Trial of Hydroxychloroquine In Covid-19 Kinetics (THICK)
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|ClinicalTrials.gov Identifier: NCT04353271|
Recruitment Status : Active, not recruiting
First Posted : April 20, 2020
Last Update Posted : April 28, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|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|
|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|
Subjects in this arm will receive the study drug
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
Placebo take 4 tabs, then 6-8 hours later take 3 tabs, then take 1 tab three times per day for 4 days.
- 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
- 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) .
- Incidence of hospitalization [ Time Frame: 14 days ]Number of subjects in each arm who are hospitalized for Covid 19 infection
- Incidence of Death [ Time Frame: 70 Days (10 weeks) ]Number of subjects in each arm who die secondary to Covid-19 infection
- Incidence of confirmed SARS-CoV-2 Detection [ Time Frame: 14 days ]Number of subjects in each arm who have confirmed Covid-19 infection
- 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
- Immunity to Covid-19 [ Time Frame: 70 days (10 weeks) ]Blood tests to determine level of immunity in each subject
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
|United States, Alabama|
|University of South Alabama|
|Mobile, Alabama, United States, 36604|
|Principal Investigator:||William O Richards, MD||University of South Alabama College of Medicine|