Trial Outcomes & Findings for PATCH 2&3:Prevention & Treatment of COVID-19 (Severe Acute Respiratory Syndrome Coronavirus 2) With Hydroxychloroquine (NCT NCT04353037)

Results Overview

Number of COVID-19+ PCR patients in self-quarantine who are hospitalized up to 31 days after beginning HCQ or Placebo

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

Until completion of study, 29 to 31 days after beginning treatment.

Results posted on

2021-10-19

Participant Flow

Sub study 1 HCQ \& Placebo groups were identified as patient at least 50 years old self-reported as having a fever within the last four days will undergo swab testing for COVID-19, and then sent home for a self-imposed quarantine that will end 14 days from the start of treatment and consenting patients were randomized. Sub study 2 HCQ and Placebo groups were recruited first through completion of an interest questionnaire then contacted by study PI or designee to assess eligibility consent.

If Sub Study 1 patients received a negative PCR-test then they were considered no longer a part of the study and had a conversation with the PI or designee. Recruitment was done this way because early in the pandemic, time to receive PCR test results was unclear. At study conclusion 9 substudy 1 participants were Covid positive. 6 of those Covid positive participants completed the study. 30 participants from sub study 2 met eligibility criteria with 13 participants completing the full study.

Participant milestones

Participant milestones
Measure	Sub Study 1 Group 1 (HCQ) COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with hydroxychloroquine 400mg twice a day for 14 days.	Sub Study 1 Group 2 (Placebo) COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with placebo 2 pills twice a day for 14 days.	Sub Study 2 Group 1 (HCQ) Currently employed as a health care worker. Must be asymptomatic and presumed negative for COVID-19. Health care workers randomized into this arm will be treated with hydroxychloroquine 600 mg qd (three 200 mg tablets taken once a day) for 2 months.	Sub Study 2 Group 2 (Placebo) Currently employed as a health care worker. Must be asymptomatic and presumed negative for COVID-19. Health care workers randomized into this arm will be treated with Placebo pills (three 200 mg tablets taken once a day) for 2 months.
Overall Study STARTED	6	3	13	17
Overall Study COMPLETED	6	0	6	7
Overall Study NOT COMPLETED	0	3	7	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Sub Study 1 Group 2 (Placebo) COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with placebo 2 pills twice a day for 14 days.	Sub Study 2 Group 1 (HCQ) Currently employed as a health care worker. Must be asymptomatic and presumed negative for COVID-19. Health care workers randomized into this arm will be treated with hydroxychloroquine 600 mg qd (three 200 mg tablets taken once a day) for 2 months.	Sub Study 2 Group 2 (Placebo) Currently employed as a health care worker. Must be asymptomatic and presumed negative for COVID-19. Health care workers randomized into this arm will be treated with Placebo pills (three 200 mg tablets taken once a day) for 2 months.
Overall Study Lost to Follow-up	1	2	3
Overall Study Withdrawal by Subject	2	3	5
Overall Study Adverse Event	0	2	0
Overall Study Exposure Change	0	0	2

Baseline Characteristics

PATCH 2&3:Prevention & Treatment of COVID-19 (Severe Acute Respiratory Syndrome Coronavirus 2) With Hydroxychloroquine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Substudy 1 Group 1 (HCQ) n=6 Participants COVID-19 positive PCR patients aged 50-75 in self-quarantine randomized to this arm will be treated with hydroxychloroquine 400mg twice a day for 14 days.	Substudy 1 Group 2 (Placebo) n=3 Participants COVID-19 positive PCR patients aged 50-75 in self-quarantine randomized to this arm will be treated with placebo 2 pills twice a day for 14 days.	Substudy 2 Group 1 (HCQ) n=13 Participants Currently employed as a health care worker aged 18 or older. Must be asymptomatic and presumed negative for COVID-19. Health care workers randomized into this arm will be treated with hydroxychloroquine 600 mg daily (three 200 mg tablets taken once a day) for 2 months.	Substudy 2 Group 2 (Placebo) n=17 Participants Currently employed as a health care worker aged 18 or older. Must be asymptomatic and presumed negative for COVID-19. Health care workers randomized into this arm will be treated with Placebo pills (three 200 mg tablets taken once a day) for 2 months.	Total n=39 Participants Total of all reporting groups
Age, Continuous	59 years n=5 Participants	58 years n=7 Participants	45 years n=5 Participants	49 years n=4 Participants	49 years n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants	11 Participants n=4 Participants	23 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	16 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	1 Participants n=7 Participants	13 Participants n=5 Participants	17 Participants n=4 Participants	36 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	0 Participants n=7 Participants	10 Participants n=5 Participants	11 Participants n=4 Participants	25 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants

PRIMARY outcome

Timeframe: Until completion of study, 29 to 31 days after beginning treatment.

Population: Evaluable for primary outcome, having completed the study.

Number of COVID-19+ PCR patients in self-quarantine who are hospitalized up to 31 days after beginning HCQ or Placebo

Outcome measures

Outcome measures
Measure	Sub Study 1 Group 1 (HCQ) n=6 Participants COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with hydroxychloroquine 400mg twice a day for 14 days.	Sub Study 1 Group 2 (Placebo) COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with placebo 2 pills twice a day for 14 days.
Substudy 1 - Number of COVID-19+ PCR Patients in Self-quarantine Who Are Hospitalized	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Until completion of study, 2 months after start of treatment.

Population: Evaluable for primary outcome, having completed the study.

Rate of COVID-19 infection (confirmed by accepted testing methods) at 2 months

Outcome measures

Outcome measures
Measure	Sub Study 1 Group 1 (HCQ) n=6 Participants COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with hydroxychloroquine 400mg twice a day for 14 days.	Sub Study 1 Group 2 (Placebo) n=7 Participants COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with placebo 2 pills twice a day for 14 days.
Sub Study 2:Number of Health Care Workers Testing Positive at 2 Months	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Until completion of study, 29 to 31 days after beginning treatment.

Population: Co-inhabitants of patients evaluable for primary outcome, who completed the study. There were 16 co-inhabitants of the Sub study 1 Group 1 (HCQ).

Co-inhabitants of COVID-19 positive PCR patients in self-quarantine that test positive up to 31 days after patient begins treatment with HCQ or Placebo

Outcome measures

Outcome measures
Measure	Sub Study 1 Group 1 (HCQ) n=16 Participants COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with hydroxychloroquine 400mg twice a day for 14 days.	Sub Study 1 Group 2 (Placebo) COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with placebo 2 pills twice a day for 14 days.
Sub Study 1 - Secondary Infection of Co-inhabitants of COVID-19 Positive PCR Patients in Self-quarantine	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 15-17 days after completion of 14 day treatment

Population: Evaluable for primary outcome, having completed the study.

Rate of negative tests at end of treatment for COVID-19 positive PCR patients in self-quarantine

Outcome measures

Outcome measures
Measure	Sub Study 1 Group 1 (HCQ) n=6 Participants COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with hydroxychloroquine 400mg twice a day for 14 days.	Sub Study 1 Group 2 (Placebo) COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with placebo 2 pills twice a day for 14 days.
Sub Study 1 - Rate of Negative Tests at End of Treatment for COVID-19 Positive PCR Patients in Self-quarantine	6 Participants	0 Participants

SECONDARY outcome

Timeframe: 1-3 days after completion of 14 day treatment

Population: Evaluable for primary outcome, having completed the study.

Rate of negative tests at end of treatment for COVID-19 positive PCR patients in self-quarantine

Outcome measures

Outcome measures
Measure	Sub Study 1 Group 1 (HCQ) n=6 Participants COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with hydroxychloroquine 400mg twice a day for 14 days.	Sub Study 1 Group 2 (Placebo) COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with placebo 2 pills twice a day for 14 days.
Sub Study 1 - Rate of Negative Tests at End of Treatment for COVID-19 Positive PCR Patients in Self-quarantine	4 Participants	0 Participants

SECONDARY outcome

Timeframe: up to ~60 days after enrollment

Population: We had no positive Covid-19 tests for Sub Study 2 healthcare workers so we couldn't measure this outcome.

Any work time missed because the participant experienced COVID-like symptoms during their active 2 month period

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Until completion of study, 2 months (~60 days) after start of treatment.

Population: Evaluable for primary outcome, having completed the study or removed from study due to moderate or more serious adverse event

Assessment of any medical events that occur during the \~60 day active period that is felt to be related to receipt of HCQ

Outcome measures

Outcome measures
Measure	Sub Study 1 Group 1 (HCQ) n=8 Participants COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with hydroxychloroquine 400mg twice a day for 14 days.	Sub Study 1 Group 2 (Placebo) n=7 Participants COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with placebo 2 pills twice a day for 14 days.
Sub Study 2:Health Care Workers: Assessment of Any Medical Events That Occur During the ~60 Day Active Period minor adverse events	1 Participants	0 Participants
Sub Study 2:Health Care Workers: Assessment of Any Medical Events That Occur During the ~60 Day Active Period moderate adverse events	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Until completion of study, 2 months after start of treatment.

Population: Evaluable for primary outcome, having completed the study.

if the participant gets COVID and has severe symptoms and hospitalized, end point reached if before the end of the 2 month period

Outcome measures

Outcome measures
Measure	Sub Study 1 Group 1 (HCQ) n=6 Participants COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with hydroxychloroquine 400mg twice a day for 14 days.	Sub Study 1 Group 2 (Placebo) n=7 Participants COVID-19 positive PCR patients in self-quarantine randomized to this arm will be treated with placebo 2 pills twice a day for 14 days.
Sub Study 2:Health Care Workers:Rate of Hospitalization	0 Participants	0 Participants

Adverse Events

Sub Study 1 Group 1 (HCQ)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sub Study 1 Group 2 (Placebo)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sub Study 2 Group 1 (HCQ)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Sub Study 2 Group 2 (Placebo)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sub Study 1 Group 1 (HCQ) n=6 participants at risk COVID-19+ PCR patients in self-quarantine randomized to this arm will be treated with hydroxychloroquine 400mg bid for 14 days.	Sub Study 1 Group 2 (Placebo) n=3 participants at risk COVID-19+ PCR patients in self-quarantine randomized to this arm will be treated with Place 2 pills bid for 14 days.	Sub Study 2 Group 1 (HCQ) n=8 participants at risk Currently employed as a health care worker. Must be asymptomatic and presumed negative for COVID-19. Health care workers randomized into this arm will be treated with hydroxychloroquine 600 mg daily (three 200 mg tablets taken once a day) for 2 months.	Sub Study 2 Group 2 (Placebo) n=7 participants at risk Currently employed as a health care worker. Must be asymptomatic and presumed negative for COVID-19. Health care workers randomized into this arm will be treated with Placebo pills (three 200 mg tablets taken once a day) for 2 months.
General disorders Nasal congestion	0.00% 0/6 • Until completion of study, 2 months after start of treatment. No adverse events were reported for Sub study 1. For SubStudy 2 group 1, 6 participants completed and were evaluable for primary outcomes, 2 participants were removed from study due to moderate or serious adverse event prior to meeting the evaluable benchmark.	0.00% 0/3 • Until completion of study, 2 months after start of treatment. No adverse events were reported for Sub study 1. For SubStudy 2 group 1, 6 participants completed and were evaluable for primary outcomes, 2 participants were removed from study due to moderate or serious adverse event prior to meeting the evaluable benchmark.	12.5% 1/8 • Number of events 1 • Until completion of study, 2 months after start of treatment. No adverse events were reported for Sub study 1. For SubStudy 2 group 1, 6 participants completed and were evaluable for primary outcomes, 2 participants were removed from study due to moderate or serious adverse event prior to meeting the evaluable benchmark.	0.00% 0/7 • Until completion of study, 2 months after start of treatment. No adverse events were reported for Sub study 1. For SubStudy 2 group 1, 6 participants completed and were evaluable for primary outcomes, 2 participants were removed from study due to moderate or serious adverse event prior to meeting the evaluable benchmark.
General disorders Headache	0.00% 0/6 • Until completion of study, 2 months after start of treatment. No adverse events were reported for Sub study 1. For SubStudy 2 group 1, 6 participants completed and were evaluable for primary outcomes, 2 participants were removed from study due to moderate or serious adverse event prior to meeting the evaluable benchmark.	0.00% 0/3 • Until completion of study, 2 months after start of treatment. No adverse events were reported for Sub study 1. For SubStudy 2 group 1, 6 participants completed and were evaluable for primary outcomes, 2 participants were removed from study due to moderate or serious adverse event prior to meeting the evaluable benchmark.	12.5% 1/8 • Number of events 1 • Until completion of study, 2 months after start of treatment. No adverse events were reported for Sub study 1. For SubStudy 2 group 1, 6 participants completed and were evaluable for primary outcomes, 2 participants were removed from study due to moderate or serious adverse event prior to meeting the evaluable benchmark.	0.00% 0/7 • Until completion of study, 2 months after start of treatment. No adverse events were reported for Sub study 1. For SubStudy 2 group 1, 6 participants completed and were evaluable for primary outcomes, 2 participants were removed from study due to moderate or serious adverse event prior to meeting the evaluable benchmark.
General disorders Angioedema	0.00% 0/6 • Until completion of study, 2 months after start of treatment. No adverse events were reported for Sub study 1. For SubStudy 2 group 1, 6 participants completed and were evaluable for primary outcomes, 2 participants were removed from study due to moderate or serious adverse event prior to meeting the evaluable benchmark.	0.00% 0/3 • Until completion of study, 2 months after start of treatment. No adverse events were reported for Sub study 1. For SubStudy 2 group 1, 6 participants completed and were evaluable for primary outcomes, 2 participants were removed from study due to moderate or serious adverse event prior to meeting the evaluable benchmark.	12.5% 1/8 • Number of events 1 • Until completion of study, 2 months after start of treatment. No adverse events were reported for Sub study 1. For SubStudy 2 group 1, 6 participants completed and were evaluable for primary outcomes, 2 participants were removed from study due to moderate or serious adverse event prior to meeting the evaluable benchmark.	0.00% 0/7 • Until completion of study, 2 months after start of treatment. No adverse events were reported for Sub study 1. For SubStudy 2 group 1, 6 participants completed and were evaluable for primary outcomes, 2 participants were removed from study due to moderate or serious adverse event prior to meeting the evaluable benchmark.
General disorders Nausea	0.00% 0/6 • Until completion of study, 2 months after start of treatment. No adverse events were reported for Sub study 1. For SubStudy 2 group 1, 6 participants completed and were evaluable for primary outcomes, 2 participants were removed from study due to moderate or serious adverse event prior to meeting the evaluable benchmark.	0.00% 0/3 • Until completion of study, 2 months after start of treatment. No adverse events were reported for Sub study 1. For SubStudy 2 group 1, 6 participants completed and were evaluable for primary outcomes, 2 participants were removed from study due to moderate or serious adverse event prior to meeting the evaluable benchmark.	12.5% 1/8 • Number of events 1 • Until completion of study, 2 months after start of treatment. No adverse events were reported for Sub study 1. For SubStudy 2 group 1, 6 participants completed and were evaluable for primary outcomes, 2 participants were removed from study due to moderate or serious adverse event prior to meeting the evaluable benchmark.	0.00% 0/7 • Until completion of study, 2 months after start of treatment. No adverse events were reported for Sub study 1. For SubStudy 2 group 1, 6 participants completed and were evaluable for primary outcomes, 2 participants were removed from study due to moderate or serious adverse event prior to meeting the evaluable benchmark.
General disorders Decreased Appetite	0.00% 0/6 • Until completion of study, 2 months after start of treatment. No adverse events were reported for Sub study 1. For SubStudy 2 group 1, 6 participants completed and were evaluable for primary outcomes, 2 participants were removed from study due to moderate or serious adverse event prior to meeting the evaluable benchmark.	0.00% 0/3 • Until completion of study, 2 months after start of treatment. No adverse events were reported for Sub study 1. For SubStudy 2 group 1, 6 participants completed and were evaluable for primary outcomes, 2 participants were removed from study due to moderate or serious adverse event prior to meeting the evaluable benchmark.	12.5% 1/8 • Number of events 1 • Until completion of study, 2 months after start of treatment. No adverse events were reported for Sub study 1. For SubStudy 2 group 1, 6 participants completed and were evaluable for primary outcomes, 2 participants were removed from study due to moderate or serious adverse event prior to meeting the evaluable benchmark.	0.00% 0/7 • Until completion of study, 2 months after start of treatment. No adverse events were reported for Sub study 1. For SubStudy 2 group 1, 6 participants completed and were evaluable for primary outcomes, 2 participants were removed from study due to moderate or serious adverse event prior to meeting the evaluable benchmark.
General disorders abdominal pain	0.00% 0/6 • Until completion of study, 2 months after start of treatment. No adverse events were reported for Sub study 1. For SubStudy 2 group 1, 6 participants completed and were evaluable for primary outcomes, 2 participants were removed from study due to moderate or serious adverse event prior to meeting the evaluable benchmark.	0.00% 0/3 • Until completion of study, 2 months after start of treatment. No adverse events were reported for Sub study 1. For SubStudy 2 group 1, 6 participants completed and were evaluable for primary outcomes, 2 participants were removed from study due to moderate or serious adverse event prior to meeting the evaluable benchmark.	12.5% 1/8 • Number of events 1 • Until completion of study, 2 months after start of treatment. No adverse events were reported for Sub study 1. For SubStudy 2 group 1, 6 participants completed and were evaluable for primary outcomes, 2 participants were removed from study due to moderate or serious adverse event prior to meeting the evaluable benchmark.	0.00% 0/7 • Until completion of study, 2 months after start of treatment. No adverse events were reported for Sub study 1. For SubStudy 2 group 1, 6 participants completed and were evaluable for primary outcomes, 2 participants were removed from study due to moderate or serious adverse event prior to meeting the evaluable benchmark.

Additional Information

Mike Lahm, Director Data Science

UnitedHealth Group R&D / Optum Labs

Phone: 302-379-0209

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place