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Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore

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: NCT04350450
Recruitment Status : Withdrawn (PI withdrew the submission to the IRB)
First Posted : April 17, 2020
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Priya Nori, Montefiore Medical Center

Brief Summary:
Given the high prevalence of COVID19 illness (both SARS-CoV-2 RT-PCR confirmed and highly suspect cases) among healthcare workers (HCW) within the Montefiore Health System (MHS), hydroxychloroquine (HCQ) will be prescribed to healthcare workers who are at the highest risk for severe COVID19 illness.

Condition or disease Intervention/treatment Phase
COVID Coronavirus COVID-19 Drug: Hydroxychloroquine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore: a Review of Process Feasibility, Safety, and Clinical Outcomes
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020


Arm Intervention/treatment
Experimental: Treatment Group
Eligible participants will be offered the standard Montefiore HCQ dosing regimen of 400mg every 12 hours x 24 hours, then 400mg daily for remaining 4 days and complete a survey study
Drug: Hydroxychloroquine
400 mg tablet

No Intervention: Control Group
Participants who opt not to receive the study drug will also be invited to participate in the survey study assessing COVID19 symptoms



Primary Outcome Measures :
  1. Time to resolution of symptoms [ Time Frame: up to 4 weeks ]
    Time that it takes for symptoms to be resolved in those who were treated vs untreated


Secondary Outcome Measures :
  1. Number of days from onset of illness to symptom resolution [ Time Frame: up to 4 weeks ]
  2. Number of days to return to work [ Time Frame: up to 4 weeks ]
  3. Rate of hospital admission in treated and untreated healthcare workers [ Time Frame: up to 4 weeks ]
  4. Adverse effect of HCQ during treatment [ Time Frame: up to 5 days ]


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 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic with COVID illness (either RT-PCR test confirmed or highly suspect clinical symptoms)
  • Call into office within the first 7 days of illness
  • Have any of the following high risk conditions:

    • Age >60
    • HTN, CAD, or chronic heart disease
    • Diabetes
    • Chronic kidney disease
    • Chronic lung disease
    • Active or recent chemotherapy for malignancy
    • Organ transplant
    • Taking Immune-suppressing medications
    • HIV with CD4 <200 cells/mm3
  • Experiencing at least one of the following high risk symptoms:

    • Severe cough
    • Fever 100.0F or greater
    • Diarrhea
    • Shortness of Breath
    • Hypoxia

Exclusion Criteria:

• HCW not meeting high-risk criteria or those with a contraindication to HCQ will not be offered HCQ


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): NCT04350450


Locations
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Priya Nori, MD Montefiore Medical Center
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Responsible Party: Priya Nori, Principal Investigator, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT04350450    
Other Study ID Numbers: 2020-11445
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: Yes
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents