CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

DuvelisibWiki

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


Correlated Drug Terms (6)

Name (Synonyms) Correlation
drug3299 imaging, blood tests Wiki 0.71
drug771 Cooking Training Wiki 0.71
drug2824 Table Setting Training Wiki 0.71
drug1789 Multi-tasking Training Wiki 0.71
drug2093 Peripheral blood draw Wiki 0.50
drug2122 Placebo Wiki 0.07

Correlated MeSH Terms (4)

Name (Synonyms) Correlation
D060825 Cognitive Dysfunction NIH 0.22
D011014 Pneumonia NIH 0.04
D045169 Severe Acute Respiratory Syndrome NIH 0.03
D018352 Coronavirus Infections NIH 0.03

Correlated HPO Terms (2)

Name (Synonyms) Correlation
HP:0001268 Mental deterioration HPO 0.22
HP:0002090 Pneumonia HPO 0.04

There are 2 clinical trials

Clinical Trials

1 A Pilot Study of Duvelisib to Combat COVID-19

The exceedingly high mortality rates of severe and critical COVID-19 warrant the identification and evaluation of novel therapies that could potentially mitigate the advanced disease manifestations. Based on preclinical data from this institution and others, the investigators hypothesize that PI3K inhibition with duvelisib could potentially quell aberrant hyperactivtation of the innate immune system, preferentially polarize macrophages, reduce pulmonary inflammation, and limit viral persistence, thereby improving patient outcomes.

NCT04372602 COVID-19 Drug: Duvelisib Procedure: Peripheral blood draw Drug: Placebo

Primary Outcomes

Measure: Overall survival

Time: Through 28 days

Secondary Outcomes

Measure: Length of hospital stay

Time: Through completion of follow-up (estimated to be 7 months)

Measure: Length of ICU stay

Time: Through completion of follow-up (estimated to be 7 months)

Description: -For those on a ventilator at the time of randomization

Measure: Duration of ventilator use

Time: Through completion of follow-up (estimated to be 7 months)

Measure: Duration of vasopressors use

Time: Through completion of follow-up (estimated to be 7 months)

Measure: Duration on renal replacement therapy

Time: Through completion of follow-up (estimated to be 7 months)

Description: -Defined as increase in viral load of >0.5 log on two consecutive days, or >1 log increase in one day, not in keeping with any baseline trend of rising viral loads during the pre-treatment viral testing

Measure: Viral kinetics as measured by virologic failure

Time: Through completion of follow-up (estimated to be 7 months)

Measure: Number of adverse events as measured by CTCAE v. 5.0

Time: Through completion of follow-up (estimated to be 7 months)

2 Duvelisib Ameliorates Manifestations of Pneumonia in Established Novel Coronavirus Infection

In this study, a total of 80 patients with severe coronavirus disease 2019 (COVID-19) infection will be randomized to receive Duvelisib or a placebo. Participants will be enrolled at Emory University Hospital and at the University of Pennsylvania and will be identified and recruited by their treating physician and research team.

NCT04487886 COVID-19 Drug: Duvelisib Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: This is a composite endpoint of the number of participants who require mechanical ventilation or who die within four weeks of randomization.

Measure: Number of Participants Requiring Mechanical Ventilation or Dying

Time: Up to Day 29

Secondary Outcomes

Description: Time to recovery (in days) is defined as a score of greater than 5 from the following eight categories from the NIAID ordinal scale. The scale is as follows: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized, limitation on activities and/or requiring home oxygen; 8. Not hospitalized, no limitations on activities.

Measure: Days to Recovery

Time: Up to Day 29

Description: The number of days spent hospitalized will be compared between study arms.

Measure: Duration of Hospitalization

Time: Up to Day 29

Description: The incidence of death within 29 days of randomization will be compared between study arms.

Measure: Incidence of Death

Time: Up to Day 29

Description: Comparing the proportion of subjects in each group requiring ICU transfer within 29 days of randomization

Measure: Proportion of Participants Transferred to ICU

Time: Up to Day 29

Description: The ECOG Performance Status instrument includes a single item assessing overall physical status. Health status is rated on a scale of 0 to 5 where 0 = fully active and 5 = dead. Median ECOG performance will be compared between study arms.

Measure: Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score

Time: Day 15, Day 29

Description: The incidence of grade III-V adverse events or Serious Adverse Events (SAEs), as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5, will be compared between study arms.

Measure: Incidence of Grade III-V Adverse Events

Time: Up to Day 29

Description: The incidence of documented secondary bacterial or viral infections among participants will be compared between study arms.

Measure: Incidence of Secondary Bacterial or Viral Infections

Time: Up to Day 29

Description: The mean frequency of Th1 T cells in blood mononuclear cells will be compared between study arms.

Measure: Change in Th1 T Cell Frequency

Time: Weeks 1, 2, and 4

Description: The mean frequency of Th17 T cells in blood mononuclear cells will be compared between study arms.

Measure: Change in Th17 T Cell Frequency

Time: Weeks 1, 2, and 4

Description: Mean levels of the inflammatory serum biomarker IL-2 will be compared between study arms.

Measure: Change in Interleukin-2 (IL-2)

Time: Weeks 1, 2, and 4

Description: Mean levels of the inflammatory serum biomarker IL-2R will be compared between study arms.

Measure: Change in Interleukin-2 receptor (IL-2R)

Time: Weeks 1, 2, and 4

Description: Mean levels of the inflammatory serum biomarker IL-6 will be compared between study arms.

Measure: Change in Interleukin-6 (IL-6)

Time: Weeks 1, 2, and 4

Description: Mean levels of the inflammatory serum biomarker IL-7 will be compared between study arms.

Measure: Change in Interleukin-7 (IL-7)

Time: Weeks 1, 2, and 4

Description: Mean levels of the inflammatory serum biomarker IL-8 will be compared between study arms.

Measure: Change in Interleukin-8 (IL-8)

Time: Weeks 1, 2, and 4

Description: Mean levels of the inflammatory serum biomarker IL-10 will be compared between study arms.

Measure: Change in Interleukin-10 (IL-10)

Time: Weeks 1, 2, and 4

Description: Mean levels of the inflammatory serum biomarker IP-10 will be compared between study arms.

Measure: Change in Interferon gamma-induced Protein 10 (IP-10)

Time: Weeks 1, 2, and 4

Description: Mean levels of the inflammatory serum biomarker MIP-1a will be compared between study arms.

Measure: Change in Macrophage Inflammatory Protein 1alpha (MIP-1a)

Time: Weeks 1, 2, and 4

Description: Mean levels of the inflammatory serum biomarker MCP-1 will be compared between study arms.

Measure: Change in Monocyte Chemoattractant Protein-1 (MCP-1)

Time: Weeks 1, 2, and 4

Description: Mean levels of the inflammatory serum biomarker G-CSF will be compared between study arms.

Measure: Change in Granulocyte Colony-stimulating Factor (G-CSF)

Time: Weeks 1, 2, and 4

Description: Mean levels of the inflammatory serum biomarker TNF-alpha will be compared between study arms.

Measure: Change in Tumor Necrosis Factor (TNF)-alpha

Time: Weeks 1, 2, and 4

Description: VIP is a peptide hormone with immunosuppressive properties. Mean levels VIP will be compared between study arms.

Measure: Change in Vasoactive Intestinal Peptide (VIP)

Time: Weeks 1, 2, and 4

Description: Mean levels of the Tregs will be compared between study arms.

Measure: Change in Gene Expression Profile of Regulatory T Cells (Tregs)

Time: Weeks 1, 2, and 4

Description: Mean levels of CD8+IFNg+GM-CSF+ will be compared between study arms.

Measure: Change in Gene Expression Profile of cluster of differentiation 8 (CD8)+Interferon Gamma (IFNg)+ Granulocyte-macrophage colony-stimulating factor (GM-CSF)+

Time: Weeks 1, 2, and 4

Description: Mean levels of CD8+Tim3+PD-1+ will be compared between study arms.

Measure: Change in Gene Expression Profile of CD8+ T cell immunoglobulin and mucin domain-containing protein 3 (Tim3)+ Programmed cell death protein 1 (PD-1)+

Time: Weeks 1, 2, and 4

Description: Mean levels of CD14+CD16+ monocytes will be compared between study arms.

Measure: Change in Gene Expression Profile of cluster of differentiation 14 (CD14)+ cluster of differentiation (CD16)+ monocytes

Time: Weeks 1, 2, and 4

Description: Mean levels of SARS-CoV-2 viremia in respiratory specimens will be compared between study arms.

Measure: Change in SARS-CoV-2 Viremia

Time: Weeks 1, 2, and 4

Description: Median titers of IgG antibodies to SARS-CoV-2 will be compared between study arms.

Measure: Change in Immunoglobulin G (IgG) Antibodies

Time: Weeks 1, 2, and 4

Description: Median titers of IgM antibodies to SARS-CoV-2 will be compared between study arms.

Measure: Change in Immunoglobulin M (IgM) Antibodies

Time: Weeks 1, 2, and 4

Description: Overall survival is defined as days from randomization to death and censored at last follow up.

Measure: Overall Survival

Time: Up to Day 29

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