Hyperimmune Plasma for Critical Patients With COVID-19

COVID-19 Clinical Trial

— COV19-PLASMA  

Official title:

Plasma From Donors Recovered From New Coronavirus 2019 As Therapy For Critical Patients With Covid-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04321421
• Other study ID #: IRCCSSanMatteoH
• Status: Completed
• Phase: N/A
• Start date: March 17, 2020
• Est. completion date: May 7, 2020

Study information

• Verified date: May 2020
• Source: Foundation IRCCS San Matteo Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has become pandemic. To date, no specific treatment has been proven to be effective. Promising results were obtained in China using Hyperimmune plasma from patients recovered from the disease.The investigators plan to treat critical Covid-19 patients with hyperimmune plasma.

Description:

Apheresis from recovered donors will be performed with a cell separator device , with 500-600 mL of plasma obtained from each donor. Donors are males, age 18 yrs or more, evaluated for transmissible diseases according to the italian law. Adjunctive tests will be for hepatitis A virus, hepatitis E virus and Parvovirus B-19. All donors will be tested for the Covid-19 neutralizing title. Each plasma bag obtained from plasmapheresis will be immediately divided in two units and frozen according to the national standards and stored separately.

Based on experience published in literature 250-300 mL of convalescent plasma will be used to treat each of the recruited patients at most 3 times over 5 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 7, 2020
• Est. primary completion date: April 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age >=18 yrs

• positive for reverse transcription polymerase chain reaction (RT-PCR) severe acute respiratory syndrome (SARS)-CoV-2

• Acute respiratory distress syndrome (ARDS) moderate to severe, according to Berlin definition, lasting less than10 days

• Polymerase chain reaction (PCR) increased by 3.5 with respect to baseline or >1.8 mg/dl

• need for mechanical ventilation or continuous positive airway pressure (CPAP)

• signed informed consent unless unfeasible for the critical condition

Exclusion Criteria:

• Moderate to severe ARDS lasting more than 10 days

• proven hypersensitivity or allergic reaction to hemoderivatives or immunoglobulins

• consent denied

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• hyperimmune plasma
administration of hyperimmune plasma at day 1 and based on clinical response on day 3 and 5

Locations

Country	Name	City	State
Italy	Ospedale Asst Carlo Poma Mantova	Mantova
Italy	Catherine Klersy	Pavia	PV

Sponsors (2)

Lead Sponsor	Collaborator
Foundation IRCCS San Matteo Hospital	OSPEDALE CARLO POMA ASST MANTOVA

Country where clinical trial is conducted

Italy, 

References & Publications (7)

Arabi Y, Balkhy H, Hajeer AH, Bouchama A, Hayden FG, Al-Omari A, Al-Hameed FM, Taha Y, Shindo N, Whitehead J, Merson L, AlJohani S, Al-Khairy K, Carson G, Luke TC, Hensley L, Al-Dawood A, Al-Qahtani S, Modjarrad K, Sadat M, Rohde G, Leport C, Fowler R. Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol. Springerplus. 2015 Nov 19;4:709. doi: 10.1186/s40064-015-1490-9. eCollection 2015. — View Citation

Chen L, Xiong J, Bao L, Shi Y. Convalescent plasma as a potential therapy for COVID-19. Lancet Infect Dis. 2020 Apr;20(4):398-400. doi: 10.1016/S1473-3099(20)30141-9. Epub 2020 Feb 27. — View Citation

Holshue ML, DeBolt C, Lindquist S, Lofy KH, Wiesman J, Bruce H, Spitters C, Ericson K, Wilkerson S, Tural A, Diaz G, Cohn A, Fox L, Patel A, Gerber SI, Kim L, Tong S, Lu X, Lindstrom S, Pallansch MA, Weldon WC, Biggs HM, Uyeki TM, Pillai SK; Washington State 2019-nCoV Case Investigation Team. First Case of 2019 Novel Coronavirus in the United States. N Engl J Med. 2020 Mar 5;382(10):929-936. doi: 10.1056/NEJMoa2001191. Epub 2020 Jan 31. — View Citation

Hung IF, To KK, Lee CK, Lee KL, Chan K, Yan WW, Liu R, Watt CL, Chan WM, Lai KY, Koo CK, Buckley T, Chow FL, Wong KK, Chan HS, Ching CK, Tang BS, Lau CC, Li IW, Liu SH, Chan KH, Lin CK, Yuen KY. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011 Feb 15;52(4):447-56. doi: 10.1093/cid/ciq106. Epub 2011 Jan 19. — View Citation

Lai ST. Treatment of severe acute respiratory syndrome. Eur J Clin Microbiol Infect Dis. 2005 Sep;24(9):583-91. Review. — View Citation

WHO. Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected. 2020. https://www.who. int/docs/default-source/coronaviruse/clinical-management-of-novel-cov. pdf (accessed Feb 20, 2020).

WHO. Use of convalescent whole blood or plasma collected from patients recovered from Ebola virus disease for transfusion, as an empirical treatment during outbreaks. 2014. http://apps.who.int/iris/rest/ bitstreams/604045/retrieve (accessed Feb 20, 2020).

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death	death from any cause	within 7 days
Secondary	time to extubation	days since intubation	within 7 days
Secondary	length of intensive care unit stay	days from entry to exit from ICU	within 7 days
Secondary	time to CPAP weaning	days since CPAP initiation	within 7 days
Secondary	viral load	naso-pharyngeal swab, sputum and BAL	at days 1, 3 and 7
Secondary	immune response	neutralizing title	at days 1, 3 and 7