Trial Outcomes & Findings for Convalescent Plasma in the Early Treatment of High-Risk Patients With SARS-CoV-2 (COVID-19) Infection (NCT NCT04513158)
NCT ID: NCT04513158
Last Updated: 2024-10-24
Results Overview
Measured by respiratory rate \>30/min, blood oxygen saturation \<93%, partial pressure of arterial oxygen to fraction of inspired oxygen ration \<300 and received a medical diagnosis of respiratory failure, septic shock or multiple
TERMINATED
PHASE2
2 participants
Through study completion, an average of 30 days
2024-10-24
Participant Flow
This study was open label, so there was no pre-assignment.
Participant milestones
| Measure |
Treatment Arm
Study is single arm all patients hospitalized meeting inclusion/exclusion criteria and providing informed consent to receive one unit (approximately 200 mL) of convalescent plasma with data collected daily on routine (non-research) clinical assessments/physical exams and lab results.
Convalescent Plasma: Plasma obtained from individuals previously diagnosed with SARS-CoV-2 (COVID-19) is administered to hospitalized patients meeting inclusion/exclusion criteria and have provided informed consent.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment Arm
Study is single arm all patients hospitalized meeting inclusion/exclusion criteria and providing informed consent to receive one unit (approximately 200 mL) of convalescent plasma with data collected daily on routine (non-research) clinical assessments/physical exams and lab results.
Convalescent Plasma: Plasma obtained from individuals previously diagnosed with SARS-CoV-2 (COVID-19) is administered to hospitalized patients meeting inclusion/exclusion criteria and have provided informed consent.
|
|---|---|
|
Overall Study
Screen Failure
|
1
|
Baseline Characteristics
Data was not collected or analyzed.
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Through study completion, an average of 30 daysPopulation: Data was not collected or analyzed.
Measured by respiratory rate \>30/min, blood oxygen saturation \<93%, partial pressure of arterial oxygen to fraction of inspired oxygen ration \<300 and received a medical diagnosis of respiratory failure, septic shock or multiple
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, an average of 14 daysPopulation: Data was not collected or analyzed.
SARS-CoV-2 Ag levels through RT-PCR
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, an average of 14 daysPopulation: Data was not collected or analyzed.
Measure normalization of laboratory parameters for risk
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, an average of 14 daysPopulation: Data was not collected or analyzed.
Measure normalization of laboratory parameters for risk
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, an average of 14 daysPopulation: Data was not collected or analyzed.
Measure normalization of laboratory parameters for risk
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, an average of 14 daysPopulation: Data was not collected or analyzed.
Measure normalization of laboratory parameters for risk
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, an average of 14 daysPopulation: Data was not collected or analyzed.
Measure normalization of laboratory parameters for risk
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, an average of 14 daysPopulation: Data was not collected or analyzed.
Measure normalization of laboratory parameters for risk
Outcome measures
Outcome data not reported
Adverse Events
Treatment Arm
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