MedDataX Logo

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

NCT ID: NCT04347889

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-20

Study Completion Date

2020-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open label, controlled, RCT
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Outcomes assessors will be masked to study assignment

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hydroxychloroquine

Oral loading dose of 800 mg followed by once weekly oral hydroxychloroquine 400 mg for 3 months

Group Type EXPERIMENTAL

Hydroxychloroquine

Intervention Type DRUG

Oral loading dose followed by once weekly dosing

Vitamin C

Oral Vitamin C 1,000 mg daily for three months

Group Type ACTIVE_COMPARATOR

Vitamin C

Intervention Type OTHER

Once daily vitamin C 1 gm

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hydroxychloroquine

Oral loading dose followed by once weekly dosing

Intervention Type DRUG

Vitamin C

Once daily vitamin C 1 gm

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stony Brook University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Adam Singer

Professor and Vice Chairman for Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB2020-00222

Identifier Type: -

Identifier Source: org_study_id