Clincosm LogoSign in Get a demo

THICK: Trial of Hydroxychloroquine In Covid-19 Kinetics

Sponsor
University of South Alabama (Other)
Overall Status
Terminated
CT.gov ID
NCT04353271
Collaborator
(none)
3
Enrollment
1
Location
2
Arms
2.7
Actual Duration (Months)
1.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized placebo verses medication clinical trialRandomized placebo verses medication clinical trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Blinded to subject and investigators
Primary Purpose:
Treatment
Official Title:
A Randomized Phase 2/3 Trial of Hydroxychloroquine In Covid-19 Kinetics
Actual Study Start Date :
Apr 17, 2020
Actual Primary Completion Date :
Jul 8, 2020
Actual Study Completion Date :
Jul 8, 2020

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants Who Are Virus Free [7 days after initiation of trial]

      Nasopharyngeal swab PCR measurement of viral load expressed as the % of negative PCR swabs

    2. Disease Severity [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) .

    Secondary Outcome Measures

    1. Number of Participants Who Are Hospitalized for Covid 19 Infection [14 days]

      Number of subjects in each arm who are hospitalized for Covid 19 infection

    2. Number of Participants Who Die Secondary to Covid 19 Infection [70 Days (10 weeks)]

      Number of subjects in each arm who die secondary to Covid-19 infection

    3. Number of Participants Who Have Confirmed Covid 19 Infection [14 days]

      Number of subjects in each arm who have confirmed Covid-19 infection

    4. Number of Participants Who Discontinue or Withdraw Medication Use for Any Reason [14 days]

      Number of subjects in each arm who discontinue or withdraw medication use for any reason

    5. Immunity to Covid-19 [70 days (10 weeks)]

      Blood tests to determine level of immunity in each subject

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of South Alabama Mobile Alabama United States 36604

    Sponsors and Collaborators

    • University of South Alabama

    Investigators

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

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    William Richards, Professor and Chair Surgery, University of South Alabama
    ClinicalTrials.gov Identifier:
    NCT04353271
    Other Study ID Numbers:
    • [1582736-1]
    First Posted:
    Apr 20, 2020
    Last Update Posted:
    Jan 3, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by William Richards, Professor and Chair Surgery, University of South Alabama
    covid 19
    plaquenil
    hydroxychloroquine
    Additional relevant MeSH terms:
    COVID-19
    Coronavirus Infections
    Hydroxychloroquine

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Treatment Control
    Arm/Group Description Subjects in this arm will receive the study 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. Subjects in this arm will take placebo for 6 days Placebo: Placebo take 4 tabs, then 6-8 hours later take 3 tabs, then take 1 tab three times per day for 4 days.
    Period Title: Overall Study
    STARTED 1 2
    COMPLETED 1 1
    NOT COMPLETED 0 1

    Baseline Characteristics

    Arm/Group Title Treatment Control Total
    Arm/Group Description Subjects in this arm will receive the study 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. Subjects in this arm will take placebo for 6 days Placebo: Placebo take 4 tabs, then 6-8 hours later take 3 tabs, then take 1 tab three times per day for 4 days. Total of all reporting groups
    Overall Participants 1 2 3
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    1
    100%
    2
    100%
    3
    100%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    1
    100%
    1
    50%
    2
    66.7%
    Male
    0
    0%
    1
    50%
    1
    33.3%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    1
    50%
    1
    33.3%
    White
    1
    100%
    1
    50%
    2
    66.7%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Treatment Control
    Arm/Group Description Subjects in this arm will receive the study 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. Subjects in this arm will take placebo for 6 days Placebo: Placebo take 4 tabs, then 6-8 hours later take 3 tabs, then take 1 tab three times per day for 4 days.
    Measure Participants 1 1
    Number [participants]
    0
    0%
    0
    0%
    2. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Treatment Control
    Arm/Group Description Subjects in this arm will receive the study 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. Subjects in this arm will take placebo for 6 days Placebo: Placebo take 4 tabs, then 6-8 hours later take 3 tabs, then take 1 tab three times per day for 4 days.
    Measure Participants 1 1
    no COVID19 illness (score of 1)
    1
    100%
    0
    0%
    COVID19 illness with no hospitalization (score of 2)
    0
    0%
    1
    50%
    COVID19 illness with hospitalization (score of 3)
    0
    0%
    0
    0%
    Covid 19 with care requiring hospitalization (score of 4)
    0
    0%
    0
    0%
    Covid 19 with death (Score of 5)
    0
    0%
    0
    0%
    3. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Treatment Control
    Arm/Group Description Subjects in this arm will receive the study 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. Subjects in this arm will take placebo for 6 days Placebo: Placebo take 4 tabs, then 6-8 hours later take 3 tabs, then take 1 tab three times per day for 4 days.
    Measure Participants 1 1
    Count of Participants [Participants]
    0
    0%
    0
    0%
    4. Secondary Outcome
    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)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Treatment Control
    Arm/Group Description Subjects in this arm will receive the study 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. Subjects in this arm will take placebo for 6 days Placebo: Placebo take 4 tabs, then 6-8 hours later take 3 tabs, then take 1 tab three times per day for 4 days.
    Measure Participants 1 2
    Count of Participants [Participants]
    0
    0%
    0
    0%
    5. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Treatment Control
    Arm/Group Description Subjects in this arm will receive the study 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. Subjects in this arm will take placebo for 6 days Placebo: Placebo take 4 tabs, then 6-8 hours later take 3 tabs, then take 1 tab three times per day for 4 days.
    Measure Participants 1 2
    Count of Participants [Participants]
    1
    100%
    2
    100%
    6. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Treatment Control
    Arm/Group Description Subjects in this arm will receive the study 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. Subjects in this arm will take placebo for 6 days Placebo: Placebo take 4 tabs, then 6-8 hours later take 3 tabs, then take 1 tab three times per day for 4 days.
    Measure Participants 1 2
    Count of Participants [Participants]
    0
    0%
    1
    50%
    7. Secondary Outcome
    Title Immunity to Covid-19
    Description Blood tests to determine level of immunity in each subject
    Time Frame 70 days (10 weeks)

    Outcome Measure Data

    Analysis Population Description
    Participants refused blood draw. Data was not collected
    Arm/Group Title Treatment Control
    Arm/Group Description Subjects in this arm will receive the study 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. Subjects in this arm will take placebo for 6 days Placebo: Placebo take 4 tabs, then 6-8 hours later take 3 tabs, then take 1 tab three times per day for 4 days.
    Measure Participants 0 0

    Adverse Events

    Time Frame Adverse Events were collected up to 10 weeks after treatment
    Adverse Event Reporting Description
    Arm/Group Title Treatment Control
    Arm/Group Description Subjects in this arm will receive the study 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. Subjects in this arm will take placebo for 6 days Placebo: Placebo take 4 tabs, then 6-8 hours later take 3 tabs, then take 1 tab three times per day for 4 days.
    All Cause Mortality
    Treatment Control
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/1 (0%) 0/2 (0%)
    Serious Adverse Events
    Treatment Control
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/1 (0%) 0/2 (0%)
    Other (Not Including Serious) Adverse Events
    Treatment Control
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/1 (0%) 0/2 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Office of Research Complaince
    Organization University of South Alabama
    Phone 2514607573
    Email swhite@southalabama.edu
    Responsible Party:
    William Richards, Professor and Chair Surgery, University of South Alabama
    ClinicalTrials.gov Identifier:
    NCT04353271
    Other Study ID Numbers:
    • [1582736-1]
    First Posted:
    Apr 20, 2020
    Last Update Posted:
    Jan 3, 2022
    Last Verified:
    Dec 1, 2021