A Phase 2 interventional study of Convalescent Plasma in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), COVID and Coronavirus, sponsored by Trinity Health Of New England. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-09-24.
Sponsored by Trinity Health Of New England · Phase 2, Interventional, and Treatment
The purpose of this study is to collect blood from previously COVID-19 infected persons who have recovered and use it as a treatment for those who are currently sick with a severe or life-threatening COVID-19 infection.
The purpose of this prospective interventional study is to gain clinical experience using convalescent plasma transfusion administered to critically ill patients with COVID-19.
1 To study the efficacy of plasma from patients recovered from COVID-19 infection with a high neutralizing antibody titer (NAT) as treatment for individuals who are critically ill with COVID-19.
929 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.
This study's enrollment of 48 is below the median of 107 across 541 interventional studies indexed under Coronavirus Infections.
Browse Coronavirus Infections studies →Trinity Health Of New England is the lead sponsor of 19 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Severe disease is defined as:
Life-threatening disease is defined as:
Exclusion Criteria:
Severely ill COVID-19 patients treated with convalescent plasma
Biological: Convalescent Plasma
treatment with 2 Units of convalescent plasma
Mortality
Mortality within 28 days
Time frame: Up to 28 days
Viral Load
Median Viral Load at Day 0, Day 3, Day 5, and Day 7 Plasma Viral Load was measured using a research-use only real-time reverse transcription polymerase chain reaction (rRT -PCR) method which targets two regions of the SARS-CoV-2 N gene using TaqMan chemistry. The limit of detection for this assay is 75 copies/mL (standard curve of 75 copies/mL to 10,000,000 copies/mL of in vitro transcribed RNA prepared from the full SARS-CoV-2 N gene).
Time frame: Day 0, Day 3, Day 5, and Day 7
Serum Antibody Titers
Median Serum Antibody Titers at Day 0, Day 3, Day 5 and Day 7 Serum Antibody titers were measured using chemiluminescent SARS-CoV-2 immunoglobulin G (IgG) assay from Diazyme (Poway, CA) Positive IgG serum value is \> or = 1.0 arbitrary units/mL \[AU/mL\] (linear reportable range for IgG is 0.20 - 100.00 AU/mL)
Time frame: Day 0, Day 3, Day 5, and Day 7
| Milestone | COVID-19 Patients Treated With Convalescent Plasma |
|---|---|
| Started | 48 |
| Completed | 40 |
| Not completed | 8 |
| Withdrew: Adverse event | 1 |
| Withdrew: Received inadequate amount of antibodies | 7 |
Mortality within 28 days
| Participants | COVID-19 Patients Treated With Convalescent Plasma |
|---|---|
| Mortality | 19 |
Median Viral Load at Day 0, Day 3, Day 5, and Day 7 Plasma Viral Load was measured using a research-use only real-time reverse transcription polymerase chain reaction (rRT -PCR) method which targets two regions of the SARS-CoV-2 N gene using TaqMan chemistry. The limit of detection for this assay is 75 copies/mL (standard curve of 75 copies/mL to 10,000,000 copies/mL of in vitro transcribed RNA prepared from the full SARS-CoV-2 N gene).
| copies per mL | COVID-19 Patients Treated With Convalescent Plasma |
|---|---|
| Detectable Viral Load Day 0 | 3524 (868 to 8315) |
| Detectable Viral Load Day 3 | 2033 (243 to 6386) |
| Detectable Viral Load Day 5 | 315 (214 to 4162) |
| Detectable Viral Load Day 7 | 494 (102 to 1292) |
Median Serum Antibody Titers at Day 0, Day 3, Day 5 and Day 7 Serum Antibody titers were measured using chemiluminescent SARS-CoV-2 immunoglobulin G (IgG) assay from Diazyme (Poway, CA) Positive IgG serum value is \> or = 1.0 arbitrary units/mL \[AU/mL\] (linear reportable range for IgG is 0.20 - 100.00 AU/mL)
| arbitrary units/mL (AU/mL) | COVID-19 Patients Treated With Convalescent Plasma |
|---|---|
| SARS-CoV-2 Antibodies Day 0 | 18.5 (1.0 to 75.0) |
| SARS-CoV-2 Antibodies Day 3 | 37.2 (4.5 to 74.6) |
| SARS-CoV-2 Antibodies Day 5 | 47.4 (6.7 to 80.7) |
| SARS-CoV-2 Antibodies Day 7 | 55.2 (10.3 to 96.9) |
Collected over Treatment and non-treatment related events were collected by non-systematic methods until discharge from the hospital or death, up to 28 days (which ever came first).. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| COVID-19 Patients Treated With Convalescent Plasma | 22/48 (45.8%) | 8/48 (16.7%) | 8/48 (16.7%) |
| Event | COVID-19 Patients Treated With Convalescent Plasma |
|---|---|
| Gastrointestinal bleedGastrointestinal disorders | 2/48 |
| Persistent HypoxemiaRespiratory, thoracic and mediastinal disorders | 1/48 |
| Acute Kidney InjuryRenal and urinary disorders | 1/48 |
| Atrial fibrillationCardiac disorders | 1/48 |
| Hypotension; HypoxiaRespiratory, thoracic and mediastinal disorders | 1/48 |
| pneumothorax; subcutaneous emphysemaRespiratory, thoracic and mediastinal disorders | 1/48 |
| Pneumatosis intestinalisGastrointestinal disorders | 1/48 |
| Event | COVID-19 Patients Treated With Convalescent Plasma |
|---|---|
| Insufficient AntibodiesProduct Issues | 7/48 |
| FeverImmune system disorders | 1/48 |
| Age, Categorical(Participants) | COVID-19 Patients Treated With Convalescent Plasma |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 24 |
| >=65 years | 24 |
| Age, Continuous(years) | COVID-19 Patients Treated With Convalescent Plasma |
|---|---|
| Mean | 65 ± 12.75 |
| Sex: Female, Male(Participants) | COVID-19 Patients Treated With Convalescent Plasma |
|---|---|
| Female | 21 |
| Male | 27 |
| Ethnicity (NIH/OMB)(Participants) | COVID-19 Patients Treated With Convalescent Plasma |
|---|---|
| Hispanic or Latino | 12 |
| Not Hispanic or Latino | 34 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | COVID-19 Patients Treated With Convalescent Plasma |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 16 |
| White | 17 |
| More than one race | 12 |
| Unknown or Not Reported | 3 |
| Region of Enrollment(participants) | COVID-19 Patients Treated With Convalescent Plasma |
|---|---|
| United States | 48 |
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Trinity Health Of New England