Trial of Hydroxychloroquine In Covid-19 Kinetics

• Status: Terminated
• Trial end date: 2020-07-08
• Target enrollment: 0
• Participant gender: All

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 design is a randomized (5 days of medication v. 5 days of placebo) clinical trial initiated immediately after diagnosis in ambulatory health care workers at University of South Alabama Health, or in ambulatory USA patients. At 7 days after enrollment another nasopharyngeal swab will be taken to measure if the virus is still present. At 10 weeks we will measure immunity from Covid-19 using a single blood sample. It is a phase 2/3 clinical trial.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of South Alabama
• Treatments: Hydroxychloroquine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.