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LAU-7bWiki

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


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug541 ChAdOx1 MERS Wiki 0.71
drug1852 Placebo oral capsule Wiki 0.58

Correlated MeSH Terms (2)

Name (Synonyms) Correlation
D013577 Syndrome NIH 0.11
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 RESOLUTION: A Double-blind, Randomized, Placebo-controlled, Pilot Phase II Study of the Efficacy and Safety of LAU-7b in the Treatment of Adult Hospitalized Patients With COVID-19 Disease

A randomized, double-blind, placebo-controlled Phase 2 Study of LAU-7b against confirmed COVID-19 Disease in hospitalized patients at a higher risk of complications.

NCT04417257 COVID-19 Disease Drug: LAU-7b Drug: Placebo oral capsule

Primary Outcomes

Description: 7-point ordinal scale, a higher score is worse than a low score. Not hospitalized, no limitations on activities; Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation; Death.

Measure: Health status of the patient on the 7-point ordinal scale (World Health Organization) compared to placebo

Time: On Day 14

Secondary Outcomes

Description: This will be assessed through monitoring and probing

Measure: The safety of LAU-7b therapy will be assessed through the monitoring of treatment emergent adverse events, compared to placebo

Time: From baseline to Day 29

Description: This will be assessed through daily health status scoring using the 7-point ordinal scale

Measure: Rate of COVID-19 disease-related aggravation, depicted by a change from baseline in the ordinal scale score of at least one category, compared to placebo

Time: From baseline to Day 29

Description: This will be assessed through daily health status scoring using the 7-point ordinal scale

Measure: Rate of COVID-19 disease-related transfer to intensive care unit, depicted by a change from baseline in the ordinal scale score to categories 5 or 6, compared to placebo

Time: From baseline to Day 29

Description: This will be assessed through daily health status scoring using the 7-point ordinal scale

Measure: Rate of COVID-19 disease-related transfer to mechanical ventilation, depicted by a change from baseline in the ordinal scale score to category 6, compared to placebo

Time: From baseline to Day 29

Description: This will be assessed through Days 14 and 29 health status scoring using the 7-point ordinal scale

Measure: Rate of COVID-19 disease-related death, depicted by a change from baseline in the ordinal scale score to category 7

Time: On Days 14 and 29

Description: 7-point ordinal scale, a higher score is worse than a low score. Not hospitalized, no limitations on activities; Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation; Death.

Measure: Health status of the patient on the 7-point ordinal scale (World Health Organization), compared to placebo

Time: On Day 29

Description: This will be assessed through daily health status scoring using the 7-point ordinal scale

Measure: Mean change from baseline of the ordinal scale patient health status as a function of assessment time, compared to placebo

Time: From baseline to Day 29

Description: This will be assessed through daily health status scoring using the 7-point ordinal scale

Measure: Time to an improvement of one category on the ordinal scale patient health status, compared to placebo

Time: From baseline to Day 29

Description: This will be assessed through daily health status scoring using the 7-point ordinal scale

Measure: Time to recovery, defined here as the time to reach categories 2 or 1 on the ordinal scale patient health status (first occurrence if more than once), compared to placebo

Time: From baseline to Day 29

Description: This will be assessed through daily health status scoring using the 7-point ordinal scale

Measure: Time to mechanical ventilation, defined here as time to reach category 6 on the ordinal scale patient health status, compared to placebo

Time: From baseline to Day 29

Description: This will be assessed through daily health status scoring using the 7-point ordinal scale

Measure: Time to death, defined here as a tim to reach category 7 on the ordinal scale patient health status, censored to Day 29 if it happens later than Day 29, compared to placebo

Time: From baseline to Day 29

Description: Monitoring of the hospitalization

Measure: Duration of hospitalization (days) within the study period Days 1-29, compared to placebo

Time: From baseline to Day 29

Description: This will be assessed through serial oropharyngeal swabs for SARS-CoV-2 viral detection

Measure: Time to attain an undetectable viral load through oropharyngeal swabs done at specified times, compared to placebo

Time: On Days 1, 5, 8, 12 and 14

Description: This will be assessed through questionnaire filling, in person or remotely

Measure: The change from baseline in the score obtained on the EQ-5D-5L quality-of-life survey

Time: On Days 1, 14, 29 and 60

No related HPO nodes (Using clinical trials)