Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore

NCT04350450 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 2020-11445
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID; Coronavirus; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Hydroxychloroquine DRUG

400 mg tablet

Treatment Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• HCW not meeting high-risk criteria or those with a contraindication to HCQ will not be offered HCQ

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Priya Nori, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 17, 2020
• Study Start: April 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: May 27, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)