Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore

Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore: a Review of Process Feasibility, Safety, and Clinical Outcomes

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.

Study Overview

• Status: Withdrawn
• Conditions: COVID-19; COVID; Coronavirus
• Intervention / Treatment: Drug: Hydroxychloroquine

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to resolution of symptoms	Time that it takes for symptoms to be resolved in those who were treated vs untreated	up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of days from onset of illness to symptom resolution	up to 4 weeks
Number of days to return to work	up to 4 weeks
Rate of hospital admission in treated and untreated healthcare workers	up to 4 weeks
Adverse effect of HCQ during treatment	up to 5 days

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Priya Nori, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2020
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 17, 2020

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 22, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Hydroxychloroquine
• Other Study ID Numbers: 2020-11445

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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.: Yes