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Completed

NCT Number: NCT04428021

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

AO Città della salute e della scienza di Torino

Torino, 10126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Therapy Protocol (STP)

Drug

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

STP + Standard Plasma (SP)

Other

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

STP + COVID-19 Convalescent Plasma (CP)

Other

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

Primary outcomes

  1. 30-days survival

    Time frame: 30 days after randomization

    Proportion of patients alive 30 days after randomization

Secondary outcomes

  1. Ventilator free survival

    Time frame: 30 days after randomization

    Cumulative incidence of mechanical ventilation or death

  2. 6-months survival

    Time frame: 6 months after randomization

    Probability of being alive at 6 months after randomization

  3. Incidence of complications

    Time frame: Within 12 months

    Proportion of patients developing any serious medical or procedure related complications

  4. Days in intensive care units (ICU)

    Time frame: From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 12 months

    Proportion of days spent in ICU on the total length of hospital stay

  5. Positivity for Immunoglobulin G to SARS-Cov-2

    Time frame: On day 0, 2, 4, 6,10,14, 21, 28 after randomization and at date of discharge or death from any cause, whichever came first, assessed up to 12 months

    Proportion of patients showing seroconversion to Immunoglobulin G (IgG) anti-SARS-Cov-2

  6. Clearance of viral load

    Time frame: On day 0, 2, 4, 6,10,14, 21, 28 after randomization and at date of discharge or death from any cause, whichever came first, assessed up to 12 months

    Proportion of patients showing viral clearance by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) on plasma and respiratory tract samples

  7. Sequential Organ Failure Assessment (SOFA) score

    Time frame: On day 0, 2, 4, 6, 10, 14, 28 after randomization and at date of discharge or death from any cause, whichever came first, assessed up to 12 months

    Variations in SOFA Score (range 0-24; higher score mean a worse outcome)

  8. Any variation from Standard Therapy Protocol

    Time frame: From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed daily up to 2 months

    Proportion of patients needing introduction of new drug or discontinuation of drug from standard therapy protocol

Sponsors and collaborators

Lead sponsor

A.O.U. Città della Salute e della Scienza

Other

Registry information

Official study title

Effectiveness of Adding Standard Plasma or COVID-19 Convalescent Plasma to Standard Treatment, Versus Standard Treatment Alone, in Patients With Recent Onset of COVID-19 Respiratory Failure. A Randomized, Three-arms, Phase 2 Trial

Acronym: PLACO-COVID

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 11, 2020
Registry last updated
Feb 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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