- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04428021
Standard or Convalescent Plasma in Patients With Recent Onset of COVID-19 Respiratory Failure (PLACO-COVID)
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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Torino, Italy, 10126
- AO Città della Salute e della Scienza di Torino
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / 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.
|
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)
|
Standard Therapy Protocol according to the best evidence treatment recommended by the Regional Health System emergency committee
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
|
Standard Therapy Protocol according to the best evidence treatment recommended by the Regional Health System emergency committee
Transfusion of three SARS-Cov-2 neutralizing antibodies positive Plasma Units (CP) on day 1,3,5 in addition to STP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
30-days survival
Time Frame: 30 days after randomization
|
Proportion of patients alive 30 days after randomization
|
30 days after randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ventilator free survival
Time Frame: 30 days after randomization
|
Cumulative incidence of mechanical ventilation or death
|
30 days after randomization
|
6-months survival
Time Frame: 6 months after randomization
|
Probability of being alive at 6 months after randomization
|
6 months after randomization
|
Incidence of complications
Time Frame: Within 12 months
|
Proportion of patients developing any serious medical or procedure related complications
|
Within 12 months
|
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
|
From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 12 months
|
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
|
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
|
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
|
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
|
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)
|
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
|
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
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Paola Maria Manzini, MD, AO Città della Salute e della Scienza di Torino
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CS3/33
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
Massachusetts General HospitalRecruitingPost Acute COVID-19 Syndrome | Long COVID | Post Acute Sequelae of COVID-19 | Long COVID-19United States
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
Jonathann Kuo, MDActive, not recruitingSARS-CoV2 Infection | Post-COVID-19 Syndrome | Dysautonomia | Post Acute COVID-19 Syndrome | Long COVID | Long Covid19 | COVID-19 Recurrent | Post-Acute COVID-19 | Post-Acute COVID-19 Infection | Post Acute Sequelae of COVID-19 | Dysautonomia Like Disorder | Dysautonomia Orthostatic Hypotension Syndrome | Post... and other conditionsUnited States
-
First Affiliated Hospital Xi'an Jiaotong UniversityShangluo Central Hospital; Ankang Central Hospital; Hanzhong Central Hospital; Yulin... and other collaboratorsRecruitingCOVID-19 | Post-COVID-19 Syndrome | Post-Acute COVID-19 | Acute COVID-19China
Clinical Trials on Standard Therapy Protocol (STP)
-
University Hospital, BordeauxInstitut National de la Santé Et de la Recherche Médicale, France; Université... and other collaboratorsCompletedAlzheimer's DiseaseFrance
-
University of Alabama at BirminghamUnited States Department of DefenseCompletedTraumatic Brain InjuryUnited States
-
UNICEF - VenezuelaRecruitingWasting | Acute Malnutrition in Childhood | Child MalnutritionVenezuela
-
Thais Amanda RodriguesCompleted
-
Ergoterapia Manoegomito SaglUnknownSurgery | Distal Radius Fracture | CRPS (Complex Regional Pain Syndromes) | Wrist Fracture
-
Vanderbilt University Medical CenterNational Heart, Lung, and Blood Institute (NHLBI)RecruitingLymphedema, Secondary | Lymphedema of Leg | Lymphedema Related FibrosisUnited States
-
Qassim UniversityCairo UniversityCompleted
-
Istituto Ortopedico RizzoliCompletedHip Osteoarthritis | Arthropathy of HipItaly
-
Ciclo de MutaçãoSao Jose do Rio Preto Medical SchoolCompleted
-
Karolinska InstitutetCompletedEvaluate CBCT Protocols in Subjective Image QualitySweden