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Trial of Hydroxychloroquine In Covid-19 Kinetics (THICK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04353271
Recruitment Status : Active, not recruiting
First Posted : April 20, 2020
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
William Richards, University of South Alabama

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
Covid 19 Corona Virus Infection Drug: Hydroxychloroquine Other: Placebo 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 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 : April 17, 2020
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 1, 2020


Arm Intervention/treatment
Experimental: Treatment
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 Name: plaquenil

Placebo Comparator: Control
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.




Primary Outcome Measures :
  1. Percentage of virus free subjects [ Time Frame: 7 days after initiation of trial ]
    Nasopharyngeal swab PCR measurement of viral load expressed as the % of negative PCR swabs

  2. 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) .


Secondary Outcome Measures :
  1. Incidence of hospitalization [ Time Frame: 14 days ]
    Number of subjects in each arm who are hospitalized for Covid 19 infection

  2. Incidence of Death [ Time Frame: 70 Days (10 weeks) ]
    Number of subjects in each arm who die secondary to Covid-19 infection

  3. Incidence of confirmed SARS-CoV-2 Detection [ Time Frame: 14 days ]
    Number of subjects in each arm who have confirmed Covid-19 infection

  4. Incidence of all-cause study medication discontinuation or withdrawal [ Time Frame: 14 days ]
    Number of subjects in each arm who discontinue or withdraw medication use for any reason

  5. Immunity to Covid-19 [ Time Frame: 70 days (10 weeks) ]
    Blood tests to determine level of immunity in each subject



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04353271


Locations
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United States, Alabama
University of South Alabama
Mobile, Alabama, United States, 36604
Sponsors and Collaborators
University of South Alabama
Investigators
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Principal Investigator: William O Richards, MD University of South Alabama College of Medicine
Publications:
Stokkermans TJ, Trichonas G: Chloroquine And Hydroxychloroquine Toxicity. In: StatPearls. edn. Treasure Island (FL); 2020.
Cascella M, Rajnik M, Cuomo A, Dulebohn SC, Di Napoli R: Features, Evaluation and Treatment Coronavirus (COVID-19). In: StatPearls. edn. Treasure Island (FL); 2020.

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Responsible Party: William Richards, Professor and Chair Surgery, University of South Alabama
ClinicalTrials.gov Identifier: NCT04353271    
Other Study ID Numbers: [1582736-1]
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, University of South Alabama:
covid 19
plaquenil
hydroxychloroquine
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents