CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

standard concomitant therapyWiki

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


Correlated Drug Terms (4)

Name (Synonyms) Correlation
drug1430 Inspiratory training device Wiki 1.00
drug1046 Expiratory training device Wiki 1.00
drug2708 Standard of care (SOC) Wiki 0.71
drug1087 Favipiravir Wiki 0.23

Correlated MeSH Terms (4)

Name (Synonyms) Correlation
D012120 Respiration Disorders NIH 0.26
D012140 Respiratory Tract Diseases NIH 0.21
D003141 Communicable Diseases NIH 0.08
D007239 Infection NIH 0.05

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 Randomized Open-label Multicenter Parallel-group Study of Efficacy and Safety of TL-FVP-t vs. Standard of Care Therapy in Patients With Mild to Moderate Coronavirus Disease (SARS-CoV-2/COVID-19)

Randomized open-label multicenter parallel-group study of efficacy and safety of TL-FVP-t vs. standard of care therapy in patients with mild to moderate coronavirus disease (SARS-CoV-2/COVID-19)

NCT04501783 COVID-19 Drug: Favipiravir Drug: Standard of care (SOC) Drug: standard concomitant therapy

Primary Outcomes

Description: To determine the effect of TL-FVP-t vs. SOC on time to clinical improvement. The clinical improvement is defined as reduction on at least 1 score of patient clinical status according to WHO 8-category Ordinal Scale for Clinical Improvement compared to screening

Measure: Time to clinical improvement

Time: through Day 28

Description: To determine the effect of TL-FVP-t vs. SOC on time to viral clearance of SARS-CoV-2 virus as measured by PCR in oropharyngeal sampling

Measure: Time to viral clearance

Time: through Day 28

Secondary Outcomes

Description: To determine the effect of TL-FVP-t vs. SOC on proportion of subjects (%) with clinical improvement according to WHO 8-category Ordinal Scale for Clinical Improvement

Measure: Rate of clinical improvement at separate time points

Time: Day 7

Description: To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with viral clearance of SARS-CoV-2 virus as measured by PCR in oropharyngeal sampling at separate time points

Measure: Rate of viral clearance at separate time points

Time: Days 5 and 7

Description: To determine the effect of TL-FVP-t vs. SOC on time to body temperature normalization determined as body temperature < 37°C without antipyretics for at least 48 hours.

Measure: Time to body temperature normalization

Time: through Day 28

Description: To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with resolution of lung changes on CT

Measure: Rate of resolution of lung changes on CT

Time: Day 14

Description: To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with ADR and serious ADR

Measure: Rate of adverse drug reactions (ADR) and serious ADR

Time: through Day 28

Description: To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with severe ADR

Measure: Rate of severe ADR

Time: through Day 28

Description: To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) discontinued therapy due ADR

Measure: Rate therapy termination due to ADR

Time: through Day 28

No related HPO nodes (Using clinical trials)