CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

STI-1499Wiki

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


Correlated Drug Terms (3)

Name (Synonyms) Correlation
drug256 Awake Proning Wiki 1.00
drug2319 Standard of Care Wiki 0.20
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (2)

Name (Synonyms) Correlation
D045169 Severe Acute Respiratory Syndrome NIH 0.05
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A Randomized, Placebo-controlled Study to Evaluate Safety, Pharmacokinetics, Preliminary Efficacy of Three Dose Levels of a Single Dose of STI-1499 (COVI-GUARD), a COVID-19 Targeting Monoclonal Antibody, in COVID-19 Hospitalized Patients

Randomized, placebo-controlled study to evaluate the safety, pharmacokinetics, preliminary efficacy of four dose levels of a single dose of STI-1499 (COVI-GUARD), a COVID-19 targeting monoclonal antibody, in hospitalized patients with COVID-19

NCT04454398 Covid-19 Biological: STI-1499 Other: Standard of Care Drug: Placebo

Primary Outcomes

Description: Types, frequencies, and severities of adverse events and their relationships to STI-1499

Measure: Incidence of treatment-emergent adverse events (safety and tolerability of STI-1499)

Time: Randomization through study completion at 28 days

Secondary Outcomes

Description: All-cause mortality at Day 28

Measure: All-cause mortality

Time: Randomization through Day 28

Description: Change from baseline in clinical status on a 7-point ordinal scale where higher score means better outcome (1=Death, 7=Not hospitalized and no limitations on activities)

Measure: Change in clinical status

Time: Randomization to Day 7, 14, 28

Description: Change from baseline in SOFA score where lower score means better outcome

Measure: Change in Sequential Organ Failure Assessment (SOFA) score

Time: Randomization to Day 7, 14, 28

Description: Change from baseline in ratio of partial pressure of arterial oxygen to fraction of inspired oxygen

Measure: Change in PaO2:FiO2

Time: Randomization to Day 7, 14, 28

Description: Length of hospitalization of participants (followed up to Day 28)

Measure: Length of hospitalization

Time: Randomization up to Day 28

Description: Percentage of participants requiring mechanical ventilation at Day 7, 14, and 28

Measure: Percentage of participants requiring mechanical ventilation

Time: Randomization to Day 7, 14, 28

Description: Change from baseline in viral shedding as assessed by RT-PCR

Measure: Change in viral shedding

Time: Randomization to Day 7, 14, 21, 28

Description: Incidence of anti-drug antibody (ADA)

Measure: Immunogenicity of STI-1499

Time: Randomization to Day 21, 28

No related HPO nodes (Using clinical trials)