Covid 19 Research using Clinical Trials (Home Page)
PrednisoneWiki
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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug438 | Filgotinib Wiki | 0.41 |
| drug869 | Placebo to match filgotinib Wiki | 0.41 |
| drug306 | Control group Wiki | 0.33 |
| drug503 | Hydrocortisone Wiki | 0.33 |
Correlated MeSH Terms (3)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D014605 | Uveitis NIH | 0.58 |
| D011014 | Pneumonia NIH | 0.09 |
| D011024 | Pneumonia, Viral NIH | 0.08 |
Correlated HPO Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0000554 | Uveitis HPO | 0.58 |
| HP:0002090 | Pneumonia HPO | 0.09 |
There are 3 clinical trials
Clinical Trials
1 A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects With Active Noninfectious Uveitis
The primary objective of this study is to evaluate the efficacy of filgotinib versus placebo for the treatment of the signs and symptoms of noninfectious uveitis in participants failing treatment for active noninfectious uveitis.
NCT03207815 Noninfectious Uveitis Drug: Filgotinib Drug: Placebo to match filgotinib Drug: Prednisone MeSH:Uveitis
HPO:Uveitis
Primary Outcomes
Description: Treatment failure will be defined as a participant meeting at least one of the following criteria in at least one eye:
New active, inflammatory lesions relative to Day 1/Baseline (during all visits beginning Week 6 visit)
Inability to achieve ≤ grade 0.5+ (at Week 6); or 2-step increase (all visits after Week 6) relative to best state achieved in Anterior Chamber Cell grade (SUN Criteria)
Inability to achieve ≤ grade 0.5+ (at Week 6); or 2-step increase (all visits after Week 6) relative to best state achieved in Vitreous Haze (VH) grade (NEI/SUN Criteria)
Worsening of best corrected visual acuity (BCVA) by ≥ 15 letters relative to best state achieved (during all visits beginning at Week 6 visit)
Measure: Proportion of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24 Time: Baseline to Week 24
Secondary Outcomes
Description: Treatment failure will be defined as a participant meeting at least one of the following criteria in at least one eye:
New active, inflammatory lesions relative to Day 1/Baseline (during all visits beginning Week 6 visit)
Inability to achieve ≤ grade 0.5+ (at Week 6); or 2-step increase (all visits after Week 6) relative to best state achieved in Anterior Chamber Cell grade (SUN Criteria)
Inability to achieve ≤ grade 0.5+ (at Week 6); or 2-step increase (all visits after Week 6) relative to best state achieved in VH grade (NEI/SUN Criteria)
Worsening of best corrected visual acuity (BCVA) by ≥ 15 letters relative to best state achieved (during all visits beginning at Week 6 visit)
Measure: Time to Treatment Failure on or After Week 6 Time: Baseline to Week 52
Measure: Change in VH Grade in Each Eye (NEI/SUN criteria), from Best State Achieved Prior to Week 6 to Week 52 or End of Treatment (EOT) visit Time: Baseline to Week 52
Measure: Change in Anterior Chamber (AC) Cell Grade in Each Eye, from Best State Achieved Prior to Week 6 to Week 52 or EOT Visit Time: Baseline to Week 52
Measure: Change in Logarithm of the Minimal Angle of Resolution (logMAR) BCVA in Each Eye, from Best State Achieved Prior to Week 6 to Week 52 or EOT Visit Time: Baseline to Week 52
Measure: Log Change in Central Retinal Thickness in Each Eye, from Best State Achieved Prior to Week 6 to Week 52 or EOT Visit Time: Baseline to Week 52
Description: Macular edema is determined by optical coherence tomography (OCT)
Measure: Time to Development of Macular Edema in At Least One Eye on or After Week 6 Time: Baseline to Week 52
Measure: Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845 Time: Baseline to Week 52
2 Corticosteroids During Covid-19 Viral Pneumonia Related to SARS-Cov-2 Infection
Primary Outcomes
Description: Treatment failure will be defined as a participant meeting at least one of the following criteria in at least one eye: New active, inflammatory lesions relative to Day 1/Baseline (during all visits beginning Week 6 visit) Inability to achieve ≤ grade 0.5+ (at Week 6); or 2-step increase (all visits after Week 6) relative to best state achieved in Anterior Chamber Cell grade (SUN Criteria) Inability to achieve ≤ grade 0.5+ (at Week 6); or 2-step increase (all visits after Week 6) relative to best state achieved in Vitreous Haze (VH) grade (NEI/SUN Criteria) Worsening of best corrected visual acuity (BCVA) by ≥ 15 letters relative to best state achieved (during all visits beginning at Week 6 visit)
Measure: Proportion of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24 Time: Baseline to Week 24Secondary Outcomes
Description: Treatment failure will be defined as a participant meeting at least one of the following criteria in at least one eye: New active, inflammatory lesions relative to Day 1/Baseline (during all visits beginning Week 6 visit) Inability to achieve ≤ grade 0.5+ (at Week 6); or 2-step increase (all visits after Week 6) relative to best state achieved in Anterior Chamber Cell grade (SUN Criteria) Inability to achieve ≤ grade 0.5+ (at Week 6); or 2-step increase (all visits after Week 6) relative to best state achieved in VH grade (NEI/SUN Criteria) Worsening of best corrected visual acuity (BCVA) by ≥ 15 letters relative to best state achieved (during all visits beginning at Week 6 visit)
Measure: Time to Treatment Failure on or After Week 6 Time: Baseline to Week 52Measure: Change in VH Grade in Each Eye (NEI/SUN criteria), from Best State Achieved Prior to Week 6 to Week 52 or End of Treatment (EOT) visit Time: Baseline to Week 52
Measure: Change in Anterior Chamber (AC) Cell Grade in Each Eye, from Best State Achieved Prior to Week 6 to Week 52 or EOT Visit Time: Baseline to Week 52
Measure: Change in Logarithm of the Minimal Angle of Resolution (logMAR) BCVA in Each Eye, from Best State Achieved Prior to Week 6 to Week 52 or EOT Visit Time: Baseline to Week 52
Measure: Log Change in Central Retinal Thickness in Each Eye, from Best State Achieved Prior to Week 6 to Week 52 or EOT Visit Time: Baseline to Week 52
Description: Macular edema is determined by optical coherence tomography (OCT)
Measure: Time to Development of Macular Edema in At Least One Eye on or After Week 6 Time: Baseline to Week 52Measure: Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845 Time: Baseline to Week 52
Infection with the SARS-Cov-2 virus, responsible of severe acute respiratory distress syndrome (SARS), is an emerging infectious disease called Covid-19 and declared as pandemic by the World Health Organization on March 11, 2020. This pandemic is responsible of significant mortality. In France, several thousand patients are hospitalized in intensive care units, and their number continues to increase. Mortality during Covid-19 is mainly linked to acute respiratory distress syndrome, which frequency is estimated in France to occur in 6% of infected patients. Comorbidities such as cardiovascular conditions, obesity and diabetes increase susceptibility to severe forms of Covid-19 and associated mortality. Therapeutic management has three components: symptomatic management, including supplementary oxygen therapy and in case of respiratory distress mechanical ventilation; the antiviral approach; and immunomodulation, aiming at reducing inflammation associated with viral infection, which is considered to take part in severe presentations of the disease. During Covid-19 viral pneumonia related to SARS-COv-2, there is a significant release of pro-inflammatory cytokines in the acute phase of viral infection, which could participate in viral pneumonia lesions. In children with less mature immune system than adults, SARS-Cov-2 infection is less severe. The current prevailing assumption is that severe forms of Covid-19 may not only be related to high viral replication, but also to an excessive inflammatory response favoring acute lung injury and stimulating infection. The investigators hypothesize that early control of the excessive inflammatory response may help reducing the risk of acute respiratory distress syndrome. The investigators will evaluate the benefit, safety and tolerability of corticosteroid therapy to reduce the rate of subjects hospitalized for Covid-19 viral pneumonia who experience clinical worsening with a need of high-flow supplemental oxygen supplementation or transfer in intensive care units for respiratory support.
NCT04344288 Viral Pneumonia Human Coronavirus COVID-19 Drug: Prednisone Other: Control group MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia
Primary Outcomes
Description: SpO2 <90% stabilized at rest and under not more than 5 L / min of supplemental oxygen using medium concentration mask. measured twice at 5-15 min intervalsThe average value of the two measurements will be calculated.
Measure: Number of patients with a theoretical respiratory indication for transfer to intensive care unit evaluated by a SpO2 <90% stabilized at rest and under not more than 5 L / min of supplemental oxygen using medium concentration mask. Time: 7 days
Secondary Outcomes
Description: level1: not hospitalized no limited activities, level 7: death
Measure: disease severity assessed on a 7-level ordinal scale Time: 7 days
Measure: number of patients with a supplemental oxygen use Time: 7 days
Description: Reduction of radiological signs on chest imaging
Measure: radiological signs on chest imaging Time: 7 days
Measure: number of patients transferred to intensive care unit Time: 21 days
Measure: number of patients requiring invasive ventilation Time: 21 days
Description: duration on days
Measure: Duration of oxygen therapy Time: 21 days
Measure: number of adverse events induced by corticosteroid treatment Time: 21 days
Measure: number of patients with infections other than SARS-CoV-2 Time: 21 days
Measure: number of deaths Time: 21 days
3 Efficacy and Safety of Corticosteroids in Oxygen-dependent Patients With COVID-19 Pneumonia in Grand Ouest Interregion France
Primary Outcomes
Description: SpO2 <90% stabilized at rest and under not more than 5 L / min of supplemental oxygen using medium concentration mask. measured twice at 5-15 min intervalsThe average value of the two measurements will be calculated.
Measure: Number of patients with a theoretical respiratory indication for transfer to intensive care unit evaluated by a SpO2 <90% stabilized at rest and under not more than 5 L / min of supplemental oxygen using medium concentration mask. Time: 7 daysSecondary Outcomes
Description: level1: not hospitalized no limited activities, level 7: death
Measure: disease severity assessed on a 7-level ordinal scale Time: 7 daysMeasure: number of patients with a supplemental oxygen use Time: 7 days
Description: Reduction of radiological signs on chest imaging
Measure: radiological signs on chest imaging Time: 7 daysMeasure: number of patients transferred to intensive care unit Time: 21 days
Measure: number of patients requiring invasive ventilation Time: 21 days
Description: duration on days
Measure: Duration of oxygen therapy Time: 21 daysMeasure: number of adverse events induced by corticosteroid treatment Time: 21 days
Measure: number of patients with infections other than SARS-CoV-2 Time: 21 days
Measure: number of deaths Time: 21 days
To date, there is no efficient therapeutics to prevent or treat COVID-19 related pulmonary failure. Corticosteroids (CS) could be a helpful therapeutic. Retrospective reports suggested survival improvement in patients with acute respiratory distress syndrome (ARDS). CT scan for COVID19 hospitalized patients showed sometimes unusual aspects of pneumonia, suggestive of an organizing phase of diffuse alveolar damage (DAD). We hypothesize that, in the context of alveolar aggression induced by COVID-19, CT scan could help to individualize patients with a high probability of pulmonary organizing process who could benefit from CS treatment.
NCT04359511 COVID-19 Drug: Prednisone Drug: Hydrocortisone MeSH:Pneumonia
HPO:Pneumonia
Primary Outcomes
Description: The 7-category ordinal scale is as follow:
Not hospitalized with resumption of usual activities
Not hospitalized, but unable to resume usual activities
Hospitalized, not requiring O2
Hospitalized, requiring O2 from 1 to 5 l/min
Hospitalized, requiring O2 >6 l/min, nasal high-flow O2, non-invasive mechanical ventilation, or both
Hospitalized, requiring ECMO, invasive mechanical ventilation, or both
Death.
Measure: Clinical improvement defined by the improvement of 2 points on a 7-category ordinal scale, at 14 days. Time: 14 days
Secondary Outcomes
Measure: Proportion of patients free of oxygen at day 14 and 28 Time: 14 and 28 days
Measure: Proportion of patients discharged alive from hospital at day 14 and 28 Time: 14 and 28 days
Measure: Time to discharge for patients alive Time: 28 days
Measure: Proportion of patients that were hospitalized to ICU or who died at day 14 and 28 Time: 14 and 28 days
Measure: 14 and 28 day mortality rate Time: 14 and 28 days
Measure: The time until weaning from oxygen therapy Time: 28 days
Measure: The proportion of patients with clinical degradation of at least 1 point on the ordinal scale to 7 categories on D14 and D28 Time: 14 and 28 days
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 SNP 0
HP:0000554: Uveitis
Genes 47
TNFAIP3 LACC1 MBTPS2 TKT ANKRD55 ATOH7 MST1 MALT1 IL2RA HLA-DRB1 STAT4 NOD2 IKBKG BIRC3 PTPN2 TCF4 NLRP3 HLA-DRB1 TNFRSF1A FAS DNASE1L3 BTNL2 IKBKG FOXP1 CD247 IL6 IGH NOD2 FAS HLA-B NLRP1 FASLG STUB1 TKT NLRC4 GPR35 RASGRP1 BCL10 CASP10 HLA-DRB1 PTPN22 CAPN5 PRKCD IL2RB NLRP3 MIF BTNL2 Protein Mutations 0
SNP 0
Primary Outcomes
Description: The 7-category ordinal scale is as follow: Not hospitalized with resumption of usual activities Not hospitalized, but unable to resume usual activities Hospitalized, not requiring O2 Hospitalized, requiring O2 from 1 to 5 l/min Hospitalized, requiring O2 >6 l/min, nasal high-flow O2, non-invasive mechanical ventilation, or both Hospitalized, requiring ECMO, invasive mechanical ventilation, or both Death.
Measure: Clinical improvement defined by the improvement of 2 points on a 7-category ordinal scale, at 14 days. Time: 14 daysSecondary Outcomes
Measure: Proportion of patients free of oxygen at day 14 and 28 Time: 14 and 28 daysMeasure: Proportion of patients discharged alive from hospital at day 14 and 28 Time: 14 and 28 days
Measure: Time to discharge for patients alive Time: 28 days
Measure: Proportion of patients that were hospitalized to ICU or who died at day 14 and 28 Time: 14 and 28 days
Measure: 14 and 28 day mortality rate Time: 14 and 28 days
Measure: The time until weaning from oxygen therapy Time: 28 days
Measure: The proportion of patients with clinical degradation of at least 1 point on the ordinal scale to 7 categories on D14 and D28 Time: 14 and 28 days