COVID-19 Clinical Trial
— COPLASCOV19Official title:
DETERMINATION OF THE DOSE AND EFFECTIVENESS OF CONVALESCENT PLASMA IN SEVERELY AND VERY SEVERELY ILL PATIENTS BY COVID-19
The present study will try to respond first in an initial phase, what is the minimum
effective dose necessary of convalescent plasma for getting better in severly ill (not
intubated) or very severely ill (intubated) patients.
Once the dose will be determined by each type of patient group (severely ill vs. very
severely ill) has been determined, phase 2 of the study will begin, where the safety and
efficacy of the use of plasma will be evaluated based on clinical, imaging and laboratory
criteria.
So, our hypotheses are:
1. Is there a minimum effective dose to treat seriously ill patients with convalescent
plasma with COVID-19?
2. the plasma dose with the minimum effective effect will improve the clinical, laboratory
and clearance conditions of the presence of the virus in the severely ill patient?
Status | Recruiting |
Enrollment | 90 |
Est. completion date | December 2020 |
Est. primary completion date | November 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: All patients with COVID-19 test positive and... Severe ill patient 1. Respiratory difficulty 2. Sat O2 <93% without O2 but improves with the use of supplemental oxygen 3. CT scan image: COVID-19 compatible pneumonia 4. one or more of at least: SOFA = 0 D-dimer =500 Age = 65 years Comorbidities such as high blood pressure, diabetes mellitus type I and II, chronic kidney failure, controlled or cured cancer, = 1 degree of obesity Very severe ill: 1. Respiratory difficulty that does not improve with supplemental oxygen, requiring intubation and connecting to ventilatory support of no more than 72hrs or 3 days. 2. CT image: COVID-19 compatible pneumonia 3. one or more of at least: SOFA =1 Dimer D = 750 Age = 65 years Comorbidities such as hypertension, diabetes mellitus type I and II, Chronic Kidney Failure, Controlled or cured cancer, = 1 degree of obesity. 4. Survival over 5 days. Other inclusion criteria: a) Pregnant women are accepted Exclusion Criteria: 1. patients with asymptomatic/mild disease for COVID-19 2. Children less than 16 years old 3. patients with atypical pneumonia without COVID-19 diagnostic for PCR-RT |
Country | Name | City | State |
---|---|---|---|
Mexico | Hospital Del Issste Regional En Guadalajara Jalisco | Guadalajara | Jalisco |
Mexico | Secretaria de Salud Del Estado de Sonora, Hospital General Del Estado | Hermosillo | Sonora |
Mexico | Hospital Central Norte Pemex | Mexico City |
Lead Sponsor | Collaborator |
---|---|
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado | CENTRO ESTATAL DE LA TRANSFUSION SANGUINEA, HOSPITAL CENTRAL NACIONAL PEMEX NORTE, HOSPITAL DE ZONA No. 2 IMSS, HOSPITAL DE ZONA No.14 IMSS, HOSPITAL GENERAL DEL ESTADO DE SONORA, SECRETARIA DE SALUD DEL ESTADO DE SONORA |
Mexico,
Burnouf T, Seghatchian J. Ebola virus convalescent blood products: where we are now and where we may need to go. Transfus Apher Sci. 2014 Oct;51(2):120-5. Review. — View Citation
Duan K, Liu B, Li C, Zhang H, Yu T, Qu J, Zhou M, Chen L, Meng S, Hu Y, Peng C, Yuan M, Huang J, Wang Z, Yu J, Gao X, Wang D, Yu X, Li L, Zhang J, Wu X, Li B, Xu Y, Chen W, Peng Y, Hu Y, Lin L, Liu X, Huang S, Zhou Z, Zhang L, Wang Y, Zhang Z, Deng K, Xia Z, Gong Q, Zhang W, Zheng X, Liu Y, Yang H, Zhou D, Yu D, Hou J, Shi Z, Chen S, Chen Z, Zhang X, Yang X. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. Proc Natl Acad Sci U S A. 2020 Apr 28;117(17):9490-9496. doi: 10.1073/pnas.2004168117. Epub 2020 Apr 6. — View Citation
Jahrling PB, Frame JD, Rhoderick JB, Monson MH. Endemic Lassa fever in Liberia. IV. Selection of optimally effective plasma for treatment by passive immunization. Trans R Soc Trop Med Hyg. 1985;79(3):380-4. — View Citation
Keller MA, Stiehm ER. Passive immunity in prevention and treatment of infectious diseases. Clin Microbiol Rev. 2000 Oct;13(4):602-14. Review. — View Citation
Rajam G, Sampson J, Carlone GM, Ades EW. An augmented passive immune therapy to treat fulminant bacterial infections. Recent Pat Antiinfect Drug Discov. 2010 Jun;5(2):157-67. Review. — View Citation
Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 May;46(5):846-848. doi: 10.1007/s00134-020-05991-x. Epub 2020 Mar 3. Erratum — View Citation
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical improvement | no fever, respiratory improvement and blood oxygenation (Sat02, Sat02 / Fi02), general laboratory improvement. | day -1 to day +22 | |
Primary | improvement in tomographic image | before convalescent plasma infusion, the CT image will be compared and subsequently the evolution of images in the CT will be evaluated every 72 hours on 3 times . | day -1 to day +12 | |
Primary | test positivity for COVID-19 | the patients will be evaluated on three occasions the positivity of the test (PCR-RT). If two of them are negative, it will be defined as a virus-free patient. | day +6 to day +12 | |
Primary | early and late complications associated to convalescent plasma | Patients will be evaluated for adverse events during the plasma infusion up to 30 days after that. Especially mild and severe allergic reactions (anaphylaxis), other issues like TRALI. | day 0 to day +30 | |
Secondary | days at ICU | days of stay at ICU will be evaluated | day 0 to day +30 |
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