COVID-19
Conditions
Brief summary
This is an open label pilot study designed to provide access to treatment with investigational convalescent plasma and assess the relationship between NAb titers in the investigational convalescent plasma compared to changes in NAb levels in the recipient in hospitalized patients with COVID-19.
Detailed description
Primary objectives are as follows: 1. To provide access to treatment with investigational convalescent plasma to inpatients with documented COIVD-19 infection 2. To measure NAb titers in an aliquot of the CP administered, to measure the volume of CP administered, and determine whether there is a correlation between the NAb dose (in NAb units/kg body weight, where a unit is the reciprocal of the endpoint NAb titer in the CP multiplied by the volume in ml) and change or lack of change when comparing pre-treatment and day one NAb titers. Secondary, exploratory objectives are as follows: 1. To evaluate the safety of convalescent plasma (CP) administration in hospitalized COVID-19 patients 2. To evaluate viral shedding of SARSCoV-2 in nasopharyngeal or nasal samples before and on days 3, 7, and 14 after CP transfusion 3. To perform genomic analysis of the SARS-CoV-2 from patients before and after treatment with CP transfusion 4. Determine cumulative incidence of disease severity (transfer to ICU, type of respiratory support, LOS, and mortality)
Interventions
DRUGConvalescent Plasma
Study subjects will receive 1 unit (200mL) of SARS-CoV-2 convalescent plasma collected from a single donor who recovered from COVID-19.
Sponsors
University of New Mexico
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients must be 18 years of age or older. 2. Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. If COVID-19 test results are pending or done at enrolment, test results must be positive prior to administration of convalescent plasma. 3. Patient (or legally authorized representative, LAR) is willing and able to provide written informed consent and comply with all protocol requirements. 4. For patients unable to consent, consent by the legally authorized representative (LAR) may be obtained by phone.
Exclusion criteria
1. Female subjects with positive pregnancy test or breastfeeding. 2. Receipt of pooled immunoglobulin in past 30 days. 3. Contraindication to transfusion or history of prior severe allergic reactions to transfused blood products. 4. On ECMO or in refractory shock at entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NAb Dose Titer in the Convalescent Plasma (CP), Pre-treatment, and Day One in Hospitalized Patients With Documented COVID-19 Infection | Day of convalescent plasma infusion (day 0) and following day (day 1) | Neutralizing antibody titer (PRNT 80) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Rapid Deterioration as Evidenced by Increase in Ordinal Score | 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. |
| Number of Participants With Clearance of Viral Shedding of SARS CoV-2 in Nasopharyngeal Samples | Day 0,1,3,7 and 14 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age, Continuous | 52 years |
| Race (NIH/OMB) American Indian or Alaska Native | 11 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
NAb Dose Titer in the Convalescent Plasma (CP), Pre-treatment, and Day One in Hospitalized Patients With Documented COVID-19 Infection
Neutralizing antibody titer (PRNT 80)
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm | 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 |
| Single Arm | 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 |
| Single Arm | 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
Number of Participants With Clearance of Viral Shedding of SARS CoV-2 in Nasopharyngeal Samples
Time frame: Day 0,1,3,7 and 14
Population: Data was not collected
Secondary
Number of Participants With Rapid Deterioration as Evidenced by Increase in Ordinal Score
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.
Time frame: Within 4 hours of transfusion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Number of Participants With Rapid Deterioration as Evidenced by Increase in Ordinal Score | 0 Participants |