Clinical trial NCT04803370: 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
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: COVID19, Immune Plasma
Lead sponsor: Hospital Son Llatzer
Sponsor class: OTHER
Collaborators: name: Fundació d'investigació Sanitària de les Illes Balears
First posted: 2021-03-17
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II
timeFrame: Day 7
measure: Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II
timeFrame: Day 14
Secondary outcomes:
measure: Anti-SARS-CoV-2 S IgG Serum Titer
timeFrame: At inclusion, Day 21
measure: Time of Hospitalization
timeFrame: Day 21
measure: Time to Negativization of RT-PCR
timeFrame: Day 21
measure: Diastolic Blood Pressure
timeFrame: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
measure: Systolic Blood Pressure
timeFrame: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
measure: Temperature
timeFrame: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
measure: Cardiac Frequency
timeFrame: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
measure: Respiratory Frequency
timeFrame: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
measure: Oxygen Saturation
timeFrame: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21
measure: Hemoglobin
timeFrame: At inclusion, Day 3, Day 7, Day 14, Day 21
measure: Leucocytes
timeFrame: At inclusion, Day 3, Day 7, Day 14, Day 21
measure: Neutrophils
timeFrame: At inclusion, Day 3, Day 7, Day 14, Day 21
measure: Absolute Lymphocytes
timeFrame: At inclusion, Day 3, Day 7, Day 14, Day 21
measure: Activated Partial Thromboplastin Time
timeFrame: At inclusion, Day 3, Day 7, Day 14, Day 21
measure: Fibrinogen Level
timeFrame: At inclusion, Day 3, Day 7, Day 14, Day 21
measure: Fragment D-dimer Assessment
timeFrame: At inclusion, Day 3, Day 7, Day 14
measure: Glomerular Filtration Rate Assessment
timeFrame: At inclusion, Day 3, Day 7, Day 14, Day 21
measure: Troponin I Assessment
timeFrame: At inclusion, Day 3, Day 7, Day 14, Day 21
measure: Procalcitonin Assessment
timeFrame: At inclusion, Day 3, Day 7, Day 14, Day 21
measure: C-reactive Protein Assessment
timeFrame: At inclusion, Day 3, Day 7, Day 14, Day 21
measure: Lactate Dehydrogenase (LDH) Assessment
timeFrame: At inclusion, Day 3, Day 7, Day 14, Day 21
measure: Interleukin-6 Assessment
timeFrame: At inclusion, Day 3, Day 7, Day 14, Day 21
measure: Ferritin Blood Assessment
timeFrame: At inclusion, Day 3, Day 7, Day 14, Day 21
measure: Percentage of Patients Requiring Admission to Intensive Care Units.
timeFrame: Day 21
measure: Mortality Rate at 15 Days
timeFrame: Day 15
measure: Mortality Rate at 30 Days
timeFrame: Day 30
Other outcomes:
Locations:
city: Palma De Mallorca
country: Spain
facility: University Hospital Son Llatzer
state: Islas De Balears
Study officials:
References:
citation: 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.