Trial of Hydroxychloroquine In Covid-19 Kinetics (THICK)

December 29, 2021 updated by: William Richards, University of South Alabama

A Randomized Phase 2/3 Trial of Hydroxychloroquine In Covid-19 Kinetics

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604
        • University of South Alabama

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydroxychloroquine
Subjects in this arm will receive the study drug
Drug: Hydroxychloroquine
Hydroxychloroquine 800 mg initial dose then 6-8 hours later HCQ 600 mg, then 200 mg three times per day for 4 days.
Other Names:
  • plaquenil
Placebo Comparator: Placebo
Subjects in this arm will take placebo for 6 days
Other: Placebo
Placebo take 4 tabs, then 6-8 hours later take 3 tabs, then take 1 tab three times per day for 4 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Are Virus Free
Time Frame: 7 days after initiation of trial
Nasopharyngeal swab PCR measurement of viral load expressed as the % of negative PCR swabs
7 days after initiation of trial
Disease Severity
Time Frame: 6 days
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) .
6 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Are Hospitalized for Covid 19 Infection
Time Frame: 14 days
Number of subjects in each arm who are hospitalized for Covid 19 infection
14 days
Number of Participants Who Die Secondary to Covid 19 Infection
Time Frame: 70 Days (10 weeks)
Number of subjects in each arm who die secondary to Covid-19 infection
70 Days (10 weeks)
Number of Participants Who Have Confirmed Covid 19 Infection
Time Frame: 14 days
Number of subjects in each arm who have confirmed Covid-19 infection
14 days
Number of Participants Who Discontinue or Withdraw Medication Use for Any Reason
Time Frame: 14 days
Number of subjects in each arm who discontinue or withdraw medication use for any reason
14 days
Immunity to Covid-19
Time Frame: 70 days (10 weeks)
Blood tests to determine level of immunity in each subject
70 days (10 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Alabama

Investigators

  • Principal Investigator: William O Richards, MD, University of South Alabama College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2020

Primary Completion (Actual)

July 8, 2020

Study Completion (Actual)

July 8, 2020

Study Registration Dates

First Submitted

March 25, 2020

First Submitted That Met QC Criteria

April 17, 2020

First Posted (Actual)

April 20, 2020

Study Record Updates

Last Update Posted (Actual)

January 3, 2022

Last Update Submitted That Met QC Criteria

December 29, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [1582736-1]

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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