Clinical trial NCT04747158: COVID-19 Convalescent Plasma Therapy
Official title: COVID-19 Convalescent Plasma Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: SARS-CoV-2 Infection
COVID-19 Infection
Keywords: SARS-CoV-2 infection
Convalescent plasma
Lead sponsor: Universidad Nacional de Asunción
Sponsor class: OTHER
Collaborators: name: Consejo Nacional de Ciencias y Tecnología, Paraguay
name: Ministerio de Salud Pública y Bienestar Social, Paraguay
name: Centro de información y recursos para el desarrollo, Paraguay
First posted: 2021-02-10
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Overall survival (30-day mortality)
timeFrame: 30 days
Secondary outcomes:
measure: Median length of hospital stay
timeFrame: 30 days
measure: Change in clinical status
timeFrame: 0, 3, 7 and 14 days
measure: Change in inflammatory marker: ferritin
timeFrame: 0, 7 and 14 days
measure: Change in inflammatory marker: D dimer
timeFrame: 0, 7 and 14 days
measure: Change in inflammatory marker: leukocytes
timeFrame: 0, 7 and 14 days
measure: Serum Antibody Titers
timeFrame: 0, 3 and 7 days
measure: Transfer to ICU
timeFrame: 30 days
measure: Transfusion related events
timeFrame: 4 hours
Other outcomes:
Locations:
city: Asunción
country: Paraguay
facility: Facultad de Ciencias Médicas - Universidad Nacional de Asunción
Study officials:
affiliation: Facultad de Ciencias Médicas - Universidad Nacional de Asunción
name: Angelica Jimenez de Samudio, MD,MSc
role: PRINCIPAL_INVESTIGATOR
References:
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 [Preprint]. 2020 Dec 4:2020.12.02.20242909. doi: 10.1101/2020.12.02.20242909.
citation: 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.
citation: Clinical Management of COVID-19 - Interim guidance 27 May 2020. WHO reference number: WHO/2019-nCoV/clinical/2020.5