CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Standard Therapy Protocol (STP)Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)


Name (Synonyms) Correlation
drug2174 STP + COVID-19 Convalescent Plasma (CP) Wiki 1.00
drug2175 STP + Standard Plasma (SP) Wiki 1.00

Correlated MeSH Terms (0)


Name (Synonyms) Correlation

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 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

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.

NCT04428021 COVID-19 Drug: Standard Therapy Protocol (STP) Other: STP + Standard Plasma (SP) Other: STP + COVID-19 Convalescent Plasma (CP)
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: Proportion of patients alive 30 days after randomization

Measure: 30-days survival

Time: 30 days after randomization

Secondary Outcomes

Description: Cumulative incidence of mechanical ventilation or death

Measure: Ventilator free survival

Time: 30 days after randomization

Description: Probability of being alive at 6 months after randomization

Measure: 6-months survival

Time: 6 months after randomization

Description: Proportion of patients developing any serious medical or procedure related complications

Measure: Incidence of complications

Time: Within 12 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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


No related HPO nodes (Using clinical trials)