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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Results First Posted : October 19, 2021
Last Update Posted : October 19, 2021
Sponsor:
Collaborators:
ProHealth Care Associates
University of Pennsylvania
Information provided by (Responsible Party):
Dr. Deneen Vojta, UnitedHealth Group

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronavirus Corona Virus Infection Drug: Group 1 HCQ Drug: Group 2 Placebo Phase 2

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
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
Official Title: PATCH 2 & 3: (Prevention and Treatment of COVID-19 With Hydroxychloroquine) A Double-blind Placebo Controlled Randomized Trial of Hydroxychloroquine in the Prevention and Treatment of COVID-19
Actual Study Start Date : April 7, 2020
Actual Primary Completion Date : July 11, 2020
Actual Study Completion Date : July 11, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Sub Study 1 Patients
Patients tested for COVID-19 who meet symptomology and age requirements for eligibility
 Drug: Group 1 HCQ
Enrolled participants randomized in Group 1 receive the HCQ drug
Other Name: HCQ Group

Drug: Group 2 Placebo
Enrolled participants randomized in Group 2 will receive a placebo drug
Other Name: Placebo Group
Experimental: Sub Study 2 Health Care Workers
Rate of COVID-19 infection (confirmed by accepted testing methods) at 2 months
 Drug: Group 1 HCQ
Enrolled participants randomized in Group 1 receive the HCQ drug
Other Name: HCQ Group

Drug: Group 2 Placebo
Enrolled participants randomized in Group 2 will receive a placebo drug
Other Name: Placebo Group


Outcome Measures
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Primary Outcome Measures :
  1. Substudy 1 - Number of COVID-19+ PCR Patients in Self-quarantine Who Are Hospitalized [ Time Frame: Until completion of study, 29 to 31 days after beginning treatment. ]
    Number of COVID-19+ PCR patients in self-quarantine who are hospitalized up to 31 days after beginning HCQ or Placebo

  2. Sub Study 2:Number of Health Care Workers Testing Positive at 2 Months [ Time Frame: Until completion of study, 2 months after start of treatment. ]
    Rate of COVID-19 infection (confirmed by accepted testing methods) at 2 months


Secondary Outcome Measures :
  1. Sub Study 1 - Secondary Infection of Co-inhabitants of COVID-19 Positive PCR Patients in Self-quarantine [ Time Frame: Until completion of study, 29 to 31 days after beginning treatment. ]
    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

  2. Sub Study 1 - 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 ]
    Rate of negative tests at end of treatment for COVID-19 positive PCR patients in self-quarantine

  3. Sub Study 1 - 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 ]
    Rate of negative tests at end of treatment for COVID-19 positive PCR patients in self-quarantine

  4. 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

  5. Sub Study 2:Health Care Workers: Assessment of Any Medical Events That Occur During the ~60 Day Active Period [ Time Frame: Until completion of study, 2 months (~60 days) after start of treatment. ]
    Assessment of any medical events that occur during the ~60 day active period that is felt to be related to receipt of HCQ

  6. Sub Study 2:Health Care Workers:Rate of Hospitalization [ Time Frame: Until completion of study, 2 months after start of treatment. ]
    if the participant gets COVID and has severe symptoms and hospitalized, end point reached if before the end of the 2 month period


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04353037


Locations
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United States, New York
ProHealth New York
New York, New York, United States, 11042
Sponsors and Collaborators
UnitedHealth Group
ProHealth Care Associates
University of Pennsylvania
Investigators
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Principal Investigator: Deneen Vojta, MD UnitedHealth Group
  Study Documents (Full-Text)

Documents provided by Dr. Deneen Vojta, UnitedHealth Group:
Study Protocol and Statistical Analysis Plan  [PDF] May 12, 2020

More Information
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Publications:

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Responsible Party: Dr. Deneen Vojta, Chief Medical Officer, Research and Development, UnitedHealth Group
ClinicalTrials.gov Identifier: NCT04353037    
Other Study ID Numbers: 2020-0003
First Posted: April 20, 2020    Key Record Dates
Results First Posted: October 19, 2021
Last Update Posted: October 19, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 1 year

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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
Additional relevant MeSH terms:
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Coronavirus Infections
Infections
Virus Diseases
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections