that occur during the 14 day active period that is felt to be related to receipt of HCQ
  • Sub Study 1: Patients: Negative for COVID-19 [ Time Frame: up to 5 days after enrolling ]
    If a test comes back negative, participant would be notified as such and told to destroy their pills as they are withdrawn
  • Sub Study 2:Health Care Workers:Number of shifts missed [ Time Frame: up to ~60 days after enrollment ]
    Any work time missed because the participant experienced COVID-like symptoms during their active 2 month period
  • Sub Study 2:Health Care Workers:Rate of adverse events [ Time Frame: up to ~60 days after enrollment ]
    Assessment of any medical events that occur during the ~60 day active period that is felt to be related to receipt of HCQ
  • Sub Study 2:Health Care Workers:Rate of hospitalization [ Time Frame: up to ~60 days after enrollment ]
    if the participant gets COVID and has severe symptoms and hospitalized, end point reached if before the end of the 2 month period
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PATCH 2&3:Prevention & Treatment of COVID-19 (Severe Acute Respiratory Syndrome Coronavirus 2) With Hydroxychloroquine
Official Title  ICMJE 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
Brief 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.
Detailed Description

Sub-Study 1: COVID-19 patients in self-quarantine. Arm 1: Hydroxychloroquine 400 mg bid (two 200 mg tablets taken twice a day; totaling 800 mg per day) for two weeks; Arm 2: Placebo 2 pills twice a day for two weeks

Sub-Study 2: Asymptomatic health care worker prophylaxis. Arm 1: Hydroxychloroquine 600 mg once a day (three 200 mg tablets taken once a day) for up to 2 months; Arm 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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.
Primary Purpose: Treatment
Condition  ICMJE
  • Coronavirus
  • Corona Virus Infection
Intervention  ICMJE
  • Drug: Group A HCQ
    Enrolled participants randomized in Group A receive the HCQ drug
    Other Name: HCQ Arm
  • Drug: Group B Control
    Enrolled participants randomized in Group B will receive a placebo drug
    Other Name: Placebo Arm
Study Arms  ICMJE
  • Experimental: Sub Study 1 Patients
    Patients tested for COVID-19 who meet symptomology and age requirements for eligibility
    Interventions:
    • Drug: Group A HCQ
    • Drug: Group B Control
  • Experimental: Sub Study 2 Health Care Workers
    Rate of COVID-19 infection (confirmed by accepted testing methods) at 2 months
    Interventions:
    • Drug: Group A HCQ
    • Drug: Group B Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 9, 2021)
21
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2020)
850
Actual Study Completion Date  ICMJE July 11, 2020
Actual Primary Completion Date July 11, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04353037
Other Study ID Numbers  ICMJE 2020-0003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data will be collected and managed by Optumcare and UnitedHealth Group Research & Development. Redacted/aggregate data will be shared with the University Of Penn using approved data sharing protocols.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: 1 year
Responsible Party Dr. Deneen Vojta, UnitedHealth Group
Study Sponsor  ICMJE UnitedHealth Group
Collaborators  ICMJE
  • ProHealth Care Associates
  • University of Pennsylvania Perelman School of Medicine
Investigators  ICMJE
Principal Investigator: Deneen Vojta, MD UnitedHealth Group
PRS Account UnitedHealth Group
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP