Transfusion of Convalescent Plasma for the Early Treatment of Patients With COVID-19

NCT ID: NCT04393727

Last Updated: 2020-11-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2020-09-30

Brief Summary

No specific therapeutic agents or vaccines for COVID-19 are available. Several therapies, are under investigation, but the antiviral efficacy of these drugs is not yet known. The use of convalescent plasma was recommended as an empirical treatment during outbreaks of Ebola virus in 2014, and a protocol for treatment of Middle East respiratory syndrome coronavirus with convalescent plasma was established in 2015. Accordingly, we hypothesized that use of convalescent plasma transfusion could be beneficial in patients infected with SARS-CoV-2.

This is a multicenter prospective randomized clinical trial to evaluate safety and efficacy of early use of convalescent plasma in patients with SARS-CoV2 pneumonia.

Primary endpoint will be the efficacy, evaluated as the need of invasive mechanical ventilation defined by PaO2/FiO2 ratio <150.

Secondary endpoints will be: mortality rates, time to invasive mechanical ventilation, time to virological cure, length of hospital stay, toxicity.

Patients with SARS-CoV2 pneumonia not requiring mechanical ventilation (both non invasive and invasive) will be randomized 1:1 to receive or not convalescent plasma. Patients in the plasma group will receive 200 ml of convalescent plasma, continuing already administered standard therapy, while patients in the control group will continue to receive the standard therapy. A rescue therapy will be allowed in case of clinical worsening.

Patients will be followed-up until 30 days from randomization.

Detailed Description

This is a multicenter prospective randomized open-label clinical trials. Patients with pneumonia due to SARS-CoV-2 will be included and randomized to receive or not convalescent plasma.

Convalescent plasma will be collected by cured patients with previous diagnosis of COVID-19. More specifically, inclusion and exclusion criteria for donors will be the following.

Inclusion criteria for donors:

• age > 18 and <60 years
• confirmed diagnosis of COVID-19: PCR on nasopharynx swab or positive IgG
• presence of 2 negative nasopharynx swabs for patients with previous positive swab and presence of 1 negative nasopharynx swab for patients with positive IgG

Exclusion criteria for donors:

• age < 18 ys or >60 ys
• other conditions that controindicate blood donation

Collected plasma will undergo all procedures for blood preparation. Plasma will be tested with enzyme-linked immunosorbent assay (ELISA) and neutralizing antibody titers.

Patients eligible for the study will be selected among hospitalized patients with SARS-CoV2 pneumonia. More specifically, the following criteria will used for inclusion in the study.

Inclusion criteria for recipients:

• age >18 ys
• confirmed diagnosis of SARS-CoV2 pneumonia
• PaO2/FiO2 200-350

Exclusion criteria for recipients:

• PaO2/FiO2 <200
• need of non invasive or invasive mechanical ventilation

Patients will be randomized 1:1 to receive or not convalescent plasma. All patients will be followed-up for 30 days after randomization.

Primary endpoint will be the need of mechanical ventilation, defined as PaO2/FiO2 <150.

Conditions

COVID; SARS-CoV 2

Keywords

covid-19; SARS-CoV2; pneumonia; convalescent plasma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Patients in the intervention group will receive 200 cc of convalescent plasma

Group Type: EXPERIMENTAL

CONVALESCENT PLASMA

Intervention Type: BIOLOGICAL

Convalescent plasma will be collected by healthy donors, cured by COVID-19 and, after standard preparation and dosage of neutralizing antibodies, will be administered to patients with SARS-CoV2 pneumonia

Control

Patients will continue to receive standard therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CONVALESCENT PLASMA

Convalescent plasma will be collected by healthy donors, cured by COVID-19 and, after standard preparation and dosage of neutralizing antibodies, will be administered to patients with SARS-CoV2 pneumonia

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Any gender
• Age > 18 years on day of signing informed consent
• Informed written consent for participation in the study
• Virological diagnosis of SARS-CoV-2 infection (real-time PCR)
• Hospitalized due to clinical instrumental diagnosis of pneumonia
• PaO2/FiO2 ratio 200-350

Exclusion Criteria

• mechanical ventilation (both invasive and non-invasive)
• PaO2/FiO2<200
• known hypersensitivity to immunoglobulin or blood components

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero, Universitaria Pisana

OTHER

Sponsor Role: lead

Responsible Party

Francesco Menichetti

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesco Menichetti

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliero, Universitaria Pisana

Locations

Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

Countries

Italy

References

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.

Reference Type: RESULT

PMID: 32219428 (View on PubMed)

Other Identifiers

TSUNAMI

Identifier Type: -

Identifier Source: org_study_id