Covid 19 Research using Clinical Trials (Home Page)
Best PracticeWiki
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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (8)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1326 | Lazertinib Wiki | 0.58 |
| drug360 | Biosensors Wiki | 0.58 |
| drug2806 | draw blood Wiki | 0.58 |
| drug1269 | Itraconazole Wiki | 0.41 |
| drug1376 | Low Dose Radiation Therapy Wiki | 0.41 |
| drug2093 | Rifampin Wiki | 0.41 |
| drug1163 | Ibrutinib Wiki | 0.41 |
| drug2527 | Tocilizumab Wiki | 0.11 |
Correlated MeSH Terms (15)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D000741 | Anemia, Aplastic NIH | 0.58 |
| D010265 | Paraproteinemias NIH | 0.58 |
| D008998 | Monoclonal Gammopathy of Undetermined Significance NIH | 0.58 |
| D008218 | Lymphocytosis NIH | 0.58 |
| D009190 | Myelodysplastic Syndromes NIH | 0.33 |
| D003324 | Coronary Artery Disease NIH | 0.29 |
| D009369 | Neoplasms, NIH | 0.26 |
| D007676 | Kidney Failure, Chronic NIH | 0.24 |
| D029424 | Pulmonary Disease, Chronic Obstructive NIH | 0.20 |
| D008173 | Lung Diseases, Obstructive NIH | 0.19 |
| D020521 | Stroke NIH | 0.18 |
| D011014 | Pneumonia NIH | 0.03 |
| D007239 | Infection NIH | 0.03 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.03 |
| D018352 | Coronavirus Infections NIH | 0.02 |
Correlated HPO Terms (9)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0100827 | Lymphocytosis HPO | 0.58 |
| HP:0012133 | Erythroid hypoplasia HPO | 0.58 |
| HP:0002863 | Myelodysplasia HPO | 0.33 |
| HP:0001677 | Coronary artery atherosclerosis HPO | 0.29 |
| HP:0002664 | Neoplasm HPO | 0.26 |
| HP:0006510 | Chronic pulmonary obstruction HPO | 0.20 |
| HP:0006536 | Pulmonary obstruction HPO | 0.19 |
| HP:0001297 | Stroke HPO | 0.18 |
| HP:0002090 | Pneumonia HPO | 0.03 |
There are 3 clinical trials
Clinical Trials
1 Tociluzumab for Cytokine Release Syndrome With SARS-CoV-2: An Open-Labeled, Randomized Phase 3 Trial
This phase III trial compares the effect of adding tocilizumab to standard of care versus standard of care alone in treating cytokine release syndrome (CRS) in patients with SARS-CoV-2 infection. CRS is a potentially serious disorder caused by the release of an excessive amount of substance that is made by cells of the immune system (cytokines) as a response to viral infection. Tocilizumab is used to decrease the body's immune response. Adding tocilizumab to standard of care may work better in treating CRS in patients with SARS-CoV-2 infection compared to standard of care alone.
NCT04361552 Cerebrovascular Accident Chronic Obstructive Pulmonary Disease Chronic Renal Failure Coronary Artery Disease Diabetes Mellitus Malignant Neoplasm SARS Coronavirus 2 Infection Other: Best Practice Biological: Tocilizumab MeSH:Infection Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Stroke Kidney Failure, Chronic Coronary Artery Disease Neoplasms
HPO:Chronic pulmonary obstruction Coronary artery atherosclerosis Neoplasm Pulmonary obstruction Stroke
Primary Outcomes
Description: The 7-day length of invasive MV for each arm will be estimated with 95% confidence intervals (CIs) using the exact binomial distribution. Their difference by the arms will be tested by Cochran-Mantel-Haenszel (CMH) test stratified by the age group and Sequential Organ Failure Assessment (SOFA) score at significance level of 0.05.
Measure: 7-day length of invasive mechanical ventilation (MV) Time: Up to 7 days
Description: Defined as death within 30-day after randomization. The 30-day mortality rate for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.
Measure: 30-day mortality rate Time: Up to 30-day after randomization
Secondary Outcomes
Description: The rate of ICU transfer for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.
Measure: Rate of intensive care (ICU) transfer Time: Up to 2 years
Description: The rate of invasive mechanical ventilation for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.
Measure: Rate of invasive mechanical ventilation Time: Up to 2 years
Description: The rate of tracheostomy for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.
Measure: Rate of tracheostomy Time: Up to 2 years
Description: Will first be described by median and inter-quartile, and then compared between two arms by Wilcoxon Sum-Rank test
Measure: Length of ICU stay Time: Up to 2 years
Measure: Length of hospital stay Time: Up 2 years
2 Radiation Eliminates Storming Cytokines and Unchecked Edema as a 1-Day Treatment for COVID-19 (RESCUE 1-19): A Randomized Phase III of Best Supportive Care +/- Whole Lung Low-Dose Radiation Therapy in Hospitalized Patients
Primary Outcomes
Description: The 7-day length of invasive MV for each arm will be estimated with 95% confidence intervals (CIs) using the exact binomial distribution. Their difference by the arms will be tested by Cochran-Mantel-Haenszel (CMH) test stratified by the age group and Sequential Organ Failure Assessment (SOFA) score at significance level of 0.05.
Measure: 7-day length of invasive mechanical ventilation (MV) Time: Up to 7 daysDescription: Defined as death within 30-day after randomization. The 30-day mortality rate for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.
Measure: 30-day mortality rate Time: Up to 30-day after randomizationSecondary Outcomes
Description: The rate of ICU transfer for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.
Measure: Rate of intensive care (ICU) transfer Time: Up to 2 yearsDescription: The rate of invasive mechanical ventilation for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.
Measure: Rate of invasive mechanical ventilation Time: Up to 2 yearsDescription: The rate of tracheostomy for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.
Measure: Rate of tracheostomy Time: Up to 2 yearsDescription: Will first be described by median and inter-quartile, and then compared between two arms by Wilcoxon Sum-Rank test
Measure: Length of ICU stay Time: Up to 2 yearsMeasure: Length of hospital stay Time: Up 2 years
This phase III trial compares low dose whole lung radiation therapy to best supportive care plus physicians choice in treating patients with COVID-19 infection. Low dose whole lung radiation therapy may work better than the current best supportive care and physician's choice in improving patients' clinical status, the radiographic appearance of their lungs, or their laboratory blood tests.
NCT04433949 Pneumonia Severe Acute Respiratory Syndrome Symptomatic COVID-19 Infection Laboratory-Confirmed Other: Best Practice Radiation: Low Dose Radiation Therapy MeSH:Laboratory Infection Severe Acute Respiratory Syndrome Coronavirus Infections Pneumonia
HPO:Pneumonia
Primary Outcomes
Description: Will be measured by improvements on oxygenation need prior to intervention compared with after intervention and/or hospital discharge.
Measure: Time to clinical recovery Time: Up to follow-up day 14 after study start
Secondary Outcomes
Description: The rates from both cohort will be reported.
Measure: Freedom from ICU admission Time: Up to follow-up day 14 after study start; This may be extended up to 28 days after preplanned interim analysis.
Description: Temperature in degrees (F)
Measure: Temperature Time: Up to follow-up day 14 after study start
Description: Heart rate in beats per minutes
Measure: Heart rate Time: Up to follow-up day 14 after study start
Description: Systolic blood pressure in mm Hg
Measure: Systolic Blood pressure Time: Up to follow-up day 14 after study start
Description: Oxygen saturation in percentage
Measure: Oxygen saturation Time: Up to follow-up day 14 after study start
Description: Oxygen saturation in percentage
Measure: Supplemental oxygenation need Time: Up to follow-up day 14 after study start
Description: Respiratory rate in breaths per minute.
Measure: Respiratory rate Time: Up to follow-up day 14 after study start
Description: Pre and post intervention; Minimum of 3 (poor) to best (15)
Measure: Glasgow Comma Scale from minimum of 3 to maximum of 15. Time: Up to follow-up day 14 after study start
Description: Easter Cooperative Oncology Group (ECOG) Performance Status Scale from 0-5; 0 being best; 5 being dead;
Measure: Performance status Time: Up to follow-up day 14 after study start
Description: Survival in percentage
Measure: Survival Time: Up to follow-up day 14 after study start; This may be extended to 28 days after preplanned interim analysis.
Description: Serial chest x-rays categorized using published scale into ordinal ranks 1-5 for SARS.
Measure: Serial chest x-rays severe acute respiratory syndrome (SARS) scoring Time: Up to follow-up day 14 after study start;
Description: CT scans with volume of consolidation measured in cubic centimeters.
Measure: Changes on computed tomography (CT) scans pre and post RT Time: Baseline up to follow-up day 14 after study start
Description: C-Reactive Protein in mg/L
Measure: CRP Time: Up to follow-up day 14 after study start
Description: Will be summarized descriptively.
Measure: Serum chemistry + complete blood cell (CBC) with differential Time: Up to follow-up day 14 after study start
Description: pH (no unit)
Measure: Blood gases pH(when available) Time: Up to follow-up day 14 after study start
Description: Albumin in gm/dL
Measure: Albumin Time: Up to follow-up day 14 after study start
Description: Procalcitonin in ng/mL
Measure: Procalcitonin Time: Up to follow-up day 14 after study start
Description: Asparatate Aminotransferase in units/L
Measure: Aspartate aminotransferase (AST) Time: Up to follow-up day 14 after study start
Description: Creatinine in mg/dL
Measure: Creatine kinase Time: Up to follow-up day 14 after study start
Description: Coagulation pathway time in seconds
Measure: Prothrombin time (PT)/partial thromboplastin time (PTT) Time: Up to follow-up day 14 after study start
Description: Troponin-I in ng/mL
Measure: Troponin Time: Up to follow-up day 14 after study start
Description: Lactic Acid in mmol/L
Measure: Lactate Time: Up to follow-up day 14 after study start
Description: B-Natriuretic Peptid in pg/mL
Measure: NT-pBNP (cardiac injury) Time: Up to follow-up day 14 after study start
Description: Gamma-glutamyl transferase in units/L
Measure: Gamma-glutamyl transferase (GGT) Time: Up to follow-up day 14 after study start
Description: Trygliciericdes in mg/dL
Measure: Triglycerides Time: Up to follow-up day 14 after study start
Description: Fibrinogen in mg/dL
Measure: Fibrinogen Time: Up to follow-up day 14 after study start
Description: Will be summarized descriptively.
Measure: Changes in CD8 T cells Time: Up to follow-up day 14 after study start
Description: Will be summarized descriptively.
Measure: Changes in CD4 T cells Time: Up to follow-up day 14 after study start
Description: Will be summarized descriptively.
Measure: Changes in serum antibodies against COVID-19 epitope Time: Up to follow-up day 14 after study start
Description: Lactate Dehydrogenase in units/L
Measure: LDH Time: Up to follow-up day 14 after study start
Description: D-Dimer in ng/mL
Measure: D-Dimer Time: Up to follow-up day 14 after study start
Description: Interleukin-6 in pg/mL
Measure: IL-6 Time: Up to follow-up day 14 after study start
Description: Myoglobin in ng/mL
Measure: Myoglobin Time: Up to follow-up day 14 after study start
Description: Potassium in mmol/L
Measure: Potassium Time: Up to follow-up day 14 after study start
Description: Ferritin in ng/mL
Measure: Ferritin Time: Up to follow-up day 14 after study start
Description: Alanine Aminotransferase in units/L
Measure: ALT Time: Up to follow-up day 14 after study start
3 Randomized Double-Blind Phase 2 Trial of Ibrutinib Versus Standard Treatment for COVID-19 Illness Requiring Hospitalization With Safety Lead-In
Primary Outcomes
Description: Will be measured by improvements on oxygenation need prior to intervention compared with after intervention and/or hospital discharge.
Measure: Time to clinical recovery Time: Up to follow-up day 14 after study startSecondary Outcomes
Description: The rates from both cohort will be reported.
Measure: Freedom from ICU admission Time: Up to follow-up day 14 after study start; This may be extended up to 28 days after preplanned interim analysis.Description: Temperature in degrees (F)
Measure: Temperature Time: Up to follow-up day 14 after study startDescription: Heart rate in beats per minutes
Measure: Heart rate Time: Up to follow-up day 14 after study startDescription: Systolic blood pressure in mm Hg
Measure: Systolic Blood pressure Time: Up to follow-up day 14 after study startDescription: Oxygen saturation in percentage
Measure: Oxygen saturation Time: Up to follow-up day 14 after study startDescription: Oxygen saturation in percentage
Measure: Supplemental oxygenation need Time: Up to follow-up day 14 after study startDescription: Respiratory rate in breaths per minute.
Measure: Respiratory rate Time: Up to follow-up day 14 after study startDescription: Pre and post intervention; Minimum of 3 (poor) to best (15)
Measure: Glasgow Comma Scale from minimum of 3 to maximum of 15. Time: Up to follow-up day 14 after study startDescription: Easter Cooperative Oncology Group (ECOG) Performance Status Scale from 0-5; 0 being best; 5 being dead;
Measure: Performance status Time: Up to follow-up day 14 after study startDescription: Survival in percentage
Measure: Survival Time: Up to follow-up day 14 after study start; This may be extended to 28 days after preplanned interim analysis.Description: Serial chest x-rays categorized using published scale into ordinal ranks 1-5 for SARS.
Measure: Serial chest x-rays severe acute respiratory syndrome (SARS) scoring Time: Up to follow-up day 14 after study start;Description: CT scans with volume of consolidation measured in cubic centimeters.
Measure: Changes on computed tomography (CT) scans pre and post RT Time: Baseline up to follow-up day 14 after study startDescription: C-Reactive Protein in mg/L
Measure: CRP Time: Up to follow-up day 14 after study startDescription: Will be summarized descriptively.
Measure: Serum chemistry + complete blood cell (CBC) with differential Time: Up to follow-up day 14 after study startDescription: pH (no unit)
Measure: Blood gases pH(when available) Time: Up to follow-up day 14 after study startDescription: Albumin in gm/dL
Measure: Albumin Time: Up to follow-up day 14 after study startDescription: Procalcitonin in ng/mL
Measure: Procalcitonin Time: Up to follow-up day 14 after study startDescription: Asparatate Aminotransferase in units/L
Measure: Aspartate aminotransferase (AST) Time: Up to follow-up day 14 after study startDescription: Creatinine in mg/dL
Measure: Creatine kinase Time: Up to follow-up day 14 after study startDescription: Coagulation pathway time in seconds
Measure: Prothrombin time (PT)/partial thromboplastin time (PTT) Time: Up to follow-up day 14 after study startDescription: Troponin-I in ng/mL
Measure: Troponin Time: Up to follow-up day 14 after study startDescription: Lactic Acid in mmol/L
Measure: Lactate Time: Up to follow-up day 14 after study startDescription: B-Natriuretic Peptid in pg/mL
Measure: NT-pBNP (cardiac injury) Time: Up to follow-up day 14 after study startDescription: Gamma-glutamyl transferase in units/L
Measure: Gamma-glutamyl transferase (GGT) Time: Up to follow-up day 14 after study startDescription: Trygliciericdes in mg/dL
Measure: Triglycerides Time: Up to follow-up day 14 after study startDescription: Fibrinogen in mg/dL
Measure: Fibrinogen Time: Up to follow-up day 14 after study startDescription: Will be summarized descriptively.
Measure: Changes in CD8 T cells Time: Up to follow-up day 14 after study startDescription: Will be summarized descriptively.
Measure: Changes in CD4 T cells Time: Up to follow-up day 14 after study startDescription: Will be summarized descriptively.
Measure: Changes in serum antibodies against COVID-19 epitope Time: Up to follow-up day 14 after study startDescription: Lactate Dehydrogenase in units/L
Measure: LDH Time: Up to follow-up day 14 after study startDescription: D-Dimer in ng/mL
Measure: D-Dimer Time: Up to follow-up day 14 after study startDescription: Interleukin-6 in pg/mL
Measure: IL-6 Time: Up to follow-up day 14 after study startDescription: Myoglobin in ng/mL
Measure: Myoglobin Time: Up to follow-up day 14 after study startDescription: Potassium in mmol/L
Measure: Potassium Time: Up to follow-up day 14 after study startDescription: Ferritin in ng/mL
Measure: Ferritin Time: Up to follow-up day 14 after study startDescription: Alanine Aminotransferase in units/L
Measure: ALT Time: Up to follow-up day 14 after study startThis phase Ib/II trial studies the side effects and best dose of ibrutinib and how well it works in treating patients with COVID-19 requiring hospitalization. Ibrutinib may help improve COVID-19 symptoms by lessening the inflammatory response in the lungs, while preserving overall immune function. This may reduce the need to be on a ventilator to help with breathing.
NCT04439006 Aplastic Anemia Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Monoclonal B-Cell Lymphocytosis Monoclonal Gammopathy of Undetermined Significance Myelodysplastic Syndrome Symptomatic COVID-19 Infection Laboratory-Confirmed Other: Best Practice Drug: Ibrutinib MeSH:Laboratory Infection Myelodysplastic Syndromes Anemia, Aplastic Paraproteinemias Monoclonal Gammopathy of Undetermined Significance Lymphocytosis Neoplasms
HPO:Aplastic anemia Erythroid hypoplasia Hypoplastic anemia Lymphocytosis Myelodysplasia Neoplasm
Primary Outcomes
Description: Associations between baseline characteristics and the primary endpoint will be evaluated with logistic regression, adjusting for arm. These analyses will be largely descriptive, as a result of a limited sample size.
Measure: Proportion of patients with diminished respiratory failure and death Time: During hospitalization for COVID-19 infection or within 30 days of registration
Measure: Death Time: During hospitalization for COVID-19 infection or within 30 days of registration
Secondary Outcomes
Description: Fever-free will be assessed by a temperature of < 100.5 degrees Fahrenheit orally. Will be estimated for each arm using the method of Kaplan-Meier. Medians estimates and/or estimates at specific time points will be provided with 95% confidence intervals.
Measure: Time from study initiation to 48 hours fever-free Time: Up to 14 days
Description: Will be estimated for each arm using the method of Kaplan-Meier. Medians estimates and/or estimates at specific time points will be provided with 95% confidence intervals.
Measure: Duration of hospitalization Time: Up to 14 days
Measure: Time in intensive care unit (ICU) Time: Up to 14 days
Measure: Time to ICU admission Time: Up to 14 days
Measure: Number of days requiring supplemental oxygen Time: Up to 14 days
Measure: Total days of mechanical ventilation Time: Up to 14 days
Measure: Time to mechanical ventilation Time: Up to 14 days
Measure: Shock and need for pressure support Time: Up to 14 days
Measure: Incidence of any infection (viral, fungal, bacterial) Time: Up to 14 days
Measure: Time to clinical resolution Time: Up to 14 days
Description: Adverse events will be summarized by grade, type, and attribution (regardless of attribution and treatment-related) for each arm.
Measure: Incidence of grade 3 or higher adverse events Time: Up to 12 months
Description: The proportion of patients with viral clearance at the time of hospital discharge will be estimated with 95% confidence intervals for each arm.
Measure: At the end of therapy (day 14) Time: Up to 14 days
Description: Will be estimated for each arm using the method of Kaplan-Meier. Medians estimates and/or estimates at specific time points will be provided with 95% confidence intervals.
Measure: Time to viral clearance Time: Up to 12 months
Description: Patients will be followed for up to 12 months or until death or withdrawal of study consent for further follow-up. Following hospitalization, study visits will be telephone or video encounters.
Measure: Survival Time: Up to12 months
Related HPO nodes (Using clinical trials)
HP:0001915: Aplastic anemia
Genes 32
PALB2 ACD TCIRG1 TERT DNAJC21 SBDS TINF2 NHP2 ELANE CD27 TINF2 TERT TERT SRP54 TERT TINF2 XIAP NBN SRP72 SRP54 IFNG PRF1 SBDS TERC DNAJC21 GATA2 HOXA11 PIGA EFL1 TERC GFI1 NOP10 Protein Mutations 0
SNP 0
HP:0001677: Coronary artery atherosclerosis
Genes 51
ZNF687 ACTA2 SERPIND1 LOX KCNJ5 LDLR SMAD4 ESR1 PRKG1 ABCA1 SMAD3 ABCC6 MFAP5 SMPD1 CYP7A1 ABCG8 LMNA ACTA2 CEP19 LMNA LOX TGFBR2 ELN APOE XYLT1 ABCA1 LDLRAP1 MYLK TGFB3 LMNA PCSK9 APOB APOB MAT2A FBN1 PPARG ZMPSTE24 LMNA LMNA LMNA TGFBR1 TGFB2 ABCG5 LMNA XYLT2 FOXE3 MYH11 MYH11 LIPC ABCG8 MYH11 Protein Mutations 1
C825T Protein Mutations 0
SNP 0
Protein Mutations 0
SNP 0
HP:0100827: Lymphocytosis
Genes 21
LMNB2 BTNL2 PRKCD CASP10 IL7R SH2D1A XIAP CARD11 ARPC1B CASP10 RNASEH2B FAS PRKCD HLA-DRB1 ZAP70 RASGRP1 FAS NRAS NLRP12 FASLG KRAS Protein Mutations 0
SNP 0
HP:0002863: Myelodysplasia
Genes 94
FANCE TCIRG1 HSPA9 CEP57 FANCG FANCM FANCG ATRX ERCC4 GATA2 GINS1 TET2 MYSM1 MAD2L2 SLX4 ELANE JAK2 KIT FANCC FANCL SRP54 RAF1 TERT RFWD3 TINF2 SRP54 TET2 FANCI NBEAL2 BRAF BUB3 FANCD2 PTPN11 SF3B1 DDX41 BRIP1 ERBB3 TERC GATA2 FANCA RECQL4 BUB1 TET2 SF3B1 SAMD9 THPO TET2 LIG4 RFWD3 RPS14 DNAJC21 GFI1B SH2B3 SRSF2 DNAJC21 XRCC2 RPS14 ASXL1 ASXL1 MPL DKC1 TET2 RAD51C GATA2 BRCA2 HAX1 JAK2 SMARCD2 UBE2T RUNX1 FANCF TET2 MPL TRIP13 SRP72 SRP54 SBDS RPS19 TP53 PALB2 SBDS MPL NAGS BRCA1 FANCB BUB1B PIGA ATRX CALR EFL1 GFI1 TET2 JAK2 RAD51 Protein Mutations 22
C282Y C283Y D835Y H63D I332E R132C R132G R132H R132L R132S R132V R140L R140Q R140W R172G R172K R172M R172S R172W S1612C S239D T315I SNP 0
HP:0002664: Neoplasm
Genes 1515
EPCAM BAP1 CYLD WT1 CTBP1 GLI3 CTNNB1 ELMO2 ATRX TERT EDN3 MTAP TSC2 RAD51 BLNK KCNAB2 WDPCP SPINK1 ARID1B PTEN STK11 XPA PTH1R TCF4 EPCAM NF1 GPC3 ERCC3 MC1R CASP10 PDGFRA RPL5 CDH1 BRIP1 RUNX1 KRAS SFTPC GPR35 MYLK STS DYNC2LI1 RAG2 CBL FOXE1 STAT3 TTC37 ABL1 NSD1 ATM KCNH1 GPR101 IGH KRT17 SUFU TERT KRAS GPC3 CYP11B2 MLH3 PTCH1 FAH MSH2 EXT1 CCND1 MSH3 ATP7A SEC23A PHOX2B HAX1 MYD88 LMO1 PIK3CA PRLR AXIN1 TCF4 RUNX1 AKT1 ERBB2 REST DCLRE1C SERPINA1 ERCC3 TMC6 RASA1 MSH3 TRNL1 CALR HRAS INS RNF113A SETBP1 CDH1 SLC37A4 TFAP2A CDH1 PTCH1 KIT PTEN IL1RN MLH3 MUTYH PTEN KIT GBA BCL2 KCNH1 GINS1 ESCO2 TET2 SLX4 DICER1 PALB2 NEK1 ESCO2 COL7A1 PTCH2 WT1 WRN GCM2 BRD4 BRAF TREX1 THPO SUFU NRAS CDC73 POU6F2 GNAS DAXX BUB3 RSPO1 MNX1 ERCC2 RPS28 ANTXR2 CTNNB1 POT1 FANCA KDM6B RET MST1 NOTCH3 FGFR1 KRAS LYST CHIC2 TMC6 MET KRT10 UROD SLC25A11 ARSA EVC2 TEK XRCC2 CASP8 ASCL1 IL1B TERF2IP DICER1 MPL OFD1 RHBDF2 DICER1 MDM2 WT1 MMP1 CDKN2A FGF8 NR4A3 FGFR2 OCRL TP53 ERCC2 SUFU ERCC4 ALX4 TINF2 DCLRE1C SRY SRP72 NF2 GNAS LETM1 TP53 FANCB TAL1 TDGF1 BRCA1 LEMD3 NF2 BRAF NUP214 RAD21 COL18A1 SDHD ICOS CEP57 BAP1 FANCM PTPRJ FANCE SLC22A18 PIK3R1 JAK2 FLT4 SMO WIPF1 DLST NF2 RAD50 MEN1 CHEK2 GPC4 WDPCP CYP2A6 HBB GANAB XRCC4 TET2 ATP7B EP300 DIS3L2 HFE CARD14 OFD1 ALX3 VANGL1 BAP1 SDHB EXTL3 PIK3CA GATA2 ALX3 BCL10 KIT WAS FGFR2 RMRP TWIST1 BMPR1B DIS3L2 ERCC3 FOXP1 SMAD4 CALR APC PCGF2 USP8 DMPK NRAS DKC1 BRCA1 ADAR BCR RSPO1 SLC45A2 GJC2 TNFRSF4 AKT1 IFIH1 MSH6 DICER1 PAX6 TGFBR2 SRY KLHDC8B CPLX1 MSH6 AIP PMS1 CREBBP ERCC2 CTSA APC MMP1 SH2B3 PKD1 TRNF SEC23B DNAJC21 STK11 BCR HBB MITF IGLL1 ALX4 MDH2 AKT1 SCN4A SDHAF2 PRKN PLA2G2A RNF43 DNMT3A TERT NSD2 RMRP FANCG BRCA2 CAT TP53 BMPR1A MAD2L2 SIX6 DDB2 GREM1 KRT17 PAX4 RPS17 TRPV3 ERCC4 C11ORF95 APC IL12RB1 BRIP1 PPM1D SDHB NODAL HNF1A FLT4 MSH6 ERCC6 BTK SLC26A4 SEMA3C AR NEK1 TERC RPL35A RPS20 CDKN1C SF3B1 TERC PTEN RFWD3 BRCA2 KCNQ1OT1 RPL10 ACTG2 MAGT1 ALK BLM H19 LEMD3 RPL31 MLLT10 PYGL RPL15 IRF1 CR2 MITF PTEN MYC PTPN11 TUBB TCF4 KCNQ1 NFKB2 ALX1 HLA-DRB1 APC EWSR1 NBN CDKN2A ERCC4 GCK DLL1 SLC25A11 PDGFB L2HGDH PRKCD CTC1 PIK3CA SUFU RPL27 KIF1B SRC CIB1 RECQL4 CDKN2B MSH3 BRCA2 PALB2 PDE6D SDHC SDHD CCL2 CHEK2 PMVK XPC STK11 PIK3CA MVD DHCR7 KIT GPC6 KARS1 MNX1 VHL TUBB NAB2 KEAP1 TSC1 NQO2 APC SDHB VHL TCTN3 RECQL4 PMS2 RAD51C STAG3 SNAI2 MAP3K8 SETBP1 SDHB NPM1 RAD51C RARA ERBB2 ERCC5 ATRX CHEK2 KRAS BRCA1 TFAP2A SLCO2A1 PHOX2B PTEN COL2A1 PIGL PDGFRA APC CPLANE1 AURKA SDHD LAMA3 VHL RPS26 GFI1B CDKN1B PRDM16 AXIN2 FZD2 AP2S1 LZTR1 TP53 TP53 GNA14 CTNNB1 MSTO1 PIK3CA RPS29 CALR DHX37 MYF6 SDHC MALT1 ELANE SDHD SLC26A4 MAP3K1 GDNF MSH2 SDHC TGFBR1 RUNX1 CREB1 CDKN2A TSC2 KRAS TNFRSF10B LMNA WWOX PHOX2B EDN3 RPS10 RSPRY1 TRIM37 RET MEN1 BCL10 MSH2 TNFRSF13C FOXE1 FANCC H19-ICR BLM ERCC6 LIG4 BDNF LMOD1 NF2 TMEM107 CYLD GJB2 EXT1 CTSC PHOX2B RAD51D RASGRP1 RB1 TGFBR2 SRY MYH8 KRAS TINF2 RECQL4 H19 PRF1 GDNF MXI1 SMPD1 WT1 HRAS COL1A1 PDGFRB FAS FANCD2 NF1 DISP1 PDGFRL IKBKG BIN1 BRCA2 ADA POLE AXIN2 SEMA4A KRAS NRAS PALB2 CHEK2 ASCL1 POLE TLR2 PIK3CA MINPP1 SOS1 CYLD CTLA4 POT1 ASXL1 CDC73 APC SAMD9L WT1 TRAF7 GATA4 PIK3CA DYNC2LI1 ATP7A CBFB MST1R GCGR MPL COL4A5 SMAD4 CDKN1A SDHD TRIM28 POLH GPR101 PIK3CA FLCN GPR143 RB1 SBDS SLC12A3 KLF6 ICOS GNB1 PIGA TYROBP GFI1 RAD51 SLC26A2 MC1R TREM2 SFTPA2 JAG1 BAP1 EGFR IGH KIT PLCB4 NLRP1 HNF1B ZFHX3 EPHB2 KLLN OCA2 WT1 FAH FH TERT SRD5A3 LIG4 NFKB1 RNF43 KIT STAT1 IFNG BMPR1A ERCC3 TBX18 TET2 MAP2K1 EXT2 HRAS RTEL1 FGFR3 PTEN CTNNB1 MAP2K2 MEN1 APC CLCNKB AKT1 ESCO2 CDC73 MS4A1 BRAF CRKL NUTM1 CDK4 NTHL1 ETV6 TET2 SQSTM1 FAM20C PIGL SEC23A ATM PALB2 TYR SRSF2 EXT2 GJB2 DNMT3A HRAS TCOF1 CHEK2 CDH1 FH DKC1 POLE PIK3CA PTCH2 AKT1 PAX3 FH ADAMTS3 APC PMS1 RAD51C PLCD1 PUF60 DIS3L2 CDH23 SCN9A FOXC2 SMARCB1 CDKN2A VANGL2 ENG SH2D1A SDHB SOX9 BRAF SDHA PGM3 ERCC2 GJB2 TBC1D24 CHD7 MPL DHH PTCH1 CALR IL12A TNFRSF13B CD28 MLH1 PTPN12 OFD1 MLH3 REST CCDC22 APPL1 COL14A1 IGH PSENEN IL2RG MC1R SMARCA4 CYLD KIF11 PHKG2 JAK2 COL2A1 AXIN2 FLNA WNT5A TYR EP300 GLI3 EXT2 MGAT2 KCNE3 ECE1 PARN IDH2 TSC1 ARL6IP6 FGFR3 SMAD4 HMBS SLC6A17 PRKAR1A BAP1 KDSR DHCR24 CXCR4 DDX41 GABRD RET NR0B1 DMRT3 CCND1 GDF5 POU6F2 CTLA4 TBXT FANCA NRTN PHKA2 KIT ITK RNASEH2A PERP CDC73 OFD1 CYP2D6 RET MEN1 CD27 PARN FUZ RPS19 MSH2 SMARCE1 TNFSF12 ZSWIM6 TERT RHOH NF1 BUB1B SLX4 LIG4 PDGFRL TNFSF15 OPCML APC PRKCD SETD2 RPS19 BRCA1 FAT4 ANTXR1 WNT10A SUFU TP63 EFL1 IL7 MN1 DOCK8 CDC73 SSX1 TMEM231 MPLKIP VHL MINPP1 BIRC3 PDX1 STS PSAP HNF1A JAK2 FANCL POT1 GNAS TERT CD79A KLF11 WRN MAPRE2 LIG4 CYSLTR2 DNM2 SH3GL1 KIT FOXH1 RELA KRAS PRKAR1A ERBB3 FGFR2 H19 TJP2 CD81 PNP MSH6 WT1 THPO ATP6V1B2 GNAQ BRCA1 WRAP53 ERCC3 CHRNG KRT14 TSC1 DLC1 CTNNB1 FGFRL1 SDHC GDNF HABP2 NRAS ATR TRNK BMPR1A TERT BRAF AKT1 XPC FGFR3 NUP214 TRIP13 SMARCD2 ZSWIM6 PIEZO2 EVC IL6 HRAS GPC4 TNFRSF13B PALLD CDKN2A POLR1D TP53 FOXO1 BRCA2 FIBP CDH23 RB1CC1 B3GALT6 FLT3 GJA1 SH2B3 MRAP MTOR AR FOXI1 TP53 GNAQ KRT6B MYD88 KRT16 TP53 NF1 MYSM1 MGMT KIT NF1 GPC4 GCM2 SIX3 PIK3CA RAD21 HRAS PMS2 ASCC1 BRCA2 GAS1 FASLG SDHD NRAS C2CD3 KDR SDHA SMAD4 SOX2 NBEAL2 SRGAP1 AGGF1 ATM AKT1 RPGRIP1L NOD2 BAX BRCA2 H19-ICR TGIF1 MAPK1 ESR1 EXT1 RPL11 KRAS BCL10 SKI LAMB3 XIAP SDHC HABP2 TRNS1 CCM2 FIBP PIK3CA TRIM28 HRAS SCN10A NF1 WT1 CPLANE1 HFE F5 C2CD3 GNPTAB TBX2 KLF6 GATA2 VEGFC RNASEH2B CBL SEMA3D ARMC5 CXCR4 JAK2 IGF2 FGFR2 NRAS UBE2T ARHGAP26 SCN11A MEN1 LMX1B F13A1 BCR COMP EDN1 SDHC ACTB GDNF CDKN2C ASPSCR1 NAGS PDGFRB PALB2 DLEC1 BCL10 STAR GNA11 PORCN RNR1 FLCN SPIB WT1 RET SDHB SLC22A18 ERCC4 CDKN2A CTHRC1 DLST OGG1 POLD1 DCC IL2RG REST SRP54 RAF1 TSC1 SRP54 IDH1 ACD KIT ACAN NSD2 TOP2A CASP10 DVL1 PTPN11 CASP10 STIM1 KRT9 AR CIB1 GNAS AR VAMP7 MRE11 GFI1 RPS14 BCL10 CACNA1S TP53 VANGL1 SKIV2L PTCH2 G6PC LRP5 PDGFRB BARD1 RPS27 RPS7 GNAS ENPP1 STAT6 ACVR1 MTM1 NEUROD1 TNFRSF13C PKD2 RUNX1 STK11 FGF3 TRIP13 SIX1 BRCA2 LAMC2 NELFA DVL3 GJB4 NSUN2 CDKN1B CTNNB1 POLR1C GJB3 SMARCB1 SBDS LMNA KRAS TRNH ECM1 STK4 ANTXR2 SOS1 BAP1 MSX2 DICER1 SDHB ACD WRAP53 BRCA1 ATP7A BUB1B RYR1 RET BRCA2 TP53 DPM1 BRCA2 BCR POLD1 TCIRG1 PTPN11 HOXD13 CR2 TARS1 JAK2 BMP2 MUTYH FLT3 TRNS2 MTMR14 NR5A1 ABCA5 RET AHCY TSC2 KIT KCNQ1OT1 RNF6 RAD54L HNF1A HMMR RNF139 WWOX TCTN3 BRAF FCN3 RNASEH2C AIP PRKN SF3B1 MSH6 NSD1 PTCH2 CCBE1 RECQL4 PMS2 ERCC2 HNF4A MMEL1 BUB1 TET2 TRPS1 ABCC6 RET IRF5 CDKN2B PDGFB USP9X TAL2 INTU GNAS HDAC4 MFN2 DYNC2H1 PIK3CA PLAG1 ATM MAX FAS PIK3CA CYP11B1 CCND1 H19-ICR PTCH1 MUTYH ABL1 ODC1 FGFR2 COL7A1 MSR1 BRCA1 RB1 TNFRSF1B COL7A1 FLT4 GPC3 TGFBR2 ATRX RAG1 PRCC BRAF TNFRSF1B FANCE RAD54L CBL SDHB TERT SDHD RPS24 FASLG MET KRT17 GATA1 ERBB2 FGFR1 KAT6B ABCA5 SDHAF2 SLC25A13 NOP10 GATA2 RFWD3 PDGFRA SPRTN MLH1 NKX2-1 IGF2R CD19 MAP3K1 TREX1 TRNP ZFPM2 CTNNB1 TRNQ WWOX IGHM MYH11 TMEM127 CDON NF2 SAMD9 PTEN RNASEL IDH2 HNF4A GTF2H5 GLI3 HRAS LPP DDB2 KIT PIK3CA PDCD10 HSPG2 HFE RPL26 BRIP1 ASXL1 SDHD CEBPA ACVRL1 NRAS CD19 GNAQ TET2 TCTN3 SMARCB1 FLCN ABCB11 BLK RAD54B SDHC FH AKT1 ANTXR1 FANCF HNF1B EXOC6B SAMHD1 SHOX MYO1H COL11A2 KCNJ10 TRIP13 CC2D2A LZTS1 SEC23B GPR101 DOCK8 BRCA2 NBN SLC26A2 SPRED1 VHL KRT1 LIN28B GTF2E2 NRAS ZIC2 SNAI2 SH3KBP1 SHOX BCL6 NTHL1 RHBDF2 CD28 MCM4 CCND1 FANCG SMARCAD1 GATA2 RERE YY1 ASXL1 IL7R TMEM67 C1S TAF1 FGFR3 NBN KRAS KIF1B AIP KCNJ11 LETM1 FANCI MLH1 MBTPS2 NRAS NEK9 GNAI3 APC2 EYA1 ZAP70 EXT2 BUB1 SSX2 LIG4 CARMIL2 SLC17A9 TMC8 PCNA EPAS1 TFE3 BRCA2 DHH MAP2K1 CASP8 CDK4 PDGFB RTEL1 EWSR1 PTEN VHL GJB6 NDP RNF6 TNPO3 TGFBR2 TXNRD2 PNP TAF15 TRNK SMO NOTCH1 LRRC8A RASA1 TSC2 ABCC8 PRKAR1A BAX IDH1 SLC22A18 ADA FAN1 TG PTEN BMPR1A MSTO1 ERCC5 IRF1 MLH1 NRAS MLH1 PICALM FANCD2 SF3B1 BICC1 RPS15A TERT KLLN ELANE FAM149B1 GATA1 SASH1 INPP5E TP53 WT1 BMPR1A PTPN11 PTPN11 MYCN XPA EDNRB TP53 FLI1 GDF2 PHB BMPER FGFR3 PTEN MCC EXT1 MC2R KCNN3 DNASE1L3 DHCR7 RASGRP1 SHH NPM1 SLC26A2 SLC37A4 IGF2 RPL18 SH2B3 PTCH1 BRAF PAX7 INHBA BMPR1A KIF7 XRCC3 IGF2 POU2AF1 DNAJC21 CYP26C1 RB1 MPL REST KIAA0753 DNMT3A ERCC6 MUC5B MLH3 ASXL1 MPL NOTCH3 KCNJ10 SMARCE1 TSR2 RPL10 KRT1 SLC25A13 WT1 NNT TP53 GNA11 GLI1 BARD1 FLCN COL7A1 SRP54 GLI2 EDN3 PTPN3 WT1 TMEM127 CD79B GATA2 TERC FN1 EIF2AK4 RAD51 WASHC5 SAMD9L AIP TP53 AAGAB RB1 TP53 KRT5 ADA2 HSPA9 PIK3CA SRSF2 PHF21A IDH1 KRAS KRAS CHEK2 BUB1B RET FANCC TP53 WHCR RAD54B NUMA1 SDHB HMBS TMEM216 SMAD4 MAFA MSH2 RPL35 CDKN1B IGF2 PPP2R1B CD70 CEL MAD1L1 MAX ALK GPC3 FERMT1 KIF1B TCF3 POLH PIK3R1 USF3 FDPS MYC DNAJC21 TNFSF12 HACE1 CDH1 SDHA ND5 NHP2 PIK3CA RPS14 NBN WNT10A ING1 CASR SUFU FGFR3 HPGD BTK ENG DCC CASP8 PHOX2B STAC3 USB1 KRIT1 PHOX2B TET2 SMAD4 JAK2 BCHE APC MVK SMAD7 SMO DKC1 SMARCB1 VHL F13B TINF2 USP8 FGFR1 FOXI1 TET2 CD96 TET2 JAK2 KRAS Protein Mutations 75
C10D C377T C677T C797S D816V D835V D842V E10A E17K E542K E545K F1174L F31I G12C G12D G12V G13D G156A G20210A G719A G719C H1047R H1112L H1112Y H1124D K652E L1213V L265P L858R L861Q M1149T M1268T P1009S P13K P1446A P286R P4503A Q12H Q21D R132C R132G R132H R132L R132S R132V R140L R140Q R140W R172G R172K R172M R172S R172W R988C T1010I T1191I T315I T790M V1110L V1206L V1238I V411L V57I V600D V600E V600K V600M V600R V617F V941L Y1248C Y1248D Y1248H Y1253D Y842C 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 SNP 0
HP:0006536: Pulmonary obstruction
Genes 86
CYBB CYBC1 VPS33A DNAJB13 RSPH1 CYBA SPEF2 CCDC40 SPAG1 FOXJ1 MGP NFKB1 HMOX1 MCIDAS ZMYND10 WIPF1 DNAAF4 GAS2L2 SCNN1A NCF2 DNAH1 CCDC151 CCDC39 ARMC4 DNAL1 TTC25 DNAAF2 CTLA4 APC DNASE1L3 DNAI2 ARVCF SCNN1G TBX1 DRC1 COMT NEK10 CFAP221 GLA RSPH3 NCF4 LRRC6 WAS MYH7 DNAAF1 DNAAF5 CCNO RPGR RSPH9 STK36 JMJD1C CFTR NCF1 DNAH9 HYDIN GLA DNAAF6 SEC24C OFD1 RSPH4A MMP1 DNAH5 CCDC114 HIRA CCDC103 LRRC56 RREB1 DNAAF4 NME8 GAS8 HLA-DPB1 TTC12 HLA-DPA1 PTPN22 GP1BB CCDC65 CFAP298 SCNN1B DNAAF3 SERPINA1 TBX1 UFD1 CFAP300 PRTN3 DNAH11 DNAI1 HP:0001297: Stroke
Genes 174
TANGO2 JAG1 SMARCAL1 LIMK1 MMUT RFC2 VHL TREX1 PCNT ENG JAK2 TTR CCM2 COX2 COX1 TRNF GTF2I KRAS CPS1 GDF2 SMAD3 TET2 TRNW ABCC6 MFAP5 TGFBR3 APP ELN ADA2 TRNF OTC LMNA LOX FLNA GATA6 CLIP2 ELN XYLT1 APP PNP THPO GNAQ ADA2 SH2B3 TRNC GYS1 F2 SCN5A GATA4 TGFB3 SNAP29 HBB GLA SMAD4 NPPA TRNS2 COL4A1 ACVRL1 TRNK TRNL1 ND1 ND4 TNNT2 KCNQ1 FBN1 COX1 ACVRL1 AGXT COL3A1 TGFBR1 MYPN TGFB2 TRNW APP ALOX5AP PRNP COX3 TRNQ ND5 RFT1 TP53 XYLT2 MYH11 MPL CALR MYBPC3 MECP2 ND6 CST3 CYTB ACTA2 MYD88 ND5 F5 ENG ELN CYTB SMAD4 TRNV SLC2A10 PRKG1 MLXIPL GUCY1A1 HTRA1 TBL2 COX3 MTHFR PRKCH PRKAG2 NR3C1 TREX1 SLC19A2 PIK3C2A APP NR2F2 ZAP70 TGFBR2 WFS1 GLA MYLK APP NOTCH3 TRNS1 COX2 TPP2 COL4A1 KIF20A CBS BAZ1B TRNS2 ANGPTL6 TNXB TRNQ MPL ENG MAT2A JAK2 ZMPSTE24 ASS1 CYP11B1 TET2 SMAD4 MPL TNNI3 ACAD9 ND6 TRNS1 STIM1 HSD11B2 SLC19A2 DYRK1B PMM2 FLNC GTF2IRD1 SON ACTG1 FOXE3 TRNL1 THSD1 NOS3 GUCY1A1 MYH11 ACTB TRNH NAGS HTRA1 PIGA CST3 MYH11 COL3A1 ND1 JAK2 DPM3 CRELD1
Primary Outcomes
Description: Associations between baseline characteristics and the primary endpoint will be evaluated with logistic regression, adjusting for arm. These analyses will be largely descriptive, as a result of a limited sample size.
Measure: Proportion of patients with diminished respiratory failure and death Time: During hospitalization for COVID-19 infection or within 30 days of registrationMeasure: Death Time: During hospitalization for COVID-19 infection or within 30 days of registration
Secondary Outcomes
Description: Fever-free will be assessed by a temperature of < 100.5 degrees Fahrenheit orally. Will be estimated for each arm using the method of Kaplan-Meier. Medians estimates and/or estimates at specific time points will be provided with 95% confidence intervals.
Measure: Time from study initiation to 48 hours fever-free Time: Up to 14 daysDescription: Will be estimated for each arm using the method of Kaplan-Meier. Medians estimates and/or estimates at specific time points will be provided with 95% confidence intervals.
Measure: Duration of hospitalization Time: Up to 14 daysMeasure: Time in intensive care unit (ICU) Time: Up to 14 days
Measure: Time to ICU admission Time: Up to 14 days
Measure: Number of days requiring supplemental oxygen Time: Up to 14 days
Measure: Total days of mechanical ventilation Time: Up to 14 days
Measure: Time to mechanical ventilation Time: Up to 14 days
Measure: Shock and need for pressure support Time: Up to 14 days
Measure: Incidence of any infection (viral, fungal, bacterial) Time: Up to 14 days
Measure: Time to clinical resolution Time: Up to 14 days
Description: Adverse events will be summarized by grade, type, and attribution (regardless of attribution and treatment-related) for each arm.
Measure: Incidence of grade 3 or higher adverse events Time: Up to 12 monthsDescription: The proportion of patients with viral clearance at the time of hospital discharge will be estimated with 95% confidence intervals for each arm.
Measure: At the end of therapy (day 14) Time: Up to 14 daysDescription: Will be estimated for each arm using the method of Kaplan-Meier. Medians estimates and/or estimates at specific time points will be provided with 95% confidence intervals.
Measure: Time to viral clearance Time: Up to 12 monthsDescription: Patients will be followed for up to 12 months or until death or withdrawal of study consent for further follow-up. Following hospitalization, study visits will be telephone or video encounters.
Measure: Survival Time: Up to12 months