search
Back to results

Efficacy of Reinforcing Standard Therapy in COVID-19 Patients With Repeated Transfusion of Convalescent Plasma

Primary Purpose

Covid19

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Convalescent Plasma with antibody against SARS-CoV-2.
Standard treatment for COVID-19
Sponsored by
Hospital Son Llatzer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID19, Immune Plasma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ability to understand the HIP and sign the study IC
  • male or female =/> 18 years
  • Patient hospitalized with a COVID-19 diagnosis by PCR on nasopharyngeal swabs or any other biological sample.
  • Presence of respiratory symptoms and / or fever associated with COVID-19, with clinical evolution time for COVID-19 equal to or less than 7 days.
  • Presence of pneumonia on chest X-ray and / or SatO2 <94% aa.
  • Sequential Organ Failure Assessment (SOFA) score ≤ 6.
  • Accept the condition of complying with the procedures established in the protocol.

Exclusion Criteria:

  • Patients with a previous history of allergic transfusion reaction.
  • Lactating or pregnant women and a positive pregnancy test.
  • Patients who have been treated with plasma in the 21 days prior to the screening / baseline visit.
  • Patients who are at the time of study, participating in another clinical trial.
  • Patients who haven't completed all study procedures.

Sites / Locations

  • University Hospital Son LlatzerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control group

Intervention group

Arm Description

Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).

Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).

Outcomes

Primary Outcome Measures

WHO clinical progression scale
The scale provides a measure of illness severity across a range from 0 (not infected) to 9 (Mechanical ventilation pO2/FiO2 <150 and vasopressors, dialysis, or ECMO)

Secondary Outcome Measures

lung X-ray
Evaluation of the lungs with a chest x-ray
Concomitant medication assessment
Indicate if the patient had to take a concomitant medication and specify the type of medication.
Hematimetry
blood count
Activated partial thromboplastin time
measurement of the number of seconds it takes for a clot to form in a patient's blood.
Fibrinogen level
measurement of the level of fibrinogen in the blood (mg / dl), as a measure of assessing the severity of the disease.
Fragment D-dimer assessment
Determination of the existence of the D-dimer fragment in blood as a measure of assessing the severity of the disease.
Glomerular Filtration Rate assessment
estimation of how much blood passes per minute through the glomerular filters of the kidneys (ml/min).
Ferritin blood assessment
measurement of the amount of ferritin (blood protein) in ng/ml in the blood, as a measure of assessing the severity of the disease.
C-reactive protein assessment
measurement of the level of c-reactive protein in the blood (mg/dl), as a measure of a change in inflammation
Lactate Dehydrogenase (LDH) assessment
measurement of the level of lactate dehydrogenase in the blood (U/L), as a measure of assessing the severity of the disease.
Troponin I assessment
measurement of the levels of troponin I proteins in the blood (ng/L), as a measure of assessing the severity of the disease.
Procalcitonin assessment
measurement of the levels of procalcitonin in the blood (ng/ml), as a measure of assessing the severity of the disease.
Interleukin-6 assessment
measurement of serum levels Interleukin-6 in pg/mL, as a measure of assessing the severity of the disease.
partial pressure of oxygen (pO2) assessment
measurement of the oxygen pressure in the blood (mmHg), as a measure of assessing the severity of the disease.
Quantitative determination of antibodies
Anti-SARS-Cov 2 immunoglobulin G / A level and anti-SARS-Cov 2 neutralizing antibody levels.
SARS-Cov-2 viral quantification in a nasopharyngeal specimen
RT-PCR test for the diagnosis of SARS-COV-2 virus
Time to negativization of RT-PCR
total time elapsed until negative RT-PCR test
Pneumonia Severity Index (PSI) score
be used to assess the COVID-19 severity and predict the 14-day mortality risk in cases of COVID-19 pneumonia. The patient is then stratified into five classes ( class I: low risk, class V: high risk by his/her score on the PSI scale based on physical or laboratory examination.
Percentage of patients requiring admission to intensive care units.
Mortality rate at 15 days
Mortality rate at 30 days
Length of stay

Full Information

First Posted
March 9, 2021
Last Updated
March 16, 2021
Sponsor
Hospital Son Llatzer
Collaborators
Fundació d'investigació Sanitària de les Illes Balears
search

1. Study Identification

Unique Protocol Identification Number
NCT04803370
Brief Title
Efficacy of Reinforcing Standard Therapy in COVID-19 Patients With Repeated Transfusion of Convalescent Plasma
Official Title
Study of the Efficacy of Reinforcing of the Standard Therapy in COVID-19 Patients With Repeated Transfusion of Immune Plasma From COVID-19 Convalescents vs Exclusive Standard Therapy in Hospitalized COVID-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 8, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Son Llatzer
Collaborators
Fundació d'investigació Sanitària de les Illes Balears

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
The coronavirus disease 2019 (COVID-19) was classified as a pandemic by the WHO in March 2020. The SARS-COV-2 virus is easily transmissible and there is currently no approved treatment with effective results. Although the main epidemiological parameters are currently being studied, apparently the speed of contagion, the incidence and the mortality rate in severe cases appear to be high. Therefore, there is an urgent need to find a viable therapeutic option. The present trial is a pilot study with an objective to determine the efficacy of standard treatment reinforced with two repeated doses in two consecutive days of plasma from former convalescent people of the COVID-19 disease already discharged and / or with results in negative COVID-19 screenings, transfused to hospitalized COVID-19 patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
COVID19, Immune Plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Other
Arm Description
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
Intervention Type
Other
Intervention Name(s)
Convalescent Plasma with antibody against SARS-CoV-2.
Intervention Description
Convalescent plasma plus standard treatment for COVID-19. The convalescent plasma is from patients recovered from COVID-19 and negative viremia in the test detection COVID-19. The infusions will be given on days 1 and 2, of the study, after the positive result for COVID-19 of the recipient patient.
Intervention Type
Other
Intervention Name(s)
Standard treatment for COVID-19
Intervention Description
The patients will receive the standard treatment for COVID-19, according to guidelines for COVID-19 (retrovirals drugs, interferon-α / β, anti-IL-6 monoclonal antibody, oxygen therapy, etc..)
Primary Outcome Measure Information:
Title
WHO clinical progression scale
Description
The scale provides a measure of illness severity across a range from 0 (not infected) to 9 (Mechanical ventilation pO2/FiO2 <150 and vasopressors, dialysis, or ECMO)
Time Frame
Day 21
Secondary Outcome Measure Information:
Title
lung X-ray
Description
Evaluation of the lungs with a chest x-ray
Time Frame
At inclusion, Day 21
Title
Concomitant medication assessment
Description
Indicate if the patient had to take a concomitant medication and specify the type of medication.
Time Frame
At inclusion, Day 3, Day 7, Day 14, Day 21
Title
Hematimetry
Description
blood count
Time Frame
At inclusion, Day 3, Day 7, Day 14, Day 21
Title
Activated partial thromboplastin time
Description
measurement of the number of seconds it takes for a clot to form in a patient's blood.
Time Frame
At inclusion, Day 3, Day 7, Day 14, Day 21
Title
Fibrinogen level
Description
measurement of the level of fibrinogen in the blood (mg / dl), as a measure of assessing the severity of the disease.
Time Frame
At inclusion, Day 3, Day 7, Day 14, Day 21
Title
Fragment D-dimer assessment
Description
Determination of the existence of the D-dimer fragment in blood as a measure of assessing the severity of the disease.
Time Frame
At inclusion, Day 3, Day 7, Day 14, Day 21
Title
Glomerular Filtration Rate assessment
Description
estimation of how much blood passes per minute through the glomerular filters of the kidneys (ml/min).
Time Frame
At inclusion, Day 3, Day 7, Day 14, Day 21
Title
Ferritin blood assessment
Description
measurement of the amount of ferritin (blood protein) in ng/ml in the blood, as a measure of assessing the severity of the disease.
Time Frame
At inclusion, Day 3, Day 7, Day 14, Day 21
Title
C-reactive protein assessment
Description
measurement of the level of c-reactive protein in the blood (mg/dl), as a measure of a change in inflammation
Time Frame
At inclusion, Day 3, Day 7, Day 14, Day 21
Title
Lactate Dehydrogenase (LDH) assessment
Description
measurement of the level of lactate dehydrogenase in the blood (U/L), as a measure of assessing the severity of the disease.
Time Frame
At inclusion, Day 3, Day 7, Day 14, Day 21
Title
Troponin I assessment
Description
measurement of the levels of troponin I proteins in the blood (ng/L), as a measure of assessing the severity of the disease.
Time Frame
At inclusion, Day 3, Day 7, Day 14, Day 21
Title
Procalcitonin assessment
Description
measurement of the levels of procalcitonin in the blood (ng/ml), as a measure of assessing the severity of the disease.
Time Frame
At inclusion, Day 3, Day 7, Day 14, Day 21
Title
Interleukin-6 assessment
Description
measurement of serum levels Interleukin-6 in pg/mL, as a measure of assessing the severity of the disease.
Time Frame
At inclusion, Day 3, Day 7, Day 14, Day 21
Title
partial pressure of oxygen (pO2) assessment
Description
measurement of the oxygen pressure in the blood (mmHg), as a measure of assessing the severity of the disease.
Time Frame
At inclusion, Day 3, Day 7, Day 14, Day 21
Title
Quantitative determination of antibodies
Description
Anti-SARS-Cov 2 immunoglobulin G / A level and anti-SARS-Cov 2 neutralizing antibody levels.
Time Frame
At inclusion, Day 3, Day 7, Day 14, Day 21
Title
SARS-Cov-2 viral quantification in a nasopharyngeal specimen
Description
RT-PCR test for the diagnosis of SARS-COV-2 virus
Time Frame
At inclusion, Day 3, Day 7, Day 14, Day 21
Title
Time to negativization of RT-PCR
Description
total time elapsed until negative RT-PCR test
Time Frame
Day 21
Title
Pneumonia Severity Index (PSI) score
Description
be used to assess the COVID-19 severity and predict the 14-day mortality risk in cases of COVID-19 pneumonia. The patient is then stratified into five classes ( class I: low risk, class V: high risk by his/her score on the PSI scale based on physical or laboratory examination.
Time Frame
At inclusion, Day 3, Day 7, Day 14, Day 21
Title
Percentage of patients requiring admission to intensive care units.
Time Frame
At inclusion, Day 3, Day 7, Day 14, Day 21
Title
Mortality rate at 15 days
Time Frame
Day 15
Title
Mortality rate at 30 days
Time Frame
Day 30
Title
Length of stay
Time Frame
Day 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to understand the HIP and sign the study IC male or female =/> 18 years Patient hospitalized with a COVID-19 diagnosis by PCR on nasopharyngeal swabs or any other biological sample. Presence of respiratory symptoms and / or fever associated with COVID-19, with clinical evolution time for COVID-19 equal to or less than 7 days. Presence of pneumonia on chest X-ray and / or SatO2 <94% aa. Sequential Organ Failure Assessment (SOFA) score ≤ 6. Accept the condition of complying with the procedures established in the protocol. Exclusion Criteria: Patients with a previous history of allergic transfusion reaction. Lactating or pregnant women and a positive pregnancy test. Patients who have been treated with plasma in the 21 days prior to the screening / baseline visit. Patients who are at the time of study, participating in another clinical trial. Patients who haven't completed all study procedures.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Arrizabalaga Asenjo
Phone
0034871202000
Email
marrizab@hsll.es
Facility Information:
Facility Name
University Hospital Son Llatzer
City
Palma De Mallorca
State/Province
Islas De Balears
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Arrizabalaga Asenjo
Phone
0034871202000
Email
marrizab@hsll.es
First Name & Middle Initial & Last Name & Degree
Maria Arrizabalaga Asenjo
First Name & Middle Initial & Last Name & Degree
Joan Bargay Lleonart
First Name & Middle Initial & Last Name & Degree
Manuel Raya
First Name & Middle Initial & Last Name & Degree
Jose Maria Guerra Coll
First Name & Middle Initial & Last Name & Degree
Maria Fiorella Sarubbo
First Name & Middle Initial & Last Name & Degree
Josep Borràs Vives
First Name & Middle Initial & Last Name & Degree
Maria Victoria Fernández Baca del Alamo
First Name & Middle Initial & Last Name & Degree
Maria Antonia Bautista Gili
First Name & Middle Initial & Last Name & Degree
Laia Vilaplana Marz
First Name & Middle Initial & Last Name & Degree
Juan Tena Anies
First Name & Middle Initial & Last Name & Degree
Khaoulah El Haji
First Name & Middle Initial & Last Name & Degree
Maria Magdalena Flexas
First Name & Middle Initial & Last Name & Degree
Aina Vidal Balle
First Name & Middle Initial & Last Name & Degree
Carmen Gallegos
First Name & Middle Initial & Last Name & Degree
Maria Arranda

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Reinforcing Standard Therapy in COVID-19 Patients With Repeated Transfusion of Convalescent Plasma

We'll reach out to this number within 24 hrs