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CONVALESCENT PLASMA FOR ILL PATIENTS BY COVID-19 (COPLASCOV19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04356482
Recruitment Status : Recruiting
First Posted : April 22, 2020
Last Update Posted : June 5, 2020
Sponsor:
Collaborators:
SECRETARIA DE SALUD DEL ESTADO DE SONORA
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
Information provided by (Responsible Party):
Luis Villela, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

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. 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?

Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV 2 Convalescence Plasma Doses Biological: convalescent plasma Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DETERMINATION OF THE DOSE AND EFFECTIVENESS OF CONVALESCENT PLASMA IN SEVERELY AND VERY SEVERELY ILL PATIENTS BY COVID-19
Actual Study Start Date : May 20, 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: single arm

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

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.

Other Name: no apply




Primary Outcome Measures :
  1. Clinical improvement [ Time Frame: day -1 to day +22 ]
    no fever, respiratory improvement and blood oxygenation (Sat02, Sat02 / Fi02), general laboratory improvement.

  2. improvement in tomographic image [ Time Frame: day -1 to day +12 ]
    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 .

  3. test positivity for COVID-19 [ Time Frame: day +6 to day +12 ]
    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.

  4. early and late complications associated to convalescent plasma [ Time Frame: day 0 to day +30 ]
    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.


Secondary Outcome Measures :
  1. days at ICU [ Time Frame: day 0 to day +30 ]
    days of stay at ICU will be evaluated



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04356482


Contacts
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Contact: Luis M Villela, MD +526624756529 luisvillela@yahoo.com
Contact: Diego Espinoza, MD +526623862375 dr.espinoza.peralta@gmail.com

Locations
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Mexico
Hospital Del Issste Regional En Guadalajara Jalisco Not yet recruiting
Guadalajara, Jalisco, Mexico, 45100
Contact: CARLOS BEST, MD    +523310722818    carlosbest@gmail.com   
Secretaria de Salud Del Estado de Sonora, Hospital General Del Estado Not yet recruiting
Hermosillo, Sonora, Mexico, 64890
Contact: LUIS villela, MD    +526624756529    luisvillela@yahoo.com   
Contact: Melani Otañez, MD    +526629374833    otanezmelani@gmail.com   
Sub-Investigator: Diego Espinoza, MD         
Hospital Central Norte Pemex Recruiting
Mexico City, Mexico, 02720
Contact: FERNANDO PEREZ-JACOBO, MD    +525540821871    fernando.perez.jacobo@hotmail.com   
Sponsors and Collaborators
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
SECRETARIA DE SALUD DEL ESTADO DE SONORA
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
Investigators
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Principal Investigator: Luis M Villela, MD ISSSTESON
Publications of Results:
Other Publications:
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Responsible Party: Luis Villela, MD,MSc, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
ClinicalTrials.gov Identifier: NCT04356482    
Other Study ID Numbers: TERAPLASCOV2
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Luis Villela, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado:
covid-19
convalescent plasma doses
sars-Cov 2
treatment
response
Additional relevant MeSH terms:
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Convalescence
Disease Attributes
Pathologic Processes