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TofacitinibWiki

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


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug1086 Hydroxychloroquine Wiki 0.07
drug1822 Placebo Wiki 0.04

Correlated MeSH Terms (2)

Name (Synonyms) Correlation
D017563 Lung Diseases, Interstitial NIH 0.22
D011014 Pneumonia NIH 0.08

Correlated HPO Terms (2)

Name (Synonyms) Correlation
HP:0006515 Interstitial pneumonitis HPO 0.22
HP:0002090 Pneumonia HPO 0.08

There are 2 clinical trials

Clinical Trials

1 TOFAcitinib Plus Hydroxycloroquine vs Hydroxycloroquine in Patients With Early Onset SARS-CoV2 (COVID-19) Interstitial Pneumonia:a Multicenter Randomized Controlled Open Label Trial

Multifocal interstitial pneumonia represents the most common cause of admission in intensive care units and death in SARS-CoV2 infections. In our Hospital, similarly to what reported in literature, up to 25% of admitted patients with pneumonitis requires mechanical ventilation or oro-tracheal intubation within 5-10 days. No established treatment is available for this condition. Preliminary evidence is accumulating about the efficacy of an aggressive treatment of the corona virus-induced inflammation and, in particular, investigators believe that blocking JAK1 is clinically rewarding in down-regulating IL-6 driven inflammation in patients with corona-virus infection. Thus, investigators designed a randomized controlled trial to test the hypothesis that adding Tofacitinib to the standard treatment in the early phase of COVID related pneumonitis could prevent the development of severe respiratory failure needing mechanical ventilation.

NCT04390061 Pneumonitis, Interstitial COVID-19 Drug: Tofacitinib Drug: Hydroxychloroquine
MeSH:Pneumonia Lung Diseases, Interstitial
HPO:Interstitial pneumonitis Interstitial pulmonary abnormality Pneumonia

Primary Outcomes

Description: Rate of patients needing mechanical ventilation to maintain PaO2/FIO2>150

Measure: Prevention of severe Respiratory Failure requiring mechanical ventilation

Time: 14 days

Secondary Outcomes

Description: Rate of patients needing admission to the intensive care unit

Measure: Prevention of need of ICU admission

Time: 28 days

Description: Rate of patients who die due to COVID-19 related conditions

Measure: Prevention of COVID-19 related Deaths

Time: 28 days

Description: Role of some clinical and laboratory factors in predicting outcome (Age, sex, smoking status, Body Mass Index (BMI), Comorbidities (Diabetes, number of comorbidities), Respiratory Failure at admission defined as PaO2/FiO2<300, Extension of Ct-scan involvement, basal level of serum IL-6, vW-Factor, Thrombomodulin, KL-6, sACE2 and SP-D )

Measure: Identification of predictors of outcome

Time: 14 days

Description: Rate of severe drug-related adverse events

Measure: Incidence of Treatment-Emergent Adverse Events

Time: 28 days

2 A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY ASSESSING THE SAFETY AND EFFICACY OF TOFACITINIB IN HOSPITALIZED PARTICIPANTS WITH COVID-19 PNEUMONIA WHO ARE RECEIVING STANDARD OF CARE THERAPY

The study is designed as a multicenter, randomized, double-blind, placebo-controlled, parallel group study of the safety and efficacy of tofacitinib in hospitalized adult participants with COVID-19 pneumonia who are receiving SoC therapy and who are not on HFNC, noninvasive ventilation, invasive mechanical ventilation, or ECMO on Day 1 at the time of randomization. Participants with laboratory confirmed SARS-CoV-2 infection as determined by a positive PCR or other commercially available or public health assay, who have agreed to participate will be screened within 48 hours after hospitalization to determine eligibility. This should be completed within 48 hours prior to Day 1. Eligible participants will be randomized on Day 1 in a 1:1 ratio to the tofacitinib treatment group or the placebo treatment group and will receive treatment for up to 14 days, or until discharge from the hospital, whichever is earlier. If a participant requires intubation prior to the end of the 14-day treatment period, they will continue to receive tofacitinib or matching placebo until Day 14 (or until discharge from the hospital, if earlier than Day 14), if clinically appropriate. Participants will be assessed daily (up to Day 28) while hospitalized for clinical, safety, and laboratory parameters. Follow-up visits will occur on Day 28, 28 to 35 days after the ET/ED/EOT visit, and on Day 60. An independent, external DSMB will be convened to oversee the safety of participants and make recommendations regarding the conduct of the trial in accordance with the Charter.

NCT04412252 COVID-19 Drug: Tofacitinib Other: Placebo
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Death or respiratory failure (1, 2, or 3, on an 8-point ordinal scale of disease severity) at Day 28. 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: Clinical status using ordinal scale

Time: Day 28

Secondary Outcomes

Description: Ordinal scale of disease severity. 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: Clinical status using ordinal scale

Time: Day 14

Description: Category 3 to 8 on an ordinal scale of disease severity. The scale is as follows: 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: Status of alive and not using mechanical ventilation or extracorporeal membrane oxygenation (ECMO)

Time: Day 14 and Day 28

Description: Category 5 to 8 on an ordinal scale of disease severity. The scale is as follows: 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: Status of discharged or not requiring supplemental oxygen

Time: Day 28

Description: Category 1 on an ordinal scale of disease severity. The scale is as follows: 1) Death.

Measure: Mortality

Time: Day 60

Related HPO nodes (Using clinical trials)

HP:0006515: Interstitial pneumonitis
Genes 9
TERC PLCG2 SFTPB RAG1 SFTPC TERT STAT3 FOXP3 TINF2
Protein Mutations 1
S1009A
SNP 0
HP:0006530: Interstitial pulmonary abnormality
Genes 110
SFTPA2 NKX2-1 TERT COPA IRF5 TERT FSHR CAV1 STAT3 CASP10 CTLA4 THOC2 UNC119 TERC SFTPC RASGRP1 RAG1 SFTPC HLA-DRB1 RNF168 HLA-DRB1 SPIDR CLCA4 POLR3H FAM13A STN1 DSP ERF SCARB2 ITGA3 NHP2 MUC5B TERT NR5A1 CCR6 RTEL1 DKC1 DCTN4 BTNL2 PTPN22 CFTR BTNL2 PRTN3 GBA HPS1 STX1A HLA-DRB1 BMP15 FARSB HPS4 ALMS1 GBA BMPR2 STING1 TINF2 PARN TERT CCN2 FOXP3 IRF5 TINF2 CSF2RB FASLG SP110 SFTPC NSMCE3 SMPD1 ABCA3 KIAA0319L SFTPB AP3D1 FAS MARS1 BNC1 PARN TERC CAV1 SFTPA1 IL1RN TERC NOP10 MARS1 PLCG2 RNF168 PSMC3IP RTEL1 HLA-DRB1 CSF2RA SFTPB SFTPA2 FAS CCR6 PLEC ABCA3 HLA-DPB1 MRPS22 HLA-DPA1 GBA RCBTB1 PRKCD TERT ATP11A TGFB1 DPP9 CCN2 MUC5B NUP107 FAM111B AP3B1 ASAH1
Protein Mutations 0
SNP 0
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