Trial Outcomes & Findings for Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection (NCT NCT04381052)
NCT ID: NCT04381052
Last Updated: 2022-04-08
Results Overview
TERMINATED
PHASE2
1 participants
60 days
2022-04-08
Participant Flow
Study was closed due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
Participant milestones
| Measure |
Clazakizumab 25 mg or Placebo
The first dose will be administered as soon as possible after the patient is enrolled and randomized into a specific arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following first dose administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3.
Placebo: Intravenously administered over 30 minutes. OR Clazakizumab: Dose is 25mg intravenously over 30 minutes.
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 60 daysPopulation: Study stopped due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 daysPopulation: Study stopped due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 daysPopulation: Study stopped due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 daysPopulation: Study stopped due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 daysPopulation: Study stopped due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 daysPopulation: Study stopped due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 daysPopulation: Study stopped due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 daysPopulation: Study stopped due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 daysPopulation: Study stopped due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
Number of participants alive at day 28.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 daysPopulation: Study stopped due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
Number of participants alive at day 60, end of study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 daysPopulation: Study stopped due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 daysPopulation: Study stopped due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 daysPopulation: Study stopped due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
Outcome measures
Outcome data not reported
Adverse Events
Clazakizumab 25 mg
Placebo
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