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

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

The coronavirus disease 2019 (COVID-19) was classified as a pandemic by the World Health Organization (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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: Convalescent Plasma with antibody against SARS-CoV-2.; Other: Standard treatment for COVID-19

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Arrizabalaga Asenjo; Phone Number: 0034871202000; Email: marrizab@hsll.es

Study Locations

• Spain
  • Islas De Balears
    • Palma De Mallorca, Islas De Balears, Spain
      • University Hospital Son Llatzer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group; Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).	Other: Standard treatment for COVID-19; The patients will receive the standard treatment for COVID-19, according to guidelines for COVID-19 (retrovirals drugs, interferon-α / β, anti-Interleukin-6 monoclonal antibody, oxygen therapy, etc..)
Experimental: Intervention group; Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).	Other: Convalescent Plasma with antibody against SARS-CoV-2.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II	The scale provides a measure of COVID-19 severity based on the patient's physical situation, whose design was based on a blueprint of the WHO in treating COVID-19.; 1= Death; 2= Hospitalized. on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3= Hospitalized. on non-invasive ventilation or high flow oxygen devices; 4= Hospitalized. requiring supplemental oxygen; 5= Hospitalized. not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6= Hospitalized. not requiring supplemental oxygen - no longer requiring ongoing medical care.; 7= Not hospitalized. limitation on activities and/or requiring home oxygen; 8= Not hospitalized. no limitations on activities.	Day 7
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II	The scale provides a measure of COVID-19 severity based on the patient's physical situation, whose design was based on a blueprint of the WHO in treating COVID-19.; 1= Death; 2= Hospitalized. on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3= Hospitalized. on non-invasive ventilation or high flow oxygen devices; 4= Hospitalized. requiring supplemental oxygen; 5= Hospitalized. not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6= Hospitalized. not requiring supplemental oxygen - no longer requiring ongoing medical care.; 7= Not hospitalized. limitation on activities and/or requiring home oxygen; 8= Not hospitalized. no limitations on activities.	Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-SARS-CoV-2 S IgG Serum Titer	The levels of Anti-SARS-CoV-2 S IgG serum	At inclusion, Day 21
Time of Hospitalization	time that the patients have passed in the hospital.	Day 21
Time to Negativization of RT-PCR	total time elapsed until negative RT-PCR test	Day 21
Diastolic Blood Pressure	the pressure of blood in the artery when the heart relaxes between beats.	At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
Systolic Blood Pressure	The pressure of blood in the artery when the heart contracts. It is the high number in a blood pressure measurement.	At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
Temperature		At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
Cardiac Frequency	The number of heart contractions or beats per unit of time. The normal values in adults at rest range between 60 and 100 beats per minit.	At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
Respiratory Frequency	Number of breaths the patient takes per minute.	At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
Oxygen Saturation	blood oxygen percentage. A healthy percentage of oxygen in the blood is between 95% and 100%.	At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
Hemoglobin	hemoglobin levels in the blood	At inclusion, Day 3, Day 7, Day 14, Day 21
Leucocytes	Leucocyte count a patient's blood.	At inclusion, Day 3, Day 7, Day 14, Day 21
Neutrophils	Neutrophils count a patient's blood.	At inclusion, Day 3, Day 7, Day 14, Day 21
Absolute Lymphocytes	lymphocyte count a patient's blood.	At inclusion, Day 3, Day 7, Day 14, Day 21
Activated Partial Thromboplastin Time	measurement of the number of seconds it takes for a clot to form in a patient's blood.	At inclusion, Day 3, Day 7, Day 14, Day 21
Fibrinogen Level	measurement of the level of fibrinogen in the blood (mg / dl), as a measure of assessing the severity of the disease.	At inclusion, Day 3, Day 7, Day 14, Day 21
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.	At inclusion, Day 3, Day 7, Day 14
Glomerular Filtration Rate Assessment	estimation of how much blood passes per minute through the glomerular filters of the kidneys (ml/min).	At inclusion, Day 3, Day 7, Day 14, Day 21
Troponin I Assessment	measurement of the levels of troponin I proteins in the blood (ng/mL), as a measure of assessing the severity of the disease.	At inclusion, Day 3, Day 7, Day 14, Day 21
Procalcitonin Assessment	measurement of the levels of procalcitonin in the blood (ng/L), as a measure of assessing the severity of the disease.	At inclusion, Day 3, Day 7, Day 14, Day 21
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	At inclusion, Day 3, Day 7, Day 14, Day 21
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.	At inclusion, Day 3, Day 7, Day 14, Day 21
Interleukin-6 Assessment	measurement of serum levels Interleukin-6 in pg/mL, as a measure of assessing the severity of the disease.	At inclusion, Day 3, Day 7, Day 14, Day 21
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.	At inclusion, Day 3, Day 7, Day 14, Day 21
Percentage of Patients Requiring Admission to Intensive Care Units.	Percentage of patients requiring admission to intensive care units.	Day 21
Mortality Rate at 15 Days	number of dead participants through day 15	Day 15
Mortality Rate at 30 Days	number of dead participants through day 30	Day 30

Collaborators and Investigators

• Sponsor: Hospital Son Llatzer
• Collaborators: Fundació d'investigació Sanitària de les Illes Balears

Publications and helpful links

General Publications

• Bargay-Lleonart J, Sarubbo F, Arrizabalaga M, Guerra JM, Borras J, El Haji K, Flexas M, Perales J, Fernandez-Baca V, Gallegos C, Cruz MR, Velasco S, Lopez V, Cruz A, Bautista-Gili A, Jimenez-Marco T, Girona-Llobera E, Vilaplana L, Calonge L, Tena J, Galan MP, Payeras A. Reinforcement of the Standard Therapy with Two Infusions of Convalescent Plasma for Patients with COVID-19: A Randomized Clinical Trial. J Clin Med. 2022 May 27;11(11):3039. doi: 10.3390/jcm11113039.

Helpful Links

• Publications of results

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2020
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Estimated): April 26, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: COVID19, Immune Plasma
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: CO-PLASMA-2020

Drug and device information, study documents

• 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