Trial Outcomes & Findings for Trial of Hydroxychloroquine In Covid-19 Kinetics (NCT NCT04353271)
NCT ID: NCT04353271
Last Updated: 2022-01-03
Results Overview
Nasopharyngeal swab PCR measurement of viral load expressed as the % of negative PCR swabs
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
3 participants
Primary outcome timeframe
7 days after initiation of trial
Results posted on
2022-01-03
Participant Flow
Participant milestones
| Measure |
Treatment
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.
|
Control
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.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Hydroxychloroquine In Covid-19 Kinetics
Baseline characteristics by cohort
| Measure |
Treatment
n=1 Participants
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.
|
Control
n=2 Participants
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
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 days after initiation of trialNasopharyngeal swab PCR measurement of viral load expressed as the % of negative PCR swabs
Outcome measures
| Measure |
Treatment
n=1 Participants
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.
|
Control
n=1 Participants
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.
|
|---|---|---|
|
Number of Participants Who Are Virus Free
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 6 daysParticipants 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) .
Outcome measures
| Measure |
Treatment
n=1 Participants
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.
|
Control
n=1 Participants
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.
|
|---|---|---|
|
Disease Severity
no COVID19 illness (score of 1)
|
1 Participants
|
0 Participants
|
|
Disease Severity
COVID19 illness with no hospitalization (score of 2)
|
0 Participants
|
1 Participants
|
|
Disease Severity
COVID19 illness with hospitalization (score of 3)
|
0 Participants
|
0 Participants
|
|
Disease Severity
Covid 19 with care requiring hospitalization (score of 4)
|
0 Participants
|
0 Participants
|
|
Disease Severity
Covid 19 with death (Score of 5)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 daysNumber of subjects in each arm who are hospitalized for Covid 19 infection
Outcome measures
| Measure |
Treatment
n=1 Participants
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.
|
Control
n=1 Participants
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.
|
|---|---|---|
|
Number of Participants Who Are Hospitalized for Covid 19 Infection
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 70 Days (10 weeks)Number of subjects in each arm who die secondary to Covid-19 infection
Outcome measures
| Measure |
Treatment
n=1 Participants
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.
|
Control
n=2 Participants
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.
|
|---|---|---|
|
Number of Participants Who Die Secondary to Covid 19 Infection
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 daysNumber of subjects in each arm who have confirmed Covid-19 infection
Outcome measures
| Measure |
Treatment
n=1 Participants
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.
|
Control
n=2 Participants
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.
|
|---|---|---|
|
Number of Participants Who Have Confirmed Covid 19 Infection
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 14 daysNumber of subjects in each arm who discontinue or withdraw medication use for any reason
Outcome measures
| Measure |
Treatment
n=1 Participants
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.
|
Control
n=2 Participants
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.
|
|---|---|---|
|
Number of Participants Who Discontinue or Withdraw Medication Use for Any Reason
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 70 days (10 weeks)Population: Participants refused blood draw. Data was not collected
Blood tests to determine level of immunity in each subject
Outcome measures
Outcome data not reported
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Office of Research Complaince
University of South Alabama
Phone: 2514607573
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place