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

Hospital Son Llatzer

Status: Completed

Conditions: Covid19

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04803370

CO-PLASMA-2020

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Control group

Other group

Description:

Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).

Treatment:

Other: Standard treatment for COVID-19

Intervention group

Experimental group

Description:

Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).

Treatment:

Other: Convalescent Plasma with antibody against SARS-CoV-2.