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

Sponsor
UnitedHealth Group (Industry)
Overall Status
Terminated
CT.gov ID
NCT04353037
Collaborator
ProHealth Care Associates (Other), University of Pennsylvania Perelman School of Medicine (Other)
39
Enrollment
1
Location
2
Arms
3.1
Actual Duration (Months)
12.5
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Treatment and prevention studyTreatment 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 :
Apr 7, 2020
Actual Primary Completion Date :
Jul 11, 2020
Actual Study Completion Date :
Jul 11, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Substudy 1 - Number of COVID-19+ PCR Patients in Self-quarantine Who Are Hospitalized [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 [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 [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 [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 [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 [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 [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 ProHealth New York New York New York United States 11042

    Sponsors and Collaborators

    • UnitedHealth Group
    • ProHealth Care Associates
    • University of Pennsylvania Perelman School of Medicine

    Investigators

    • Principal Investigator: Deneen Vojta, MD, UnitedHealth Group

    Study Documents (Full-Text)

    More Information

    Publications

    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:
    Apr 20, 2020
    Last Update Posted:
    Oct 19, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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:
    Coronavirus Infections

    Study Results

    Participant Flow

    Recruitment Details Sub study 1 HCQ & Placebo groups were identified as patient at least 50 years old self-reported as having a fever within the last four days will undergo swab testing for COVID-19, and then sent home for a self-imposed quarantine that will end 14 days from the start of treatment and consenting patients were randomized. Sub study 2 HCQ and Placebo groups were recruited first through completion of an interest questionnaire then contacted by study PI or designee to assess eligibility consent.
    Pre-assignment Detail If Sub Study 1 patients received a negative PCR-test then they were considered no longer a part of the study and had a conversation with the PI or designee. Recruitment was done this way because early in the pandemic, time to receive PCR test results was unclear. At study conclusion 9 substudy 1 participants were Covid positive. 6 of those Covid positive participants completed the study. 30 participants from sub study 2 met eligibility criteria with 13 participants completing the full study.
    Arm/Group Title Sub Study 1 Group 1 (HCQ) Sub Study 1 Group 2 (Placebo) Sub Study 2 Group 1 (HCQ) Sub Study 2 Group 2 (Placebo)
    Arm/Group Description COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with hydroxychloroquine 400mg twice a day for 14 days. COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with placebo 2 pills twice a day for 14 days. Currently employed as a health care worker. Must be asymptomatic and presumed negative for COVID-19. Health care workers randomized into this arm will be treated with hydroxychloroquine 600 mg qd (three 200 mg tablets taken once a day) for 2 months. Currently employed as a health care worker. Must be asymptomatic and presumed negative for COVID-19. Health care workers randomized into this arm will be treated with Placebo pills (three 200 mg tablets taken once a day) for 2 months.
    Period Title: Overall Study
    STARTED 6 3 13 17
    COMPLETED 6 0 6 7
    NOT COMPLETED 0 3 7 10

    Baseline Characteristics

    Arm/Group Title Substudy 1 Group 1 (HCQ) Substudy 1 Group 2 (Placebo) Substudy 2 Group 1 (HCQ) Substudy 2 Group 2 (Placebo) Total
    Arm/Group Description COVID-19 positive PCR patients aged 50-75 in self-quarantine randomized to this arm will be treated with hydroxychloroquine 400mg twice a day for 14 days. COVID-19 positive PCR patients aged 50-75 in self-quarantine randomized to this arm will be treated with placebo 2 pills twice a day for 14 days. Currently employed as a health care worker aged 18 or older. Must be asymptomatic and presumed negative for COVID-19. Health care workers randomized into this arm will be treated with hydroxychloroquine 600 mg daily (three 200 mg tablets taken once a day) for 2 months. Currently employed as a health care worker aged 18 or older. Must be asymptomatic and presumed negative for COVID-19. Health care workers randomized into this arm will be treated with Placebo pills (three 200 mg tablets taken once a day) for 2 months. Total of all reporting groups
    Overall Participants 6 3 13 17 39
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    59
    58
    45
    49
    49
    Sex: Female, Male (Count of Participants)
    Female
    3
    50%
    1
    33.3%
    8
    61.5%
    11
    64.7%
    23
    59%
    Male
    3
    50%
    2
    66.7%
    5
    38.5%
    6
    35.3%
    16
    41%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    1
    16.7%
    2
    66.7%
    0
    0%
    0
    0%
    3
    7.7%
    Not Hispanic or Latino
    5
    83.3%
    1
    33.3%
    13
    100%
    17
    100%
    36
    92.3%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    1
    7.7%
    4
    23.5%
    5
    12.8%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    1
    33.3%
    1
    7.7%
    0
    0%
    2
    5.1%
    Black or African American
    1
    16.7%
    0
    0%
    1
    7.7%
    1
    5.9%
    3
    7.7%
    White
    4
    66.7%
    0
    0%
    10
    76.9%
    11
    64.7%
    25
    64.1%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    1
    16.7%
    2
    66.7%
    0
    0%
    1
    5.9%
    4
    10.3%

    Outcome Measures

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

    Outcome Measure Data

    Analysis Population Description
    Evaluable for primary outcome, having completed the study.
    Arm/Group Title Sub Study 1 Group 1 (HCQ) Sub Study 1 Group 2 (Placebo)
    Arm/Group Description COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with hydroxychloroquine 400mg twice a day for 14 days. COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with placebo 2 pills twice a day for 14 days.
    Measure Participants 6 0
    Count of Participants [Participants]
    0
    0%
    0
    0%
    2. Primary Outcome
    Title Sub Study 2:Number of Health Care Workers Testing Positive at 2 Months
    Description Rate of COVID-19 infection (confirmed by accepted testing methods) at 2 months
    Time Frame Until completion of study, 2 months after start of treatment.

    Outcome Measure Data

    Analysis Population Description
    Evaluable for primary outcome, having completed the study.
    Arm/Group Title Sub Study 2 Group 1 (HCQ) Sub Study 2 Group 2 (Placebo)
    Arm/Group Description Currently employed as a health care worker. Must be asymptomatic and presumed negative for COVID-19. Health care workers randomized into this arm will be treated with hydroxychloroquine 600 mg daily (three 200 mg tablets taken once a day) for 2 months. Currently employed as a health care worker. Must be asymptomatic and presumed negative for COVID-19. Health care workers randomized into this arm will be treated with Placebo pills (three 200 mg tablets taken once a day) for 2 months.
    Measure Participants 6 7
    Count of Participants [Participants]
    0
    0%
    0
    0%
    3. Secondary Outcome
    Title Sub Study 1 - Secondary Infection of Co-inhabitants of COVID-19 Positive PCR Patients in Self-quarantine
    Description 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
    Time Frame Until completion of study, 29 to 31 days after beginning treatment.

    Outcome Measure Data

    Analysis Population Description
    Co-inhabitants of patients evaluable for primary outcome, who completed the study. There were 16 co-inhabitants of the Sub study 1 Group 1 (HCQ).
    Arm/Group Title Sub Study 1 Group 1 (HCQ) Sub Study 1 Group 2 (Placebo)
    Arm/Group Description COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with hydroxychloroquine 400mg twice a day for 14 days. COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with placebo 2 pills twice a day for 14 days.
    Measure Participants 16 0
    Count of Participants [Participants]
    0
    0%
    0
    0%
    4. Secondary Outcome
    Title Sub Study 1 - Rate of Negative Tests at End of Treatment for COVID-19 Positive PCR Patients in Self-quarantine
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Evaluable for primary outcome, having completed the study.
    Arm/Group Title Sub Study 1 Group 1 (HCQ) Sub Study 1 Group 2 (Placebo)
    Arm/Group Description COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with hydroxychloroquine 400mg twice a day for 14 days. COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with placebo 2 pills twice a day for 14 days.
    Measure Participants 6 0
    Count of Participants [Participants]
    6
    100%
    0
    0%
    5. Secondary Outcome
    Title Sub Study 1 - Rate of Negative Tests at End of Treatment for COVID-19 Positive PCR Patients in Self-quarantine
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Evaluable for primary outcome, having completed the study.
    Arm/Group Title Sub Study 1 Group 1 (HCQ) Sub Study 1 Group 2 (Placebo)
    Arm/Group Description COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with hydroxychloroquine 400mg twice a day for 14 days. COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with placebo 2 pills twice a day for 14 days.
    Measure Participants 6 0
    Count of Participants [Participants]
    4
    66.7%
    0
    0%
    6. Secondary Outcome
    Title Sub Study 2:Health Care Workers:Number of Shifts Missed
    Description Any work time missed because the participant experienced COVID-like symptoms during their active 2 month period
    Time Frame up to ~60 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    We had no positive Covid-19 tests for Sub Study 2 healthcare workers so we couldn't measure this outcome.
    Arm/Group Title Sub Study 2 Group 1 (HCQ) Sub Study 2 Group 2 (Placebo)
    Arm/Group Description Currently employed as a health care worker. Must be asymptomatic and presumed negative for COVID-19. Health care workers randomized into this arm will be treated with hydroxychloroquine 600 mg daily (three 200 mg tablets taken once a day) for 2 months. Currently employed as a health care worker. Must be asymptomatic and presumed negative for COVID-19. Health care workers randomized into this arm will be treated with Placebo pills (three 200 mg tablets taken once a day) for 2 months.
    Measure Participants 0 0
    7. Secondary Outcome
    Title Sub Study 2:Health Care Workers: Assessment of Any Medical Events That Occur During the ~60 Day Active Period
    Description Assessment of any medical events that occur during the ~60 day active period that is felt to be related to receipt of HCQ
    Time Frame Until completion of study, 2 months (~60 days) after start of treatment.

    Outcome Measure Data

    Analysis Population Description
    Evaluable for primary outcome, having completed the study or removed from study due to moderate or more serious adverse event
    Arm/Group Title Sub Study 2 Group 1 (HCQ) Sub Study 2 Group 2 (Placebo)
    Arm/Group Description Currently employed as a health care worker. Must be asymptomatic and presumed negative for COVID-19. Health care workers randomized into this arm will be treated with hydroxychloroquine 600 mg daily (three 200 mg tablets taken once a day) for 2 months. Currently employed as a health care worker. Must be asymptomatic and presumed negative for COVID-19. Health care workers randomized into this arm will be treated with Placebo pills (three 200 mg tablets taken once a day) for 2 months.
    Measure Participants 8 7
    moderate adverse events
    2
    33.3%
    0
    0%
    minor adverse events
    1
    16.7%
    0
    0%
    8. Secondary Outcome
    Title Sub Study 2:Health Care Workers:Rate of Hospitalization
    Description if the participant gets COVID and has severe symptoms and hospitalized, end point reached if before the end of the 2 month period
    Time Frame Until completion of study, 2 months after start of treatment.

    Outcome Measure Data

    Analysis Population Description
    Evaluable for primary outcome, having completed the study.
    Arm/Group Title Sub Study 2 Group 1 (HCQ) Sub Study 2 Group 2 (Placebo)
    Arm/Group Description Currently employed as a health care worker. Must be asymptomatic and presumed negative for COVID-19. Health care workers randomized into this arm will be treated with hydroxychloroquine 600 mg daily (three 200 mg tablets taken once a day) for 2 months. Currently employed as a health care worker. Must be asymptomatic and presumed negative for COVID-19. Health care workers randomized into this arm will be treated with Placebo pills (three 200 mg tablets taken once a day) for 2 months.
    Measure Participants 6 7
    Count of Participants [Participants]
    0
    0%
    0
    0%

    Adverse Events

    Time Frame Until completion of study, 2 months after start of treatment.
    Adverse Event Reporting Description No adverse events were reported for Sub study 1. For SubStudy 2 group 1, 6 participants completed and were evaluable for primary outcomes, 2 participants were removed from study due to moderate or serious adverse event prior to meeting the evaluable benchmark.
    Arm/Group Title Sub Study 1 Group 1 (HCQ) Sub Study 1 Group 2 (Placebo) Sub Study 2 Group 1 (HCQ) Sub Study 2 Group 2 (Placebo)
    Arm/Group Description COVID-19+ PCR patients in self-quarantine randomized to this arm will be treated with hydroxychloroquine 400mg bid for 14 days. COVID-19+ PCR patients in self-quarantine randomized to this arm will be treated with Place 2 pills bid for 14 days. Currently employed as a health care worker. Must be asymptomatic and presumed negative for COVID-19. Health care workers randomized into this arm will be treated with hydroxychloroquine 600 mg daily (three 200 mg tablets taken once a day) for 2 months. Currently employed as a health care worker. Must be asymptomatic and presumed negative for COVID-19. Health care workers randomized into this arm will be treated with Placebo pills (three 200 mg tablets taken once a day) for 2 months.
    All Cause Mortality
    Sub Study 1 Group 1 (HCQ) Sub Study 1 Group 2 (Placebo) Sub Study 2 Group 1 (HCQ) Sub Study 2 Group 2 (Placebo)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/6 (0%) 0/3 (0%) 0/8 (0%) 0/7 (0%)
    Serious Adverse Events
    Sub Study 1 Group 1 (HCQ) Sub Study 1 Group 2 (Placebo) Sub Study 2 Group 1 (HCQ) Sub Study 2 Group 2 (Placebo)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/6 (0%) 0/3 (0%) 0/8 (0%) 0/7 (0%)
    Other (Not Including Serious) Adverse Events
    Sub Study 1 Group 1 (HCQ) Sub Study 1 Group 2 (Placebo) Sub Study 2 Group 1 (HCQ) Sub Study 2 Group 2 (Placebo)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/6 (0%) 0/3 (0%) 3/8 (37.5%) 0/7 (0%)
    General disorders
    Nasal congestion 0/6 (0%) 0 0/3 (0%) 0 1/8 (12.5%) 1 0/7 (0%) 0
    Headache 0/6 (0%) 0 0/3 (0%) 0 1/8 (12.5%) 1 0/7 (0%) 0
    Angioedema 0/6 (0%) 0 0/3 (0%) 0 1/8 (12.5%) 1 0/7 (0%) 0
    Nausea 0/6 (0%) 0 0/3 (0%) 0 1/8 (12.5%) 1 0/7 (0%) 0
    Decreased Appetite 0/6 (0%) 0 0/3 (0%) 0 1/8 (12.5%) 1 0/7 (0%) 0
    abdominal pain 0/6 (0%) 0 0/3 (0%) 0 1/8 (12.5%) 1 0/7 (0%) 0

    Limitations/Caveats

    No healthcare workers had a positive Covid test during the study period so the outcome for missed shifts due a positive Covid result was not measured. Due to low enrollment numbers, only a descriptive analysis was reported and we did not test any of the hypotheses described in the statistical analysis plan.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Mike Lahm, Director Data Science
    Organization UnitedHealth Group R&D / Optum Labs
    Phone 302-379-0209
    Email MichaelLahm@uhg.com
    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:
    Apr 20, 2020
    Last Update Posted:
    Oct 19, 2021
    Last Verified:
    Oct 1, 2021