Covid 19 Clinical Trials

Part 1 of this trial enrolled 30 patients to receive Auxora (formerly CM4620) in a 2:1 randomized, open label trial of patients with severe and critical COVID-19 pneumonia. Part 2 will consist of a randomized, double blind, placebo-controlled (RCT) study that will evaluate efficacy, safety, and the pharmacokinetic profile of Auxora in patients with severe COVID-19 pneumonia. Four hundred patients will be randomized 1:1 to receive Auxora or matching placebo. Patients with an estimated PaO2/FiO2 of 101-200 will be stratified to ensure balanced randomization between the Auxora and placebo arms. Subgroup analyses will be performed to explore how time to recovery is influenced by baseline variables and to evaluate the treatment effect at different levels of each of these variables. The dose of Auxora will be 2.0 mg/kg (1.25 mL/kg) administered at 0 hour, and then 1.6 mg/kg (1 mL/kg) at 24 hours and 1.6 mg/kg (1 mL/kg) at 48 hours from the SFISD. The dose of placebo will be 1.25 mL/kg administered at 0 hour and then 1 mL/kg at 24 hours and 1 mL/kg at 48 hours from the SFISD. Both remdesivir and corticosteroids will be allowed. The infusion of Auxora will start within 12 hours from the time the patient or LAR provides informed consent.

NCT04345614 Pneumonia Drug: Auxora Drug: Placebo

MeSH:Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: Defined as the number of days hospitalized but not requiring supplemental oxygen or ongoing medical care, or; discharged and requiring supplemental oxygen, or; discharged, not requiring supplemental oxygen.

Measure: Number of days from the Start of the First Infusion of Study Drug (SFISD) to recovery

Time: From start of first infusion of study drug to day 30

Secondary Outcomes

Measure: Proportion of patients requiring invasive mechanical ventilation or dying

Time: from start of start of first infusion of study drug and up to day 30

Measure: Proportion of patients requiring invasive mechanical ventilation

Time: from start of start of first infusion of study drug and up to day 30

Description: The ordinal scale is an assessment of the clinical status in a given day. The scale is as follows: 1. Death 2. Hospitalized, requiring invasive mechanical ventilation or ECMO 3. Hospitalized, requiring non-invasive ventilation or high flow supplemental oxygen 4. Hospitalized, requiring low flow supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care 6. Hospitalized, not requiring supplemental oxygen or ongoing medical care 7. discharged, requiring supplemental oxygen 8. Discharged, not requiring supplemental oxygen

Measure: Differences in outcomes as measured by an 8-point ordinal scale

Time: from randomization through Days 12 and 30

Measure: Proportion of patients who have died at day 30 (mortality)

Time: Day 30

Measure: Number of days in the hospital

Time: from admission into the hospital until discharge from the hospital

Measure: Number of days in the Intensive Care Unit (ICU)

Time: from admission into ICU until discharge from ICU

Measure: Incidence of treatment emergent adverse events (TEAE) and serious adverse events (SAE)

Time: from randomization and through day 30

Description: Concentration measured using a validated assay

Measure: CM4620-IE serum concentration

Time: enrollment through 72 hours

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

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation

Correlated Drug Terms (1)

Correlated MeSH Terms (1)

Correlated HPO Terms (1)

Clinical Trials

1 A Randomized Double Blind, Placebo-Controlled Study of Auxora for the Treatment of Severe COVID-19 Pneumonia (CARDEA)