Back to resultsHydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore
Primary Purpose
COVID, Coronavirus, COVID-19
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hydroxychloroquine
Sponsored by
About this trial
This is an interventional treatment trial for COVID
Eligibility 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
Sites / Locations
- Montefiore Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment Group
Control Group
Arm Description
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
Participants who opt not to receive the study drug will also be invited to participate in the survey study assessing COVID19 symptoms
Outcomes
Primary Outcome Measures
Time to resolution of symptoms
Time that it takes for symptoms to be resolved in those who were treated vs untreated
Secondary Outcome Measures
Number of days from onset of illness to symptom resolution
Number of days to return to work
Rate of hospital admission in treated and untreated healthcare workers
Adverse effect of HCQ during treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04350450
Brief Title
Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore
Official Title
Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore: a Review of Process Feasibility, Safety, and Clinical Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Withdrawn
Why Stopped
PI withdrew the submission to the IRB
Study Start Date
April 2020 (Anticipated)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID, Coronavirus, COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants who opt not to receive the study drug will also be invited to participate in the survey study assessing COVID19 symptoms
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
400 mg tablet
Primary Outcome Measure Information:
Title
Time to resolution of symptoms
Description
Time that it takes for symptoms to be resolved in those who were treated vs untreated
Time Frame
up to 4 weeks
Secondary Outcome Measure Information:
Title
Number of days from onset of illness to symptom resolution
Time Frame
up to 4 weeks
Title
Number of days to return to work
Time Frame
up to 4 weeks
Title
Rate of hospital admission in treated and untreated healthcare workers
Time Frame
up to 4 weeks
Title
Adverse effect of HCQ during treatment
Time Frame
up to 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Priya Nori, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore
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