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

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Status and phase: Completed; Phase 2

Conditions: COVID-19

Treatments: Drug: Standard Therapy Protocol (STP); Other: STP + COVID-19 Convalescent Plasma (CP); Other: STP + Standard Plasma (SP)

Study type: Interventional

Funder types: Other

Identifiers

NCT04428021

CS3/33

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Pregnancy
• Previous severe reactions to plasma transfusion
• Unavailability of blood group compatible COVID-19 convalescent plasma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 3 patient groups

Standard therapy protocol (STP)

Active Comparator group

Description:

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.

Treatment:

Drug: Standard Therapy Protocol (STP)

STP + Standard Plasma (SP)

Experimental group

Description:

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

Treatment:

Other: STP + Standard Plasma (SP)

Drug: Standard Therapy Protocol (STP)

STP + COVID-19 Convalescent Plasma (CP)

Experimental group

Description:

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

Treatment:

Other: STP + COVID-19 Convalescent Plasma (CP)

Drug: Standard Therapy Protocol (STP)