CovidResearchTrials by Shray Alag

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OpaganibWiki

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


Correlated Drug Terms (4)

Name (Synonyms) Correlation
drug2652 Virtual Care at Home Wiki 0.58
drug2808 ensoETM device Wiki 0.58
drug2319 Standard of Care Wiki 0.11
drug1822 Placebo Wiki 0.07

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 (1)

Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.07

There are 3 clinical trials

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

2 Compassionate Use of Opaganib in Patients With Severe COVID-19

Shaare-Zedek Medical Center is a tertiary academic hospital in Jerusalem, Israel. On March 2020, a dramatic increase in the number of COVID-19 cases were diagnosed in Jerusalem. RedHill Biopharma, Ltd. offered opaganib under compassionate use for the treatment of COVID-19 patients. Eligible patients were those hospitalized with COVID-19 confirmed by a reverse-transcriptase-polymerase-chain-reaction assay. Patients received opaganib and Standard of Care. For the purpose of this study, the opaganib and Standard of Care patient group was compared to a group of patients that received only Standard of Care. Opaganib is an investigational drug under development and not approved for commercial distribution.

NCT04435106 Coronavirus Infections Drug: Opaganib Drug: Standard of Care
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Measure the time to weaning from high-flow nasal cannula

Time: Every day from day 1 to day 14

Measure: Measure the time to breathing ambient (room) air

Time: Every day from day 1 to day 14

Secondary Outcomes

Measure: Measure change in lymphocyte count

Time: On day of admission or day 1 of treatment and every 2-4 days, till day 14

Measure: Measure change in C-reactive protein

Time: On day of admission or day 1 of treatment and every 2-4 days, till day 14

3 Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia: a Randomized, Double-blind, Placebo-Controlled Phase 2/3 Study, in Adult Subjects Hospitalized With Severe SARS-CoV-2 Positive Pneumonia

A phase 2/3 multi-center randomized, double-blind, parallel arm, placebo- controlled study in Adult Subjects Hospitalized with Severe SARS-CoV-2 Positive Pneumonia to determine the potential of opaganib to improve and/or stabilize the clinical status of the patient.

NCT04467840 COVID-19 Lung Infection Drug: Opaganib Drug: Placebo
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: To compare the proportion of patients requiring intubation and mechanical ventilation by Day 14 between subjects taking opaganib and those on placebo.

Measure: Intubation and mechanical ventilation

Time: 14 days

Secondary Outcomes

Description: Compare scores of subjects taking opaganib and those on placebo, lower scores indicate improvement.

Measure: WHO Ordinal Scale for Clinical Improvement with a scale ranging from 8 down to 0

Time: 14 days

Description: To compare the time to intubation and mechanical ventilation between subjects taking opaganib and those on placebo.

Measure: Time to intubation and mechanical ventilation

Time: 14 days

Description: To compare the time to low oxygen flow via nasal cannula e.g. from high oxygen flow via nasal cannula or CPAP, if high oxygen flow is not an available option between subjects taking opaganib and those on placebo.

Measure: Time to low oxygen flow via nasal cannula

Time: 14 days

Description: To compare the proportion of patients no longer requiring supplemental oxygen for at least 24 hours by Day 14 between subjects taking opaganib and those on placebo.

Measure: Supplemental oxygen requirement

Time: 14 days

Description: To compare the total oxygen requirement (area under the curve) using daily supplemental oxygen flow (L/min) over 14 days (Day 1 to Day 14) between subjects taking opaganib and those on placebo.

Measure: Total daily oxygen requirement

Time: 14 days

Description: To compare the time to two consecutive negative swabs for SARS-CoV-2 by PCR between subjects taking opaganib and those on placebo.

Measure: Time to negative swabs for SARS-CoV-2

Time: 14 days

Description: To compare the proportion of patients with two consecutive negative swabs for SARS-CoV-2 by PCR at Day 14 between subjects taking opaganib and those on placebo.

Measure: Negative swabs for SARS-CoV-2 at day 14

Time: 14 days

Description: To compare 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 between subjects taking opaganib and those on placebo.

Measure: Fever

Time: 14 days

Description: To compare mortality 30 days post-baseline between subjects taking opaganib and those taking placebo

Measure: Mortality

Time: 30 days post baseline

Other Outcomes

Description: To compare the number of adverse events in patients with severe COVID-19 pneumonia between subjects taking opaganib and subjects taking placebo

Measure: Adverse events

Time: Up to 14 days and at the end of the 4 weeks follow-up after the end of treatment

Description: To compare the change in the systemic marker of inflammation, D-dimer, over the treatment period between subjects taking opaganib and those on placebo.

Measure: Inflammatory markers - D-dimer

Time: 14 days

Description: To compare the change in the systemic marker of inflammation, cardiac troponin, over the treatment period between subjects taking opaganib and those on placebo.

Measure: Inflammatory markers - cardiac troponin

Time: 14 days

Description: To compare the change in the systemic marker of inflammation, C-reactive protein [CRP], over the treatment period between subjects taking opaganib and those on placebo.

Measure: Inflammatory markers - C-reactive protein

Time: 14 days

Description: To compare the change in the systemic marker of inflammation lactate dehydrogenase [LDH] over the treatment period between subjects taking opaganib and those on placebo.

Measure: Inflammatory markers - lactate dehydrogenase

Time: 14 days

Description: To compare the change in the systemic marker of inflammation ferritin over the treatment period between subjects taking opaganib and those on placebo.

Measure: Inflammatory markers - ferritin

Time: 14 days

Related HPO nodes (Using clinical trials)

HP:0002090: Pneumonia
Genes 220
KMT2D OSTM1 GBA RSPH1 DOCK8 NKX2-1 RNU4ATAC SPAG1 RAG1 MCIDAS AFF4 TNFRSF13C DNAH1 NOTCH3 CD19 ALMS1 NADK2 UNC119 SFTPC FOXN1 CD79B CFAP221 CD81 SAMD9 MED25 ZAP70 RAG2 IGLL1 DNAAF1 RPGR STK36 LTBP3 PLOD1 DNAH9 BTK TERT COL11A2 OFD1 TNFRSF11A LRBA RSPH4A CD19 NME8 SMARCD2 GAS8 CFTR TNFRSF13B CCDC65 CFAP298 COL11A2 RAG1 ORC6 P4HTM MAN2B1 CFAP300 JAK3 CACNA1C ICOS SETBP1 TNFRSF13C SPEF2 LIG4 NIPBL STAT3 ZMYND10 IL7R MAN2B1 HLA-DQA1 IL21R SELENON SP110 ACADVL CCDC39 ARMC4 NSMCE3 NFIX DNAI2 ACP5 PTPRC ZAP70 KIAA0586 FCGR2A NFKB2 NEK10 MTHFD1 EGFR RYR1 ADA DNAI1 TGFB1 DNAAF6 IL2RG KCNJ6 DCLRE1C CCDC103 IGHM GNPTAB DNAAF4 PNP CFB DCLRE1C TAF1 CARD11 USB1 ADA ICOS FMO3 IL2RG HLA-DQB1 GFI1 SFTPA2 ICOS CD3D FOXJ1 CRLF1 ELANE IL2RG SRP54 NFKB1 PANK2 GAS2L2 CD247 IRF8 GAS8 RAG2 CCDC151 WAS ZBTB24 CD3E DNAL1 EXTL3 SLC35A1 NCF1 TK2 MS4A1 IFNGR1 RNF168 RMRP RSPH9 NHLRC1 MUC5B TNFRSF13C DNAH5 DNMT3B RNF125 EPM2A TTC12 JAK3 LEP RAC1 CYBA PGM3 NOS1 DDR2 AFF4 TBC1D24 CHD7 TNFRSF13B OFD1 DNAI1 RANBP2 TCIRG1 DNAJB13 CR2 CCDC40 IL2RG NCF2 RAG2 SLC25A24 SGCG WDR19 FOXP3 RNU4ATAC ACTA1 UBB CFAP410 BTK TTC25 CARD11 DNAAF2 CXCR4 MASP2 DRC1 TBCD DCLRE1C CYBB RSPH3 LRRC6 PIGN TNFSF12 DNAAF5 CCNO CSPP1 CR2 SLC35C1 HYDIN TIMM8A NBN NFKB2 CCDC114 CASP8 ADA IL7R CCDC114 TNFSF12 BTK LRRC56 PEPD BLNK CD55 GRHL3 NBN PRKCD KPTN PMM2 DNAAF3 KDM6A POLA1 RAG1 DNAH11
Protein Mutations 6
A2063G G551D K55R L460D R287Q S1009A
SNP 0