Trial Outcomes & Findings for Convalescent Plasma as Treatment for Hospitalized Subjects With COVID-19 Infection (NCT NCT04343755)

NCT ID: NCT04343755

Last Updated: 2023-09-18

Results Overview

Mechanical ventilation rate at 7 days from starting treatment in hospitalized COVID-19 patients

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 52 participants
• Primary outcome timeframe: 7 Days
• Results posted on: 2023-09-18

Participant Flow

Participant milestones

Measure	Convalescent Plasma Fresh or frozen plasma will be infused one time to patients Convalescent Plasma: Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection
Overall Study STARTED	52
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Measure	Convalescent Plasma Fresh or frozen plasma will be infused one time to patients Convalescent Plasma: Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection
Overall Study Death	11
Overall Study Screen Failure	1

Baseline Characteristics

Convalescent Plasma as Treatment for Hospitalized Subjects With COVID-19 Infection

Baseline characteristics by cohort

Measure	Convalescent Plasma n=52 Participants Fresh or frozen plasma will be infused one time to patients Convalescent Plasma: Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Age, Continuous	56 years n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 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	3 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	30 Participants n=5 Participants
Region of Enrollment United States	52 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 Days

Population: Of the 52 participants enrolled, 36 were not intubated at time of enrollment.

Mechanical ventilation rate at 7 days from starting treatment in hospitalized COVID-19 patients

Outcome measures

Measure	Convalescent Plasma n=36 Participants Fresh or frozen plasma will be infused one time to patients Convalescent Plasma: Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection
Number of Participants Hospitalized for COVID-19 But Not Intubated	5 Participants

PRIMARY outcome

Timeframe: 30 Days

Mortality rate at 30 days from starting treatment for patients with COVID-19

Outcome measures

Measure	Convalescent Plasma n=15 Participants Fresh or frozen plasma will be infused one time to patients Convalescent Plasma: Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection
Primary Objective for Patients With COVID-19 Already Intubated	7 Participants

SECONDARY outcome

Timeframe: 60 Days

Population: The study was terminated early due to rapid change in standard therapy. This information was not collected or analyzed due to early termination.

The duration of hospitalization is defined as the time in days from the first day of hospitalized to the date of discharge or death. Patients who are not discharged, are alive and still in the hospital on the date of closing follow-up, or lost follow-up on the date of closing follow-up will be considered censored on that date.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60 Days

Population: The study was terminated early due to rapid change in standard therapy. This information was not collected or analyzed due to early termination.

The duration of mechanical ventilation is defined as the time in days from the first day of using mechanical ventilation to the last day of using mechanical ventilation. All evaluable patients will be included and no censoring for this analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60 Days

Population: Due to the early termination of the trial, data regarding this outcome were not collected.

The time to symptom resolution is defined as the time in days from new therapy initiation to the first documented symptom resolution as assessed by local site. Patients whose symptom are not resolved, who are dead, or lost follow-up on the designed follow-up date will be censored on that date.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60 Days

Overall survival rate at 60 days from starting treatment for patients with COVID-19

Outcome measures

Measure	Convalescent Plasma n=51 Participants Fresh or frozen plasma will be infused one time to patients Convalescent Plasma: Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection
Overall Survival	40 Participants

SECONDARY outcome

Timeframe: 10 Days

Outcome measures

Measure	Convalescent Plasma n=8 Participants Fresh or frozen plasma will be infused one time to patients Convalescent Plasma: Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection
Rate of Virologic Clearance by Nasopharyngeal Swab at Day 10	7 Participants

SECONDARY outcome

Timeframe: 30 Days

Outcome measures

Measure	Convalescent Plasma n=8 Participants Fresh or frozen plasma will be infused one time to patients Convalescent Plasma: Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection
Rate of Virologic Clearance by Nasopharyngeal Swab at Day 30	8 Participants

SECONDARY outcome

Timeframe: 60 Days

Population: The study was terminated early due to rapid change in standard therapy. This information was not collected or analyzed due to early termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60 Days

Population: The study was terminated early due to rapid change in standard therapy. This information was not collected or analyzed due to early termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0 Days (pre-infusion)

Outcome measures

Measure	Convalescent Plasma n=51 Participants Fresh or frozen plasma will be infused one time to patients Convalescent Plasma: Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection
Recipient Anti-SARS-CoV2 Titer Assessment on Days 0 (Pre-infusion) IgG Levels >=10,000	8 Participants
Recipient Anti-SARS-CoV2 Titer Assessment on Days 0 (Pre-infusion) IgG Levels 1000-10,000	23 Participants
Recipient Anti-SARS-CoV2 Titer Assessment on Days 0 (Pre-infusion) IgG Levels 500-1,000	4 Participants
Recipient Anti-SARS-CoV2 Titer Assessment on Days 0 (Pre-infusion) IgG Levels 100-500	8 Participants
Recipient Anti-SARS-CoV2 Titer Assessment on Days 0 (Pre-infusion) IgG Levels BLQ	8 Participants

SECONDARY outcome

Timeframe: 3 Days

Outcome measures

Measure	Convalescent Plasma n=47 Participants Fresh or frozen plasma will be infused one time to patients Convalescent Plasma: Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection
Recipient Anti-SARS-CoV2 Titer Assessment on Days 3 IgG Levels >=10,000	23 Participants
Recipient Anti-SARS-CoV2 Titer Assessment on Days 3 IgG Levels 1000-10,000	16 Participants
Recipient Anti-SARS-CoV2 Titer Assessment on Days 3 IgG Levels 500-1,000	2 Participants
Recipient Anti-SARS-CoV2 Titer Assessment on Days 3 IgG Levels 100-500	6 Participants
Recipient Anti-SARS-CoV2 Titer Assessment on Days 3 IgG Levels BLQ	0 Participants

SECONDARY outcome

Timeframe: 10 Days

Outcome measures

Measure	Convalescent Plasma n=47 Participants Fresh or frozen plasma will be infused one time to patients Convalescent Plasma: Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection
Recipient Anti-SARS-CoV2 Titer Assessment on Day 10 IgG Levels >=10,000	35 Participants
Recipient Anti-SARS-CoV2 Titer Assessment on Day 10 IgG Levels 1000-10,000	7 Participants
Recipient Anti-SARS-CoV2 Titer Assessment on Day 10 IgG Levels 500-1,000	0 Participants
Recipient Anti-SARS-CoV2 Titer Assessment on Day 10 IgG Levels 100-500	4 Participants
Recipient Anti-SARS-CoV2 Titer Assessment on Day 10 IgG Levels BLQ	1 Participants

SECONDARY outcome

Timeframe: 30 Days

Outcome measures

Measure	Convalescent Plasma n=33 Participants Fresh or frozen plasma will be infused one time to patients Convalescent Plasma: Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection
Recipient Anti-SARS-CoV2 Titer Assessment on Day 30 IgG Levels >=10,000	29 Participants
Recipient Anti-SARS-CoV2 Titer Assessment on Day 30 IgG Levels 1000-10,000	3 Participants
Recipient Anti-SARS-CoV2 Titer Assessment on Day 30 IgG Levels 500-1,000	0 Participants
Recipient Anti-SARS-CoV2 Titer Assessment on Day 30 IgG Levels 100-500	1 Participants
Recipient Anti-SARS-CoV2 Titer Assessment on Day 30 IgG Levels BLQ	0 Participants

SECONDARY outcome

Timeframe: 60 Days

Outcome measures

Measure	Convalescent Plasma n=31 Participants Fresh or frozen plasma will be infused one time to patients Convalescent Plasma: Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection
Recipient Anti-SARS-CoV2 Titer Assessment on Day 60 IgG Levels BLQ	0 Participants
Recipient Anti-SARS-CoV2 Titer Assessment on Day 60 IgG Levels >=10,000	25 Participants
Recipient Anti-SARS-CoV2 Titer Assessment on Day 60 IgG Levels 1000-10,000	5 Participants
Recipient Anti-SARS-CoV2 Titer Assessment on Day 60 IgG Levels 500-1,000	0 Participants
Recipient Anti-SARS-CoV2 Titer Assessment on Day 60 IgG Levels 100-500	1 Participants

Adverse Events

Convalescent Plasma

Serious events: 24 serious events

Other events: 0 other events

Deaths: 11 deaths

Serious adverse events

Measure	Convalescent Plasma n=52 participants at risk Fresh or frozen plasma will be infused one time to patients Convalescent Plasma: Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection
Investigations Aneurysm	1.9% 1/52 • Number of events 1 • Safety assessment performed on post infusion day 0,3,10, 30, and 60 days
Gastrointestinal disorders Appendicitis	1.9% 1/52 • Number of events 1 • Safety assessment performed on post infusion day 0,3,10, 30, and 60 days
Nervous system disorders Cerebral Edema	1.9% 1/52 • Number of events 1 • Safety assessment performed on post infusion day 0,3,10, 30, and 60 days
Infections and infestations Death	19.2% 10/52 • Number of events 10 • Safety assessment performed on post infusion day 0,3,10, 30, and 60 days
Infections and infestations Readmission	3.8% 2/52 • Number of events 2 • Safety assessment performed on post infusion day 0,3,10, 30, and 60 days
Gastrointestinal disorders Worsening Abdominal Pain	1.9% 1/52 • Number of events 1 • Safety assessment performed on post infusion day 0,3,10, 30, and 60 days
Respiratory, thoracic and mediastinal disorders Worsening Condition Intubation	15.4% 8/52 • Number of events 8 • Safety assessment performed on post infusion day 0,3,10, 30, and 60 days

Other adverse events

Adverse event data not reported

Additional Information

Joshua Zenreich

Hackensack Meridian Health

Phone: 15519964248

Email: joshua.zenreich@hmhn.org

Results disclosure agreements

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