Treatment of Critically Ill Patients With Covid-19 With Convalescent Plasma

Covid19 Clinical Trial

Official title:

Treatment of Critically Ill Patients With Covid-19 With Convalescent Plasma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04468009
• Other study ID #: 1725
• Status: Completed
• Phase: Phase 2
• Start date: June 25, 2020
• Est. completion date: June 19, 2021

Study information

• Verified date: August 2021
• Source: Hospital de Infecciosas Francisco Javier Muniz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to collect convalescent plasma and use it as experimental treatment in critically ill Covid-19 patients in order to reduce mortality and length of stay in intensive care unit.

Description:

This study aims to use convalescent plasma as experimental treatment in critically ill Covid-19 patients in order to reduce mortality and length of stay in intensive care unit. Donors must have anti-SARS CoV2 antibodies. Recipients must be critically ill Covid-19 patients on mechanical ventilation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: June 19, 2021
• Est. primary completion date: January 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Age: 18 years or more.
• Patient with Covid-19 confirmed with nuclear acid testing
• Critically ill patients with Covid-19 on mechanical ventilation. Potencially critically ill patients (with acute respiratory distress syndrome, septic shock and/or multiple organ failure) with Covid-19.
• Diagnosed with acute respiratory distress syndrome.
• Informed consent.

Exclusion Criteria:

• No consent.
• Symptoms for a period longer than 20 days.
• Not detectable by acid nuclear testing within 48 hours prior to elegibility.
• Descompensated congestive heart failure, in which receiving 500ml of intrasvascular volume signifies a life risk.
• History of severe adverse events or anaphylaxis to plasma components

Related Conditions & MeSH terms

• Covid19
• SARS-Associated Coronavirus
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Biological:
• Convalescent plasma
Convalescent plasma from patients recovering from Covid-19 and which had anti-SARS-Cov-2 antibodies

Locations

Country	Name	City	State
Argentina	Hospital Francisco Javier Muñiz	Ciudad Autonoma de Buenos Aire

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Infecciosas Francisco Javier Muniz

Country where clinical trial is conducted

Argentina, 

References & Publications (25)

Ahn JY, Sohn Y, Lee SH, Cho Y, Hyun JH, Baek YJ, Jeong SJ, Kim JH, Ku NS, Yeom JS, Roh J, Ahn MY, Chin BS, Kim YS, Lee H, Yong D, Kim HO, Kim S, Choi JY. Use of Convalescent Plasma Therapy in Two COVID-19 Patients with Acute Respiratory Distress Syndrome in Korea. J Korean Med Sci. 2020 Apr 13;35(14):e149. doi: 10.3346/jkms.2020.35.e149. — View Citation

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Duan K, Liu B, Li C, Zhang H, Yu T, Qu J, Zhou M, Chen L, Meng S, Hu Y, Peng C, Yuan M, Huang J, Wang Z, Yu J, Gao X, Wang D, Yu X, Li L, Zhang J, Wu X, Li B, Xu Y, Chen W, Peng Y, Hu Y, Lin L, Liu X, Huang S, Zhou Z, Zhang L, Wang Y, Zhang Z, Deng K, Xia Z, Gong Q, Zhang W, Zheng X, Liu Y, Yang H, Zhou D, Yu D, Hou J, Shi Z, Chen S, Chen Z, Zhang X, Yang X. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. Proc Natl Acad Sci U S A. 2020 Apr 28;117(17):9490-9496. doi: 10.1073/pnas.2004168117. Epub 2020 Apr 6. — View Citation

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Leider JP, Brunker PA, Ness PM. Convalescent transfusion for pandemic influenza: preparing blood banks for a new plasma product? Transfusion. 2010 Jun;50(6):1384-98. doi: 10.1111/j.1537-2995.2010.02590.x. Epub 2010 Feb 11. Review. — View Citation

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Mair-Jenkins J, Saavedra-Campos M, Baillie JK, Cleary P, Khaw FM, Lim WS, Makki S, Rooney KD, Nguyen-Van-Tam JS, Beck CR; Convalescent Plasma Study Group. The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis. J Infect Dis. 2015 Jan 1;211(1):80-90. doi: 10.1093/infdis/jiu396. Epub 2014 Jul 16. Review. — View Citation

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lenght of hospitalization after ICU discharge	Duration (number of days) of hospitalization after ICU discharge	Duration (number of days) of hospitalization through study completion, an average of 3 months
Other	Days without ventilation after enrollment	Number of days without ventilation after enrollment	Days without ventilation through study completion, an average of 3 months
Other	Days without vasopressors after enrollment	Number of days without vasopressors after enrollment	Days without vasopressors through study completion, an average of 3 months
Other	Changes in Chest X-ray	Changes in Chest X-ray (unilateral, bilateral, unique, multiple, pleural effusion) after enrollment	Changes in Chest X-ray through study completion, an average of 3 months
Primary	Mortality at ICU at 30 days	Mortality at 30 days of Intensive Care Unit (ICU) admission	Mortality at 30 days
Primary	Mortality at ICU at 90 days	Mortality at 90 days of ICU admission	Mortality at 90 days
Secondary	SOFA score of study days 1, 3, 5, 7, 14 and 28	Sequential Organ Failure Assessment (SOFA) of study days 1, 3, 5, 7, 14 and 28	Study days 1, 3, 5, 7, 14 and 28
Secondary	Need for supportive therapy after enrollment	Duration (number of days) of supportive therapy (oxygen and ventilation, dialysis, vasopressors) after enrollment	Duration of supportive therapy through study completion, an average of 3 months
Secondary	Lenght of stay in ICU	Duration (number of days) of stay in ICU between ICU admission and ICU final discharge	Duration of stay in ICU through study completion, an average of 3 months
Secondary	Lenght of mechanical ventilation	Duration (number of days) of mechanical ventilation between beginning and final liberation from mechanical ventilation	Duration of mechanical ventilation through study completion, an average of 3 months
Secondary	Lenght of hospitalization	Duration (number of days) of hospitalization between hospital admission and final hospital discharge	Duration of hospitalization through study completion, an average of 3 months