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

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ClinicalTrials.gov Identifier: NCT04428021
Recruitment Status : Not yet recruiting
First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Paola Maria Manzini, Azienda Ospedaliera Città della Salute e della Scienza di Torino

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Standard Therapy Protocol (STP) Other: STP + Standard Plasma (SP) Other: STP + COVID-19 Convalescent Plasma (CP) Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three arms randomized trial, partially blinded
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: 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
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : June 15, 2020
Estimated Primary Completion Date : June 15, 2021
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Drug: Standard Therapy Protocol (STP)
Standard Therapy Protocol according to the best evidence treatment recommended by the Regional Health System emergency committee

Experimental: STP + Standard Plasma (SP)
STP + 3 units on day 1-3-5 of Standard Plasma collected in pre-COVID era (January-September 2019)
Drug: Standard Therapy Protocol (STP)
Standard Therapy Protocol according to the best evidence treatment recommended by the Regional Health System emergency committee

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

Experimental: 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
Drug: Standard Therapy Protocol (STP)
Standard Therapy Protocol according to the best evidence treatment recommended by the Regional Health System emergency committee

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




Primary Outcome Measures :
  1. 30-days survival [ Time Frame: 30 days after randomization ]
    Proportion of patients alive 30 days after randomization


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Responsible Party: Paola Maria Manzini, Principal Investigator, Azienda Ospedaliera Città della Salute e della Scienza di Torino
ClinicalTrials.gov Identifier: NCT04428021    
Other Study ID Numbers: CS3/33
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All Individual Participant Data requests should be submitted to the corresponding author for consideration. Access to deidentified participant data may be granted following review, after the publication of major results
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: Data will be available after 12 months from study ending and for the following 5 years
Access Criteria: Data requests should be submitted to the corresponding author for consideration.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases