Covid 19 Research using Clinical Trials (Home Page)
Report for D009410: Nerve Degeneration NIH
(Synonyms: Nerve Degeneration)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (16)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1236 | Hemanext One Wiki | 0.71 |
| drug1338 | Hyperbaric oxygen therapy Wiki | 0.71 |
| drug2171 | Placebo- 1.00 mg/kg Wiki | 0.71 |
| drug2129 | Placebo 0.20 mg + 2.00 mg/kg Wiki | 0.71 |
| drug929 | Drug: NA-831 - 0.10 mg/kg Wiki | 0.71 |
| drug925 | Drug: GS-5734 - 1.00 mg/kg Wiki | 0.71 |
| drug932 | Drugs: NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg) Wiki | 0.71 |
| drug2170 | Placebo- 0.20 mg/kg Wiki | 0.71 |
| drug2128 | Placebo 0.10 mg + 1.00 mg/kg Wiki | 0.71 |
| drug2172 | Placebo- 2.00 mg/kg Wiki | 0.71 |
| drug930 | Drug: NA-831 - 0.20 mg/kg Wiki | 0.71 |
| drug2169 | Placebo- 0.10 mg/kg Wiki | 0.71 |
| drug933 | Drugs: NA-831 (0.20 mg/kg) plus GS-5734 (2.00 mg/kg) Wiki | 0.71 |
| drug1924 | Normobaric oxygen therapy Wiki | 0.71 |
| drug926 | Drug: GS-5734 - 2.00 mg/kg Wiki | 0.71 |
| drug3208 | blood samples Wiki | 0.50 |
Correlated MeSH Terms (9)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D004660 | Encephalitis NIH | 0.71 |
| D012141 | Respiratory Tract Infections NIH | 0.14 |
| D003141 | Communicable Diseases NIH | 0.11 |
| D014777 | Virus Diseases NIH | 0.08 |
| D007239 | Infection NIH | 0.07 |
| D013577 | Syndrome NIH | 0.07 |
| D011014 | Pneumonia NIH | 0.04 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.03 |
| D018352 | Coronavirus Infections NIH | 0.03 |
Correlated HPO Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002180 | Neurodegeneration HPO | 1.00 |
| HP:0002383 | Encephalitis HPO | 0.71 |
| HP:0011947 | Respiratory tract infection HPO | 0.14 |
| HP:0002090 | Pneumonia HPO | 0.04 |
There are 2 clinical trials
Clinical Trials
1 Neurodegeneration Markers and Neurological Course in Severe Covid-19 Infection - MARNEVO-Covid
Emergence of Covid-19 virus is associated with high frequency of extremely severe clinical pictures, with minor signs of CNS impairment (e.g. anosmia, headache). Since neurotropism is a common feature of coronavirus infection in animals, the investigators examine if indirect signs of CNS lesion are observed in association with severe Covid-19 infection.
NCT04361344 COVID-19 Infection Encephalitis Biological: blood samples MeSH:Infection Communicable Diseases Encephalitis Nerve Degeneration
HPO:Encephalitis Neurodegeneration
Primary Outcomes
Description: Change of neurofilament light chain (NFL) (pg/ml) level between first day of hospitalisation and one week; and change of GFAP (pg/ml) level between first day of hospitalisation and one week.
Measure: Change of neurodegeneration markers level Time: Level of neurofilament light chain (NFL) is dosed at inclusion (day 0) and week 1. Level of GFAP is dosed at inclusion (day 0) and week 1 (day 7).
2 A Randomized, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Inhaled Nanoparticle Formulation of Remdesivir (GS-5734) and in Combination With NA-831 in Healthy Volunteers
Primary Outcomes
Description: Change of neurofilament light chain (NFL) (pg/ml) level between first day of hospitalisation and one week; and change of GFAP (pg/ml) level between first day of hospitalisation and one week.
Measure: Change of neurodegeneration markers level Time: Level of neurofilament light chain (NFL) is dosed at inclusion (day 0) and week 1. Level of GFAP is dosed at inclusion (day 0) and week 1 (day 7).The clinical study is designed to evaluate the safety, tolerability and pharmacokinetics of inhaled nanoparticle nanoparticle formulation of Remdesivir (GS-5734) alone and in combination with NA-831 in 48 healthy volunteers.
NCT04480333 Covid19 Corona Virus Infection Severe Acute Respiratory Syndrome Severe Acute Respiratory Infection Severe Acute Respiratory Syndrome (SARS) Pneumonia Severe Acute Respiratory Syndrome of Upper Respiratory Tract Neurodegeneration Neuroinflammatory Response Drug: Drug: NA-831 - 0.10 mg/kg Drug: Placebo- 0.10 mg/kg Drug: Drug: NA-831 - 0.20 mg/kg Drug: Placebo- 0.20 mg/kg Drug: Drug: GS-5734 - 1.00 mg/kg Drug: Placebo- 1.00 mg/kg Drug: Drug: GS-5734 - 2.00 mg/kg Drug: Placebo- 2.00 mg/kg Combination Product: Drugs: NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg) Combination Product: Placebo 0.10 mg + 1.00 mg/kg Combination Product: Drugs: NA-831 (0.20 mg/kg) plus GS-5734 (2.00 mg/kg) Combination Product: Placebo 0.20 mg + 2.00 mg/kg MeSH:Infection Communicable Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Coronavirus Infections Pneumonia Syndrome Nerve Degeneration Virus Diseases
HPO:Neurodegeneration Pneumonia Respiratory tract infection
Primary Outcomes
Description: AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Measure: Proportion of Participants Experiencing any Treatment-Emergent Adverse Events Time: First dose date up to Day 30 Follow-up Assessment
Description: This will be assessed at various time points by clinical laboratory tests and vital signs.
Measure: Proportion of Participants Experiencing any Treatment-Emergent Graded Laboratory Abnormalities Time: First dose date up to Day 30 Follow-up Assessment
Secondary Outcomes
Description: Monitoring of the levels of drugs in subject sera at various time points to elucidate the maximum concentration (Cmax) of NA-831 and GS-5734 in human serum.
Measure: Maximum Concentration (Cmax) - Pharmacokinetic Assessment Time: 7 days
Description: Monitoring of the levels of drugs in subject sera at various time points to elucidate the time to maximum concentration (Tmax) of NA-831 and GS-5734 in human serum
Measure: Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment Time: 7 days
Description: Monitoring of the levels of drugs in subject sera at various time points to elucidate the area under the curve from time of administration to the last measurable of NA-831 and GS-5734
Measure: AUC calculated from time of administration to the last measurable concentration (AUC0-last) - Pharmacokinetic Assessment Time: 7 days
Description: Monitoring of the levels of drugs in subject sera at various time points to elucidate the area under the curve extrapolated to infinity (AUC0-∞) of NA-831 and GS-5734
Measure: Area Under the Curve Extrapolated to Infinity (AUC0-∞) Time: 7 days
Description: Monitoring of the levels of drugs in subject sera at various time points to elucidate the half-life (t1/2) of NA-831 and GS-5734 in human serum.
Measure: Half-Life (t1/2) - Pharmacokinetic Assessment Time: 7 days
Description: Monitoring of the levels of drugs in subject sera through various time points to elucidate the volume of distribution (Vd) of NA-831 and GS-5734 in human serum.
Measure: Volume of Distribution (Vd) - Pharmacokinetic Assessment Time: 7 days
Description: Monitoring of the levels of drugs in subject sera through at various time points to elucidate clearance [CL] of NA-831 and GS-5734 in human serum.
Measure: Clearance [CL] - Pharmacokinetic Assessment Time: 7 days
HPO Nodes
HP:0002180: Neurodegeneration
Genes 82
IDUA PANK2 PFN1 COASY OPTN UCHL1 TTC19 PDE8B DAO NARS2 CHMP2B ANG C9ORF72 GLT8D1 VAPB CFAP410 UNC13A DCTN1 TREX1 TBK1 TANGO2 GM2A CSF1R FTL UBTF RNASEH2C PON2 PON1 AARS2 TREM2 GALC ZBTB20 ANXA11 PPARGC1A FA2H PCNA NEFH HNRNPA1 RNASEH2A SOD1 LYST WDR45 C19ORF12 FIG4 ERBB4 UBQLN2 NBN PCNA TAF15 PRPH MAPT MFSD8 SQSTM1 ADAR RNASEH2B EPHA4 ATXN2 ATXN3 VCP IFIH1 PLA2G6 TARDBP FUS ATXN3 GM2A TXN2 SAMHD1 NAXD GLE1 PLA2G6 IDS FOLR1 ABCD1 CHCHD10 MATR3 COQ2 PON3 ATXN3 PRNP GUSB NEK1 CCNF SNP 1
rs6971
Primary Outcomes
Description: AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Measure: Proportion of Participants Experiencing any Treatment-Emergent Adverse Events Time: First dose date up to Day 30 Follow-up AssessmentDescription: This will be assessed at various time points by clinical laboratory tests and vital signs.
Measure: Proportion of Participants Experiencing any Treatment-Emergent Graded Laboratory Abnormalities Time: First dose date up to Day 30 Follow-up AssessmentSecondary Outcomes
Description: Monitoring of the levels of drugs in subject sera at various time points to elucidate the maximum concentration (Cmax) of NA-831 and GS-5734 in human serum.
Measure: Maximum Concentration (Cmax) - Pharmacokinetic Assessment Time: 7 daysDescription: Monitoring of the levels of drugs in subject sera at various time points to elucidate the time to maximum concentration (Tmax) of NA-831 and GS-5734 in human serum
Measure: Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment Time: 7 daysDescription: Monitoring of the levels of drugs in subject sera at various time points to elucidate the area under the curve from time of administration to the last measurable of NA-831 and GS-5734
Measure: AUC calculated from time of administration to the last measurable concentration (AUC0-last) - Pharmacokinetic Assessment Time: 7 daysDescription: Monitoring of the levels of drugs in subject sera at various time points to elucidate the area under the curve extrapolated to infinity (AUC0-∞) of NA-831 and GS-5734
Measure: Area Under the Curve Extrapolated to Infinity (AUC0-∞) Time: 7 daysDescription: Monitoring of the levels of drugs in subject sera at various time points to elucidate the half-life (t1/2) of NA-831 and GS-5734 in human serum.
Measure: Half-Life (t1/2) - Pharmacokinetic Assessment Time: 7 daysDescription: Monitoring of the levels of drugs in subject sera through various time points to elucidate the volume of distribution (Vd) of NA-831 and GS-5734 in human serum.
Measure: Volume of Distribution (Vd) - Pharmacokinetic Assessment Time: 7 daysDescription: Monitoring of the levels of drugs in subject sera through at various time points to elucidate clearance [CL] of NA-831 and GS-5734 in human serum.
Measure: Clearance [CL] - Pharmacokinetic Assessment Time: 7 days