Preventing COVID-19 in Healthcare Workers With HCQ: A RCT | NCT04347889

Studies
Preventing COVID-19 in Healthcare Workers With HCQ: A RCT

NCT04347889

Sponsor

Stony Brook University

Status

Withdrawn

Last Update Posted

Nov 2, 2020Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Covid-19

Interventions

Hydroxychloroquine
Vitamin C

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Evidence that HCQ ineffective, loss of HCW interest,

Expanded Access Info

Start Date

Apr 20, 2020Estimated

Primary Completion Date

Dec 30, 2020Estimated

Completion Date

Dec 30, 2020Estimated

First Submitted Date

Apr 13, 2020

First Submission Date that Met QC Criteria

Apr 13, 2020

First Posted Date

Apr 15, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2020

Last Update Posted Date

Nov 2, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Healthcare workers (HCW) at risk of Covid-19 will have baseline serology for SARS-CoV-2 to see if they are already immune to Covid-19. HCW will get baseline assessment and if meeting inclusion criteria and no exclusion criteria they will be randomized in a 2:1 ratio to hydroxychloroquine or Vitamin C on a weekly basis for three months. Subjects will complete daily diary of symptoms and temperature, and will have repeat SARS-CoV-2 serology at 6 weeks and 3 months to determine seroconversion.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hydroxychloroquine	Experimental	Oral loading dose of 800 mg followed by once weekly oral hydroxychloroquine 400 mg for 3 months	Drug: Hydroxychloroquine
Vitamin C	Active Comparator	Oral Vitamin C 1,000 mg daily for three months	Other: Vitamin C

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hydroxychloroquine	Drug	Oral loading dose followed by once weekly dosing	Hydroxychloroquine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
COVID-19 Seroconversion rate	Percentage of healthcare worker who develop antibodies to SARS-CoV-2	3 months

Secondary Outcomes

Measure	Description	Time Frame
Admission for Covid-19	Percentage of study subjects who require admission to a hospital for Covid-19	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthcare worker at risk of Covid-19

Exclusion Criteria:

Known hypersensitivity or allergic reactions to 4-aminoquinoline compounds or its ingredients.
Current, or history of, ocular macular disease or retinal damage.
Current, or history of, subnormal glomerular filtration.
Current use of tamoxifen citrate.
Current, or history of, cardiomyopathy, atrial, nodal, or ventricular arrhythmias, torsades de pointes, conduction disorders (bundle branch block/atrio-ventricular heart block) or biventricular hypertrophy.
Subjects taking other drugs that have the potential to prolong QT interval if taken with HCQ.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006886	Hydroxychloroquine
D001205	Ascorbic Acid

Ancestor Terms

ID	Term
D002738	Chloroquine
D000634	Aminoquinolines
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring

Browse Leaves

Not provided

Browse Branches

Not provided