Trial Outcomes & Findings for Convalescent Plasma as Treatment for Subjects With Early COVID-19 Infection (NCT NCT04456413)

Results Overview

The hospitalization rate will be summarized by frequency (%) and compared between the Treatment and Control arms by Mantel-Haenszel test.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

10 Days

Results posted on

2023-10-10

Participant Flow

Participant milestones

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	Best Supportive Care Patients will receive best supportive care. Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease. Best Supportive Care: Patients will receive best supportive care. Patients randomized to this arm may receive plasma should they require hospitalization for progression of COVID-19 disease.
Overall Study STARTED	10	11
Overall Study COMPLETED	10	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Convalescent Plasma n=10 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	Best Supportive Care n=11 Participants Patients will receive best supportive care. Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease. Best Supportive Care: Patients will receive best supportive care. Patients randomized to this arm may receive plasma should they require hospitalization for progression of COVID-19 disease.	Total n=21 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	11 participants n=7 Participants	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 Days

The hospitalization rate will be summarized by frequency (%) and compared between the Treatment and Control arms by Mantel-Haenszel test.

Outcome measures

Outcome measures
Measure	Convalescent Plasma n=10 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	Best Supportive Care n=11 Participants Patients will receive best supportive care. Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease. Best Supportive Care: Patients will receive best supportive care. Patients randomized to this arm may receive plasma should they require hospitalization for progression of COVID-19 disease.
Hospitalization Rate	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 2 Months

Population: Due to a lack of funding and early termination of the trial, these data were not collected.

The time to symptoms resolution is defined as the time in days from therapies initiation to the first documented symptoms resolution as assessed by a local site. Patients whose symptoms are not resolved, or result in death, 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: 2 Months

Overall survival (OS) will be defined as Rate of death

Outcome measures

Outcome measures
Measure	Convalescent Plasma n=10 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	Best Supportive Care n=11 Participants Patients will receive best supportive care. Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease. Best Supportive Care: Patients will receive best supportive care. Patients randomized to this arm may receive plasma should they require hospitalization for progression of COVID-19 disease.
Overall Survival Rate	0 Patient Deaths	0 Patient Deaths

SECONDARY outcome

Timeframe: 2 Weeks

Outcome measures

Outcome measures
Measure	Convalescent Plasma n=10 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	Best Supportive Care n=9 Participants Patients will receive best supportive care. Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease. Best Supportive Care: Patients will receive best supportive care. Patients randomized to this arm may receive plasma should they require hospitalization for progression of COVID-19 disease.
Rate of Virologic Clearance by Nasopharyngeal Swab at 2 Weeks	6 Participants	6 Participants

SECONDARY outcome

Timeframe: 2 Months

Population: Due to a lack of funding and early termination of the trial, these data were not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 Months

Rate of Donor Titer Levels \>1:1000

Outcome measures

Outcome measures
Measure	Convalescent Plasma n=69 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	Best Supportive Care Patients will receive best supportive care. Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease. Best Supportive Care: Patients will receive best supportive care. Patients randomized to this arm may receive plasma should they require hospitalization for progression of COVID-19 disease.
Rate of Donor Titers Level	55 Participants	—

SECONDARY outcome

Timeframe: 2 Months

Population: Due to a lack of funding and early termination of the trial, these data were not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Prior to treatment, 2 Weeks, 4 Weeks, and 2 Months

Population: Due to a lack of funding and early termination of the trial, these data were not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 Weeks

Outcome measures

Outcome measures
Measure	Convalescent Plasma n=6 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	Best Supportive Care n=4 Participants Patients will receive best supportive care. Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease. Best Supportive Care: Patients will receive best supportive care. Patients randomized to this arm may receive plasma should they require hospitalization for progression of COVID-19 disease.
Rate of Virologic Clearance by Nasopharyngeal Swab at 4 Weeks	5 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0

Univariate test will be performed in terms of identifying the association between exploratory objective and the hospitalization rate, Mantel-Haenszel test for categorical variables, and t-test or its non-parametric version for the continuous variables based on the normalized of the data.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 Weeks and 4 Weeks

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 Weeks and 4 Weeks

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 3 and 7, Weeks 2 and 4

Safety assessment will be performed on infusion day for the Treatment group (immediately post infusion), and for all patients on randomization day +3 and +7 days (by telephone, closest business day is acceptable), +2 weeks (+/- 3 days), +4 weeks (+/- 3 days).

Outcome measures

Outcome data not reported

Adverse Events

Convalescent Plasma

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Best Supportive Care

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Convalescent Plasma n=10 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	Best Supportive Care n=11 participants at risk Patients will receive best supportive care. Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease. Best Supportive Care: Patients will receive best supportive care. Patients randomized to this arm may receive plasma should they require hospitalization for progression of COVID-19 disease.
Infections and infestations Worsening Covid Symptoms	10.0% 1/10 • Number of events 1 • Up to 4 weeks	27.3% 3/11 • Number of events 3 • Up to 4 weeks

Other adverse events

Other adverse events
Measure	Convalescent Plasma n=10 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	Best Supportive Care n=11 participants at risk Patients will receive best supportive care. Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease. Best Supportive Care: Patients will receive best supportive care. Patients randomized to this arm may receive plasma should they require hospitalization for progression of COVID-19 disease.
Nervous system disorders Anosmia	10.0% 1/10 • Number of events 1 • Up to 4 weeks	0.00% 0/11 • Up to 4 weeks
Nervous system disorders Ageusia	10.0% 1/10 • Number of events 1 • Up to 4 weeks	0.00% 0/11 • Up to 4 weeks

Additional Information

Joshua Zenreich

Hackensack Meridian Health

Phone: 551-996-4248

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place