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LSALT peptideWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (9)

Name (Synonyms) Correlation
drug65 ACT-541478 dose E1 Wiki 1.00
drug60 ACT-541478 10 mg Wiki 1.00
drug61 ACT-541478 100 mg Wiki 1.00
drug66 ACT-541478 high or low dose (or placebo) Wiki 1.00
drug62 ACT-541478 1000 mg Wiki 1.00
drug64 ACT-541478 300 mg Wiki 1.00
drug63 ACT-541478 30 mg Wiki 1.00
drug1442 Matching placebo Wiki 0.71
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (5)

Name (Synonyms) Correlation
D058186 Acute Kidney Injury NIH 0.24
D014947 Wounds and Injuries NIH 0.22
D013577 Syndrome NIH 0.11
D045169 Severe Acute Respiratory Syndrome NIH 0.05
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0001919 Acute kidney injury HPO 0.24

There is one clinical trial.

Clinical Trials

1 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study of LSALT Peptide as Prevention of Acute Respiratory Distress Syndrome (ARDS) and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19)

To evaluate the proportion of subjects alive and free of respiratory failure (e.g. need for non-invasive or invasive mechanical ventilation, high flow oxygen, or ECMO) and free of the need for continued renal replacement therapy (RRT) on Day 28. The need for continued RRT at Day 28 will be defined as either dialysis in the past 3 days (Day 26, 27, or 28) or an eGFR on Day 28 <10 mL/min/1.73 m2.

NCT04402957 COVID Severe Acute Respiratory Syndrome Sars-CoV2 Acute Kidney Injury Drug: LSALT peptide Drug: Placebo
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Acute Kidney Injury Syndrome Wounds and Injuries
HPO:Acute kidney injury

Primary Outcomes

Description: To evaluate the efficacy of intravenous LSALT peptide plus standard of care to prevent the progression of COVID-19 to mild, moderate or severe ARDS, acute kidney injury, cardiomyopathy, acute liver injury, coagulopathy, or death in patients infected with SARS-CoV-2 compared with placebo plus standard of care.

Measure: Development of Acute Respiratory Distress Syndrome (ARDS) and Other Organ Injuries

Time: 28 days

Secondary Outcomes

Description: High-frequency oscillatory ventilation, with its rapid delivery of low tidal volumes and a respiratory rate in the range of 60 to 900 breaths/minute, has also been utilized in ARDS patients.

Measure: Ventilation-free days

Time: 28 days

Description: Oxygen therapy provided as non-invasive therapy for ARDS patients.

Measure: Time on nasal cannula or oxygen masks

Time: 28 days

Description: 28 day mortality - all cause and attributable

Measure: 28 day mortality - all cause and attributable

Time: 28 days

Description: ICU and hospitalization length of stay (days)

Measure: ICU and hospitalization length of stay (days)

Time: 28 days

Description: Swab (nasopharyngeal, nasal, throat, sputum, or lower respiratory tract) at baseline (Day 1) and every 3 days thereafter until eradication → virologic clearance rate

Measure: SARS-CoV2 testing

Time: 28 days

Description: Extracorporeal membrane oxygenation (ECMO) is often used for severe ARDS to allow lung healing/repair and reverse respiratory failure.

Measure: Need and duration for extracorporeal membrane oxygenation (ECMO)

Time: 28 days

Description: Vasopressor free days

Measure: Vasopressor free days

Time: 28 days

Description: Chest X-rays performed at Baseline, Day 3, at clinical improvement, and end-of-treatment (EOT) and study (EOS) to determine presence of bilateral opacities.

Measure: Radiographic pulmonary assessments

Time: 28 days

Description: Change in daily mMRC dyspnea and SOFA scores (0 to 4) with 4 being the most severe outcome

Measure: Change in modified Medical Research Council (mMRC) dyspnea and Sequential Organ Failure Assessment (SOFA) scores

Time: 28 days

Description: Incidence of other organ (non-lung) disorders

Measure: Incidence of non-lung disorders

Time: 28 days

Description: Change in liver function tests (ALT, AST, and total bilirubin levels) from baseline

Measure: Measures of liver dysfunction

Time: 28 days

Description: Change in SCr and eGFR from baseline

Measure: Measures of kidney dysfunction

Time: 28 days

Description: Change in highly-sensitive troponin (hs-troponin) from baseline

Measure: Measures of cardiac dysfunction

Time: 28 days

Description: Change from baseline ACT, aPTT, and/or PT/INR levels

Measure: Measures of coagulopathies

Time: 28 days

Description: Change in baseline antiviral immunoglobulins (IgG, IgM) at EOS.

Measure: Changes in immunogenic responses

Time: 28 days

Description: Changes in total healthcare costs from admission to discharge between treatment groups.

Measure: Healthcare outcomes

Time: 28 days

Description: Change in serum cytokines including IL-1α, IL-1ß, IL-1ra, IL-5, IL-6, IL-8, IL-12, TNFα, CXCL10/IP10, MCP-3, and ferritin drawn at the same time as LSALT peptide levels

Measure: Molecular changes in pro-inflammatory pathways

Time: 28 days

Description: Pharmacokinetics of LSALT peptide over the study period.

Measure: Pharmacokinetics of LSALT peptide

Time: 28 days

Related HPO nodes (Using clinical trials)

HP:0001919: Acute kidney injury
Genes 29
STOX1 TCN2 DGKE SAA1 CFH LPIN1 CD46 C3 CD46 FLT1 CACNA1S CFB RYR1 CFH APRT HPRT1 HNF1B CCND1 CORIN CFHR1 HELLPAR CFI SLC26A1 THBD PYGM CFHR3 HNF4A CFI SLC22A12
Protein Mutations 0
SNP 0