CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (5)

Name (Synonyms) Correlation
drug283 Atorvastatin Wiki 0.58
drug2516 SEL-212A Wiki 0.58
drug2655 Sodium Nitrite Wiki 0.58
drug2517 SEL-212B Wiki 0.58
drug2476 SAB-185 Wiki 0.41

Correlated MeSH Terms (9)

Name (Synonyms) Correlation
D006073 Gout NIH 0.58
D055370 Lung Injury NIH 0.11
D011024 Pneumonia, Viral NIH 0.07
D055371 Acute Lung Injury NIH 0.06
D012127 Respiratory Distress Syndrome, Newborn NIH 0.05
D012128 Respiratory Distress Syndrome, Adult NIH 0.05
D011014 Pneumonia NIH 0.03
D045169 Severe Acute Respiratory Syndrome NIH 0.03
D018352 Coronavirus Infections NIH 0.02

Correlated HPO Terms (2)

Name (Synonyms) Correlation
HP:0001997 Gout HPO 0.58
HP:0002090 Pneumonia HPO 0.03

There are 3 clinical trials

Clinical Trials

1 Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Study

This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of intravenous Sodium Nitrite Injection for treatment of patients infected with COVID-19 who develop lung injury and require mechanical ventilation.

NCT04401527 COVID-19 Acute Respiratory Distress Syndrome Acute Respiratory Failure Drug: Sodium Nitrite Drug: Normal Saline
MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury Lung Injury

Primary Outcomes

Description: Proportion of study subjects who are alive and free of respiratory failure at Day 28

Measure: Survival with Unassisted Breathing

Time: Day 28

Secondary Outcomes

Description: Number of days alive without mechanical ventilation from start of study through Day 28

Measure: Survival without Mechanical Ventilation

Time: Day 28

Description: Number of days alive and not in the intensive care unit from start of study through Day 28.

Measure: Survival without Intensive Care

Time: Day 28

Description: Number of days alive and not in hospital from start of study through Day 28.

Measure: Survival without Hospitalization

Time: Day 28

Description: Alive on Day 28 and no use of ECMO therapy any time between start of study and Day 28.

Measure: Survival without ECMO

Time: Day 28

Description: Alive on Day 28

Measure: Survival

Time: Day 28

Other Outcomes

Description: Oxygenation index (PaO2/FIO2) at Day 14

Measure: Lung Status

Time: Day 14

Description: Blood urea nitrogen (BUN) at Day 14

Measure: Kidney Status (1)

Time: Day 14

Description: Creatinine at Day 14

Measure: Kidney Status (2)

Time: Day 14

Description: Liver function tests (ALT and AST) at Day 14

Measure: Liver Status

Time: Day 14

2 A Phase 1B, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of SAB-185 in Ambulatory Subjects With COVID-19

: Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SAB Biotherapeutics has developed SAB-185, an Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (transchromosomic [Tc] bovine-derived), as a potential therapeutic to treat COVID-19. This study will evaluate the safety, immunogenicity, and pharmacokinetics of SAB-185 in ambulatory participants with COVID-19.

NCT04469179 COVID-19 SARS-CoV2 Biological: SAB-185 Other: Normal Saline

Primary Outcomes

Description: Incidence and severity of other adverse events and severe adverse events (SAE)

Measure: Number of Participants Having Adverse Events

Time: 29 Days

Description: transfusion-related adverse events

Measure: Number of Participants Having Transfusion-Related Adverse Events

Time: 29 Days

Secondary Outcomes

Description: Incidence and severity of adverse events and SAEs from Screening through Study Day 90

Measure: Number of Participants Having Adverse Events

Time: 90 Days

Description: Measurement of SARS CoV-2 neutralizing (PRNT80) antibody titers from screening through Study Day 90

Measure: Assesment of the PD of SAB-185 administered intravenously

Time: 90 Days

Description: Measurement of Rheumatoid factor through day 90

Measure: Immune response elicited by SAB-185

Time: 90 Days

Description: Measurement of anti-SAB-185 antibodies through screening day 90

Measure: Concentration of subject anti-SAB-185 antibodies elicited by SAB-185

Time: 90 Days

Description: Incidence of SARS-CoV-2 in swab specimens as measured by quantitative RT-PCR through Study Day 29

Measure: Incidence of SARS-CoV-2 in oropharyngeal (OP) or nasopharyngeal (NP) swab specimens

Time: 29 Days

Description: Level of SARS-CoV-2 in swab specimens as measured by quantitative RT-PCR through Study Day 29

Measure: Level of SARS-CoV-2 in oropharyngeal (OP) or nasopharyngeal (NP) swab specimens

Time: 29 Days

3 A Randomized Double-Blind, Placebo-Controlled Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy

This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm trials to determine the safety and efficacy of two different dose levels of SEL-212 compared to placebo. Approximately 105 patients, stratified as to the presence or absence of tophi, will be randomized in a 1:1:1 allocation ratio prior to Baseline to receive treatment with one of two dose levels of SEL-212 or placebo every 28 days for approximately 6 months in each trial (SEL-212/301 and SEL-212/302). Analysis of efficacy will be performed at Day 28 of Treatment Period 6. Safety will be monitored throughout the study.

NCT04513366 Chronic Gout Drug: SEL-212A Drug: SEL-212B Other: Normal Saline
MeSH:Gout
HPO:Gout

Primary Outcomes

Description: The percentage of patients who achieve and maintain reduction in serum uric acid (sUA) < 6 mg/dL for at least 80% of the time during month 6 in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo

Measure: Serum uric acid control during month 6

Time: 6 months

Secondary Outcomes

Description: To assess changes in number of tender and swollen joints in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo

Measure: Tender and Swollen Joint Counts

Time: 6 months

Description: To assess change in tophus burden by photographic area assessment in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo

Measure: Tophus burden

Time: 6 months

Description: To assess change in Patient Reported Outcomes (PROs) including assessments of: activity limitation (HAQ-DI) in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo

Measure: HAQ-DI

Time: 6 months

Description: To assess change in Patient Reported Outcomes (PROs) including assessments of: patients' quality of life (QoL) (SF-36) in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo

Measure: SF-36

Time: 6 months

Description: To assess changes in gout flare incidence in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo

Measure: Gout Flare Incidence

Time: 6 months

Related HPO nodes (Using clinical trials)

HP:0001997: Gout
Genes 24
SLC37A4 MUC1 SLC4A1 HPRT1 SPTA1 SEC61A1 G6PC HNF1B HPRT1 LRP6 SPTB ANK1 CLCNKB UMOD SLC12A3 EPB42 HPRT1 APOE UMOD SLC37A4 PFKM PRPS1 HPRT1 DNAJB11
Protein Mutations 0
SNP 0