CONVALESCENT PLASMA FOR ILL PATIENTS BY COVID-19

NCT04356482 | Unknown Phase 1

• 1 other identifier: TERAPLASCOV2
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief Summary

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. 1.Is there a minimum effective dose to treat seriously ill patients with convalescent plasma with COVID-19?
2. 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?

Conditions

COVID-19; SARS-CoV 2; Convalescence; Plasma; Doses

Keywords

covid-19; convalescent plasma doses; sars-Cov 2; treatment; response

Outcome Measures

Primary Outcomes (4)

• Clinical improvement

  no fever, respiratory improvement and blood oxygenation (Sat02, Sat02 / Fi02), general laboratory improvement.

  day -1 to day +22

• 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

• 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

• 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 Outcomes (1)

• days at ICU

  day 0 to day +30

Study Arms (1)

single arm

EXPERIMENTAL

Determine the convalescent plasma dose to be administered to two groups: one severely ill (not intubated) and one very severely ill (intubated). Second phase: safety and efficacy of the plasma dose found in the same two types of patients.

Biological: convalescent plasma

Interventions

convalescent plasma BIOLOGICAL

In phase 1, different amounts of convalescent plasma will be evaluated depending on the severity of the case. In phase 2, both clinical, laboratory, imaging and viral presence (effectiveness) and safety will be evaluated.

Also known as: no apply

single arm

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with COVID-19 test positive and... Severe ill patient
• Respiratory difficulty
• Sat O2 \<93% without O2 but improves with the use of supplemental oxygen
• CT scan image: COVID-19 compatible pneumonia
• 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:
• Respiratory difficulty that does not improve with supplemental oxygen, requiring intubation and connecting to ventilatory support of no more than 72hrs or 3 days.
• CT image: COVID-19 compatible pneumonia
• 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.
• Survival over 5 days.
• a) Pregnant women are accepted

You may not qualify if:

• patients with asymptomatic/mild disease for COVID-19
• Children less than 16 years old
• patients with atypical pneumonia without COVID-19 diagnostic for PCR-RT

Sponsors & Collaborators

• Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado: lead
• SECRETARIA DE SALUD DEL ESTADO DE SONORA: collaborator
• CENTRO ESTATAL DE LA TRANSFUSION SANGUINEA: collaborator
• HOSPITAL CENTRAL NACIONAL PEMEX NORTE: collaborator
• HOSPITAL DE ZONA No. 2 IMSS: collaborator
• HOSPITAL DE ZONA No.14 IMSS: collaborator
• HOSPITAL GENERAL DEL ESTADO DE SONORA: collaborator

Study Sites (3)

Hospital Del Issste Regional En Guadalajara Jalisco

Guadalajara, Jalisco, 45100, Mexico

NOT YET RECRUITING

Secretaria de Salud Del Estado de Sonora, Hospital General Del Estado

Hermosillo, Sonora, 64890, Mexico

NOT YET RECRUITING

Hospital Central Norte Pemex

Mexico City, 02720, Mexico

RECRUITING

Related Publications (7)

• 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.

  PMID: 32253318 BACKGROUND

• 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. No abstract available.

  PMID: 32125452 RESULT

• 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. doi: 10.2174/157489110791233496.

  PMID: 20370679 RESULT

• Keller MA, Stiehm ER. Passive immunity in prevention and treatment of infectious diseases. Clin Microbiol Rev. 2000 Oct;13(4):602-14. doi: 10.1128/CMR.13.4.602.

  PMID: 11023960 RESULT

• 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. doi: 10.1016/j.transci.2014.10.003.

  PMID: 25457751 RESULT

• 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. doi: 10.1016/0035-9203(85)90388-8.

  PMID: 3898484 RESULT

• 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.

  PMID: 32219428 RESULT

MeSH Terms

Conditions

COVID-19; Convalescence

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Luis M Villela, MD

  ISSSTESON

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis M Villela, MD

CONTACT

+526624756529; luisvillela@yahoo.com

Diego Espinoza, MD

CONTACT

+526623862375; dr.espinoza.peralta@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,MSc

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 22, 2020
• Study Start: May 20, 2020
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 5, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (3)