Hydroxychloroquine for Cardiac and General Surgery Patients

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Duke Health, Durham, NCCardiac and General Surgery PatientsHydroxychloroquine - Drug
Eligibility
18+
All Sexes
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Study Summary

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

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Postoperative day 1-5

Postoperative day 1-5
Ratio of T1 relaxivity difference

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Sarilumab 150 mg by PFS (Extension Phase)
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%Nasopharyngitis
2%Thrombocytopenia
2%Contusion
1%Small intestinal obstruction
1%Lumbar spinal stenosis
1%Vertebrobasilar insufficiency
1%Thrombophlebitis superficial
1%Chronic obstructive pulmonary disease
1%Arthralgia
1%Traumatic arthritis
1%Nephrolithiasis
1%Hypertension
1%Transient ischaemic attack
1%Vomiting
1%Endometrial hyperplasia
1%Cataract
1%Pneumonia
1%Anaemia
1%Pancreatic carcinoma metastatic
1%Wolff-Parkinson-White syndrome
1%Coronary artery occlusion
1%Osteoarthritis
1%Rheumatoid lung
1%Pharyngitis
1%Femoral neck fracture
1%Leukopenia
This histogram enumerates side effects from a completed 2016 Phase 3 trial (NCT02057250) in the Sarilumab 150 mg by PFS (Extension Phase) ARM group. Side effects include: Upper respiratory tract infection with 13%, Neutropenia with 6%, Sinusitis with 6%, Alanine aminotransferase increased with 5%, Urinary tract infection with 5%.

Trial Design

5 Treatment Groups

Phase 3
1 of 5
Phase 1
1 of 5
Phase 4
1 of 5
Phase 2
1 of 5
Phase 5
1 of 5

Experimental Treatment

30 Total Participants · 5 Treatment Groups

Primary Treatment: Hydroxychloroquine · No Placebo Group · Phase 4

Phase 3
Drug
Experimental Group · 1 Intervention: Hydroxychloroquine · Intervention Types: Drug
Phase 1
Drug
Experimental Group · 1 Intervention: Hydroxychloroquine · Intervention Types: Drug
Phase 4
Drug
Experimental Group · 1 Intervention: Hydroxychloroquine · Intervention Types: Drug
Phase 2
Drug
Experimental Group · 1 Intervention: Hydroxychloroquine · Intervention Types: Drug
Phase 5
Drug
Experimental Group · 1 Intervention: Hydroxychloroquine · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydroxychloroquine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: postoperative day 1-5

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,209 Previous Clinical Trials
3,221,086 Total Patients Enrolled
Joseph P Mathew, MDPrincipal InvestigatorDuke Health

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

What are hydroxychloroquine's most common indications?

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

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.