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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04803370
• Other study ID #: CO-PLASMA-2020
• Status: Completed
• Phase: N/A
• Start date: July 8, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: November 2023
• Source: Hospital Son Llatzer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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.
• Standard treatment for COVID-19
The patients will receive the standard treatment for COVID-19, according to guidelines for COVID-19 (retrovirals drugs, interferon-a / ß, anti-Interleukin-6 monoclonal antibody, oxygen therapy, etc..)

Locations

Country	Name	City	State
Spain	University Hospital Son Llatzer	Palma De Mallorca	Islas De Balears

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Son Llatzer	Fundació d'investigació Sanitària de les Illes Balears

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Anti-SARS-CoV-2 S IgG Serum Titer	The levels of Anti-SARS-CoV-2 S IgG serum	At inclusion, Day 21
Secondary	Time of Hospitalization	time that the patients have passed in the hospital.	Day 21
Secondary	Time to Negativization of RT-PCR	total time elapsed until negative RT-PCR test	Day 21
Secondary	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
Secondary	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
Secondary	Temperature		At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
Secondary	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
Secondary	Respiratory Frequency	Number of breaths the patient takes per minute.	At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
Secondary	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
Secondary	Hemoglobin	hemoglobin levels in the blood	At inclusion, Day 3, Day 7, Day 14, Day 21
Secondary	Leucocytes	Leucocyte count a patient's blood.	At inclusion, Day 3, Day 7, Day 14, Day 21
Secondary	Neutrophils	Neutrophils count a patient's blood.	At inclusion, Day 3, Day 7, Day 14, Day 21
Secondary	Absolute Lymphocytes	lymphocyte count a patient's blood.	At inclusion, Day 3, Day 7, Day 14, Day 21
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of Patients Requiring Admission to Intensive Care Units.	Percentage of patients requiring admission to intensive care units.	Day 21
Secondary	Mortality Rate at 15 Days	number of dead participants through day 15	Day 15
Secondary	Mortality Rate at 30 Days	number of dead participants through day 30	Day 30

External Links

•   Publications of results