Covid 19 Clinical Trials

	Name (Synonyms)	Correlation
drug65	ACT-541478 dose E1 Wiki	0.71
drug60	ACT-541478 10 mg Wiki	0.71
drug61	ACT-541478 100 mg Wiki	0.71
drug1404	MAS825 Wiki	0.71
drug66	ACT-541478 high or low dose (or placebo) Wiki	0.71
drug62	ACT-541478 1000 mg Wiki	0.71
drug1313	LSALT peptide Wiki	0.71
drug64	ACT-541478 300 mg Wiki	0.71
drug63	ACT-541478 30 mg Wiki	0.71
drug1822	Placebo Wiki	0.04

Correlated MeSH Terms (6)

	Name (Synonyms)	Correlation
D058186	Acute Kidney Injury NIH	0.17
D014947	Wounds and Injuries NIH	0.16
D013577	Syndrome NIH	0.08
D011014	Pneumonia NIH	0.04
D045169	Severe Acute Respiratory Syndrome NIH	0.04
D018352	Coronavirus Infections NIH	0.03

Correlated HPO Terms (2)

	Name (Synonyms)	Correlation
HP:0001919	Acute kidney injury HPO	0.17
HP:0002090	Pneumonia HPO	0.04

There are 2 clinical trials

Clinical Trials

1 A Phase 2, Randomized, Placebo-controlled, Participant and Investigator Blinded, Multi-center Study to Assess Efficacy and Safety of MAS825 for the Treatment of SARS-CoV-2 Infected Patients With COVID-19 Pneumonia and Impaired Respiratory Function

The study will assess the efficacy and safety of MAS825 for the treatment of SARS-CoV-2 infected patients with COVID-19 pneumonia and impaired respiratory function

NCT04382651 COVID-19 Pneumonia, Impaired Respiratory Function Drug: MAS825 Drug: Matching placebo

MeSH:Pneumonia Respiratory Insufficiency

HPO:Pneumonia

Primary Outcomes

Description: The APACHE II ("Acute Physiology And Chronic Health Evaluation II") is a severity-of-disease classification system. An integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death. Worst case imputation for death will be applied.

Measure: APACHE II severity of disease score on Day 15 or on day of discharge (whichever is earlier)

Time: Up to 15 days

Secondary Outcomes

Description: C-reactive protein (CRP) is a blood test marker for inflammation in the body. For a standard CRP test, a normal reading is less than 10 milligram per liter (mg/L). It will be analyzed on a logscale fitting a repeated measures mixed model including treatment group, study day, the three stratification factors and log transformed baseline CRP as a covariate.

Measure: Serum C-reactive protein (CRP levels)

Time: Up to 15 days

Description: Ferritin is a blood test marker for inflammation in the body. For a standard Ferritin test, a normal reading is less than 300 micrograms per liter (μg/L). It will be analyzed on a logscale fitting a repeated measures mixed model including treatment group, study day, the three stratification factors and log transformed baseline Ferritin as a covariate.

Measure: Ferritin levels

Time: Up to 15 days

Description: Proportion of participants without the need for invasive mechanical ventilation for survival.

Measure: Proportion of participants without the need for invasive mechanical ventilation

Time: Day 15, Day 29

Description: Clinical status is measured with the 9-point ordinal scale. The scoring is - Uninfected patients have a score 0 (no clinical or virological evidence of infection). - Ambulatory patients (not in hospital or in hospital and ready for discharge) can have a score 1 (no limitation of activities) or 2 (limitation of activities). -Hospitalized patients with mild disease can have score 3 (no oxygen therapy defined as SpO2 ≥ 94% on room air) or 4 (oxygen by mask or nasal prongs). - Hospitalized patients with severe disease can have score 5 (noninvasive ventilation or highflow oxygen), 6 (intubation and mechanical ventilation) or 7 (ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)). - Patients who die have a score 8.

Measure: Proportion of participants with at least one level improvement in clinical status

Time: Day 15, Day 29

Measure: Clinical status over time

Time: Up to 15 days

2 Single-center, Double-blind, Randomized, Placebo-controlled, Three-part, First-in-human, Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-541478 in Healthy Subjects

A study in healthy subjects to investigate the safety and tolerability of ACT-541478 as well as what ACT-541478 does to the body and the way the body takes up, distributes, and gets rid of of ACT-541478

NCT04452006 Healthy Drug: ACT-541478 10 mg Drug: ACT-541478 30 mg Drug: ACT-541478 100 mg Drug: ACT-541478 300 mg Drug: ACT-541478 1000 mg Drug: ACT-541478 high or low dose (or placebo) Drug: ACT-541478 dose E1 Drug: Matching placebo

Primary Outcomes

Measure: Treatment-emergent (serious) AEs

Time: From (first) study treatment administration up to 96 h after last study treatment administration in the corresponding period (if applicable). Total duration: up to 5 days.