Status:
TERMINATED
Trial of Hydroxychloroquine In Covid-19 Kinetics
Lead Sponsor:
University of South Alabama
Conditions:
Covid 19
Corona Virus Infection
Eligibility:
All Genders
19-85 years
Phase:
PHASE2
PHASE3
Brief Summary
To test if the medication Hydroxychloroquine will decrease the amount of virus(as measured by PCR) , 7 days after initiation of therapy compared to control patients receiving placebo. The study desig...
Detailed Description
Hydroxychloroquine (HCQ), which is a less toxic derivative of chloroquine (CQ), has been shown to be effective in inhibiting Covid-19 infection in vitro. The evidence from clinical research trials is ...
Eligibility Criteria
Inclusion
- Symptoms occurring within 3 days prior to patient presenting to USA Facility for PCR nasopharyngeal swab
- Nasopharyngeal swab positive for Covid-19 infection and/or exposure and/or symptoms congruent with fever and cough
- Male or Female age 19 to 89 years
- Able to take oral medications
- Patients not requiring hospitalization
- Provision of informed consent
Exclusion
- Known history of EKG QTc prolongation abnormality
- Contraindication or allergy to hydroxychloroquine
- Retinal eye disease
- Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency
- Known chronic kidney disease, stage 4 or 5 or receiving dialysis
- Weight \< 40 kg
- Current use of: hydroxychloroquine or cardiac medicines of: flecainide, Tambocor; amiodarone, Cordarone, Pacerone; digoxin or Digox, Digitek, Lanoxin; procainamide or Procan, Procanbid, propafenone, Rythmal)
- Known hepatic disease (cirrhosis, hepatitis)
- Active treatment for cancer (chemotherapy, radiation, surgery within 3 months
- On immunosuppressive drugs steroids, antirejection medications.
- Recipient of solid organ transplant
- Pregnancy/breastfeeding
- Past medical history Porphyria (may exacerbate disease)
- PMH Psoariasis (can worsen disease)
- No access to internet or email
- Current suicidal thoughts according to Columbia scale
- In the screening process before signing consent, subjects will be asked if they are suicidal. If this response is yes, patients will be excluded from trial and directed to the National Suicide Prevention Lifeline: 1-800-273-8255.
Key Trial Info
Start Date :
April 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2020
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04353271
Start Date
April 17 2020
End Date
July 8 2020
Last Update
January 3 2022
Active Locations (1)
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1
University of South Alabama
Mobile, Alabama, United States, 36604