Clinical trial NCT04353271: Trial of Hydroxychloroquine In Covid-19 Kinetics
Official title: A Randomized Phase 2/3 Trial of Hydroxychloroquine In Covid-19 Kinetics
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Covid 19
Corona Virus Infection
Keywords: covid 19
plaquenil
hydroxychloroquine
Lead sponsor: University of South Alabama
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 3
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized placebo verses medication clinical trial
Primary purpose: TREATMENT

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 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.

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 sparse and has many flaws. Much of the Chinese experience with Chloroquine comes from a letter to the editor and a news briefing/conference held on February 15, 2020. The letter describes experience with more than 100 patients treated with CQ in multicenter clinical trials but the letter provides no quantitative data to back their claims. At least one non-randomized clinical trial has been performed in Europe. Covid-19 infected patients received 10 days of HCQ daily and underwent daily testing of viral loads from nasopharyngeal swabs. The subjects receiving HCQ were much more likely (P\<0.02) to clear their viral load than subjects who did not receive HCQ. The study had many flaws, which make the conclusions less valuable than rigorously designed randomized clinical trial. This study is designed as a randomized, blinded trial to either confirm or refute the efficacy of HCQ in early treatment of Covid19 infection to ameliorate disease severity, and reduce viral load.

Eligibility 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.

Primary outcomes:
measure: Number of Participants Who Are Virus Free
timeFrame: 7 days after initiation of trial
measure: Disease Severity
timeFrame: 6 days
Secondary outcomes:
measure: Number of Participants Who Are Hospitalized for Covid 19 Infection
timeFrame: 14 days
measure: Number of Participants Who Die Secondary to Covid 19 Infection
timeFrame: 70 Days (10 weeks)
measure: Number of Participants Who Have Confirmed Covid 19 Infection
timeFrame: 14 days
measure: Number of Participants Who Discontinue or Withdraw Medication Use for Any Reason
timeFrame: 14 days
measure: Immunity to Covid-19
timeFrame: 70 days (10 weeks)
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
Study officials:
affiliation: University of South Alabama College of Medicine
name: William O Richards, MD
role: PRINCIPAL_INVESTIGATOR
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