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Hydroxychloroquine for COVID-19
Phase 2 & 3
Recruiting
Led By Jon T. Giles, MD
Research Sponsored by Columbia 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 date of enrollment to 14 days post-enrollment date
Awards & highlights
Study Summary
This trial will test whether hydroxychloroquine can prevent people who have been exposed to the coronavirus from getting sick.
Eligible Conditions
- COVID-19
- Coronavirus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ date of enrollment to 14 days post-enrollment date
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date of enrollment to 14 days post-enrollment date
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with symptomatic, lab-confirmed COVID-19.
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)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: HydroxychloroquineExperimental Treatment1 Intervention
Two tablets (400mg) twice daily on day 1; for days 2-5, they will be instructed to take one tablet (200mg) twice daily.
Group II: PlaceboPlacebo Group1 Intervention
Two tablets (400mg) twice daily on day 1; for days 2-5, they will be instructed to take one tablet (200mg) twice daily.
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?
Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,459,233 Total Patients Enrolled
23 Trials studying COVID-19
10,629 Patients Enrolled for COVID-19
Jon T. Giles, MD4.47 ReviewsPrincipal Investigator - Columbia University
Columbia University
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