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

October 15, 2021 updated by: Dr. Deneen Vojta, UnitedHealth Group

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 11042
        • ProHealth New York

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • HCQ Group
Drug: Group 2 Placebo
Enrolled participants randomized in Group 2 will receive a placebo drug
Other Names:
  • 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 Names:
  • HCQ Group
Drug: Group 2 Placebo
Enrolled participants randomized in Group 2 will receive a placebo drug
Other Names:
  • Placebo Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Until completion of study, 29 to 31 days after beginning treatment.
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
Until completion of study, 2 months after start of treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
1-3 days after completion of 14 day treatment
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
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
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
Until completion of study, 2 months (~60 days) after start of treatment.
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
Until completion of study, 2 months after start of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UnitedHealth Group

Collaborators

University of Pennsylvania
ProHealth Care Associates

Investigators

  • Principal Investigator: Deneen Vojta, MD, UnitedHealth Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2020

Primary Completion (Actual)

July 11, 2020

Study Completion (Actual)

July 11, 2020

Study Registration Dates

First Submitted

April 9, 2020

First Submitted That Met QC Criteria

April 15, 2020

First Posted (Actual)

April 20, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2021

Last Update Submitted That Met QC Criteria

October 15, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-0003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

IPD Sharing Time Frame

1 year

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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