CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

OpaganibWiki

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


Correlated Drug Terms (1)

Name (Synonyms) Correlation
drug1016 Placebo Wiki 0.08

Correlated MeSH Terms (3)

Name (Synonyms) Correlation
D011014 Pneumonia NIH 0.07
D045169 Severe Acute Respiratory Syndrome NIH 0.06
D018352 Coronavirus Infections NIH 0.05

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia: a Randomized, Double-blind, Placebo-Controlled Phase 2a Study, in Adult Subjects Hospitalized With SARS-CoV-2 Positive Pneumonia

Opaganib, a sphingosine kinase-2 (SphK2) inhibitor, has been broadly tested in Phase I/II studies. Extensive nonclinical data indicates both anti-viral and anti-inflammatory activity via selective SphK2 inhibition which may prove beneficial for treating COVID-19 infection and resulting pneumonia. This proof of concept study will take place in the US and will enroll about 40 hospitalized patients diagnosed with COVID-19 infection who have developed pneumonia and require supplemental oxygen. Half of the patients, i.e. 20 patients, will receive opaganib in addition to standard of care for 14 days. The other 20 will receive matching placebo (capsules that do not contain the medication) in addition to standard of care. Study drug will be administered every day for 14 days, twice each day, unless the patient has been discharged from the hospital without requiring supplemental oxygen, in which case study drug will only be administered for 10 days. All participants will be followed up for 4 weeks after their last dose of study drug.

NCT04414618 Coronavirus Infections Drug: Opaganib Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Measurement of the oxygen requirement

Measure: Evaluation of the total oxygen requirement (area under the curve) using daily supplemental oxygen flow (L/min) over 14 days

Time: Every day from day 1 to day 14 of treatment

Secondary Outcomes

Description: Measurement of the oxygen requirement

Measure: Evaluation of the time to 50% reduction from baseline in supplemental oxygen based on oxygen flow in L/min

Time: Every day from day 1 to day 14 of treatment

Measure: Evaluation of the proportion of patients no longer requiring supplemental oxygen for at least 24 hours by Day 14

Time: From screening phase and every day from day 1 to day 14 of treatment

Description: Measurement of temperature

Measure: Evaluation of the proportion of afebrile patients at Day 14

Time: From screening phase and every day from day 1 to day 14 of treatment

Description: Nasopharyngeal or oropharyngeal swab for SARS-CoV-2

Measure: Evaluation of the time to negative swabs for SARS-CoV-2 by PCR

Time: From screening phase and every day from day 1 to day 14 of treatment and at the end of the 4 weeks follow-up after the end of treatment

Description: Nasopharyngeal or oropharyngeal swab for SARS-CoV-2

Measure: Evaluation of the proportion of patients with negative swabs for SARS-CoV-2 by PCR at Day 14

Time: From screening phase and every day from day 1 to day 14 of treatment and at the end of the 4 weeks follow-up after the end of treatment

Measure: The percentage of patients who require intubation and mechanical ventilation by Day 14

Time: From screening phase and every day from day 1 to day 14 of treatment

Measure: Evaluation of the time to mechanical ventilation

Time: From screening phase and every day from day 1 to day 14 of treatment

Description: Evaluation the proportion of patients, with at least one measurement of fever at baseline (defined as temperature >38.0 C[100.4 F]), who are afebrile (defined as temperature <37.2C [99 F]) at Day 14

Measure: Evaluation the proportion of patients, with at least one measurement of fever at baseline who are afebrile at Day 14

Time: From screening phase and every day from day 1 to day 14 of treatment

Measure: Evaluation of mortality 30 days post-baseline

Time: 30 days after day 1 of treatment

Other Outcomes

Measure: To determine the incidence rate of all treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

Time: Every day from day 1 to day 14 of treatment and at end of the 4 weeks follow-up after the end of treatment

Related HPO nodes (Using clinical trials)

HP:0002090: Pneumonia
Genes 211
CCDC103 JAK3 IL2RG CD247 DNAI1 DOCK8 CSPP1 RYR1 IL2RG DNAAF2 JAK3 OFD1 PRKCD RSPH4A IGHM CCNO GAS8 DCLRE1C ZBTB24 NOTCH3 ZAP70 OSTM1 TK2 LRRC56 TGFB1 NKX2-1 DNAH11 CHD7 FOXP3 RANBP2 DNAI2 CR2 RNU4ATAC SETBP1 NADK2 SPAG1 COL11A2 TNFRSF13C SFTPC HYDIN DNAH9 IL2RG SRP54 TNFSF12 ICOS FCGR2A ADA DNAH5 GRHL3 UBB AFF4 KIAA0586 IL7R TERT DNAH1 DNAI1 ORC6 MASP2 DCLRE1C RSPH3 MTHFD1 AFF4 IRF8 ELANE CCDC39 NME8 CASP8 CARD11 DNAAF4 SLC35C1 EPM2A CD81 KMT2D TNFSF12 UNC119 LRBA NCF2 USB1 CCDC114 NBN DCLRE1C RMRP NFKB2 SFTPA2 RSPH1 RAG2 ADA EGFR CCDC114 WAS TNFRSF13C KDM6A IL21R TNFRSF13B TBC1D24 ICOS SLC25A24 NFKB1 PNP NFIX RAG1 ARMC4 ADA STAT3 DNMT3B RAG2 CFAP300 BTK GFI1 TAF1 SPEF2 RNF125 IL2RG NCF1 TNFRSF13C CXCR4 CARD11 CD55 OFD1 CCDC151 FOXJ1 ZMYND10 PEPD GNPTAB RAG1 PIGN ALMS1 MED25 CFAP410 BTK RAC1 ACP5 ACTA1 CD19 GBA TNFRSF11A CD79B DRC1 SMARCD2 NFKB2 STK36 ZAP70 RNU4ATAC DNAAF3 P4HTM RSPH9 SAMD9 IGLL1 RPGR TNFRSF13B LTBP3 DNAL1 CFAP298 CYBA BTK MS4A1 ICOS DNAAF1 LIG4 CR2 ACADVL RAG1 GAS2L2 NSMCE3 CFAP221 SGCG FMO3 DNAAF6 DNAAF5 TTC25 PMM2 COL11A2 TCIRG1 TIMM8A SELENON RAG2 MUC5B SLC35A1 PGM3 EXTL3 KPTN CACNA1C CD3E CD19 CYBB LRRC6 KCNJ6 RNF168 IFNGR1 CD3D GAS8 CFTR PLOD1 POLA1 NBN PANK2 BLNK CFB WDR19 IL7R SP110 MCIDAS PTPRC TBCD CCDC40 NIPBL LEP NHLRC1 DDR2 DNAJB13 CCDC65
Protein Mutations 6
A2063G G551D K55R L460D R287Q S1009A
SNP 0