Trial Outcomes & Findings for COVID-19 Convalescent Plasma (NCT NCT04340050)

NCT ID: NCT04340050

Last Updated: 2024-02-28

Results Overview

Number of patients who receive convalescent plasma

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 10 participants
• Primary outcome timeframe: At time of administration
• Results posted on: 2024-02-28

Participant Flow

Participant milestones

Measure	Treatment With Anti-SARS-CoV-2 Convalescent Plasma Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours anti-SARS-CoV-2 convalescent plasma: Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

COVID-19 Convalescent Plasma

Baseline characteristics by cohort

Measure	Treatment With Anti-SARS-CoV-2 Convalescent Plasma n=10 Participants Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours anti-SARS-CoV-2 convalescent plasma: Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	4 Participants n=93 Participants
Sex: Female, Male Male	6 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=93 Participants
Region of Enrollment United States	10 participants n=93 Participants
BMI	28.7 kg/m2 n=93 Participants
interval symptoms to plasma transfusion	12 days n=93 Participants

PRIMARY outcome

Timeframe: At time of administration

Number of patients who receive convalescent plasma

Outcome measures

Measure	Treatment With Anti-SARS-CoV-2 Convalescent Plasma n=10 Participants Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours anti-SARS-CoV-2 convalescent plasma: Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours
Success of Administering Plasma Successful	10 Participants
Success of Administering Plasma Unsuccessful	0 Participants

PRIMARY outcome

Timeframe: Until discharge from hospital

Levels of respiratory support will be graded (e.g. room air, high flow oxygen, intubation) to determine the change in type of respiratory support at 28 days.

Outcome measures

Measure	Treatment With Anti-SARS-CoV-2 Convalescent Plasma n=10 Participants Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours anti-SARS-CoV-2 convalescent plasma: Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours
Type of Respiratory Support At time of administration · ECMO	2 Participants
Type of Respiratory Support At time of administration · Ventilator	1 Participants
Type of Respiratory Support At time of administration · High flow nasal cannula	1 Participants
Type of Respiratory Support At time of administration · Nasal cannula	5 Participants
Type of Respiratory Support At time of administration · Room air	1 Participants
Type of Respiratory Support At time of administration · Deceased	0 Participants
Type of Respiratory Support At time of discharge · ECMO	0 Participants
Type of Respiratory Support At time of discharge · Ventilator	0 Participants
Type of Respiratory Support At time of discharge · High flow nasal cannula	0 Participants
Type of Respiratory Support At time of discharge · Nasal cannula	3 Participants
Type of Respiratory Support At time of discharge · Room air	5 Participants
Type of Respiratory Support At time of discharge · Deceased	2 Participants

SECONDARY outcome

Timeframe: 28 days after plasma administration

Number of patients experiencing cardiac arrest.

Outcome measures

Measure	Treatment With Anti-SARS-CoV-2 Convalescent Plasma n=10 Participants Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours anti-SARS-CoV-2 convalescent plasma: Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours
Cardiac Arrest Cardiac arrest	0 Participants
Cardiac Arrest No cardiac arrest	10 Participants

SECONDARY outcome

Timeframe: 28 days

Number of patients transferred to ICU

Outcome measures

Measure	Treatment With Anti-SARS-CoV-2 Convalescent Plasma n=10 Participants Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours anti-SARS-CoV-2 convalescent plasma: Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours
Transfer to ICU Transferred to ICU	1 Participants
Transfer to ICU Already in ICU	5 Participants
Transfer to ICU Readmitted and placed in ICU	1 Participants
Transfer to ICU Never in ICU	3 Participants

SECONDARY outcome

Timeframe: Until discharge

Number of patients dying in the ICU

Outcome measures

Measure	Treatment With Anti-SARS-CoV-2 Convalescent Plasma n=10 Participants Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours anti-SARS-CoV-2 convalescent plasma: Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours
ICU Mortality Deceased	2 Participants
ICU Mortality Survived ICU treatment	5 Participants
ICU Mortality Never in ICU	3 Participants

SECONDARY outcome

Timeframe: Up to 50 days

Population: The 7 patients who were admitted to the ICU

This will be a continuous outcome defined by the amount of time between plasma administration and discharge from ICU. This will be treated as a time-to-event.

Outcome measures

Measure	Treatment With Anti-SARS-CoV-2 Convalescent Plasma n=7 Participants Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours anti-SARS-CoV-2 convalescent plasma: Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours
ICU Length of Stay	20 days Interval 2.0 to 50.0

SECONDARY outcome

Timeframe: Until discharge

Mortality during course of illness

Outcome measures

Measure	Treatment With Anti-SARS-CoV-2 Convalescent Plasma n=10 Participants Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours anti-SARS-CoV-2 convalescent plasma: Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours
Hospital Mortality Deceased	2 Participants
Hospital Mortality Alive	8 Participants

SECONDARY outcome

Timeframe: Until discharge

This will be a continuous outcome defined by the amount of time between plasma administration and discharge from hospital.

Outcome measures

Measure	Treatment With Anti-SARS-CoV-2 Convalescent Plasma n=10 Participants Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours anti-SARS-CoV-2 convalescent plasma: Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours
Hospital Length of Stay	36.2 days Interval 32.0 to 50.0

SECONDARY outcome

Timeframe: 28 days

This will be a continuous outcome defined by the amount of time between plasma administration and the transition from mechanical ventilation to non-invasive respiratory support.

Outcome measures

Measure	Treatment With Anti-SARS-CoV-2 Convalescent Plasma n=10 Participants Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours anti-SARS-CoV-2 convalescent plasma: Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours
Ventilator-free Days	21.7 days Interval 0.0 to 28.0

SECONDARY outcome

Timeframe: 28 days

28-Day Overall Survival is defined as the status of the patient at the end of 28 days, beginning from the time of plasma administration.

Outcome measures

Measure	Treatment With Anti-SARS-CoV-2 Convalescent Plasma n=10 Participants Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours anti-SARS-CoV-2 convalescent plasma: Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours
Overall Survival (28-day Mortality) Alive	10 Participants
Overall Survival (28-day Mortality) Deceased	0 Participants

Adverse Events

Treatment With Anti-SARS-CoV-2 Convalescent Plasma

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Leila Yazdanbakhsh

University of Chicago

Phone: 773-834-5087

Email: leila.yazdanbakhsh@bsd.uchicago.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place