Coronavirus Clinical Trial
— CP-COVID-19Official title:
Convalescent Plasma for Patients With COVID-19: A Pilot Study
NCT number | NCT04332380 |
Other study ID # | ABN011-1 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | May 1, 2020 |
Est. completion date | July 28, 2020 |
Verified date | August 2020 |
Source | Universidad del Rosario |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | July 28, 2020 |
Est. primary completion date | July 28, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria:Fulfilling all the following criteria 1. Aged between 18 and 60 years, male or female. 2. Hospitalized participants with diagnosis for COVID 19 by Real Time - Polymerase Chain Reaction. 3. Without treatment. 4. Moderate cases according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)". 5. Confusion, Urea, Respiratory rate, Blood pressure-65 (CURB-65) >= 2. 6. Sequential Organ Failure Assessment score (SOFA) < 6. 7. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Female subjects who are pregnant or breastfeeding. 2. Patients with prior allergic reactions to transfusions. 3. Critical ill patients in intensive care units. 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. Patients who have suspicion or evidence of coinfections. 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. |
Country | Name | City | State |
---|---|---|---|
Colombia | Universidad del Rosario | Bogota | Cundinamarca |
Lead Sponsor | Collaborator |
---|---|
Universidad del Rosario | CES University, Fundación Universitaria de Ciencias de la Salud, Instituto Distrital de Ciencia Biotecnologia e Innovacion en salud |
Colombia,
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. Erratum in: Lancet. 2020 Jan 30;:. — View Citation
Infectious, D. & Outbreaks, D. Maintaining a safe and adequate blood supply during the pandemic outbreak of coronavirus disease ( COVID-19 ). OMS 1-5 (2020).
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. Review. — View Citation
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 Mar 3. doi: 10.1001/jama.2020.3204. [Epub ahead of print] — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Viral Load | Copies of COVID-19 per ml | Days 0, 4, 7, 14 and 28 | |
Primary | Change in Immunoglobulin M COVID-19 antibodies Titers | Immunoglobulin M COVID-19 antibodies | Days 0, 4, 7, 14 and 28 | |
Primary | Change in Immunoglobulin G COVID-19 antibodies Titers | Immunoglobulin G COVID-19 antibodies | Days 0, 4, 7, 14 and 28 | |
Secondary | Intensive Care Unit Admission | Proportion of patients with Intensive Care Unit Admission requirement (days 7, 14 and 28) | Days 7, 14 and 28 | |
Secondary | Length of Intensive Care Unit stay | Days of Intensive Care Unit management (days 7, 14 and 28) | Days 7, 14 and 28 | |
Secondary | Length of hospital stay (days) | Days of Hospitalization (days 7, 14 and 28) | Days 7, 14 and 28 | |
Secondary | Requirement of mechanical ventilation | Proportion of patients with mechanical ventilation (days 7, 14 and 28) | Days 7, 14 and 28 | |
Secondary | Duration (days) of mechanical ventilation | Days with mechanical ventilation (days 7, 14 and 28) | Days 7, 14 and 28 | |
Secondary | 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 | |
Secondary | Mortality | ProportiĆ³n of death patients at days 7, 14 and 28 | Days 7, 14 and 28 |
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