Convalescent Plasma for COVID-19

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: COVID; Blood Plasma Therapy
• Intervention / Treatment: Biological: Blood plasma

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Ticino
    • Locarno, Ticino, Switzerland, CH-6600
      • Ospedale Regionale Locarno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Convalescent plasma; Convalescent plasma from patients after COVID-19	Biological: Blood plasma; Convalescent plasma after COVID-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Titers of anti-SARS-CoV-2 antibodies in the plasma derived from convalescent donors		At plasma donation
Change in titers of anti-SARS-CoV-2 antibodies in patients' plasma		Change from baseline at day 21
Change in inflammatory cytokines concentration (e.g. IL-6, HMGB1)		Change from baseline at day 7
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Enos Bernasconi
• Investigators: Principal Investigator: Stefano Fontana, M.D., Servizio Trasfusionale, Lugano

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2020
• Primary Completion (Actual): December 20, 2020
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: April 18, 2020
• First Submitted That Met QC Criteria: April 26, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 24, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2020-00895

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No