Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04350450
• Other study ID #: 2020-11445
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 2020
• Est. completion date: August 2020

Study information

• Verified date: April 2020
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• COVID
• COVID-19

Intervention

Drug:
• Hydroxychloroquine
400 mg tablet

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of days from onset of illness to symptom resolution		up to 4 weeks
Secondary	Number of days to return to work		up to 4 weeks
Secondary	Rate of hospital admission in treated and untreated healthcare workers		up to 4 weeks
Secondary	Adverse effect of HCQ during treatment		up to 5 days