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Trial of Hydroxychloroquine In Covid-19 Kinetics (THICK)

Primary Purpose

Covid 19, Corona Virus Infection

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hydroxychloroquine
Placebo
Sponsored by
University of South Alabama
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid 19 focused on measuring covid 19, plaquenil, hydroxychloroquine

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of South Alabama

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hydroxychloroquine

Placebo

Arm Description

Subjects in this arm will receive the study drug

Subjects in this arm will take placebo for 6 days

Outcomes

Primary Outcome Measures

Number of Participants Who Are Virus Free
Nasopharyngeal swab PCR measurement of viral load expressed as the % of negative PCR swabs
Disease Severity
Participants will self-report disease severity status as one of the following 5 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization (score of 3), or Covid 19 with care requiring hospitalization (score of 4), or Covid 19 with death (Score of 5) .

Secondary Outcome Measures

Number of Participants Who Are Hospitalized for Covid 19 Infection
Number of subjects in each arm who are hospitalized for Covid 19 infection
Number of Participants Who Die Secondary to Covid 19 Infection
Number of subjects in each arm who die secondary to Covid-19 infection
Number of Participants Who Have Confirmed Covid 19 Infection
Number of subjects in each arm who have confirmed Covid-19 infection
Number of Participants Who Discontinue or Withdraw Medication Use for Any Reason
Number of subjects in each arm who discontinue or withdraw medication use for any reason
Immunity to Covid-19
Blood tests to determine level of immunity in each subject

Full Information

First Posted
March 25, 2020
Last Updated
December 29, 2021
Sponsor
University of South Alabama
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1. Study Identification

Unique Protocol Identification Number
NCT04353271
Brief Title
Trial of Hydroxychloroquine In Covid-19 Kinetics
Acronym
THICK
Official Title
A Randomized Phase 2/3 Trial of Hydroxychloroquine In Covid-19 Kinetics
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
FDA recommendations to not use outside of the hospital setting or in a clinical trial due to the risk of cardiac arrhythmias
Study Start Date
April 17, 2020 (Actual)
Primary Completion Date
July 8, 2020 (Actual)
Study Completion Date
July 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Alabama

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid 19, Corona Virus Infection
Keywords
covid 19, plaquenil, hydroxychloroquine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized placebo verses medication clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Blinded to subject and investigators
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydroxychloroquine
Arm Type
Experimental
Arm Description
Subjects in this arm will receive the study drug
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects in this arm will take placebo for 6 days
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Other Intervention Name(s)
plaquenil
Intervention Description
Hydroxychloroquine 800 mg initial dose then 6-8 hours later HCQ 600 mg, then 200 mg three times per day for 4 days.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo take 4 tabs, then 6-8 hours later take 3 tabs, then take 1 tab three times per day for 4 days.
Primary Outcome Measure Information:
Title
Number of Participants Who Are Virus Free
Description
Nasopharyngeal swab PCR measurement of viral load expressed as the % of negative PCR swabs
Time Frame
7 days after initiation of trial
Title
Disease Severity
Description
Participants will self-report disease severity status as one of the following 5 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization (score of 3), or Covid 19 with care requiring hospitalization (score of 4), or Covid 19 with death (Score of 5) .
Time Frame
6 days
Secondary Outcome Measure Information:
Title
Number of Participants Who Are Hospitalized for Covid 19 Infection
Description
Number of subjects in each arm who are hospitalized for Covid 19 infection
Time Frame
14 days
Title
Number of Participants Who Die Secondary to Covid 19 Infection
Description
Number of subjects in each arm who die secondary to Covid-19 infection
Time Frame
70 Days (10 weeks)
Title
Number of Participants Who Have Confirmed Covid 19 Infection
Description
Number of subjects in each arm who have confirmed Covid-19 infection
Time Frame
14 days
Title
Number of Participants Who Discontinue or Withdraw Medication Use for Any Reason
Description
Number of subjects in each arm who discontinue or withdraw medication use for any reason
Time Frame
14 days
Title
Immunity to Covid-19
Description
Blood tests to determine level of immunity in each subject
Time Frame
70 days (10 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William O Richards, MD
Organizational Affiliation
University of South Alabama College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Trial of Hydroxychloroquine In Covid-19 Kinetics

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