Studies
| Study First Submitted Date | 2020-04-29 |
| Study First Posted Date | 2020-05-04 |
| Last Update Posted Date | 2020-08-28 |
| Verification Month Year | August 2020 |
| Verification Date | 2020-08-31 |
| Last Update Posted Date | 2020-08-28 |
Detailed Descriptions
| Sequence: | 20644078 |
| Description | COVID-19 convalescent plasma will be obtained from FDA registered blood banks and will meet all regulatory requirements for conventional plasma and FDA’s additional considerations for COVID-19 convalescent plasma (https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds). The primary objective of this expanded access program is to provide COVID-19 convalescent plasma to patients with moderate to severe or life-threatening manifestations of COVID-19, or documented to be at high risk of developing such manifestations. The secondary objective will be the evaluation of safety, as assessed by incidents of adverse events judged by the treating physician to be potentially related to the administration of COVID-19 convalescent plasma. Exploratory objectives will include assessments for antibody responses for patients that receive convalescent plasma. An exploratory analysis may be conducted correlating the level of neutralizing antibody titers with clinical outcomes observed. Due to the need to monitoring COVID19 antibody responses following infusion, blood testing at day 1 post-treatment and at discharge will be obtained as part of enrollment. |
Facilities
| Sequence: | 199234501 | Sequence: | 199234502 | Sequence: | 199234503 | Sequence: | 199234504 | Sequence: | 199234505 | Sequence: | 199234506 |
| Name | Children’s Hospital Colorado | Name | University of Colorado Hospital | Name | UCHealth Memorial Hospital North | Name | Denver Health Medical Center | Name | UCHealth Poudre Valley Hospital | Name | UCHealth Highlands Ranch Hospital |
| City | Aurora | City | Aurora | City | Colorado Springs | City | Denver | City | Fort Collins | City | Highlands Ranch |
| State | Colorado | State | Colorado | State | Colorado | State | Colorado | State | Colorado | State | Colorado |
| Zip | 80045 | Zip | 80045 | Zip | 80920 | Zip | 80204 | Zip | 80524 | Zip | 80129 |
| Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States |
Conditions
| Sequence: | 51969896 | Sequence: | 51969897 |
| Name | COVID-19 | Name | SARS-CoV 2 |
| Downcase Name | covid-19 | Downcase Name | sars-cov 2 |
Id Information
| Sequence: | 40001950 |
| Id Source | org_study_id |
| Id Value | 20-0990 |
Countries
| Sequence: | 42392861 |
| Name | United States |
| Removed | False |
Interventions
| Sequence: | 52281318 |
| Intervention Type | Biological |
| Name | COVID-19 Convalescent Plasma |
| Description | 1-2 units of COVID-19 convalescent plasma will be administered over 1 to 2 hours (rate of 100 to 200 mL/hr) |
Keywords
| Sequence: | 79552797 | Sequence: | 79552798 | Sequence: | 79552799 |
| Name | COVID-19 | Name | SARS-CoV-2 | Name | Coronavirus |
| Downcase Name | covid-19 | Downcase Name | sars-cov-2 | Downcase Name | coronavirus |
Browse Conditions
| Sequence: | 192690101 | Sequence: | 192690102 | Sequence: | 192690103 | Sequence: | 192690104 | Sequence: | 192690105 | Sequence: | 192690106 | Sequence: | 192690107 | Sequence: | 192690108 | Sequence: | 192690109 | Sequence: | 192690110 | Sequence: | 192690111 | Sequence: | 192690112 |
| Mesh Term | COVID-19 | Mesh Term | Pneumonia, Viral | Mesh Term | Pneumonia | Mesh Term | Respiratory Tract Infections | Mesh Term | Infections | Mesh Term | Virus Diseases | Mesh Term | Coronavirus Infections | Mesh Term | Coronaviridae Infections | Mesh Term | Nidovirales Infections | Mesh Term | RNA Virus Infections | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Diseases |
| Downcase Mesh Term | covid-19 | Downcase Mesh Term | pneumonia, viral | Downcase Mesh Term | pneumonia | Downcase Mesh Term | respiratory tract infections | Downcase Mesh Term | infections | Downcase Mesh Term | virus diseases | Downcase Mesh Term | coronavirus infections | Downcase Mesh Term | coronaviridae infections | Downcase Mesh Term | nidovirales infections | Downcase Mesh Term | rna virus infections | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48130781 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | University of Colorado, Denver |
Overall Officials
| Sequence: | 29170165 |
| Role | Principal Investigator |
| Name | John D Beckham, MD |
| Affiliation | University of Colorado Denver, Anschutz Medical Campus |
Eligibilities
| Sequence: | 30647130 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Criteria | Inclusion Criteria: Laboratory confirmed diagnosis of infection with SARS-CoV-2 Age at least 18 years Laboratory confirmed diagnosis of infection with SARS-CoV-2 Admitted to participating facility for the treatment of COVID-19 complications Moderate-to-Severe or life threatening COVID-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease Informed consent provided by the patient or healthcare proxy Moderate COVID-19 is defined by one or more of the following: Hospitalized with COVID-19 Respiratory rate >25/min Oxygen saturation <96% With or without radiographic evidence of pulmonary involvement Severe COVID-19 is defined by one or more of the following: dyspnea respiratory frequency ≥ 30/min blood oxygen saturation ≤ 93% Radiographic evidence of pulmonary disease Life-threatening COVID-19 is defined as one or more of the following: respiratory failure requiring mechanical ventilation or non-rebreather oxygenation in the Intensive Care Unit. Prone oxygenation. multiple organ dysfunction or failure Exclusion Criteria: Does not meet inclusion criteria History of transfusion reactions or contraindication to receiving convalescent plasma Risk of transfusion exceeds potential benefit based on clinician or blood bank determination. |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254245007 |
| Number Of Facilities | 6 |
| Registered In Calendar Year | 2020 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | False |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
Responsible Parties
| Sequence: | 28760498 |
| Responsible Party Type | Sponsor |