Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01AI152078 | U.S. NIH Grant/Contract | View source | |
| W911QY2090012 | Other Grant/Funding Number | Department of Defense | |
| U24TR001609 | U.S. NIH Grant/Contract | View source | |
| UL1TR003098 | U.S. NIH Grant/Contract | View source |
Not provided
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Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| State of Maryland | OTHER_GOV |
| Bloomberg Philanthropies | OTHER |
| United States Department of Defense | FED |
| National Institute of Allergy and Infectious Diseases (NIAID) |
Not provided
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To assess the efficacy and safety of Human coronavirus immune plasma (HCIP) to reduce the risk of hospitalization or death, the duration of symptoms and duration of nasopharyngeal or oropharyngeal viral shedding.
The purpose of this randomized, double-blind, controlled, phase 2 trial is to evaluate the efficacy of treatment with HCIP in reducing hospitalization and death prior to hospitalization among outpatient adults who have RNA detection test-confirmed COVID-19 AND have developed any symptoms of COVID-19 including but not limited to fever, cough, or other COVID associated symptoms like anosmia. Ambulatory/outpatient adults subjects 18 years of age or older, regardless of risk factors for severe illness may participate. A total of approximately 1344 eligible subjects stratified with a target goal (but not binding) of 50:50 in the <65 vs ≥ 65 age range will be randomized in a 1:1 ratio to receive either HCIP or control plasma.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SARS-CoV-2 convalescent plasma | Experimental | SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma. |
|
| Standard Control plasma | Active Comparator | Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 convalescent plasma | Biological | SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Number of Hospitalizations or Deaths Prior to Hospitalization | Cumulative Number measured as the proportion of subjects who were hospitalized or who died prior to hospitalization | Up to day 28 |
| Cumulative Incidence of Severe Infusion Reactions | Cumulative incidence measured as rate per person-years experiencing treatment-related severe infusion reactions during the study period. | Up to day 28 |
| Cumulative Incidence of Treatment-related Grade 3 or Higher Adverse Events | Cumulative incidence measured as rate per person-years experiencing a Grade 3 or higher. | Up to day 90 |
| Cumulative Incidence of Treatment-related Acute Respiratory Distress Syndrome (ARDS) | Cumulative incidence measured as rate per person-years of treatment-related severe Acute Respiratory Distress Syndrome (ARDS) during the study period. | Up to day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum SARS-CoV-2 Antibody Titers by Visit | Geometric mean Spike Receptor Binding Domain (RBD) titers at day 0, 14, 28 and 90 between the randomized arms. | Days 0, 14, 28 and 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With ICU Admission | Disease severity measured by admission to the ICU | Up to day 90 |
| Number of Participants With Invasive Mechanical Ventilation | Disease severity measured by invasive mechanical ventilation |
Inclusion Criteria:
Exclusion Criteria:
Not provided
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Not provided
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| Name | Affiliation | Role |
|---|---|---|
| David J Sullivan, MD | The Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Center for American Indian Health - Chinle Office |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34981068 | Result | Sullivan DJ, Gebo KA, Shoham S, Bloch EM, Lau B, Shenoy AG, Mosnaim GS, Gniadek TJ, Fukuta Y, Patel B, Heath SL, Levine AC, Meisenberg BR, Spivak ES, Anjan S, Huaman MA, Blair JE, Currier JS, Paxton JH, Gerber JM, Petrini JR, Broderick PB, Rausch W, Cordisco ME, Hammel J, Greenblatt B, Cluzet VC, Cruser D, Oei K, Abinante M, Hammitt LL, Sutcliffe CG, Forthal DN, Zand MS, Cachay ER, Raval JS, Kassaye SG, Foster EC, Roth M, Marshall CE, Yarava A, Lane K, McBee NA, Gawad AL, Karlen N, Singh A, Ford DE, Jabs DA, Appel LJ, Shade DM, Ehrhardt S, Baksh SN, Laeyendecker O, Pekosz A, Klein SL, Casadevall A, Tobian AAR, Hanley DF. Randomized Controlled Trial of Early Outpatient COVID-19 Treatment with High-Titer Convalescent Plasma. medRxiv [Preprint]. 2021 Dec 21:2021.12.10.21267485. doi: 10.1101/2021.12.10.21267485. | |
| 38483534 |
Not provided
Not provided
Anonymized individual participant data (IPD) collected in this study, including data dictionaries, will be made available to other researchers after the end of the study.
After publication of initial study manuscript
Public
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SARS-CoV-2 Convalescent Plasma | SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma. SARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 4, 2021 | Dec 8, 2022 |
Not provided
Not provided
| NIH |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
A total of approximately 1344 eligible subjects stratified with a target goal (but not binding) of 50:50 in the <65 vs ≥ 65 age range will be randomized in a 1:1 ratio to receive either HCIP or control plasma.
Not provided
Not provided
Not provided
|
|
| Plasma from a volunteer donor | Biological | Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative. |
|
| Up to day 90 |
| Number of Participants Who Died | Disease severity measured by death | Up to day 90 |
| Number of Participants With Resolved COVID-19 Symptoms at Day 14 | Number of participants with resolved COVID-19 symptoms at day 14 | Day 14 |
| Number of Participants With Resolved COVID-19 Symptoms at Day 28 | Number of participants with resolved COVID-19 symptoms at day 28 | Day 28 |
| Number of Participants With Resolved COVID-19 Symptoms at Day 90 | Number of participants with resolved COVID-19 symptoms at day 90 | Day 90 |
| Impact of Convalescent Plasma on Outcome as Assessed by Change in Hospitalization Rate | Assess change in hospitalization rate as measured by number of hospitalizations stratified by age groups <65 and >=65 | Day 0 to Day 90 |
| Impact of Donor Antibody Titers on Hospitalization Rate of Convalescent Plasma Recipients | Impact of donor antibody titers (high/low) will be assessed by hospitalization rate as measured by number of hospitalizations. | Day 0 to Day28 |
| Chinle |
| Arizona |
| 86503 |
| United States |
| Mayo Clinic, Phoenix | Phoenix | Arizona | 85054 | United States |
| University of Arizona, Phoenix | Tucson | Arizona | 85719 | United States |
| University of Arizona, Tuscon | Tucson | Arizona | 85724 | United States |
| Center for American Indian Health - Whiteriver Office | Whiteriver | Arizona | 85941 | United States |
| University of California, Los Angeles | Los Angeles | California | 90095 | United States |
| University of California, Irvine Health | Orange | California | 92868 | United States |
| Western Connecticut Health Network, Danbury Hospital | Danbury | Connecticut | 06810 | United States |
| Western Connecticut Health Network, Norwalk Hospital | Norwalk | Connecticut | 06856 | United States |
| University of Miami | Coral Gables | Florida | 33124 | United States |
| University of Miami Clinical Translational Research Site | Miami | Florida | 33136 | United States |
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | United States |
| Tulane University | New Orleans | Louisiana | 70112 | United States |
| Anne Arundel Medical Center | Annapolis | Maryland | 21401 | United States |
| The Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| MedStar Washington Hospital Center | Hyattsville | Maryland | 20782 | United States |
| University of Massachusetts Worcester | Worcester | Massachusetts | 01655 | United States |
| Wayne State University | Detroit | Michigan | 48202 | United States |
| University of New Mexico Health Sciences Center | Albuquerque | New Mexico | 87131 | United States |
| Center for American Indian Health - Gallup Office | Gallup | New Mexico | 87301 | United States |
| Center for American Indian Health - Shiprock Office | Shiprock | New Mexico | 87420 | United States |
| Vassar Brothers Medical Center | Poughkeepsie | New York | 12601 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | United States |
| Lifespan/BrownUniversity (Rhode Island Hospital) | Providence | Rhode Island | 02903 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| The University of Utah | Salt Lake City | Utah | 84132 | United States |
| Derived |
| Park HS, Yin A, Barranta C, Lee JS, Caputo CA, Sachithanandham J, Li M, Yoon S, Sitaras I, Jedlicka A, Eby Y, Ram M, Fernandez RE, Baker OR, Shenoy AG, Mosnaim GS, Fukuta Y, Patel B, Heath SL, Levine AC, Meisenberg BR, Spivak ES, Anjan S, Huaman MA, Blair JE, Currier JS, Paxton JH, Gerber JM, Petrini JR, Broderick PB, Rausch W, Cordisco ME, Hammel J, Greenblatt B, Cluzet VC, Cruser D, Oei K, Abinante M, Hammitt LL, Sutcliffe CG, Forthal DN, Zand MS, Cachay ER, Raval JS, Kassaye SG, Marshall CE, Yarava A, Lane K, McBee NA, Gawad AL, Karlen N, Singh A, Ford DE, Jabs DA, Appel LJ, Shade DM, Lau B, Ehrhardt S, Baksh SN, Shapiro JR, Ou J, Na YB, Knoll MD, Ornelas-Gatdula E, Arroyo-Curras N, Gniadek TJ, Caturegli P, Wu J, Ndahiro N, Betenbaugh MJ, Ziman A, Hanley DF, Casadevall A, Shoham S, Bloch EM, Gebo KA, Tobian AA, Laeyendecker O, Pekosz A, Klein SL, Sullivan DJ. Outpatient COVID-19 convalescent plasma recipient antibody thresholds correlated to reduced hospitalizations within a randomized trial. JCI Insight. 2024 Mar 14;9(8):e178460. doi: 10.1172/jci.insight.178460. |
| 37131659 | Derived | Park HS, Yin A, Barranta C, Lee JS, Caputo CA, Sachithanandham J, Li M, Yoon S, Sitaras I, Jedlicka A, Eby Y, Ram M, Fernandez RE, Baker OR, Shenoy AG, Mosnaim GS, Fukuta Y, Patel B, Heath SL, Levine AC, Meisenberg BR, Spivak ES, Anjan S, Huaman MA, Blair JE, Currier JS, Paxton JH, Gerber JM, Petrini JR, Broderick PB, Rausch W, Cordisco ME, Hammel J, Greenblatt B, Cluzet VC, Cruser D, Oei K, Abinante M, Hammitt LL, Sutcliffe CG, Forthal DN, Zand MS, Cachay ER, Raval JS, Kassaye SG, Marshall CE, Yarava A, Lane K, McBee NA, Gawad AL, Karlen N, Singh A, Ford DE, Jabs DA, Appel LJ, Shade DM, Lau B, Ehrhardt S, Baksh SN, Shapiro JR, Ou J, Na YB, Knoll MD, Ornelas-Gatdula E, Arroyo-Curras N, Gniadek TJ, Caturegli P, Wu J, Ndahiro N, Betenbaugh MJ, Ziman A, Hanley DF, Casadevall A, Shoham S, Bloch EM, Gebo KA, Tobian AAR, Laeyendecker O, Pekosz A, Klein SL, Sullivan DJ. Outpatient COVID-19 convalescent plasma recipient antibody thresholds correlated to reduced hospitalizations within a randomized trial. medRxiv [Preprint]. 2023 Dec 15:2023.04.13.23288353. doi: 10.1101/2023.04.13.23288353. |
| 36722044 | Derived | Baksh SN, Heath SL, Fukuta Y, Shade D, Meisenberg B, Bloch EM, Tobian AAR, Spivak ES, Patel B, Gerber J, Raval JS, Forthal D, Paxton J, Mosnaim G, Anjan S, Blair J, Cachay E, Currier J, Das P, Huaman M, Sutcliffe C, Yarava A, Casadevall A, Sullivan D, Hanley D, Gebo KA. Symptom Duration and Resolution With Early Outpatient Treatment of Convalescent Plasma for Coronavirus Disease 2019: A Randomized Trial. J Infect Dis. 2023 May 29;227(11):1266-1273. doi: 10.1093/infdis/jiad023. |
| 35353960 | Derived | Sullivan DJ, Gebo KA, Shoham S, Bloch EM, Lau B, Shenoy AG, Mosnaim GS, Gniadek TJ, Fukuta Y, Patel B, Heath SL, Levine AC, Meisenberg BR, Spivak ES, Anjan S, Huaman MA, Blair JE, Currier JS, Paxton JH, Gerber JM, Petrini JR, Broderick PB, Rausch W, Cordisco ME, Hammel J, Greenblatt B, Cluzet VC, Cruser D, Oei K, Abinante M, Hammitt LL, Sutcliffe CG, Forthal DN, Zand MS, Cachay ER, Raval JS, Kassaye SG, Foster EC, Roth M, Marshall CE, Yarava A, Lane K, McBee NA, Gawad AL, Karlen N, Singh A, Ford DE, Jabs DA, Appel LJ, Shade DM, Ehrhardt S, Baksh SN, Laeyendecker O, Pekosz A, Klein SL, Casadevall A, Tobian AAR, Hanley DF. Early Outpatient Treatment for Covid-19 with Convalescent Plasma. N Engl J Med. 2022 May 5;386(18):1700-1711. doi: 10.1056/NEJMoa2119657. Epub 2022 Mar 30. |
| FG001 | Standard Control Plasma | Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative. Plasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Includes participants who were randomized and received transfusion
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SARS-CoV-2 Convalescent Plasma | SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma. SARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma. |
| BG001 | Standard Control Plasma | Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative. Plasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| BMI category 1 | Count of Participants | Participants |
| ||||||||||||||||
| BMI category 2 | Count of Participants | Participants |
| ||||||||||||||||
| Hypertension | Count of Participants | Participants |
| ||||||||||||||||
| Diabetes | Count of Participants | Participants |
| ||||||||||||||||
| Asthma | Count of Participants | Participants |
| ||||||||||||||||
| HIV infection | Count of Participants | Participants |
| ||||||||||||||||
| Pregnant | Count of Participants | Participants |
| ||||||||||||||||
| Time from symptom onset to transfusion | Median | Inter-Quartile Range | days |
| |||||||||||||||
| Vaccine status | Count of Participants | 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 | Cumulative Number of Hospitalizations or Deaths Prior to Hospitalization | Cumulative Number measured as the proportion of subjects who were hospitalized or who died prior to hospitalization | Includes patients who were randomized and received transfusion | Posted | Count of Participants | Participants | Up to day 28 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Cumulative Incidence of Severe Infusion Reactions | Cumulative incidence measured as rate per person-years experiencing treatment-related severe infusion reactions during the study period. | Includes patients who were randomized and received transfusion | Posted | Number | Rate per person-years | Up to day 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Cumulative Incidence of Treatment-related Grade 3 or Higher Adverse Events | Cumulative incidence measured as rate per person-years experiencing a Grade 3 or higher. | Posted | Number | Rate per person-years | Up to day 90 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Cumulative Incidence of Treatment-related Acute Respiratory Distress Syndrome (ARDS) | Cumulative incidence measured as rate per person-years of treatment-related severe Acute Respiratory Distress Syndrome (ARDS) during the study period. | Includes patients who were randomized and received transfusion | Posted | Number | Rate per person-years | Up to day 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum SARS-CoV-2 Antibody Titers by Visit | Geometric mean Spike Receptor Binding Domain (RBD) titers at day 0, 14, 28 and 90 between the randomized arms. | Analysis limited to those that were transfused and had the titer data performed | Posted | Geometric Mean | 95% Confidence Interval | Spike Receptor Binding Domain Titer | Days 0, 14, 28 and 90 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With ICU Admission | Disease severity measured by admission to the ICU | Includes patients who were randomized and received transfusion | Posted | Count of Participants | Participants | Up to day 90 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Invasive Mechanical Ventilation | Disease severity measured by invasive mechanical ventilation | Posted | Count of Participants | Participants | Up to day 90 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants Who Died | Disease severity measured by death | Includes patients who were randomized and received transfusion | Posted | Count of Participants | Participants | Up to day 90 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Resolved COVID-19 Symptoms at Day 14 | Number of participants with resolved COVID-19 symptoms at day 14 | All participants who were transfused and had symptom data for day 14 | Posted | Count of Participants | Participants | Day 14 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Resolved COVID-19 Symptoms at Day 28 | Number of participants with resolved COVID-19 symptoms at day 28 | All participants who were transfused and had symptom data for day 28 | Posted | Count of Participants | Participants | Day 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Resolved COVID-19 Symptoms at Day 90 | Number of participants with resolved COVID-19 symptoms at day 90 | All participants who were transfused and had symptom data for day 90 | Posted | Count of Participants | Participants | Day 90 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Impact of Convalescent Plasma on Outcome as Assessed by Change in Hospitalization Rate | Assess change in hospitalization rate as measured by number of hospitalizations stratified by age groups <65 and >=65 | Includes patients who were randomized and received transfusion | Posted | Count of Participants | Participants | Day 0 to Day 90 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Impact of Donor Antibody Titers on Hospitalization Rate of Convalescent Plasma Recipients | Impact of donor antibody titers (high/low) will be assessed by hospitalization rate as measured by number of hospitalizations. | Analysis limited to those that had the donor titer measured | Posted | Count of Participants | Participants | Day 0 to Day28 |
|
|
90 days
We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.
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 | SARS-CoV-2 Convalescent Plasma | SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma. SARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma. | 0 | 592 | 34 | 592 | 106 | 592 |
| EG001 | Standard Control Plasma | Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative. Plasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative. | 3 | 589 | 55 | 589 | 109 | 589 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Chest pain - cardiac | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bronchial infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Kidney Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vasovagal reaction | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hallucinations | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Renal calculi | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sinus pain | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Chest pain - cardiac | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blurred vision | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Burning and itching eyes | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Left Lower Eyelid Edema | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Retinal tear | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Anal Fistula | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Esophageal ulcer | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Edema limbs | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fever | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Heavy chest pain feeling | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Worsening Anxiety | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Post-vaccine reaction | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bladder infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bronchial infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Herpes simplex reactivation | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Shingles | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Burn | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Facial contusions secondary to assault | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Laceration of Forehead | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Weight loss | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Alcohol intolerance | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperlipidemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Muscle spasms in lower extremities | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Right knee sprain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Transient ischemic attacks | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Twitch in lip | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Renal calculi | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urine discoloration | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Laryngeal edema | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Lymphedema | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David J. Sullivan | Johns Hopkins University Bloomberg School of Public Health | 410-502-2522 | dsulliv7@jh.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 2, 2021 | Dec 8, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 21, 2021 | Dec 8, 2022 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000093522 | COVID-19 Serotherapy |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
Not provided
Not provided
| 35 - 49 years |
|
| 50 - 64 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| >=30 |
|
| >=35 |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| Partially vaccinated |
|
| Fully vaccinated |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| No primary event of hospitalization |
|