Trial Outcomes & Findings for Cyclosporine For The Treatment Of COVID-19(+) (NCT NCT04492891)
NCT ID: NCT04492891
Last Updated: 2023-07-20
Results Overview
WHO(World Health Organization) COVID-19 clinical severity scale. Score 0-9. 0=Uninfected, 8=Death.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
on day 14
Results posted on
2023-07-20
Participant Flow
Participants were recruited at one institution between November 2020 and October 2021. The first participant enrolled on November 23, 2020, and the last participant enrolled on October 12, 2021.
Due to the decline of COVID-19 cases which led to slow accrual, the study was closed to enrollment on April 6, 2022. For this reason, the total number of participants reported in the Brief Summary and the enrollment number of participants have a discrepancy.
Participant milestones
| Measure |
Arm A Cyclosporine
Participants received Neoral 2.5mg/kg PO BID, based on the renal transplant dose for 7 days.
Neoral is an oral formulation of cyclosporine.
|
Arm B Standard of Care
Participants received standard of Care Treatment(no taking Neoral) for 7 days
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
17
|
|
Overall Study
COMPLETED
|
30
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cyclosporine For The Treatment Of COVID-19(+)
Baseline characteristics by cohort
| Measure |
Arm A Cyclosporine
n=30 Participants
Participants received Neoral 2.5mg/kg PO BID, based on the renal transplant dose for 7 days.
Neoral is an oral formulation of cyclosporine.
|
Arm B Standard of Care
n=17 Participants
Participants received standard of Care Treatment(no taking Neoral) for 7 days
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.8 years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 14.9 • n=7 Participants
|
59.8 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
|
Age, Customized
Age category · < 60 years
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Customized
Age category · >= 60 years
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
32 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
|
|
WHO score - score 4
|
30 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Comorbidity
Absence
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Comorbidity
Presence
|
21 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: on day 14Population: WHO scores were obtained during ± 3 days on each planned day 14. If no WHO score is available on the planned day because of early discharge, the last WHO score was used for analysis.
WHO(World Health Organization) COVID-19 clinical severity scale. Score 0-9. 0=Uninfected, 8=Death.
Outcome measures
| Measure |
Arm A Cyclosporine
n=30 Participants
Participants received Neoral 2.5mg/kg PO BID, based on the renal transplant dose for 7 days.
Neoral is an oral formulation of cyclosporine.
|
Arm B Standard of Care
n=17 Participants
Participants received standard of Care Treatment(no taking Neoral) for 7 days
|
|---|---|---|
|
WHO(World Health Organization) COVID-19 Clinical Severity Scale
|
2 units on a scale
Interval 0.0 to 3.0
|
2 units on a scale
Interval 1.0 to 2.0
|
Adverse Events
Arm A Cyclosporine
Serious events: 1 serious events
Other events: 13 other events
Deaths: 1 deaths
Arm B Standard of Care
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A Cyclosporine
n=30 participants at risk
Participants received Neoral 2.5mg/kg PO BID, based on the renal transplant dose for 7 days.
Neoral is an oral formulation of cyclosporine.
|
Arm B Standard of Care
n=17 participants at risk
Participants received standard of Care Treatment(no taking Neoral) for 7 days
|
|---|---|---|
|
Cardiac disorders
Chest pain - cardiac
|
3.3%
1/30 • Number of events 1 • 60 days
|
0.00%
0/17 • 60 days
|
|
General disorders
Death NOS
|
3.3%
1/30 • Number of events 1 • 60 days
|
0.00%
0/17 • 60 days
|
|
Investigations
Alanine aminotransferase increased
|
3.3%
1/30 • Number of events 1 • 60 days
|
0.00%
0/17 • 60 days
|
|
Investigations
Aspartate aminotransferase increased
|
3.3%
1/30 • Number of events 1 • 60 days
|
0.00%
0/17 • 60 days
|
Other adverse events
| Measure |
Arm A Cyclosporine
n=30 participants at risk
Participants received Neoral 2.5mg/kg PO BID, based on the renal transplant dose for 7 days.
Neoral is an oral formulation of cyclosporine.
|
Arm B Standard of Care
n=17 participants at risk
Participants received standard of Care Treatment(no taking Neoral) for 7 days
|
|---|---|---|
|
Cardiac disorders
Chest pain - cardiac
|
13.3%
4/30 • Number of events 4 • 60 days
|
0.00%
0/17 • 60 days
|
|
Ear and labyrinth disorders
Ear pain
|
3.3%
1/30 • Number of events 1 • 60 days
|
0.00%
0/17 • 60 days
|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • Number of events 1 • 60 days
|
0.00%
0/17 • 60 days
|
|
Gastrointestinal disorders
Nausea
|
3.3%
1/30 • Number of events 1 • 60 days
|
0.00%
0/17 • 60 days
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
1/30 • Number of events 1 • 60 days
|
0.00%
0/17 • 60 days
|
|
Infections and infestations
Sepsis
|
3.3%
1/30 • Number of events 1 • 60 days
|
0.00%
0/17 • 60 days
|
|
Investigations
Alanine aminotransferase increased
|
3.3%
1/30 • Number of events 1 • 60 days
|
0.00%
0/17 • 60 days
|
|
Investigations
Aspartate aminotransferase increased
|
3.3%
1/30 • Number of events 1 • 60 days
|
0.00%
0/17 • 60 days
|
|
Investigations
Investigations - Other, specify
|
3.3%
1/30 • Number of events 1 • 60 days
|
0.00%
0/17 • 60 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
1/30 • Number of events 1 • 60 days
|
0.00%
0/17 • 60 days
|
|
Nervous system disorders
Headache
|
3.3%
1/30 • Number of events 1 • 60 days
|
0.00%
0/17 • 60 days
|
|
Psychiatric disorders
Confusion
|
3.3%
1/30 • Number of events 1 • 60 days
|
0.00%
0/17 • 60 days
|
|
Renal and urinary disorders
Acute kidney injury
|
3.3%
1/30 • Number of events 1 • 60 days
|
0.00%
0/17 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
3.3%
1/30 • Number of events 1 • 60 days
|
0.00%
0/17 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.3%
1/30 • Number of events 1 • 60 days
|
0.00%
0/17 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
3.3%
1/30 • Number of events 1 • 60 days
|
0.00%
0/17 • 60 days
|
|
Vascular disorders
Hypertension
|
0.00%
0/30 • 60 days
|
5.9%
1/17 • Number of events 1 • 60 days
|
Additional Information
Michelle Almarez: Clinical Research Manager
Baylor College of Medicine
Phone: 713-798-3680
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place