Trial Outcomes & Findings for Respiratory Syncytial Virus - RSV Protocol (NCT NCT01502072)
NCT ID: NCT01502072
Last Updated: 2021-02-15
Results Overview
Patient who developed signs of lower respiratory tract infection
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
14 days
Results posted on
2021-02-15
Participant Flow
Recruitment Period: December 2011 - March 2016. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
48 participants enrolled, 4 participants did not meet enrollment criteria after screening labs were performed.
Participant milestones
| Measure |
Oral Ribavirin
Ribavirin Capsules 20 mg/kg orally 3 times/day for up to 10 days.
Ribavirin: One time loading dose of 10 mg/kg oral dose then 20 mg/kg orally (rounded to the nearest 200 mg dose) divided into three doses per day (max 1800 mg/day).
|
Inhaled Ribavirin
Inhaled form of Ribavirin 60 milligrams/milliliter 3 times/day for 3 hours for up to 10 days.
|
No Ribavirin
No Ribavirin treatment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
10
|
20
|
|
Overall Study
COMPLETED
|
13
|
9
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Oral Ribavirin
Ribavirin Capsules 20 mg/kg orally 3 times/day for up to 10 days.
Ribavirin: One time loading dose of 10 mg/kg oral dose then 20 mg/kg orally (rounded to the nearest 200 mg dose) divided into three doses per day (max 1800 mg/day).
|
Inhaled Ribavirin
Inhaled form of Ribavirin 60 milligrams/milliliter 3 times/day for 3 hours for up to 10 days.
|
No Ribavirin
No Ribavirin treatment.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
Baseline Characteristics
Respiratory Syncytial Virus - RSV Protocol
Baseline characteristics by cohort
| Measure |
Oral Ribavirin
n=13 Participants
Ribavirin Capsules 20 mg/kg orally 3 times/day for up to 10 days.
|
Inhaled Ribavirin
n=10 Participants
Inhaled form of Ribavirin 60 milligrams/milliliter 3 times/day for 3 hours for up to 10 days.
|
No Ribavirin
n=20 Participants
No Ribavirin treatment.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.4 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
41.5 years
STANDARD_DEVIATION 17.1 • n=5 Participants
|
50.8 years
STANDARD_DEVIATION 16.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
32 Participants
n=4 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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (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
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
43 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 14 daysPatient who developed signs of lower respiratory tract infection
Outcome measures
| Measure |
Oral Ribavirin
n=13 Participants
Ribavirin Capsules 20 mg/kg orally 3 times/day for up to 10 days.
|
Inhaled Ribavirin
n=10 Participants
Inhaled form of Ribavirin 60 milligrams/milliliter 3 times/day for 3 hours for up to 10 days.
|
No Ribavirin
n=20 Participants
No Ribavirin treatment.
|
|---|---|---|---|
|
Percentage of Participants With Progression to Lower Respiratory Tract Infection (LRI)
|
8 percentage of participants
|
30 percentage of participants
|
10 percentage of participants
|
Adverse Events
Oral Ribavirin
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Inhaled Ribavirin
Serious events: 5 serious events
Other events: 4 other events
Deaths: 1 deaths
No Ribavirin
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oral Ribavirin
n=13 participants at risk
Ribavirin Capsules 20 mg/kg orally 3 times/day for up to 10 days.
|
Inhaled Ribavirin
n=10 participants at risk
Inhaled form of Ribavirin 60 milligrams/milliliter 3 times/day for 3 hours for up to 10 days.
|
No Ribavirin
n=20 participants at risk
No Ribavirin treatment.
|
|---|---|---|---|
|
Psychiatric disorders
Altered mental status
|
0.00%
0/13 • At baseline, up to 2 weeks
|
10.0%
1/10 • At baseline, up to 2 weeks
|
0.00%
0/20 • At baseline, up to 2 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • At baseline, up to 2 weeks
|
0.00%
0/10 • At baseline, up to 2 weeks
|
15.0%
3/20 • At baseline, up to 2 weeks
|
|
General disorders
Graft versus host disease
|
0.00%
0/13 • At baseline, up to 2 weeks
|
0.00%
0/10 • At baseline, up to 2 weeks
|
5.0%
1/20 • At baseline, up to 2 weeks
|
|
Renal and urinary disorders
Acute renal failure
|
0.00%
0/13 • At baseline, up to 2 weeks
|
10.0%
1/10 • At baseline, up to 2 weeks
|
0.00%
0/20 • At baseline, up to 2 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Alveolar hemorrhage
|
0.00%
0/13 • At baseline, up to 2 weeks
|
10.0%
1/10 • At baseline, up to 2 weeks
|
0.00%
0/20 • At baseline, up to 2 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/13 • At baseline, up to 2 weeks
|
10.0%
1/10 • At baseline, up to 2 weeks
|
0.00%
0/20 • At baseline, up to 2 weeks
|
|
Gastrointestinal disorders
GI bleed
|
7.7%
1/13 • At baseline, up to 2 weeks
|
0.00%
0/10 • At baseline, up to 2 weeks
|
0.00%
0/20 • At baseline, up to 2 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
15.4%
2/13 • At baseline, up to 2 weeks
|
10.0%
1/10 • At baseline, up to 2 weeks
|
10.0%
2/20 • At baseline, up to 2 weeks
|
Other adverse events
| Measure |
Oral Ribavirin
n=13 participants at risk
Ribavirin Capsules 20 mg/kg orally 3 times/day for up to 10 days.
|
Inhaled Ribavirin
n=10 participants at risk
Inhaled form of Ribavirin 60 milligrams/milliliter 3 times/day for 3 hours for up to 10 days.
|
No Ribavirin
n=20 participants at risk
No Ribavirin treatment.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Worsening oral ulcer
|
7.7%
1/13 • At baseline, up to 2 weeks
|
0.00%
0/10 • At baseline, up to 2 weeks
|
0.00%
0/20 • At baseline, up to 2 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath/hypoxia
|
15.4%
2/13 • At baseline, up to 2 weeks
|
0.00%
0/10 • At baseline, up to 2 weeks
|
0.00%
0/20 • At baseline, up to 2 weeks
|
|
Psychiatric disorders
Clausterphobia
|
0.00%
0/13 • At baseline, up to 2 weeks
|
10.0%
1/10 • At baseline, up to 2 weeks
|
0.00%
0/20 • At baseline, up to 2 weeks
|
|
Psychiatric disorders
Seizure
|
0.00%
0/13 • At baseline, up to 2 weeks
|
10.0%
1/10 • At baseline, up to 2 weeks
|
0.00%
0/20 • At baseline, up to 2 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
1/13 • At baseline, up to 2 weeks
|
10.0%
1/10 • At baseline, up to 2 weeks
|
0.00%
0/20 • At baseline, up to 2 weeks
|
|
Psychiatric disorders
Jitteriness
|
0.00%
0/13 • At baseline, up to 2 weeks
|
10.0%
1/10 • At baseline, up to 2 weeks
|
0.00%
0/20 • At baseline, up to 2 weeks
|
Additional Information
Roy F. Chemaly, MD,MPH- Professor, Infectious Diseases
UT MD Anderson Cancer Center
Phone: (713) 745-1116
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place