Trial Outcomes & Findings for Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19 (NCT NCT04434131)

NCT ID: NCT04434131

Last Updated: 2023-03-08

Results Overview

Neutralizing antibody titer (PRNT 80)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Day of convalescent plasma infusion (day 0) and following day (day 1)

Results posted on

2023-03-08

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm The investigational product is anti-SARS-CoV-2 convalescent plasma obtained from former patients identified as having recovered from COVID-19 and obtained by Vitalant from local and national donors following national blood donation guidelines. All subjects receive the convalescent plasma. Convalescent Plasma: Study subjects will receive 1 unit (200mL) of SARS-CoV-2 convalescent plasma collected from a single donor who recovered from COVID-19.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=12 Participants The investigational product is anti-SARS-CoV-2 convalescent plasma obtained from former patients identified as having recovered from COVID-19 and obtained by Vitalant from local and national donors following national blood donation guidelines. All subjects receive the convalescent plasma. Convalescent Plasma: Study subjects will receive 1 unit (200mL) of SARS-CoV-2 convalescent plasma collected from a single donor who recovered from COVID-19.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	52 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	11 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Day of convalescent plasma infusion (day 0) and following day (day 1)

Population: Participants were hospitalized patients receiving CP and donors were not considered participants of the study. Again, 12 donors contributed to CP but were not enrolled in the study. Mean titer from donor CP obtained from 12 donors.

Neutralizing antibody titer (PRNT 80)

Outcome measures

Outcome measures
Measure	Single Arm n=12 Participants The investigational product is anti-SARS-CoV-2 convalescent plasma obtained from former patients identified as having recovered from COVID-19 and obtained by Vitalant from local and national donors following national blood donation guidelines. All subjects receive the convalescent plasma. Convalescent Plasma: Study subjects will receive 1 unit (200mL) of SARS-CoV-2 convalescent plasma collected from a single donor who recovered from COVID-19.
NAb Dose Titer in the Convalescent Plasma (CP), Pre-treatment, and Day One in Hospitalized Patients With Documented COVID-19 Infection Donor convalescent plasma	56.7 titer Standard Error 32.4
NAb Dose Titer in the Convalescent Plasma (CP), Pre-treatment, and Day One in Hospitalized Patients With Documented COVID-19 Infection Day 0 (pre-treatment in hospitalized patients)	390 titer Standard Error 369
NAb Dose Titer in the Convalescent Plasma (CP), Pre-treatment, and Day One in Hospitalized Patients With Documented COVID-19 Infection Day 1 (in hospitalized patients)	413 titer Standard Error 363

SECONDARY outcome

Timeframe: Within 4 hours of transfusion

World Health Organization ordinal scale, with scores defined as follows: 5, hospitalized, requiring any supplemental oxygen; 6, hospitalized, requiring noninvasive ventilation or use of high-flow oxygen devices; 7, hospitalized, receiving invasive mechanical ventilation or extracorporeal membrane oxygenation; and 8, death.

Outcome measures

Outcome measures
Measure	Single Arm n=12 Participants The investigational product is anti-SARS-CoV-2 convalescent plasma obtained from former patients identified as having recovered from COVID-19 and obtained by Vitalant from local and national donors following national blood donation guidelines. All subjects receive the convalescent plasma. Convalescent Plasma: Study subjects will receive 1 unit (200mL) of SARS-CoV-2 convalescent plasma collected from a single donor who recovered from COVID-19.
Number of Participants With Rapid Deterioration as Evidenced by Increase in Ordinal Score	0 Participants

SECONDARY outcome

Timeframe: Day 0,1,3,7 and 14

Population: Data was not collected

Outcome measures

Outcome data not reported

Adverse Events

Single Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michelle Harkins

University of New Mexico Health Sciences Center

Phone: 5052724751

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place