Trial Outcomes & Findings for The PATCH Trial (Prevention And Treatment of COVID-19 With Hydroxychloroquine) (NCT NCT04329923)

Results Overview

Cohort 1 (home quarantined COVID-19 patients): Median time to release from quarantine by meeting the following criteria: 1) No fever for 72 hours 2) improvement in other symptoms and 3) 7 or 10 days (depending on CDC guidance at the time) have elapsed since the beginning of symptom onset.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

173 participants

Primary outcome timeframe

until quarantine release or hospitalization

Results posted on

2020-12-10

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1 HCQ COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with hydroxychloroquine 400 mg twice a day for up to 14 days Hydroxychloroquine Sulfate 400 mg twice a day: Antimalarial compound	Cohort 1 Placebo COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with placebo twice a day for up to 14 days. Crossover is allowed if symptoms worsen after 7 days of treatment. Placebo oral tablet: Placebo	Cohort 2 HCQ High Dose Hospitalized COVID-19 PCR+ patients randomized to this arm will be treated with hydroxychloroquine 600 mg twice a day for up to 14 days Hydroxychloroquine Sulfate 600 mg twice a day: Antimalarial compound	Cohort 2 HCQ Low Dose Hospitalized COVID-19 PCR+ patients randomized to this arm will be treated with hydroxychloroquine 600 mg once a day for up to 7 days Hydroxychloroquine Sulfate 600 mg once a day: Antimalarial compound	Cohort 3 HCQ Health care workers at high risk of contracting COVID-19 randomized to this arm will be treated with hydroxychloroquine 600 mg once a day for 2 months Hydroxychloroquine Sulfate 600 mg once a day: Antimalarial compound	Cohort 3 Placebo Health care workers at high risk of contracting COVID-19 randomized to this arm will be treated with placebo for 2 month. Crossover is allowed if subject becomes SARS-CoV2 positive. Placebo oral tablet: Placebo
Overall Study STARTED	17	17	4	3	66	66
Overall Study COMPLETED	16	13	3	2	64	61
Overall Study NOT COMPLETED	1	4	1	1	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 HCQ COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with hydroxychloroquine 400 mg twice a day for up to 14 days Hydroxychloroquine Sulfate 400 mg twice a day: Antimalarial compound	Cohort 1 Placebo COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with placebo twice a day for up to 14 days. Crossover is allowed if symptoms worsen after 7 days of treatment. Placebo oral tablet: Placebo	Cohort 2 HCQ High Dose Hospitalized COVID-19 PCR+ patients randomized to this arm will be treated with hydroxychloroquine 600 mg twice a day for up to 14 days Hydroxychloroquine Sulfate 600 mg twice a day: Antimalarial compound	Cohort 2 HCQ Low Dose Hospitalized COVID-19 PCR+ patients randomized to this arm will be treated with hydroxychloroquine 600 mg once a day for up to 7 days Hydroxychloroquine Sulfate 600 mg once a day: Antimalarial compound	Cohort 3 HCQ Health care workers at high risk of contracting COVID-19 randomized to this arm will be treated with hydroxychloroquine 600 mg once a day for 2 months Hydroxychloroquine Sulfate 600 mg once a day: Antimalarial compound	Cohort 3 Placebo Health care workers at high risk of contracting COVID-19 randomized to this arm will be treated with placebo for 2 month. Crossover is allowed if subject becomes SARS-CoV2 positive. Placebo oral tablet: Placebo
Overall Study Withdrawal by Subject	1	4	1	1	1	1
Overall Study early termination of study	0	0	0	0	1	2
Overall Study positive SARS-COV2 PCR at baseline	0	0	0	0	0	2

Baseline Characteristics

The PATCH Trial (Prevention And Treatment of COVID-19 With Hydroxychloroquine)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 HCQ n=17 Participants COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with hydroxychloroquine 400 mg twice a day for up to 14 days Hydroxychloroquine Sulfate 400 mg twice a day: Antimalarial compound	Cohort 1 Placebo n=17 Participants COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with placebo twice a day for up to 14 days. Crossover is allowed if symptoms worsen after 7 days of treatment. Placebo oral tablet: Placebo	Cohort 2 HCQ High Dose n=4 Participants Hospitalized COVID-19 PCR+ patients randomized to this arm will be treated with hydroxychloroquine 600 mg twice a day for up to 14 days Hydroxychloroquine Sulfate 600 mg twice a day: Antimalarial compound	Cohort 2 HCQ Low Dose n=3 Participants Hospitalized COVID-19 PCR+ patients randomized to this arm will be treated with hydroxychloroquine 600 mg once a day for up to 7 days Hydroxychloroquine Sulfate 600 mg once a day: Antimalarial compound	Cohort 3 HCQ n=66 Participants Health care workers at high risk of contracting COVID-19 randomized to this arm will be treated with hydroxychloroquine 600 mg once a day for 2 months Hydroxychloroquine Sulfate 600 mg once a day: Antimalarial compound	Cohort 3 Placebo n=66 Participants Health care workers at high risk of contracting COVID-19 randomized to this arm will be treated with placebo for 2 month. Crossover is allowed if subject becomes SARS-CoV2 positive. Placebo oral tablet: Placebo	Total n=173 Participants Total of all reporting groups
Age, Continuous	56 years n=93 Participants	49 years n=4 Participants	65 years n=27 Participants	48 years n=483 Participants	31 years n=36 Participants	34 years n=10 Participants	40 years n=115 Participants
Sex: Female, Male Female	12 Participants n=93 Participants	9 Participants n=4 Participants	2 Participants n=27 Participants	3 Participants n=483 Participants	54 Participants n=36 Participants	33 Participants n=10 Participants	113 Participants n=115 Participants
Sex: Female, Male Male	5 Participants n=93 Participants	8 Participants n=4 Participants	2 Participants n=27 Participants	0 Participants n=483 Participants	12 Participants n=36 Participants	33 Participants n=10 Participants	60 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	7 Participants n=36 Participants	7 Participants n=10 Participants	14 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	8 Participants n=93 Participants	11 Participants n=4 Participants	3 Participants n=27 Participants	3 Participants n=483 Participants	3 Participants n=36 Participants	1 Participants n=10 Participants	29 Participants n=115 Participants
Race (NIH/OMB) White	6 Participants n=93 Participants	3 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	55 Participants n=36 Participants	56 Participants n=10 Participants	121 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	2 Participants n=10 Participants	3 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants	3 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	6 Participants n=115 Participants

PRIMARY outcome

Timeframe: until quarantine release or hospitalization

Population: randomized patients that were released from quarantine on study

Cohort 1 (home quarantined COVID-19 patients): Median time to release from quarantine by meeting the following criteria: 1) No fever for 72 hours 2) improvement in other symptoms and 3) 7 or 10 days (depending on CDC guidance at the time) have elapsed since the beginning of symptom onset.

Outcome measures

Outcome measures
Measure	Cohort 1 HCQ n=15 Participants COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with hydroxychloroquine 400 mg twice a day for up to 14 days Hydroxychloroquine Sulfate 400 mg twice a day: Antimalarial compound	Cohort 1 Placebo n=13 Participants COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with placebo twice a day for up to 14 days. Crossover is allowed if symptoms worsen after 7 days of treatment. Placebo oral tablet: Placebo
Time to Release From Quarantine Time	8 days Interval 4.0 to 19.0	11 days Interval 4.0 to 18.0

PRIMARY outcome

Timeframe: until hospital discharge

Cohort 2 (hospitalized COVID-19 patients): median number of days until hospital discharge

Outcome measures

Outcome measures
Measure	Cohort 1 HCQ n=4 Participants COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with hydroxychloroquine 400 mg twice a day for up to 14 days Hydroxychloroquine Sulfate 400 mg twice a day: Antimalarial compound	Cohort 1 Placebo n=3 Participants COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with placebo twice a day for up to 14 days. Crossover is allowed if symptoms worsen after 7 days of treatment. Placebo oral tablet: Placebo
Time to Hospital Discharge	5.5 days Interval 2.0 to 15.0	4 days Interval 3.0 to 15.0

PRIMARY outcome

Timeframe: 2 months

Cohort 3 Physicians and nurse prophylaxis: Rate of COVID-19 infection at 2 months

Outcome measures

Outcome measures
Measure	Cohort 1 HCQ n=64 Participants COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with hydroxychloroquine 400 mg twice a day for up to 14 days Hydroxychloroquine Sulfate 400 mg twice a day: Antimalarial compound	Cohort 1 Placebo n=61 Participants COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with placebo twice a day for up to 14 days. Crossover is allowed if symptoms worsen after 7 days of treatment. Placebo oral tablet: Placebo
Number of Health Care Workers Who Developed SARS-COV-2 Infection	4 Participants	4 Participants

SECONDARY outcome

Timeframe: until quarantine release, or approximately <20 days

Cohort 1 rate of participant-reported secondary infection of housemates

Outcome measures

Outcome measures
Measure	Cohort 1 HCQ n=17 Participants COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with hydroxychloroquine 400 mg twice a day for up to 14 days Hydroxychloroquine Sulfate 400 mg twice a day: Antimalarial compound	Cohort 1 Placebo n=17 Participants COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with placebo twice a day for up to 14 days. Crossover is allowed if symptoms worsen after 7 days of treatment. Placebo oral tablet: Placebo
Rate of Housemate Infection	2 Participants	2 Participants

SECONDARY outcome

Timeframe: until quarantine release

Cohort 1 rate of hospitalization

Outcome measures

Outcome measures
Measure	Cohort 1 HCQ n=17 Participants COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with hydroxychloroquine 400 mg twice a day for up to 14 days Hydroxychloroquine Sulfate 400 mg twice a day: Antimalarial compound	Cohort 1 Placebo n=17 Participants COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with placebo twice a day for up to 14 days. Crossover is allowed if symptoms worsen after 7 days of treatment. Placebo oral tablet: Placebo
Rate of Hospitalization	1 Participants	0 Participants

Adverse Events

Cohort 1 HCQ

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths