Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore

NCT ID: NCT04350450

Last Updated: 2020-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-30

Study Completion Date

2020-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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COVID Coronavirus COVID-19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Hydroxychloroquine

Intervention Type DRUG

400 mg tablet

Control Group

Participants who opt not to receive the study drug will also be invited to participate in the survey study assessing COVID19 symptoms

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hydroxychloroquine

400 mg tablet

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Priya Nori

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Priya Nori, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

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Montefiore Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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2020-11445

Identifier Type: -

Identifier Source: org_study_id

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