Standard or Convalescent Plasma in Patients With Recent Onset of COVID-19 Respiratory Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-15

Study Completion Date

2021-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To date no specific treatment has been proven to be effective for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2) infection. It is possible that convalescent plasma that contains antibodies to SARS-Cov-2 might be effective against the progression of infection. Promising results have been shown by preliminary data from China cases. The investigators planned to compare effectiveness of adding COVID-19 convalescent plasma to standard therapy protocol (STP) versus adding plasma donated in pre-COVID era versus STP alone in patient with COVID-19 within 5 days from the onset of respiratory distress. STP at enrolment is the best evidence based therapy approved for treatment of COVID patients by regional Health system emergency committee.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Convalescent Plasma vs. Standard Plasma for COVID-19

NCT04344535

COVID

TERMINATED PHASE1/PHASE2

Plasma Therapy of COVID-19 in Severely Ill Patients

NCT04359810

SARS-CoV-2 Infection

COMPLETED PHASE2

Use of Convalescent Plasma for COVID-19

NCT04408040

COVID

TERMINATED PHASE2

Convalescent Plasma for the Treatment of Patients With Severe COVID-19 Infection

NCT04408209

COVID-19 Infection

COMPLETED NA

Convalescent Plasma for the Treatment of COVID-19

NCT04389710

COVID-19

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

500-700 ml of Plasma will be collected by apheresis from COVID recovered donors showing the presence of neutralizing antibodies to SARS-Cov-2 (anti-SARS-Cov-2). All plasma will be screened for transmissible diseases according to italian law (Hepatitis B Virus,Hepatitis C Virus, Human Immunodeficiency Virus 1-2, Syphilis) plus adjunctive screening for Hepatitis A Virus and Hepatitis E Virus-RNA and Parvovirus B19-DNA as requested from Italian National Blood Authority. Apheresis will be divided in two/three units (170-300 ml each), virus inactivated with Riboflavin and ultraviolet light illumination technology and immediately frozen and stored separately from other plasma bags.

Enrolled patients will be stratified according to severity of respiratory failure and randomized in three arms: 1) Standard Therapy Protocol (STP), 2) Standard Therapy Protocol + 170-350 ml standard Plasma (SP) on day 1-3-5 after randomization, 3) Standard Therapy Protocol + 170-350 ml COVID-19 Convalescent Plasma on day 1-3-5 after randomization.

The three therapeutic units of COVID-19 Convalescent plasma will be chosen in order to minimize variations among patients in the total amount of infused SARS-Cov-2 antibodies.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three arms randomized trial, partially blinded

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Only the two experimental arms are masked. COVID-19 convalescent plasma (CP) and standard plasma (SP) will be masked and delivered to the wards in identical bags; a tag printed as "PLASMA TRIAL" will cover the actual name of the product

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard therapy protocol (STP)

STP is defined as the best evidence based therapy approved for treatment of COVID-19 patients by Regional Health System emergency committee. STP could be updated during the trial.

Group Type ACTIVE_COMPARATOR

Standard Therapy Protocol (STP)

Intervention Type DRUG

Standard Therapy Protocol according to the best evidence treatment recommended by the Regional Health System emergency committee

STP + Standard Plasma (SP)

STP + 3 units on day 1-3-5 of Standard Plasma collected in pre-COVID era (January-September 2019)

Group Type EXPERIMENTAL

Standard Therapy Protocol (STP)

Intervention Type DRUG

Standard Therapy Protocol according to the best evidence treatment recommended by the Regional Health System emergency committee

STP + Standard Plasma (SP)

Intervention Type OTHER

Transfusion of three Standard Plasma Units (SP) on day 1,3,5 in addition to STP

STP + COVID-19 Convalescent Plasma (CP)

STP + 3 units on day 1-3-5 of COVID-19 Convalescent Plasma containing neutralizing SARS-Cov-2 antibodies

Group Type EXPERIMENTAL

Standard Therapy Protocol (STP)

Intervention Type DRUG

Standard Therapy Protocol according to the best evidence treatment recommended by the Regional Health System emergency committee

STP + COVID-19 Convalescent Plasma (CP)

Intervention Type OTHER

Transfusion of three SARS-Cov-2 neutralizing antibodies positive Plasma Units (CP) on day 1,3,5 in addition to STP

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standard Therapy Protocol (STP)

Standard Therapy Protocol according to the best evidence treatment recommended by the Regional Health System emergency committee

Intervention Type DRUG

STP + Standard Plasma (SP)

Transfusion of three Standard Plasma Units (SP) on day 1,3,5 in addition to STP

Intervention Type OTHER

STP + COVID-19 Convalescent Plasma (CP)

Transfusion of three SARS-Cov-2 neutralizing antibodies positive Plasma Units (CP) on day 1,3,5 in addition to STP

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Confirmed SARS-Cov-2 diagnosis by RT-PCR on nasopharyngeal swab or on bronchoalveolar lavage
* Respiratory failure onset or progression within 5 days
* Signed Informed Consent