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Antimalarial

Hydroxychloroquine for Cardiac and General Surgery Patients

Phase 4
Waitlist Available
Led By Joseph P Mathew, MD
Research Sponsored by Duke University
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 postoperative day 1-5
Awards & highlights

Study Summary

This trial will see if hydroxychloroquine can help reduce brain swelling after surgery.

Who is the study for?
This trial is for men and women over 50 who are scheduled for cardiac surgery with cardiopulmonary bypass. They must be able to consent, have no severe liver/kidney issues, not be pregnant or recently pregnant, and can't have metal implants unsafe for MRI. Excluded are those with recent heart attacks, certain eye diseases, a history of alcohol abuse or psychiatric illness needing treatment.Check my eligibility
What is being tested?
The study tests if hydroxychloroquine can reduce brain barrier leakage after surgery. Participants will receive the drug around their surgical procedure to see if it protects cognitive functions by maintaining the brain's protective barrier.See study design
What are the potential side effects?
Hydroxychloroquine may cause side effects like stomach pain, nausea, vomiting, headache and dizziness. It might also affect mood or cause skin rash in some people. Rarely it could lead to changes in vision or muscle weakness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postoperative day 1-5
This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative day 1-5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ktrans Volume transfer constant

Side effects data

From 2016 Phase 3 trial • 217 Patients • NCT02057250
13%
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)

Trial Design

5Treatment groups
Experimental Treatment
Group I: Phase 5Experimental Treatment1 Intervention
6 evaluable cardiac subjects: 1000 mg HCQ 1-2 hours after separation from CPB followed by the highest tolerated dose from the previous 4 phases divided into 2 equal daily doses until the day of MRI imaging on postoperative day 1-5.
Group II: Phase 4Experimental Treatment1 Intervention
6 evaluable cardiac subjects: 1000 mg HCQ on the day prior to surgery followed by 500 mg twice daily (1000 mg total) until the day of MRI imaging on postoperative day 1-5.
Group III: Phase 3Experimental Treatment1 Intervention
6 evaluable cardiac subjects 1000 mg HCQ on the day prior to surgery followed by 400 mg twice daily (800 mg total) until the day of MRI imaging on postoperative day 1-5.
Group IV: Phase 2Experimental Treatment1 Intervention
6 evaluable subjects (3 cardiac, 3 noncardiac patients): 1000 mg HCQ on the day prior to surgery followed by 400 mg daily until the day of MRI imaging on postoperative day 1-5
Group V: Phase 1Experimental Treatment1 Intervention
6 evaluable subjects (3 cardiac, 3 noncardiac patients): 1000 mg HCQ on the day prior to surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydroxychloroquine
2017
Completed Phase 4
~5360

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,359 Previous Clinical Trials
3,420,288 Total Patients Enrolled
Joseph P Mathew, MDPrincipal InvestigatorDuke Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are researchers hoping to enroll in this clinical trial?

"That is correct. The website clinicaltrials.gov has information stating that this clinical trial is looking for participants. The original posting was on 6/19/2017, and it was updated on 1/25/2022. They are looking for 30 participants total, from 1 location."

Answered by AI

Are there any remaining opportunities for patients to join this clinical trial?

"The aforementioned website contains information that this study is still recruiting patients. The trial was first posted on 6/19/2017 and updated as recently as 1/25/2022."

Answered by AI

What are hydroxychloroquine's most common indications?

"Hydroxychloroquine is an effective medication for treating malaria, q fever, and rheumatoid arthritis."

Answered by AI

Has the FDA released a statement about Hydroxychloroquine?

"Hydroxychloroquine is a Phase 4 treatment, which means that it has been approved, and thus received a safety score of 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Hydroxychloroquine and Cognitive Function After Surgery
2017. "Hydroxychloroquine and Cognitive Function After Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03025087.
~3 spots leftby Apr 2025
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