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

Not Applicable

Completed

Conditions: Covid19

Interventions: Other: Convalescent Plasma with antibody against SARS-CoV-2.
Other: Standard treatment for COVID-19

Registration Number: NCT04803370

Lead Sponsor: Hospital Son Llatzer

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 55

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Convalescent Plasma with antibody against SARS-CoV-2.	Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
Control group	Standard treatment for COVID-19	Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).

Primary Outcome Measures

Name	Time	Method
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II	Day 14	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.

Secondary Outcome Measures

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