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Apilimod Dimesylate CapsuleWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)

Name (Synonyms) Correlation
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D018450 Disease Progression NIH 0.26

Correlated HPO Terms (0)

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There is one clinical trial.

Clinical Trials

1 A Phase II Randomized, Double-Blind, Placebo-Controlled Study of LAM-002A for the Prevention of Progression of COVID-19

This is a clinical trial to evaluate the efficacy of LAM-002A compared to placebo treatment in adults with a confirmed SARS-CoV-2 infection who are receiving standards supportive care in an outpatient setting.

NCT04446377 COVID-19 Disease Drug: Apilimod Dimesylate Capsule Other: Placebo
MeSH:Disease Progression

Primary Outcomes

Description: To evaluate the antiviral efficacy of LAM-002A in participants with COVID-19 as the change from baseline (Day 1, pre-dose) of SARS-CoV-2 viral load as measured by qRT-PCR from nasopharyngeal samples on day 4

Measure: Viral Load Change

Time: 4 Days

Secondary Outcomes

Description: To evaluate the antiviral efficacy of LAM-002A in participants with COVID-19 as the change from baseline (Day 1, pre-dose) of SARS-CoV-2 viral load as measured by qRT-PCR from nasopharyngeal samples on day 6, compared between the LAM-002A arm and the placebo arm.

Measure: Viral Load Change

Time: 6 Days

Description: To evaluate the antiviral efficacy of LAM-002A in participants with COVID-19 as the change from baseline (Day 1, pre-dose) of SARS-CoV-2 viral load as measured by qRT-PCR from nasopharyngeal samples on day 8, compared between the LAM-002A arm and the placebo arm.

Measure: Viral Load Change

Time: 8 Days

Description: To evaluate the antiviral efficacy of LAM-002A in participants with COVID-19 as the change from baseline (Day 1, pre-dose) of SARS-CoV-2 viral load as measured by qRT-PCR from nasopharyngeal samples on day 11, compared between the LAM-002A arm and the placebo arm.

Measure: Viral Load Change

Time: 11 Days

Description: To evaluate the antiviral efficacy of LAM-002A in participants with COVID-19 as the change from baseline (Day 1, pre-dose) of SARS-CoV-2 viral load as measured by qRT-PCR from nasopharyngeal samples on day 28, compared between the LAM-002A arm and the placebo arm.

Measure: Viral Load Change

Time: 28 Days

Description: To evaluate the anti-viral efficacy of LAM-002A in participants with COVID-19 as difference in SARS-Cov-2 viral load as measured by qRT-PCR from nasopharyngeal samples based on AUC (days1-28), between LAM-002A arm and placebo arm.

Measure: Viral Load AUC

Time: 28 Days

Description: The proportion of LAM-002A treated patients who develop treatment-emergent adverse events (TEAEs) compared to placebo. TEAEs will be defined as AEs that occur on or after the date and time of study drug administration, or those that first occur pre-dose but worsen in frequency or severity after study drug administration. AEs will be followed up until complete resolution or until the Principal Investigator (PI) or Sub-Investigator deems it safe to discontinue followup.

Measure: Safety and Tolerability measured in proportion of TEAEs

Time: 28 Days

Other Outcomes

Description: To evaluate the efficacy of LAM-002A in preventing COVID-19 disease progression in participants who have proven infection with SARS-CoV-2 virus as determined by a molecular test and who have mild manifestations of COVID-19 and less than or equal to 4 days of symptoms; disease progression is defined as occurance of death or hospitalization at day 28.

Measure: Clinical Efficacy in prevention of hospitalization or death

Time: 28 Days

Description: To compare the proportion of participants at or above 95% oxygen saturation (O2 sat) between LAM-002A versus placebo.

Measure: Oxygen Saturation

Time: 1 Days

Description: To compare the proportion of participants at or above 95% oxygen saturation (O2 sat) between LAM-002A versus placebo.

Measure: Oxygen Saturation

Time: 4 Days

Description: To compare the proportion of participants at or above 95% oxygen saturation (O2 sat) between LAM-002A versus placebo.

Measure: Oxygen Saturation

Time: 6 Days

Description: To compare the proportion of participants at or above 95% oxygen saturation (O2 sat) between LAM-002A versus placebo.

Measure: Oxygen Saturation

Time: 8 Days

Description: To compare the proportion of participants at or above 95% oxygen saturation (O2 sat) between LAM-002A versus placebo.

Measure: Oxygen saturation

Time: 11 Days

Description: Change in COVID-19 clinical status as defined by the ordinal scale, of participants treated with LAM-002A as compared with placebo at Day 28, in participants who become hospitalized and continue LAM-002A/placebo treatment, based on the following scores: Not in the hospital Hospitalized, requiring low flow supplemental oxygen (such as nasal cannula) Hospitalized, not on invasive ventilation (such as 100% non-rebreather, BIPAP), (pre-ICU) Hospitalized, in the ICU, on invasive ventilation or ECMO Dead For participants (who have the same ordinal score), control versus experimental arms will be compared based on percentage of participants at each score.

Measure: Clinical Status defined by ordinal scale

Time: 28 days

No related HPO nodes (Using clinical trials)