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Completed

NCT Number: NCT04803370

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Son Llatzer

Palma de Mallorca, Islas de Balears, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Convalescent Plasma with antibody against SARS-CoV-2.

Other

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

Other

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..)

Primary outcomes

  1. Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II

    Time frame: Day 7

    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.

  2. Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II

    Time frame: 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 outcomes

  1. Anti-SARS-CoV-2 S IgG Serum Titer

    Time frame: At inclusion, Day 21

    The levels of Anti-SARS-CoV-2 S IgG serum

  2. Time of Hospitalization

    Time frame: Day 21

    time that the patients have passed in the hospital.

  3. Time to Negativization of RT-PCR

    Time frame: Day 21

    total time elapsed until negative RT-PCR test

  4. Diastolic Blood Pressure

    Time frame: 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.

  5. Systolic Blood Pressure

    Time frame: 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.

  6. Temperature

    Time frame: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21

  7. Cardiac Frequency

    Time frame: 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.

  8. Respiratory Frequency

    Time frame: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21

    Number of breaths the patient takes per minute.

  9. Oxygen Saturation

    Time frame: 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%.

  10. Hemoglobin

    Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21

    hemoglobin levels in the blood

  11. Leucocytes

    Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21

    Leucocyte count a patient's blood.

  12. Neutrophils

    Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21

    Neutrophils count a patient's blood.

  13. Absolute Lymphocytes

    Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21

    lymphocyte count a patient's blood.

  14. Activated Partial Thromboplastin Time

    Time frame: 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.

  15. Fibrinogen Level

    Time frame: 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.

  16. Fragment D-dimer Assessment

    Time frame: 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.

  17. Glomerular Filtration Rate Assessment

    Time frame: 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).

  18. Troponin I Assessment

    Time frame: 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.

  19. Procalcitonin Assessment

    Time frame: 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.

  20. C-reactive Protein Assessment

    Time frame: 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

  21. Lactate Dehydrogenase (LDH) Assessment

    Time frame: 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.

  22. Interleukin-6 Assessment

    Time frame: 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.

  23. Ferritin Blood Assessment

    Time frame: 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.

  24. Percentage of Patients Requiring Admission to Intensive Care Units.

    Time frame: Day 21

    Percentage of patients requiring admission to intensive care units.

  25. Mortality Rate at 15 Days

    Time frame: Day 15

    number of dead participants through day 15

  26. Mortality Rate at 30 Days

    Time frame: Day 30

    number of dead participants through day 30

Sponsors and collaborators

Lead sponsor

Hospital Son Llatzer

Other

Collaborators

  • Fundació d'investigació Sanitària de les Illes Balears

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 17, 2021
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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