Trial Outcomes & Findings for COlchicine in Moderate-severe Hospitalized Patients Before ARDS to Treat COVID-19 (NCT NCT04363437)
NCT ID: NCT04363437
Last Updated: 2022-02-18
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
through study completion, estimated 2 months
Results posted on
2022-02-18
Participant Flow
Participant milestones
| Measure |
Colchine
Colchicine: People in the colchine group will be given a starting dose of 1.2 mg followed, by 0.6mg after 2 hours if they do not have significant gastrointestinal symptoms, on day 1. After that, they will take colchicine 0.6mg twice a day for 14 days or until discharged or release from the hospital.
|
Usual Care
Usual Care: COVID Patients in this arm will receive usual care COVID19 treatment and will not receive colchine.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Colchine
n=10 Participants
Colchicine: People in the colchine group will be given a starting dose of 1.2 mg followed, by 0.6mg after 2 hours if they do not have significant gastrointestinal symptoms, on day 1. After that, they will take colchicine 0.6mg twice a day for 14 days or until discharged or release from the hospital.
|
Usual Care
n=11 Participants
Usual Care: COVID Patients in this arm will receive usual care COVID19 treatment and will not receive colchine.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 18.1 • n=10 Participants
|
67.1 years
STANDARD_DEVIATION 20.4 • n=11 Participants
|
64.47 years
STANDARD_DEVIATION 19.19 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=10 Participants
|
5 Participants
n=11 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=10 Participants
|
6 Participants
n=11 Participants
|
12 Participants
n=21 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
11 participants
n=11 Participants
|
21 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: through study completion, estimated 2 monthsOutcome measures
| Measure |
Colchine
n=10 Participants
Colchicine: People in the colchine group will be given a starting dose of 1.2 mg followed, by 0.6mg after 2 hours if they do not have significant gastrointestinal symptoms, on day 1. After that, they will take colchicine 0.6mg twice a day for 14 days or until discharged or release from the hospital.
|
Usual Care
n=11 Participants
Usual Care: COVID Patients in this arm will receive usual care COVID19 treatment and will not receive colchine.
|
|---|---|---|
|
Percentage of Patients Requiring Supplemental Oxygen Beyond 8L Nasal Cannula
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: through study completion, estimated 2 monthsOutcome measures
| Measure |
Colchine
n=10 Participants
Colchicine: People in the colchine group will be given a starting dose of 1.2 mg followed, by 0.6mg after 2 hours if they do not have significant gastrointestinal symptoms, on day 1. After that, they will take colchicine 0.6mg twice a day for 14 days or until discharged or release from the hospital.
|
Usual Care
n=11 Participants
Usual Care: COVID Patients in this arm will receive usual care COVID19 treatment and will not receive colchine.
|
|---|---|---|
|
Percentage of Patients Who Will Require Mechanical Ventillation
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: through study completion, estimated 2 monthsOutcome measures
| Measure |
Colchine
n=10 Participants
Colchicine: People in the colchine group will be given a starting dose of 1.2 mg followed, by 0.6mg after 2 hours if they do not have significant gastrointestinal symptoms, on day 1. After that, they will take colchicine 0.6mg twice a day for 14 days or until discharged or release from the hospital.
|
Usual Care
n=11 Participants
Usual Care: COVID Patients in this arm will receive usual care COVID19 treatment and will not receive colchine.
|
|---|---|---|
|
Mortality
|
0 Participants
|
1 Participants
|
Adverse Events
Colchine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place