CClinicalTrials.gg
Sign In
WithdrawnNCT04347889Updated Nov 2, 2020

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

A Phase 2 interventional study of Hydroxychloroquine and Vitamin C in Covid-19, sponsored by Stony Brook University. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-02.

Sponsored by Stony Brook University · Phase 2, Interventional, and Prevention

Why this study was withdrawn
Evidence that HCQ ineffective, loss of HCW interest,
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Covid-19

Browse trials for

Keywords

  • covid-19
  • healthcare workers
  • prophylaxis
  • hydroxychloroquine
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

Browse COVID-19 studies →

Lead sponsor

Stony Brook University is the lead sponsor of 191 studies on the registry; 36 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 10 (45%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Healthcare worker at risk of Covid-19

Exclusion criteria

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.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Hydroxychloroquine

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

    Drug: Hydroxychloroquine

  • Active comparator
    Vitamin C

    Oral Vitamin C 1,000 mg daily for three months

    Other: Vitamin C

Interventions

  • DrugHydroxychloroquine

    Oral loading dose followed by once weekly dosing

  • OtherVitamin C

    Once daily vitamin C 1 gm

06

What researchers measure

Primary outcomes

  1. COVID-19 Seroconversion rate

    Percentage of healthcare worker who develop antibodies to SARS-CoV-2

    Time frame: 3 months

Secondary outcomes

  1. Admission for Covid-19

    Percentage of study subjects who require admission to a hospital for Covid-19

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04347889
Lead sponsor
Stony Brook University
Responsible party
Adam Singer (Professor and Vice Chairman for Research, Stony Brook University) — Principal investigator
First posted
Apr 15, 2020
Start date
Apr 20, 2020 (estimated)
Primary completion
Dec 30, 2020 (estimated)
Completion
Dec 30, 2020 (estimated)
Last update
Nov 2, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

COVID-19→

Other studies from this sponsor

Stony Brook University

Start the discussion