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Anti-malarial drug
Chloroquine Phosphate for Atrial Fibrillation
Phase 2
Recruiting
Led By Sami Noujaim, PhD
Research Sponsored by University of South Florida
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 within 2 weeks of study drug initiation
Awards & highlights
Study Summary
The goal of this pilot study is to explore the efficacy of chloroquine in terminating persistent AF and assess its potential role as a pharmacological cardioversion agent for the management of AF.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 2 weeks of study drug initiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 2 weeks of study drug initiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients with termination of AF
Secondary outcome measures
PR interval
Percentage of AF burden
Percentages of classifications of rhythms identified
+3 moreSide effects data
From 2021 Phase 1 & 2 trial • 252 Patients • NCT0395265061%
Rhinitis
53%
Headache
53%
Malaria
47%
Blood creatinine increased
36%
Leukopenia
31%
Neutropenia
22%
Conjunctivitis
17%
Gastroenteritis
14%
Oropharyngeal pain
11%
Back pain
11%
Sinobronchitis
11%
Gastritis
11%
Wound
8%
Dental caries
8%
Abdominal pain
8%
Dizziness
8%
Ear infection
8%
Paronychia
8%
Pain
6%
Decreased appetite
6%
Bronchitis
6%
Furuncle
6%
Injection site pain
6%
Hemoglobin decreased
6%
Nausea
6%
Respiratory tract infection
3%
Candidiasis
3%
Injury
3%
Vaginal haemorrhage
3%
Arthralgia
3%
Genitourinary tract infection
3%
Influenza
3%
Parasitic gastroenteritis
3%
Tonsillitis
3%
Urticaria
3%
Vessel puncture site pain
3%
White blood cell count increased
3%
Wound infection
3%
Ecchymosis
3%
Typhoid fever
3%
Urinary tract infection
3%
Diarrhea
3%
Cough
3%
Food poisoning
100%
80%
60%
40%
20%
0%
Study treatment Arm
4b - Safety Comparator: Dosing Interval on Days: 1, 29, 57
2b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57
3a - Pilot/Safety: Dosing Interval on Days: 1
4a - Safety Comparator: Dosing Interval on Days: 1, 29, 57
1a - Pilot/Safety: Dosing Interval on Days: 1
1b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57
2a - Pilot/Safety: Dosing Interval on Days: 1
Trial Design
1Treatment groups
Experimental Treatment
Group I: Chloroquine PhosphateExperimental Treatment1 Intervention
Chloroquine Phosphate will be provided at 500 mg dosage strength for oral administration. Patient will be instructed to take 2 tablets per day on the first two days and 1 tablet each day for the next 12 days for a total of 14 days treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chloroquine
FDA approved
Find a Location
Who is running the clinical trial?
University of South FloridaLead Sponsor
411 Previous Clinical Trials
186,989 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
91 Patients Enrolled for Atrial Fibrillation
Sami Noujaim, PhDPrincipal InvestigatorUniversity of South Florida
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