Covid 19 Clinical Trials

	Name (Synonyms)	Correlation
drug74	ACT-541478 300 mg Wiki	0.58
drug343	BI 764198 Wiki	0.58
drug76	ACT-541478 high or low dose (or placebo) Wiki	0.58
drug3166	acute kidney injury Wiki	0.58
drug73	ACT-541478 30 mg Wiki	0.58
drug72	ACT-541478 1000 mg Wiki	0.58
drug70	ACT-541478 10 mg Wiki	0.58
drug1050	Exposure Therapy Wiki	0.58
drug75	ACT-541478 dose E1 Wiki	0.58
drug71	ACT-541478 100 mg Wiki	0.58
drug1643	MAS825 Wiki	0.58

Correlated MeSH Terms (11)

	Name (Synonyms)	Correlation
D009155	Mutism NIH	0.58
D009771	Obsessive-Compulsive Disorder NIH	0.41
D001010	Anxiety, Separation NIH	0.41
D000072861	Phobia, Social NIH	0.41
D003193	Compulsive Personality Disorder NIH	0.41
D000379	Agoraphobia NIH	0.41
D016584	Panic Disorder NIH	0.33
D058186	Acute Kidney Injury NIH	0.13
D004194	Disease NIH	0.10
D001008	Anxiety Disorders NIH	0.09
D011014	Pneumonia NIH	0.03

Correlated HPO Terms (5)

	Name (Synonyms)	Correlation
HP:0002300	Mutism HPO	0.58
HP:0000756	Agoraphobia HPO	0.41
HP:0000722	Obsessive-compulsive behavior HPO	0.33
HP:0001919	Acute kidney injury HPO	0.13
HP:0002090	Pneumonia HPO	0.03

There are 3 clinical trials

Clinical Trials

1 Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 764198 in Healthy Male Subjects (Double-blind, Randomised, Placebo-controlled, Parallel Group Design) and Effect of Food on the Relative Bioavailability of BI 764198 (Open-label, Randomised, Two-way Cross-over)

To investigate safety and tolerability of BI 764198 in healthy male subjects following oral administration of multiple rising doses per day over 14 days and to investigate the food effect on the relative bioavailability of BI 764198.

NCT04102462 Healthy Drug: BI 764198 Drug: Matching placebo

Primary Outcomes

Measure: percentage of subjects with drug-related adverse events

Time: Up to Day 34

Secondary Outcomes

Measure: MRD Part - AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)

Time: Up to Day 34

Measure: MRD Part -Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)

Time: Up to Day 34

Measure: MRD Part -tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state)

Time: Up to Day 34

Measure: FE Part - AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

Time: Up to Day 17

Measure: FE Part - Cmax (maximum measured concentration of the analyte in plasma)

Time: Up to Day 17

Measure: FE Part - tmax (Time from (last) dosing to the maximum measured concentration of the analyte in plasma)

Time: Up to Day 17

2 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

3 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.