Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore

Phase 2

Withdrawn

• Conditions: COVID-19; Coronavirus; COVID
• Interventions: Drug: Hydroxychloroquine

• Registration Number: NCT04350450
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study Start: 2020-04
• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-17
• Last Update Submitted: 2020-05-22
• Last Update Posted: 2020-05-27
• Primary Completion: 2020-08
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Hydroxychloroquine	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

Primary Outcome Measures

Name	Time	Method
Time to resolution of symptoms	up to 4 weeks	Time that it takes for symptoms to be resolved in those who were treated vs untreated

Secondary Outcome Measures

Name	Time	Method
Rate of hospital admission in treated and untreated healthcare workers	up to 4 weeks
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
Adverse effect of HCQ during treatment	up to 5 days

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States