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Anti-malarial drug
Hydroxychloroquine for Hydroxychloroquine (HCQPreP Trial)
Phase 3
Waitlist Available
Research Sponsored by Louisiana State University Health Sciences Center in New Orleans
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
HCQPreP Trial Summary
This trial will study if the drug hydroxychloroquine can help prevent COVID-19 infection in healthcare workers.
Eligible Conditions
- Hydroxychloroquine
- Coronavirus
- COVID-19
- Prophylaxis
- Health Care Worker
HCQPreP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of symptomatic COVID-19 infection in healthcare workers
Secondary outcome measures
Absenteeism from work due to COVID-19
Severity of COVID-19 infection
Side effects data
From 2016 Phase 3 trial • 217 Patients • NCT0205725013%
Upper respiratory tract infection
6%
Neutropenia
6%
Sinusitis
5%
Alanine aminotransferase increased
5%
Urinary tract infection
4%
Injection site erythema
4%
Accidental overdose
4%
Bronchitis
3%
Injection site pruritus
2%
Thrombocytopenia
2%
Nasopharyngitis
2%
Contusion
1%
Arthralgia
1%
Anaemia
1%
Lumbar spinal stenosis
1%
Leukopenia
1%
Coronary artery occlusion
1%
Wolff-Parkinson-White syndrome
1%
Transient ischaemic attack
1%
Vertebrobasilar insufficiency
1%
Chronic obstructive pulmonary disease
1%
Small intestinal obstruction
1%
Nephrolithiasis
1%
Cataract
1%
Thrombophlebitis superficial
1%
Vomiting
1%
Endometrial hyperplasia
1%
Traumatic arthritis
1%
Hypertension
1%
Pneumonia
1%
Pancreatic carcinoma metastatic
1%
Osteoarthritis
1%
Rheumatoid lung
1%
Pharyngitis
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sarilumab 150 mg by PFS (Extension Phase)
Sarilumab 150 mg by AID (AID Assessment Phase)
Sarilumab 150 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by AID (AID Assessment Phase)
HCQPreP Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: HydroxychloroquineExperimental Treatment1 Intervention
Hydroxychloroquine loading dose will be given as 400mg for two doses 12 hours apart. This will then be followed by maintenance dosing of 200mg twice weekly for the remainder of the trial.
Group II: PlaceboPlacebo Group1 Intervention
An identical placebo will be administered on an identical dosing interval and frequency.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydroxychloroquine
FDA approved
Find a Location
Who is running the clinical trial?
Louisiana State University Health Sciences Center in New OrleansLead Sponsor
114 Previous Clinical Trials
42,501 Total Patients Enrolled
Lafayette General HealthOTHER
University of Louisiana at LafayetteOTHER
2 Previous Clinical Trials
16 Total Patients Enrolled
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