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drug2174 | STP + COVID-19 Convalescent Plasma (CP) Wiki | 1.00 |
drug2175 | STP + Standard Plasma (SP) Wiki | 1.00 |
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There is one clinical trial.
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.
Description: Proportion of patients alive 30 days after randomization
Measure: 30-days survival Time: 30 days after randomizationDescription: Cumulative incidence of mechanical ventilation or death
Measure: Ventilator free survival Time: 30 days after randomizationDescription: Probability of being alive at 6 months after randomization
Measure: 6-months survival Time: 6 months after randomizationDescription: Proportion of patients developing any serious medical or procedure related complications
Measure: Incidence of complications Time: Within 12 monthsDescription: Proportion of days spent in ICU on the total length of hospital stay
Measure: Days in intensive care units (ICU) Time: From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 12 monthsDescription: Proportion of patients showing seroconversion to Immunoglobulin G (IgG) anti-SARS-Cov-2
Measure: Positivity for Immunoglobulin G to SARS-Cov-2 Time: 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 monthsDescription: Proportion of patients showing viral clearance by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) on plasma and respiratory tract samples
Measure: Clearance of viral load Time: 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 monthsDescription: Variations in SOFA Score (range 0-24; higher score mean a worse outcome)
Measure: Sequential Organ Failure Assessment (SOFA) score Time: 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 monthsDescription: Proportion of patients needing introduction of new drug or discontinuation of drug from standard therapy protocol
Measure: Any variation from Standard Therapy Protocol Time: 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