Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
2. Determine if the antibodies from convalescent plasma will suppress virus load in critically ill patients with COVID-19.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-19 patients treated with convalescent plasma | Experimental | Severely ill COVID-19 patients treated with convalescent plasma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Convalescent Plasma | Biological | treatment with 2 Units of convalescent plasma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Mortality within 28 days | 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). | 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) | Day 0, Day 3, Day 5, and Day 7 |
Not provided
Not provided
Inclusion Criteria:
Severe disease is defined as:
Life-threatening disease is defined as:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Latha Dulipsingh, MD | Saint Francis Hospital and Medical Centerr/Trinity Health Of New England | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trinity Health Of New England | Hartford | Connecticut | 06105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32883593 | Result | Dulipsingh L, Ibrahim D, Schaefer EJ, Crowell R, Diffenderfer MR, Williams K, Lima C, McKenzie J, Cook L, Puff J, Onoroski M, Wakefield DB, Eadie RJ, Kleiboeker SB, Nabors P, Hussain SA. SARS-CoV-2 serology and virology trends in donors and recipients of convalescent plasma. Transfus Apher Sci. 2020 Dec;59(6):102922. doi: 10.1016/j.transci.2020.102922. Epub 2020 Aug 25. | |
| 32951151 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | COVID-19 Patients Treated With Convalescent Plasma | Severely ill COVID-19 patients treated with convalescent plasma Convalescent Plasma: treatment with 2 Units of convalescent plasma |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | COVID-19 Patients Treated With Convalescent Plasma | Severely ill COVID-19 patients treated with convalescent plasma Convalescent Plasma: treatment with 2 Units of convalescent plasma |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mortality | Mortality within 28 days | 48 patients with severe or life threatening disease with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection enrolled in the study. 7 patients were excluded from analysis due to receiving plasma with insufficient antibodies. | Posted | Count of Participants | Participants | Up to 28 days |
|
|
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).
Adverse event and/or serious adverse event related to treatment with convalescent plasma
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | COVID-19 Patients Treated With Convalescent Plasma | Severely ill COVID-19 patients treated with convalescent plasma Convalescent Plasma: treatment with 2 Units of convalescent plasma |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Persistent Hypoxemia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | One subject had persistent hypoxemia and needed extracorporeal membrane oxygenation (ECMO). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | Immune system disorders | Non-systematic Assessment | Patient developed a fever 1 hour after plasma transfusion |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Latha Dulipsingh, MD | Saint Francis Hospital and Medical Center | 860-714-4402 | Latha.Dulipsingh@trinityhealthofne.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 23, 2020 | Sep 1, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Donor Consent | Apr 23, 2020 | Sep 1, 2020 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Patient Consent | Apr 24, 2020 | Sep 1, 2020 | ICF_002.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D045169 | Severe Acute Respiratory Syndrome |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ibrahim D, Dulipsingh L, Zapatka L, Eadie R, Crowell R, Williams K, Wakefield DB, Cook L, Puff J, Hussain SA. Factors Associated with Good Patient Outcomes Following Convalescent Plasma in COVID-19: A Prospective Phase II Clinical Trial. Infect Dis Ther. 2020 Dec;9(4):913-926. doi: 10.1007/s40121-020-00341-2. Epub 2020 Sep 20. |
| 37162745 | Derived | Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6. |
| 36734509 | Derived | Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5. |
| 34013969 | Derived | Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4. |
| 33044747 | Derived | Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | 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). | Plasma viral load data was available for 35 out of 41 convalescent plasma recipients on day 0. 22 patients out of 35 had non-detectable levels at Day 0; 25 patients out of 34 had non-detectable levels on Day 3; 20 patients out of 27 had non-detectable levels on Day 5; 20 patients out of 24 had non-detectable levels on Day 7. | Posted | Median | Full Range | copies per mL | Day 0, Day 3, Day 5, and Day 7 |
|
|
|
| Primary | 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) | 39 out of 41 patients had blood collected on day 0 (pre-transfusion), and on post-transfusion day 3 (n=36), 5 (n=30), and 7 (n=24) and serum antibody titers was assessed at each time point. | Posted | Median | Full Range | arbitrary units/mL (AU/mL) | Day 0, Day 3, Day 5, and Day 7 |
|
|
|
| 22 |
| 48 |
| 8 |
| 48 |
| 8 |
| 48 |
|
| Gastrointestinal bleed | Gastrointestinal disorders | Non-systematic Assessment | Two subjects had coffee ground emesis |
|
| Acute Kidney Injury | Renal and urinary disorders | Non-systematic Assessment | One subject developed acute kidney injury |
|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment | One subject developed atrial fibrillation |
|
| Hypotension; Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | One subject became hypotensive, hypoxic and was subsequently intubated |
|
| pneumothorax; subcutaneous emphysema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | One subject developed pneumothorax and needed a chest tube |
|
| Pneumatosis intestinalis | Gastrointestinal disorders | Non-systematic Assessment | One subject had pneumatosis coli of the right colon, air in the superior mesenteric vein and portal venous gas in the liver |
|
|
| Insufficient Antibodies | Product Issues | Non-systematic Assessment | Patient received convalescent plasma with insufficient antibodies |
|
Not provided
Not provided
Not provided
| D007239 |
| Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
|
| Detectable Viral Load Day 5 |
|
|
| Detectable Viral Load Day 7 |
|
|
|
| SARS-CoV-2 Antibodies Day 5 |
|
|
| SARS-CoV-2 Antibodies Day 7 |
|
|