COVID-19 Convalescent Plasma Therapy

SARS-CoV-2 Infection Clinical Trial

— TPCC  

Official title:

COVID-19 Convalescent Plasma Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04747158
• Other study ID #: PINV20-388
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 10, 2020
• Est. completion date: January 10, 2021

Study information

• Verified date: February 2021
• Source: Universidad Nacional de Asunción
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is an open-label trial in which hospitalized patients with risk factors of severe coronavirus disease 2019 [COVID-19] will be receive treatment with convalescent plasma (≤ 15 days from symptoms start).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: January 10, 2021
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 Years and older
• Presence of risk factors of severe COVID 19 diagnosed by quantitative polymerase chain reaction by reverse transcription (RT-qPCR)
• Patients with no more than 15 days from the onset of symptoms
• Signed informed consent

Exclusion Criteria:

• Severely ill patients admitted directly to the ICU.
• Need for mechanical ventilation at the time of hospital admission, regardless of the time of clinical evolution.
• History of previous hypersensitivity to plasma transfusions.
• History of immunoglobulin A (IgA) deficiency
• Pregnancy

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19 Infection
• Infection
• SARS-CoV-2 Infection

Intervention

Biological:
• Convalescent plasma
COVID-19 convalescent plasma at admission, after confirmation of eligibility, 200 ml on day 1 and 2

Locations

Country	Name	City	State
Paraguay	Facultad de Ciencias Médicas - Universidad Nacional de Asunción	Asunción

Sponsors (4)

Lead Sponsor	Collaborator
Universidad Nacional de Asunción	Centro de información y recursos para el desarrollo, Paraguay, Consejo Nacional de Ciencias y Tecnología, Paraguay, Ministerio de Salud Pública y Bienestar Social, Paraguay

Country where clinical trial is conducted

Paraguay, 

References & Publications (3)

Clinical Management of COVID-19 - Interim guidance 27 May 2020. WHO reference number: WHO/2019-nCoV/clinical/2020.5

Joyner MJ, Bruno KA, Klassen SA, Kunze KL, Johnson PW, Lesser ER, Wiggins CC, Senefeld JW, Klompas AM, Hodge DO, Shepherd JRA, Rea RF, Whelan ER, Clayburn AJ, Spiegel MR, Baker SE, Larson KF, Ripoll JG, Andersen KJ, Buras MR, Vogt MNP, Herasevich V, Dennis JJ, Regimbal RJ, Bauer PR, Blair JE, van Buskirk CM, Winters JL, Stubbs JR, van Helmond N, Butterfield BP, Sexton MA, Diaz Soto JC, Paneth NS, Verdun NC, Marks P, Casadevall A, Fairweather D, Carter RE, Wright RS. Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients. Mayo Clin Proc. 2020 Sep;95(9):1888-1897. doi: 10.1016/j.mayocp.2020.06.028. Epub 2020 Jul 19. — View Citation

Yoon HA, Bartash R, Gendlina I, Rivera J, Nakouzi A, Bortz RH 3rd, Wirchnianski AS, Paroder M, Fehn K, Serrano-Rahman L, Babb R, Sarwar UN, Haslwanter D, Laudermilch E, Florez C, Dieterle ME, Jangra RK, Fels JM, Tong K, Mariano MC, Vergnolle O, Georgiev GI, Herrera NG, Malonis RJ, Quiroz JA, Morano NC, Krause GJ, Sweeney JM, Cowman K, Allen S, Annam J, Applebaum A, Barboto D, Khokhar A, Lally BJ, Lee A, Lee M, Malaviya A, Sample R, Yang XA, Li Y, Ruiz R, Thota R, Barnhill J, Goldstein DY, Uehlinger J, Garforth SJ, Almo SC, Lai JR, Gil MR, Fox AS, Chandran K, Wang T, Daily JP, Pirofski LA. Treatment of Severe COVID-19 with Convalescent Plasma in the Bronx, NYC. medRxiv. 2020 Dec 4. pii: 2020.12.02.20242909. doi: 10.1101/2020.12.02.20242909. Update in: JCI Insight. 2021 Jan 21;:. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (30-day mortality)	To evaluate the effectiveness of convalescent plasma therapy COVID-19, to decrease mortality in hospitalized patients with COVID-19 and who present some risk factor for clinical deterioration.	30 days
Secondary	Median length of hospital stay	To describe the median length of hospital stay in days	30 days
Secondary	Change in clinical status	To asses the changes of disease severity, according to the COVID-19 disease severity from the World Health Organization (WHO) Interim guidance.	0, 3, 7 and 14 days
Secondary	Change in inflammatory marker: ferritin	To measure changes in ferritin (µg/L) at 0, 7 and 14 days	0, 7 and 14 days
Secondary	Change in inflammatory marker: D dimer	To measure changes in D dimer (mg/L) at 0, 7 and 14 days	0, 7 and 14 days
Secondary	Change in inflammatory marker: leukocytes	To measure leukocytes (/mm3) changes at 0, 7 and 14 days	0, 7 and 14 days
Secondary	Serum Antibody Titers	To measure immunoglobulin G (IgG) SARS-CoV 2 titles	0, 3 and 7 days
Secondary	Transfer to ICU	To asses the frequency of patients admitted to ICU	30 days
Secondary	Transfusion related events	To asses the frequency of adverse events to convalescent plasma	4 hours

External Links

•   Open data' page of projects funded by CONACYT, Paraguay