CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

Matching PlaceboWiki

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


Correlated Drug Terms (5)

Name (Synonyms) Correlation
drug1471 Merimepodib Wiki 0.71
drug2414 TAK-831 50 mg Wiki 0.71
drug2415 TAK-831 500 mg Wiki 0.71
drug824 Eculizumab Wiki 0.50
drug2067 Remdesivir Wiki 0.18

Correlated MeSH Terms (2)

Name (Synonyms) Correlation
D012559 Schizophrenia NIH 0.41
D018352 Coronavirus Infections NIH 0.03

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0100753 Schizophrenia HPO 0.41

There are 2 clinical trials

Clinical Trials

1 A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study to Evaluate Pharmacodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of TAK-831 in Adult Subjects With Schizophrenia

The purpose of this study is to determine whether TAK-831 is superior to placebo in improving cerebellar function as measured with the average percentage of conditioned responses during the eyeblink conditioning (EBC) test.

NCT03359785 Schizophrenia Drug: TAK-831 500 mg Drug: TAK-831 50 mg Drug: Matching Placebo
MeSH:Schizophrenia
HPO:Schizophrenia

Primary Outcomes

Description: EBC is a method used to investigate cerebellar function. In EBC, a conditioned stimulus (CS), a tone precedes but co-terminates with an unconditioned stimulus (US), an airpuff to the eyelid. Learning is demonstrated when an eyeblink (the conditioned response [CR]) occurs prior to the onset of the US. The percentage can range from 0% (no conditioned learning has occurred) to 100% (all responses are conditioned).

Measure: Average Percentage of Conditioned Responses During the Eye Blink Conditioning (EBC) Test at Day 8

Time: Day 8: For each treatment period

Secondary Outcomes

Description: MMN is an event related potential (ERP) evoked in response to unattended changes in background stimulation. MMN reflects an automatic process of detecting a mismatch between a deviant stimulus and a sensory-memory trace. Smaller amplitudes of MMN have been consistently identified in schizophrenia participants. MMN amplitude will be measured at Midline frontal electrode (Fz) of electroencephalogram [EEG].

Measure: Mean Mismatch Negativity (MMN) at Day 8

Time: Day 8: For each treatment period

Description: The P300 wave is an ERP component that is elicited by the presentation of a novel, behaviorally relevant target stimulus embedded among irrelevant stimuli in a manner similar to MMN, but requiring active listening and responding from participants. Auditory stimuli are presented in an oddball paradigm consisting of 1 standard tone and 1 target tone. Participants are instructed to push a button as quickly as possible when they hear the target tone, but not when they hear the standard tone. P300 reflects allocation of attention and activation of immediate memory. P300 amplitude indexes brain actions when the mental representation of the stimulus environment is updated, while P300 latency indexes stimulus classification speed unrelated to response selection processes. P300 amplitude will be measured at midline parietal electrode (Pz) of EEG.

Measure: Mean P300 Amplitude at Day 8

Time: Day 8: For each treatment period

Description: ASSR are evoked oscillatory responses that are entrained to the frequency and phase of temporally modulated stimuli. Individuals with schizophrenia experience subjective sensory anomalies and objective deficits on assessment of sensory function. These deficits can be produced by abnormal signaling in the sensory pathways and sensory cortex or by later-stage disturbances in the cognitive processing of such inputs. ASSR can be used to assess the integrity of sensory pathways including cortical processing. ASSR will be measured at midline central electrode (Cz) of EEG.

Measure: Mean Auditory Steady State Response (ASSR) to 40 Hz Stimulation at Day 8

Time: Day 8: For each treatment period

Description: BACS is specifically designed to measure treatment- related improvements in cognition and includes alternate forms. The battery of tests in the BACS includes brief assessments of reasoning and problem solving, verbal fluency, attention, verbal memory, working memory, and motor speed. The primary measure from each test of the BACS is standardized by creating z-scores whereby the mean of the test session of a healthy participant is set to 0 and the standard deviation set to 1. A composite score was calculated by averaging all of the 6 standardized primary measures from the BACS, and then calculating a z-score of the composite. The composite z-score indicates how much higher or lower the participant's cognition is compared to a healthy person.

Measure: Brief Assessment of Cognition in Schizophrenia (BACS) Cognitive Battery Composite Score at Day 7

Time: Day 7: For each treatment period

Measure: Mean Concentration of Plasma D-serine and L-serine Levels at Day 8

Time: Day 8: For each treatment period

Measure: Mean Plasma D-serine to Total Serine Ratio at Day 8

Time: Day 8: For each treatment period

Measure: Mean Plasma Concentration of TAK-831

Time: Day 1, 7 and 8: For each treatment period

2 A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Oral Merimepodib in Combination With Intravenous Remdesivir in Adult Patients With Advanced Coronavirus Disease 2019 (COVID-19)

The purpose of this study is to assess the safety and efficacy of merimepodib (MMPD) oral solution when administered in combination with remdesivir in adult patients with advanced COVID-19.

NCT04410354 COVID-19 Drug: Merimepodib Drug: Matching Placebo Drug: Remdesivir

Primary Outcomes

Description: Proportion of subjects alive at Day 28 who are not hospitalized or if hospitalized are free of respiratory failure

Measure: Number of subjects not hospitalized or, if hospitalized, free of respiratory failure

Time: Day 0 to Day 28

Description: Number of Adverse Events (AEs) and number & percentage of subjects experiencing AEs after administration of the first dose of study drug

Measure: Adverse Events

Time: Day 0 to Day 56

Secondary Outcomes

Description: Change in NIAID 8-point ordinal scale, where 1=Death and 8=Not hospitalized, no limitations on activities

Measure: National Institute of Allergy and Infectious Disease (NIAID) 8-Point Ordinal Scale

Time: Day 0 to Day 28

Description: Duration of fever

Measure: Temperature

Time: Day 0 to Day 37

Description: Number of deaths

Measure: Death

Time: Day 0 to Day 56

Description: Need and duration of mechanical ventilation

Measure: Mechanical ventilation

Time: Day 0 to Day 56

Description: Duration of vasopressor support

Measure: Vasopressor Support

Time: Day 0 to Day 56

Description: Duration of oxygen therapy via mechanical ventilation, face mask or nasal cannula

Measure: Oxygen Therapy

Time: Day 0 to Day 37

Description: Time to cessation of viral shedding based on absence of SARS-CoV-2 in a PCR based COVID-19 test

Measure: Cessation of Viral Shedding

Time: Day 0 to Day 37

Description: Change in SpO2/FiO2

Measure: Change in Oxygen Saturation/Fraction of Inspired Oxygen

Time: Day 0 to Day 37

Related HPO nodes (Using clinical trials)

HP:0100753: Schizophrenia
Genes 72
MSTO1 PRODH ARSG NKX2-1 DRD3 DNAJC13 PRODH GJA5 SNCA CAT PSAP FLI1 GBA PDZD7 CHI3L1 DAOA LRRK2 SHANK3 MYO7A CIB2 GJA8 WFS1 UPF3B CLRN1 ATP2A2 COMT ARVCF KRT83 TBX1 HTR2A COMT ESPN TRNE KRT86 JMJD1C SYN2 RBM12 DSG4 MSTO1 MED12 ARSA DNMT3A SEC24C KRT81 VPS35 CHRNA7 CEP78 HIRA APOL2 RREB1 MYO7A MTHFR EIF4G1 TBX1 USH2A CDH23 ZDHHC9 GIGYF2 PCDH15 GP1BB USH1C RTN4R USH1G PRODH ADGRV1 HARS1 TBX1 APOL4 UFD1 TRNS2 DISC2 WHRN
Protein Mutations 7
D61804R N40D P50I S311C S9G V158M V66M
SNP 14
rs1006737 rs1256049 rs1799732 rs1801132 rs2023239 rs2069514 rs2234693 rs2494732 rs3813929 rs4244285 rs4680 rs6971 rs762551 rs9340799