Trial Outcomes & Findings for Convalescent Plasma for Treatment of COVID-19 Patients With Pneumonia (NCT NCT04374565)
NCT ID: NCT04374565
Last Updated: 2022-04-01
Results Overview
Will be done by comparing the admission rate to the ICU between patients who received convalescent plasma and a control group who did not enroll in the study, or receive another experimental therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Days 0 - 60
Results posted on
2022-04-01
Participant Flow
Participant milestones
| Measure |
Study Participants
A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.
High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; \~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
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|---|---|
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Overall Study
STARTED
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29
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Overall Study
COMPLETED
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29
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Convalescent Plasma for Treatment of COVID-19 Patients With Pneumonia
Baseline characteristics by cohort
| Measure |
Study Participants
n=29 Participants
A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.
High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; \~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
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Age, Continuous
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57.6 years
STANDARD_DEVIATION 2.5 • n=5 Participants
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Sex: Female, Male
Female
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14 Participants
n=5 Participants
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Sex: Female, Male
Male
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15 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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12 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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17 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Days 0 - 60Will be done by comparing the admission rate to the ICU between patients who received convalescent plasma and a control group who did not enroll in the study, or receive another experimental therapy.
Outcome measures
| Measure |
Study Participants
n=29 Participants
A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.
High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; \~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
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Number of Participants Transferred to Intensive Care Unit (ICU)
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4 Participants
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PRIMARY outcome
Timeframe: Days 0 - 28Will be done by comparing the 28 day mortality rate between enrolled subjects and the control group.
Outcome measures
| Measure |
Study Participants
n=29 Participants
A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.
High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; \~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
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28 Day Mortality
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2 Participants
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SECONDARY outcome
Timeframe: Days 0 - 60Will be collected from time of enrollment until completion of the study. The adverse events will be evaluated by CTCAE V5.0 and MedDRA.
Outcome measures
| Measure |
Study Participants
n=29 Participants
A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.
High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; \~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
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|---|---|
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Number of Participants With Serious Adverse Events
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4 Participants
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SECONDARY outcome
Timeframe: Days 0 - 21Respiratory tract swabs will be collected on days, 0, 7, 14, and 21 and will be tested for SARS-CoV-2. The outcome measurement is determining the duration from date of infection until date of first documented negative PCR test, which was assed up to 21 days
Outcome measures
| Measure |
Study Participants
n=29 Participants
A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.
High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; \~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
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Duration of SARS-CoV-2 Positivity
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20.4 days
Standard Error 1.57
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SECONDARY outcome
Timeframe: Day 28Population: Median IgG anti-spoke protein (ug/ml)
Serum or plasma will be collected and analyzed for SARS-CoV-2 antibody.
Outcome measures
| Measure |
Study Participants
n=29 Participants
A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.
High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; \~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
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Serum of Plasma Antibody Titer to SARS-CoV-2
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7.7 ug/mL
Interval 0.1 to 112.1
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SECONDARY outcome
Timeframe: Day 28Blood will be collected and analyzed for for Spike IgG levels.
Outcome measures
| Measure |
Study Participants
n=29 Participants
A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.
High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; \~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
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Cellular and Humoral Immune Response
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58.0 ug/mL
Interval 34.0 to 90.0
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SECONDARY outcome
Timeframe: Days 0-28All days where a supplemental oxygen is needed will be recorded as a concomitant medication and will be subtracted from total days the participant is alive and enrolled in the study up to day 28 to determine the supplemental oxygen free days.
Outcome measures
| Measure |
Study Participants
n=29 Participants
A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.
High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; \~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
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Supplemental Oxygen Free Days
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23.5 Days
Interval 21.0 to 26.0
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SECONDARY outcome
Timeframe: Days 0 - 28All days where a ventilator is needed will be recorded as a concomitant procedure and will be subtracted from total days the participant is alive and enrolled in the study up to day 28 to determine the ventilator free days.
Outcome measures
| Measure |
Study Participants
n=29 Participants
A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.
High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; \~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
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Ventilator Free Days
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24.93 days
Standard Error 1.46
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SECONDARY outcome
Timeframe: Days 0 - 28All days where the participant is admitted to the ICU will be recorded and subtracted from total days the participant is alive and enrolled in the study up to day 28 to determine the ICU free days.
Outcome measures
| Measure |
Study Participants
n=29 Participants
A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.
High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; \~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
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ICU Free Days
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24.59 days
Standard Error 1.61
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SECONDARY outcome
Timeframe: days 0-28Population: Number of participants whose score improved throughout their admission.
Throughout the study, participants were evaluated by study physician using the sequential organ failure assessment score. This outcome measurement is looking for the number of participants who's score improved over the duration of the study.
Outcome measures
| Measure |
Study Participants
n=29 Participants
A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.
High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; \~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
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Sequential Organ Failure Assessment Score Improvement
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27 Participants
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SECONDARY outcome
Timeframe: Days 0 - 60Concomitant medications will be recorded throughout the patients participation in the study and vasopressors will be recorded, if they are needed.
Outcome measures
| Measure |
Study Participants
n=29 Participants
A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.
High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; \~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
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Number of Participants Who Needed for Vasopressors
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4 Participants
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SECONDARY outcome
Timeframe: Days 0 - 60Population: number of study patients who required renal therapy
Renal function will be assessed throughout the patients participation in the study. If renal replacement therapy is needed, it will be captured as a concomitant procedure.
Outcome measures
| Measure |
Study Participants
n=29 Participants
A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.
High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; \~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
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Number of Participants Who Needed Renal Replacement Therapy
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1 Participants
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SECONDARY outcome
Timeframe: Days 0 - 60Population: number of patients who received ECMO
Respiratory function will be assessed throughout the patients participation in the study. If ECMO is needed, it will be captured as a concomitant procedure.
Outcome measures
| Measure |
Study Participants
n=29 Participants
A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.
High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; \~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
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Number of Participants Who Needed Extracorporeal Membrane Oxygenation (ECMO)
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1 Participants
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SECONDARY outcome
Timeframe: Days 0-60Will be calculated from the date the patient entered the hospital until they were discharged.
Outcome measures
| Measure |
Study Participants
n=29 Participants
A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.
High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; \~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
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Hospital Length of Stay (LOS)
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9.39 days
Standard Error 1.56
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SECONDARY outcome
Timeframe: days 0 - 60Will be calculated from the date the patient entered the ICU until they were discharged from the ICU.
Outcome measures
| Measure |
Study Participants
n=29 Participants
A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.
High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; \~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
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ICU LOS
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2.93 days
Standard Error 1.72
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SECONDARY outcome
Timeframe: Adverse events were collected from day 0 to 7 days post infusion.All adverse events will be recorded and evaluated by CTCAE v.5.0. All grade 3 and 4 AEs will be calculated to determine safety of convalescent plasma.
Outcome measures
| Measure |
Study Participants
n=29 Participants
A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.
High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; \~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
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Number of Participants Who Had a Grade 3 or 4 Adverse Events (AEs)
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6 Participants
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Adverse Events
Study Participants
Serious events: 4 serious events
Other events: 11 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Study Participants
n=29 participants at risk
A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.
High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; \~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
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Blood and lymphatic system disorders
Sepsis
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3.4%
1/29 • Number of events 2 • Adverse events were collected from day 0 to 7 days post infusion.
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Respiratory, thoracic and mediastinal disorders
Respiratory Failure
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10.3%
3/29 • Number of events 3 • Adverse events were collected from day 0 to 7 days post infusion.
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Other adverse events
| Measure |
Study Participants
n=29 participants at risk
A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.
High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; \~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
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Respiratory, thoracic and mediastinal disorders
Hypoxia
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3.4%
1/29 • Number of events 1 • Adverse events were collected from day 0 to 7 days post infusion.
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Cardiac disorders
Hypertension urgency
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3.4%
1/29 • Number of events 1 • Adverse events were collected from day 0 to 7 days post infusion.
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Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
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17.2%
5/29 • Number of events 6 • Adverse events were collected from day 0 to 7 days post infusion.
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Cardiac disorders
hypotension
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3.4%
1/29 • Number of events 1 • Adverse events were collected from day 0 to 7 days post infusion.
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Vascular disorders
syncope
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3.4%
1/29 • Number of events 1 • Adverse events were collected from day 0 to 7 days post infusion.
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Infections and infestations
fever
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10.3%
3/29 • Number of events 3 • Adverse events were collected from day 0 to 7 days post infusion.
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General disorders
epistaxis
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3.4%
1/29 • Number of events 1 • Adverse events were collected from day 0 to 7 days post infusion.
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Hepatobiliary disorders
creatine increased
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3.4%
1/29 • Number of events 1 • Adverse events were collected from day 0 to 7 days post infusion.
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Hepatobiliary disorders
ALT/AST increased
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3.4%
1/29 • Number of events 1 • Adverse events were collected from day 0 to 7 days post infusion.
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Cardiac disorders
atrial fibrillation
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3.4%
1/29 • Number of events 1 • Adverse events were collected from day 0 to 7 days post infusion.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place