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

NCT ID: NCT04803370

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-08
• Study Completion Date: 2021-09-01

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

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

Group Type: OTHER

Standard treatment for COVID-19

Intervention Type: 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..)

Intervention group

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

Group Type: EXPERIMENTAL

Convalescent Plasma with antibody against SARS-CoV-2.

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Standard treatment for COVID-19

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..)

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundació d'investigació Sanitària de les Illes Balears

OTHER_GOV

Sponsor Role: collaborator

Hospital Son Llatzer

OTHER

Sponsor Role: lead

Responsible Party

Maria Arrizabalaga Asenjo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Son Llatzer

Palma de Mallorca, Islas de Balears, Spain

Countries

Spain

References

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.

Reference Type: RESULT

PMID: 35683427 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

CO-PLASMA-2020

Identifier Type: -

Identifier Source: org_study_id