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

NCT04803370 | Completed Results

• 1 other identifier: CO-PLASMA-2020
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Keywords

COVID19, Immune Plasma

Outcome Measures

Primary Outcomes (2)

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

  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.

  Day 7

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

  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.

  Day 14

Secondary Outcomes (26)

• Anti-SARS-CoV-2 S IgG Serum Titer

  At inclusion, Day 21

• Time of Hospitalization

  Day 21

• Time to Negativization of RT-PCR

  Day 21

• Diastolic Blood Pressure

  At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21

• Systolic Blood Pressure

  At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21

Study Arms (2)

Control group

OTHER

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

Other: Standard treatment for COVID-19

Intervention group

EXPERIMENTAL

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

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

Interventions

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.

Intervention group

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..)

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Son Llatzer: lead
• Fundació d'investigació Sanitària de les Illes Balears: collaborator

Study Sites (1)

University Hospital Son Llatzer

Palma de Mallorca, Islas de Balears, Spain

Location

Related Publications (1)

• 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.

  PMID: 35683427 RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Joan Bargay Lleonart
• Organization: Son Llàtzer University Hospital

khaoulahelhaji@gmail.com

34871202000

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 17, 2021
• Study Start: July 8, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 29, 2025
• Results First Posted: April 26, 2024

Record last verified: 2025-09

Locations

ES (1)