Trial Outcomes & Findings for Observational Study of Convalescent Plasma for Treatment of Veterans With COVID-19 (NCT NCT04545047)
NCT ID: NCT04545047
Last Updated: 2024-04-04
Results Overview
Death at 30 days recorded in the electronic health record. Follow-up starts at the treatment date, which must be within 2 days after both hospitalization and SARS-CoV-2-positive test, and ends at 30 days or death.
COMPLETED
5044 participants
30 days
2024-04-04
Participant Flow
This observational study did not recruit patients but rather analyzed patients' VA electronic health record data. Eligibility was assessed through the examination of clinical and administrative data of US Veterans with non-severe COVID-19 who were hospitalized between1 May 2020 and 17 November 2020 at a VA medical center where convalescent plasma was a current practice.
We included patients in a trial on each day of eligibility (0, 1, 2) (person-trial). Each patient could be assigned to the plasma group once and to the non-plasma group up to 3 times. Because plasma patients could contribute non-plasma person-trials on eligible days prior to treatment, the sum of patients in the 2 groups (5,044) exceeds the number of eligible patients (4,755). Of 11,269 person-trials, there were 402 plasma trials (402 patients) and 10,867 non-plasma trials (4,642 patients).
Unit of analysis: person-trials
Participant milestones
| Measure |
Exposed-Convalescent Plasma Group
Person-trials contributed by Veterans who received COVID-19 convalescent plasma therapy within 2 days of eligibility
COVID-19 convalescent plasma: Convalescent plasma collected from individuals who have recovered from COVID-19
|
Unexposed-Non-Plasma Group
Person-trials contributed by Veterans who did not receive COVID-19 convalescent plasma therapy
|
|---|---|---|
|
Overall Study
STARTED
|
402 402
|
4642 10867
|
|
Overall Study
COMPLETED
|
402 402
|
4642 10867
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Observational Study of Convalescent Plasma for Treatment of Veterans With COVID-19
Baseline characteristics by cohort
| Measure |
Exposed-Convalescent Plasma Group
n=402 Person-trials
Veterans who received COVID-19 convalescent plasma therapy within 2 days of eligibility
COVID-19 convalescent plasma: Convalescent plasma collected from individuals who have recovered from COVID-19
|
Unexposed-Non-plasma Group
n=10867 Person-trials
Veterans who did not receive COVID-19 convalescent plasma therapy
|
Total
n=11269 Person-trials
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.0 years
STANDARD_DEVIATION 11.3 • n=402 Person-trials
|
64.1 years
STANDARD_DEVIATION 12.0 • n=10867 Person-trials
|
64.2 years
STANDARD_DEVIATION 12.0 • n=11269 Person-trials
|
|
Sex: Female, Male
Female
|
32 Person-trials
n=402 Person-trials
|
766 Person-trials
n=10867 Person-trials
|
798 Person-trials
n=11269 Person-trials
|
|
Sex: Female, Male
Male
|
370 Person-trials
n=402 Person-trials
|
10101 Person-trials
n=10867 Person-trials
|
10471 Person-trials
n=11269 Person-trials
|
|
Race/Ethnicity, Customized
Race · White
|
258 Person-trials
n=402 Person-trials
|
6194 Person-trials
n=10867 Person-trials
|
6452 Person-trials
n=11269 Person-trials
|
|
Race/Ethnicity, Customized
Race · Black
|
109 Person-trials
n=402 Person-trials
|
3814 Person-trials
n=10867 Person-trials
|
3923 Person-trials
n=11269 Person-trials
|
|
Race/Ethnicity, Customized
Race · Other
|
35 Person-trials
n=402 Person-trials
|
859 Person-trials
n=10867 Person-trials
|
894 Person-trials
n=11269 Person-trials
|
|
Body mass index
|
32.2 kg/m^2
STANDARD_DEVIATION 7.1 • n=402 Person-trials
|
31.0 kg/m^2
STANDARD_DEVIATION 7.2 • n=10867 Person-trials
|
31.0 kg/m^2
STANDARD_DEVIATION 7.2 • n=11269 Person-trials
|
|
Smoking status
Never
|
109 Person-trials
n=402 Person-trials
|
2791 Person-trials
n=10867 Person-trials
|
2900 Person-trials
n=11269 Person-trials
|
|
Smoking status
Current
|
81 Person-trials
n=402 Person-trials
|
2836 Person-trials
n=10867 Person-trials
|
2917 Person-trials
n=11269 Person-trials
|
|
Smoking status
Former
|
74 Person-trials
n=402 Person-trials
|
1923 Person-trials
n=10867 Person-trials
|
1997 Person-trials
n=11269 Person-trials
|
|
Smoking status
Unknown
|
138 Person-trials
n=402 Person-trials
|
3317 Person-trials
n=10867 Person-trials
|
3455 Person-trials
n=11269 Person-trials
|
|
Cardiovascular disorder within past 5 years
|
156 Person-trials
n=402 Person-trials
|
4663 Person-trials
n=10867 Person-trials
|
4819 Person-trials
n=11269 Person-trials
|
|
Chronic obstructive pulmonary disease
|
119 Person-trials
n=402 Person-trials
|
2463 Person-trials
n=10867 Person-trials
|
2582 Person-trials
n=11269 Person-trials
|
|
Dementia
|
29 Person-trials
n=402 Person-trials
|
816 Person-trials
n=10867 Person-trials
|
845 Person-trials
n=11269 Person-trials
|
|
Diabetes
|
219 Person-trials
n=402 Person-trials
|
5145 Person-trials
n=10867 Person-trials
|
5364 Person-trials
n=11269 Person-trials
|
|
Hypertension
|
307 Person-trials
n=402 Person-trials
|
7747 Person-trials
n=10867 Person-trials
|
8054 Person-trials
n=11269 Person-trials
|
|
Estimated glomerular filtration rate within past 30 days
|
75.3 ML/min/1.73m2
STANDARD_DEVIATION 27.6 • n=402 Person-trials
|
73.5 ML/min/1.73m2
STANDARD_DEVIATION 27.8 • n=10867 Person-trials
|
73.5 ML/min/1.73m2
STANDARD_DEVIATION 27.8 • n=11269 Person-trials
|
|
In intensive care unit
|
153 Person-trials
n=402 Person-trials
|
2204 Person-trials
n=10867 Person-trials
|
2357 Person-trials
n=11269 Person-trials
|
|
Glucocorticoid use
|
215 Person-trials
n=402 Person-trials
|
2258 Person-trials
n=10867 Person-trials
|
2473 Person-trials
n=11269 Person-trials
|
|
Remdesivir use
|
187 Person-trials
n=402 Person-trials
|
1476 Person-trials
n=10867 Person-trials
|
1663 Person-trials
n=11269 Person-trials
|
|
Supplemental non-high-flow oxygen
|
9 Person-trials
n=402 Person-trials
|
161 Person-trials
n=10867 Person-trials
|
170 Person-trials
n=11269 Person-trials
|
|
Minimum oxygen saturation in past day
|
93.3 Percentage of oxyhemoglobin saturation
STANDARD_DEVIATION 2.8 • n=402 Person-trials
|
94.6 Percentage of oxyhemoglobin saturation
STANDARD_DEVIATION 3.1 • n=10867 Person-trials
|
94.5 Percentage of oxyhemoglobin saturation
STANDARD_DEVIATION 3.1 • n=11269 Person-trials
|
|
First oxygen saturation during hospitalization
|
93.8 Percentage of oxyhemoglobin saturation
STANDARD_DEVIATION 3.8 • n=402 Person-trials
|
95.5 Percentage of oxyhemoglobin saturation
STANDARD_DEVIATION 3.3 • n=10867 Person-trials
|
95.4 Percentage of oxyhemoglobin saturation
STANDARD_DEVIATION 3.4 • n=11269 Person-trials
|
|
Maximum white blood cell count in past 2 days
|
7.4 1000 cells/ul
STANDARD_DEVIATION 4.1 • n=402 Person-trials
|
6.8 1000 cells/ul
STANDARD_DEVIATION 3.9 • n=10867 Person-trials
|
6.8 1000 cells/ul
STANDARD_DEVIATION 3.9 • n=11269 Person-trials
|
|
Systemic inflammatory response syndrome
|
243 Person-trials
n=402 Person-trials
|
4739 Person-trials
n=10867 Person-trials
|
4982 Person-trials
n=11269 Person-trials
|
|
Calendar day of trial start
|
249 days
STANDARD_DEVIATION 52 • n=402 Person-trials
|
231 days
STANDARD_DEVIATION 52 • n=10867 Person-trials
|
232 days
STANDARD_DEVIATION 52 • n=11269 Person-trials
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Intention-to-treat analysis; per-protocol analysis with adjustment for baseline covariates via inverse probability weighting
Death at 30 days recorded in the electronic health record. Follow-up starts at the treatment date, which must be within 2 days after both hospitalization and SARS-CoV-2-positive test, and ends at 30 days or death.
Outcome measures
| Measure |
Convalescent Plasma Group
n=402 Person-trials
Veterans who received COVID-19 convalescent plasma therapy within 2 days of eligibility
COVID-19 convalescent plasma: Convalescent plasma collected from individuals who have recovered from COVID-19
|
Non-plasma Group
n=10867 Person-trials
Veterans who did not receive COVID-19 convalescent plasma therapy
|
|---|---|---|
|
All-cause Mortality
|
40 Person-trials
|
671 Person-trials
|
Adverse Events
Convalescent Plasma Group
Non-plasma Group
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