Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore

Montefiore Medicine Academic Health System

Status and phase: Withdrawn; Phase 2

Conditions: COVID-19; COVID; Coronavirus

Treatments: Drug: Hydroxychloroquine

Study type: Interventional

Funder types: Other

Identifiers

NCT04350450

2020-11445

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Treatment Group

Experimental group

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

Treatment:

Drug: Hydroxychloroquine

Control Group

No Intervention group

Description:

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