Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical Study
NCT ID: NCT04332835
Last Updated: 2020-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
92 participants
INTERVENTIONAL
2020-08-08
2020-11-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention Group
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.
Plasma
Day 1: CP-COVID19, 250 milliliters. Day 2: CP-COVID19, 250 milliliters.
Standard Therapy
Standard therapy defined by institutional protocol.
Control Group
Participants included in the control group will receive standard therapy defined by institutional protocol.
Standard Therapy
Standard therapy defined by institutional protocol.
Interventions
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Plasma
Day 1: CP-COVID19, 250 milliliters. Day 2: CP-COVID19, 250 milliliters.
Standard Therapy
Standard therapy defined by institutional protocol.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Hospitalized participants with diagnosis of COVID 19 by Real Time - Polymerase Chain Reaction.
3. Severe cases according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 7)".
4. Sequential Organ Failure Assessment score (SOFA) \< 6.
5. Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
2. Patients with prior allergic reactions to transfusions.
3. Critical ill patients in intensive care units with requierment of Invasive Mechanical Venitlation.
4. Patients with surgical procedures in the last 30 days.
5. Patients with active treatment for cancer (Radiotherapy or Chemotherapy).
6. HIV diagnosed patients with viral failure (detectable viral load\> 1000 copies / ml persistent, two consecutive viral load measurements within a 3 month interval, with medication adherence between measurements after at least 6 months of starting a new regimen antiretrovirals).
7. Demonstrated coinfection that explains the patient's symptoms
8. End-stage chronic kidney disease (Glomerular Filtration Rate \<15 ml / min / 1.73 m2).
9. Child Pugh C stage liver cirrhosis.
10. High cardiac output diseases.
11. Autoimmune diseases or Immunoglobulin A nephropathy.
12. Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.
18 Years
100 Years
ALL
No
Sponsors
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Fundación Universitaria de Ciencias de la Salud
OTHER
CES University
OTHER
Instituto Distrital de Ciencia Biotecnología e Innovacion en Salud
UNKNOWN
Universidad del Rosario
OTHER
Responsible Party
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Juan Manuel Anaya Cabrera
MD, PhD, Principal Investigator
Principal Investigators
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Juan M Anaya Cabrera, MD, PhD
Role: STUDY_DIRECTOR
Universidad del Rosario
Locations
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Universidad del Rosario
Bogota, Cundinamarca, Colombia
Countries
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References
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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.
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.
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.
Infectious, D. & Outbreaks, D. Maintaining a safe and adequate blood supply during the pandemic outbreak of coronavirus disease ( COVID-19 ). OMS 1-5 (2020)
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.
Other Identifiers
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ABN011-2
Identifier Type: -
Identifier Source: org_study_id