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| Name | Class |
|---|---|
| University Clinic for Infectious Diseases, North Macedonia | OTHER |
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Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection
There are currently no proven therapeutic options for coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19. Experience from prior outbreaks with other coronaviruses, such as SARS-CoV-1, MERS and H1N1 shows that convalescent plasma can be effective. Convalescent plasma will be obtained by plasmapheresis or regular whole blood donation in subjects who recovered from COVID-19 and who are otherwise eligible for donation according to the Institutional protocol. Recipients will be COVID-19 patients requiring hospitalization. A blood-type matched transfusion of convalescent plasma will be infused and recipients will be followed up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hospitalized patients with SARS CoV-2 infection | Other | Hospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-SARS-CoV-2 convalescent plasma | Biological | Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Oxygenation Support | The total number of days patients required respiratory support. | 28 days after transfusion or until hospital discharge (whichever comes first) |
| Hospital Length of Stay (LOS) | Total number of days patients were admitted to the hospital after convalescent plasma transfusion. | 28 days after transfusion or until hospital discharge (whichever comes first) |
| ICU Admission | Total number of subjects to be admitted to the ICU after the convalescent plasma transfusion. | 28 days after transfusion or until hospital discharge (whichever comes first) |
| Number of Participants With Oxygenation Free Days | Number of participants without oxygenation support after receiving convalescent plasma | 28 days after transfusion or until hospital discharge (whichever comes first) |
| Number of Participants With Serious Adverse Events | Number of participants with serious adverse events during the study protocol | 28 days after transfusion or until hospital discharge (whichever comes first) |
| Measure | Description | Time Frame |
|---|---|---|
| Type of Respiratory Support | Type of supplemental oxygen support (e.g. nasal canula, high flow nasal canula, noninvasive ventilation, intubation and invasive mechanical ventilation, rescue ventilation) | 28 days after transfusion or until hospital discharge (whichever comes first) |
| Number of Participants With Different Clinical Outcomes Including Death, Critical Illness and Recovery |
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Inclusion Criteria
Blood donors:
Patients/recipients:
Exclusion Criteria:
Blood donors:
Patients/recipients:
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| Name | Affiliation | Role |
|---|---|---|
| Rada Grubovic Rastvorceva, MD MSci PhD | Institute for Transfusion Medicine of RNM | Principal Investigator |
| Sedulla Useini, MD | Institute for Transfusion Medicine of RNM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Transfusion Medicine of RNM | Skopje | 1000 | North Macedonia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32113510 | Background | Chen L, Xiong J, Bao L, Shi Y. Convalescent plasma as a potential therapy for COVID-19. Lancet Infect Dis. 2020 Apr;20(4):398-400. doi: 10.1016/S1473-3099(20)30141-9. Epub 2020 Feb 27. No abstract available. | |
| 32219428 | Background | Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783. |
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IPD will be shared on request to other clinical researchers involved in similar trials or meta-analysis
Since the publication of results for the next 5 years
Interested researchers should write to the principal investigators of this trial explaining why they need this data
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| ID | Title | Description |
|---|---|---|
| FG000 | Hospitalized Patients With SARS CoV-2 Infection | Hospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma anti-SARS-CoV-2 convalescent plasma: Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hospitalized Patients With SARS CoV-2 Infection | Hospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma anti-SARS-CoV-2 convalescent plasma: Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Duration of Oxygenation Support | The total number of days patients required respiratory support. | This is the number of patients that required respiratory support before CCP transfusion | Posted | Mean | Standard Deviation | days | 28 days after transfusion or until hospital discharge (whichever comes first) |
|
|
During hospitalization, after receiving convalescent plasma
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hospitalized Patients With SARS CoV-2 Infection | Hospitalized adult patients with confirmed SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma anti-SARS-CoV-2 convalescent plasma: Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment | rash on the skin |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assoc. Prof. Dr. Rada M. Grubovic Rastvorceva, MD MSci PhD, CMO | Institute for Transfusion Medicine of RNM | +38923226923 | drgrubovic@gmail.com |
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| 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 | May 11, 2020 | Apr 26, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Number of participants with different clinical outcomes including death, critical illness, limitation of activities and recovery |
| 28 days after transfusion or until hospital discharge (whichever comes first) |
| Background | Huaxia, (2020). 'China puts 245 COVID-19 patients on convalescent plasma therapy', Xinhua.net, 2 February. Available at: http://www.xinhuanet.com/english/2020-02/28/c_138828177.htm |
| 32167489 | Background | Casadevall A, Pirofski LA. The convalescent sera option for containing COVID-19. J Clin Invest. 2020 Apr 1;130(4):1545-1548. doi: 10.1172/JCI138003. No abstract available. |
| 32219429 | Background | Roback JD, Guarner J. Convalescent Plasma to Treat COVID-19: Possibilities and Challenges. JAMA. 2020 Apr 28;323(16):1561-1562. doi: 10.1001/jama.2020.4940. No abstract available. |
| Background | https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-deviceexemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds Accessed on March 30,2020 |
| Background | Guidance on collection, testing, processing, storage, distribution and monitored use. An EU programme of COVID-19 convalescent plasma collection and transfusion. EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY, 08 April, 2020 |
| Background | AABB's CCP Collection Protocol - Donor Eligibility, Processing, Labeling and Distribution, 03 April, 2020 http://www.aabb.org/advocacy/regulatorygovernment/Documents/COVID-19-Convalescent-Plasma-Collection.pdf |
| 36295001 | Derived | Grubovic Rastvorceva RM, Useini S, Stevanovic M, Demiri I, Petkovic E, Franchini M, Focosi D. Efficacy and Safety of COVID-19 Convalescent Plasma in Hospitalized Patients-An Open-Label Phase II Clinical Trial. Life (Basel). 2022 Oct 9;12(10):1565. doi: 10.3390/life12101565. |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index | Count of Participants | Participants |
|
| ABO blood type | Count of Participants | Participants |
|
| WHO progression score | Count of Participants | Participants |
|
| Comorbidities | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Participants |
|
|
| Primary | Hospital Length of Stay (LOS) | Total number of days patients were admitted to the hospital after convalescent plasma transfusion. | The bellow are shown subgroups of participants according to the WHO disease progression scores 3,4 and 5, which all together comprises total investigated group of 189 participants. | Posted | Mean | Standard Deviation | days | 28 days after transfusion or until hospital discharge (whichever comes first) |
|
|
|
|
| Primary | ICU Admission | Total number of subjects to be admitted to the ICU after the convalescent plasma transfusion. | Posted | Count of Participants | Participants | 28 days after transfusion or until hospital discharge (whichever comes first) |
|
|
|
| Primary | Number of Participants With Oxygenation Free Days | Number of participants without oxygenation support after receiving convalescent plasma | Posted | Count of Participants | Participants | 28 days after transfusion or until hospital discharge (whichever comes first) |
|
|
|
| Primary | Number of Participants With Serious Adverse Events | Number of participants with serious adverse events during the study protocol | Posted | Count of Participants | Participants | 28 days after transfusion or until hospital discharge (whichever comes first) |
|
|
|
| Secondary | Type of Respiratory Support | Type of supplemental oxygen support (e.g. nasal canula, high flow nasal canula, noninvasive ventilation, intubation and invasive mechanical ventilation, rescue ventilation) | Posted | Count of Participants | Participants | 28 days after transfusion or until hospital discharge (whichever comes first) |
|
|
|
| Secondary | Number of Participants With Different Clinical Outcomes Including Death, Critical Illness and Recovery | Number of participants with different clinical outcomes including death, critical illness, limitation of activities and recovery | Posted | Count of Participants | Participants | 28 days after transfusion or until hospital discharge (whichever comes first) |
|
|
|
|
| 22 |
| 189 |
| 0 |
| 189 |
| 1 |
| 189 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
|
| patients with WHO score 4, which are on oxygen support with nasal canila or oxygen mask |
|
|
| patients with WHO score 5, which are on oxygen support with noninvasive ventilation |
|
|
|
| Participants with oxygenation free days at discharge |
|
|
| Noninvasive ventilation, high flow nasal canula before CCP transfusion |
|
| Noninvasive ventilation, high flow nasal canula 24 hours after CCP transfusion |
|
| Noninvasive ventilation, high flow nasal canula 7 days after CCP transfusion |
|
| Intubation or invasive mechanical ventilation, before CCP transfusion |
|
| Intubation or invasive mechanical ventilation, 24 hours after CCP transfusion |
|
| Intubation or invasive mechanical ventilation, 7 days after CCP transfusion |
|
| Rescue ventilation before CCP transfusion |
|
| Rescue ventilation 24 hours after CCP transfusion |
|
| Rescue ventilation 7 days after CCP transfusion |
|
| Chi-squared |
df = 2 |
| 0.05 |
p=0.000 |
| Other |
| Correlation of mortality versus stay in the intensive care unit (ICU) | Chi-squared | df = 1 | 0.05 | p = 0.000 | Other |