Trial Outcomes & Findings for Colchicine/Statins for the Prevention of COVID-19 Complications (COLSTAT) Trial (NCT NCT04472611)
NCT ID: NCT04472611
Last Updated: 2023-04-27
Results Overview
As defined by World Health Organization Ordinal Scale, which ranges from 1 to 8. Severity of COVID measured by WHO Scores 5-8: Defined as 5= Hospitalized requiring including CPAP, face mask, high flow nasal cannula (Excludes regular nasal cannula), 6= Hospitalized requiring intubation and mechanical ventilation, 7= Hospitalized requiring mechanical ventilation and additional organ support (vasopressors, renal replacement therapy, ECMO), 8= Death. Data presented is for Max WHO scores 5-8, indicating moderately to severely infected participants.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
250 participants
Primary outcome timeframe
30 Days
Results posted on
2023-04-27
Participant Flow
Participant milestones
| Measure |
Standard of Care (SOC) and Colchicine+Rosuvastatin
Patients will take Rosuvastatin 40mg daily and Colchicine 0.6mg twice for 3 days and then 0.6mg daily during hospitalization
Standard of Care (SOC) and Colchicine+Rosuvastatin: Patients will take Rosuvastatin 40mg daily and Colchicine 0.6mg twice for 3 days and then 0.6mg daily during hospitalization
|
Standard of Care (SOC)
Patients will undergo standard of care treatment during hospitalization determined by the primary care team during hospitalization
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
125
|
|
Overall Study
COMPLETED
|
122
|
125
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Colchicine/Statins for the Prevention of COVID-19 Complications (COLSTAT) Trial
Baseline characteristics by cohort
| Measure |
SOC and Colchicine and Rosuvastatin
n=125 Participants
Patients will take Rosuvastatin 40mg daily and Colchicine 0.6mg twice for 3 days and then 0.6mg daily during hospitalization
|
Standard of Care (SOC)
n=125 Participants
Patients will undergo standard of care treatment during hospitalization determined by the primary care team during hospitalization
|
Total
n=250 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
|
74 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
51 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
62.4 years
STANDARD_DEVIATION 16.1 • n=7 Participants
|
61.4 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
126 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
|
2 Participants
n=7 Participants
|
2 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
76 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
125 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
250 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 DaysPopulation: Moderately infected COVID patients requiring hospitalization.
As defined by World Health Organization Ordinal Scale, which ranges from 1 to 8. Severity of COVID measured by WHO Scores 5-8: Defined as 5= Hospitalized requiring including CPAP, face mask, high flow nasal cannula (Excludes regular nasal cannula), 6= Hospitalized requiring intubation and mechanical ventilation, 7= Hospitalized requiring mechanical ventilation and additional organ support (vasopressors, renal replacement therapy, ECMO), 8= Death. Data presented is for Max WHO scores 5-8, indicating moderately to severely infected participants.
Outcome measures
| Measure |
Standard of Care (SOC) and Colchicine+Rosuvastatin
n=17 Participants
Patients will take Rosuvastatin 40mg daily and Colchicine 0.6mg twice for 3 days and then 0.6mg daily during hospitalization
Standard of Care (SOC) and Colchicine+Rosuvastatin: Patients will take Rosuvastatin 40mg daily and Colchicine 0.6mg twice for 3 days and then 0.6mg daily during hospitalization
|
Standard of Care (SOC)
n=8 Participants
Patients will undergo standard of care treatment during hospitalization determined by the primary care team during hospitalization
|
|---|---|---|
|
Number of Participants With COVID 19 Severity
Max WHO score 5
|
5 Participants
|
4 Participants
|
|
Number of Participants With COVID 19 Severity
Max WHO score 6
|
2 Participants
|
0 Participants
|
|
Number of Participants With COVID 19 Severity
Max WHO score 7
|
4 Participants
|
1 Participants
|
|
Number of Participants With COVID 19 Severity
Max WHO score 8
|
6 Participants
|
3 Participants
|
Adverse Events
Standard of Care (SOC) and Colchicine+Rosuvastatin
Serious events: 4 serious events
Other events: 9 other events
Deaths: 7 deaths
Standard of Care (SOC)
Serious events: 4 serious events
Other events: 2 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Standard of Care (SOC) and Colchicine+Rosuvastatin
n=125 participants at risk
Patients will take Rosuvastatin 40mg daily and Colchicine 0.6mg twice for 3 days and then 0.6mg daily during hospitalization
Standard of Care (SOC) and Colchicine+Rosuvastatin: Patients will take Rosuvastatin 40mg daily and Colchicine 0.6mg twice for 3 days and then 0.6mg daily during hospitalization
|
Standard of Care (SOC)
n=125 participants at risk
Patients will undergo standard of care treatment during hospitalization determined by the primary care team during hospitalization
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Death
|
3.2%
4/125 • Number of events 4 • Adverse events were recorded for patients starting at date/time of enrollment through study exit at 60 day post-discharge timepoint.
Adverse events were recorded for patients starting at date/time of enrollment through study exit at 60 day post-discharge timepoint, up to a maximum of 90 days.
|
3.2%
4/125 • Number of events 4 • Adverse events were recorded for patients starting at date/time of enrollment through study exit at 60 day post-discharge timepoint.
Adverse events were recorded for patients starting at date/time of enrollment through study exit at 60 day post-discharge timepoint, up to a maximum of 90 days.
|
Other adverse events
| Measure |
Standard of Care (SOC) and Colchicine+Rosuvastatin
n=125 participants at risk
Patients will take Rosuvastatin 40mg daily and Colchicine 0.6mg twice for 3 days and then 0.6mg daily during hospitalization
Standard of Care (SOC) and Colchicine+Rosuvastatin: Patients will take Rosuvastatin 40mg daily and Colchicine 0.6mg twice for 3 days and then 0.6mg daily during hospitalization
|
Standard of Care (SOC)
n=125 participants at risk
Patients will undergo standard of care treatment during hospitalization determined by the primary care team during hospitalization
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal Distress
|
4.0%
5/125 • Number of events 5 • Adverse events were recorded for patients starting at date/time of enrollment through study exit at 60 day post-discharge timepoint.
Adverse events were recorded for patients starting at date/time of enrollment through study exit at 60 day post-discharge timepoint, up to a maximum of 90 days.
|
0.00%
0/125 • Adverse events were recorded for patients starting at date/time of enrollment through study exit at 60 day post-discharge timepoint.
Adverse events were recorded for patients starting at date/time of enrollment through study exit at 60 day post-discharge timepoint, up to a maximum of 90 days.
|
|
Immune system disorders
Increased Liver Function Tests
|
3.2%
4/125 • Number of events 4 • Adverse events were recorded for patients starting at date/time of enrollment through study exit at 60 day post-discharge timepoint.
Adverse events were recorded for patients starting at date/time of enrollment through study exit at 60 day post-discharge timepoint, up to a maximum of 90 days.
|
1.6%
2/125 • Number of events 2 • Adverse events were recorded for patients starting at date/time of enrollment through study exit at 60 day post-discharge timepoint.
Adverse events were recorded for patients starting at date/time of enrollment through study exit at 60 day post-discharge timepoint, up to a maximum of 90 days.
|
Additional Information
Dr. Alexandra Lansky
Yale University School of Medicine
Phone: 203 737 2142
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place