Covid 19 Clinical Trials

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: 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 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: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

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Correlated Drug Terms (1)

Correlated MeSH Terms (1)

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Clinical Trials

1 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