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| Name | Class |
|---|---|
| Fundación Universitaria de Ciencias de la Salud | OTHER |
| CES University | OTHER |
| Instituto Distrital de Ciencia BiotecnologÃa e Innovacion en Salud | UNKNOWN |
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Convalescent plasma (CP) has been used in recent years as an empirical treatment strategy when there is no vaccine or treatment available for infectious diseases. In the latest viral epidemics, such as the Ebola outbreak in West Africa in 2014, the World Health Organization issued a document outlining a protocol for the use of whole blood or plasma collected from patients who have recovered from the Ebola virus disease by transfusion to empirically treat local infectious outbreaks
The process is based on obtaining plasma from patients recovered from COVID-19 in Colombia, and through a donation of plasma from the recovered, the subsequent transfusion of this to patients infected with coronavirus disease (COVID-19). Our group has reviewed the scientific evidence regarding the application of convalescent plasma for emergency viral outbreaks and has recommended the following protocol
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Participants included in the experimental group will receive 500 milliliters of convalescent plasma, distributed in two 250 milliliters transfusions on the first and second day after starting the protocol. Simultaneously, they will receive the standard therapy defined by institutional protocol. |
|
| Control Group | Active Comparator | Participants included in the control group will receive standard therapy defined by institutional protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma | Drug | Day 1: CP-COVID19, 250 milliliters. Day 2: CP-COVID19, 250 milliliters. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Viral Load | Copies of COVID-19 per ml | Days 0, 4, 7, 14 and 28 |
| Change in Immunoglobulin G COVID-19 Titers | Immunoglobulin G COVID-19 antibodies | Days 0, 4, 7, 14 and 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Intensive Care Unit Admission | Proportion of patients with Intensive Care Unit Admission requirement (days 7, 14 and 28) | Days 7, 14 and 28 |
| Length of Intensive Care Unit stay | Days of Intensive Care Unit management (days 7, 14 and 28) |
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Inclusion Criteria:Fulfilling all the following criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan M Anaya Cabrera, MD, PhD | Universidad del Rosario | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad del Rosario | Bogota | Cundinamarca | 11100 | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31986264 | Background | Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. | |
| 32134116 |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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Not provided
| ID | Term |
|---|---|
| D000093522 | COVID-19 Serotherapy |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
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Single Blinded
| Standard Therapy | Drug | Standard therapy defined by institutional protocol. |
|
| Days 7, 14 and 28 |
| Length of hospital stay (days) | Days of Hospitalization (days 7, 14 and 28) | Days 7, 14 and 28 |
| Requirement of mechanical ventilation | Proportion of patients with mechanical ventilation (days 7, 14 and 28) | Days 7, 14 and 28 |
| Duration (days) of mechanical ventilation | Days with mechanical ventilation (days 7, 14 and 28) | Days 7, 14 and 28 |
| Clinical status assessed according to the World Health Organization guideline | 1. Hospital discharge; 2. Hospitalization, not requiring supplemental oxygen; 3. Hospitalization, requiring supplemental oxygen (but not Noninvasive Ventilation/ HFNC); 4. Intensive care unit/hospitalization, requiring Noninvasive Ventilation/ HFNC therapy; 5. Intensive care unit, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; 6. Death. (days 7, 14 and 28) | Days 7, 14 and 28 |
| Mortality | Proportion of death patients at days 7, 14 and 28 | Days 7, 14 and 28 |
| Background |
| Wang Y, Wang Y, Chen Y, Qin Q. Unique epidemiological and clinical features of the emerging 2019 novel coronavirus pneumonia (COVID-19) implicate special control measures. J Med Virol. 2020 Jun;92(6):568-576. doi: 10.1002/jmv.25748. Epub 2020 Mar 29. |
| 32125362 | Background | Young BE, Ong SWX, Kalimuddin S, Low JG, Tan SY, Loh J, Ng OT, Marimuthu K, Ang LW, Mak TM, Lau SK, Anderson DE, Chan KS, Tan TY, Ng TY, Cui L, Said Z, Kurupatham L, Chen MI, Chan M, Vasoo S, Wang LF, Tan BH, Lin RTP, Lee VJM, Leo YS, Lye DC; Singapore 2019 Novel Coronavirus Outbreak Research Team. Epidemiologic Features and Clinical Course of Patients Infected With SARS-CoV-2 in Singapore. JAMA. 2020 Apr 21;323(15):1488-1494. doi: 10.1001/jama.2020.3204. |
| Background | Infectious, D. & Outbreaks, D. Maintaining a safe and adequate blood supply during the pandemic outbreak of coronavirus disease ( COVID-19 ). OMS 1-5 (2020) |
| 35761219 | Derived | Rojas M, Rodriguez Y, Hernandez JC, Diaz-Coronado JC, Vergara JAD, Velez VP, Mancilla JP, Araujo I, Yepes JT, Ricaurte OB, Pardo-Oviedo JM, Monsalve DM, Acosta-Ampudia Y, Ramirez-Santana C, Garcia PG, Landinez LA, Correales LD, Grass JS, Perez CR, Lopez GS, Mateus N, Mancera L, Devia RR, Orjuela JE, Parra-Moreno CR, Buitrago AA, Ordonez IE, Osorio CF, Ballesteros N, Patino LH, Castaneda S, Munoz M, Ramirez JD, Bastard P, Gervais A, Bizien L, Casanova JL, Camacho B, Gallo JE, Gomez O, Rojas-Villarraga A, Perez CE, Manrique R, Mantilla RD, Anaya JM. Safety and efficacy of convalescent plasma for severe COVID-19: a randomized, single blinded, parallel, controlled clinical study. BMC Infect Dis. 2022 Jun 27;22(1):575. doi: 10.1186/s12879-022-07560-7. |
| D007239 |
| Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D056747 |
| Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |