Convalescent Plasma for COVID-19

COVID Clinical Trial

Official title:

Convalescent Plasma for the Treatment of Moderate-severe COVID-19: A Proof-of-principle Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04365439
• Other study ID #: 2020-00895
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 20, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: March 2021
• Source: Ente Ospedaliero Cantonale, Bellinzona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this proof of concept study is to provide COVID-19 convalescent plasma to patients with moderate to severe COVID-19 and assess:

• the titer of anti-COVID-19 antibodies in the donors and in the patients before and after treatment;

• the in-depth analysis of immunological parameters in the donors and in recipient before and after treatment;

• the impact of plasma transfusion on the reduction of viral load and inflammation

• safety and tolerability

• clinical efficacy

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 11
• Est. completion date: June 30, 2021
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Hospitalized adult patients 18 - 75 y.o. with confirmed COVID-19 infection by nasopharyngeal swab;

• radiologically confirmed pneumonia;

• SpO2 > 92o/o and < 96% (room air);

• ongoing thromboembolic prophylaxis.

Exclusion Criteria:

• Participation to another COVID-19 trial;

• severe COVID-19 disease (SpO2 < 93o/o in room air);

• severe allergic transfusion reactions or anaphylaxis in the patient history;

• documented lgA deficiency;

• unstable heart disease with signs of circulatory overload;

• malignancies or other concomitant diseases with poor short-term prognosis;

• pregnancy.

Related Conditions & MeSH terms

• Blood Plasma Therapy
• COVID

Intervention

Biological:
• Blood plasma
Convalescent plasma after COVID-19

Locations

Country	Name	City	State
Switzerland	Ospedale Regionale Locarno	Locarno	Ticino

Sponsors (1)

Lead Sponsor	Collaborator
Enos Bernasconi

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Titers of anti-SARS-CoV-2 antibodies in the plasma derived from convalescent donors		At plasma donation
Primary	Change in titers of anti-SARS-CoV-2 antibodies in patients' plasma		Change from baseline at day 21
Primary	Change in inflammatory cytokines concentration (e.g. IL-6, HMGB1)		Change from baseline at day 7
Primary	Viral load decay in the recipient after plasma transfusion with semiquantitative assessment of nasopharyngeal swabs	Semiquantitative measure of viral load by rtPCR for SARS-CoV-2 by nasopharyngeal swabs, at diagnosis and on day 1,3,7	Change from day of diagnosis at day 1
Secondary	Number of patients with improvement in the 7-points Ordinal Scale	7-point ordinal scale measure on day 0 (Baseline), day 1, 3 and 7 after plasma transfusion	At day 7
Secondary	Proportion of patients with adverse events, severity of adverse events	AE will be assessed by the DAIDS scale on day 1, 3, 7 and 21. Relatedness with plasma transfusion will also be reported.	At day 21