Clinical trials: Acute Severe Disease
SARS-CoV-2 (COVID-19) Severe Pneumonia
Study to Evaluate the Safety and Efficacy of ATYR1923 (Efzofitimod) In Participants With Severe Pneumonia Related to COVID-19
To evaluate the safety and preliminary efficacy of efzofitimod, compared to placebo matched to efzofitimod, in hospitalized participants with SARS-CoV-2 (COVID-19) severe pneumonia not requiring mechanical ventilation.
- Trial name
- NCT04412668
- Testing
- Efzofitimod 1 mg/kg, Efzofitimod 3 mg/kg
- Where
- 10 sites in United States, Puerto Rico
- Volunteers
- 36 people
- Sponsor
- aTyr Pharma, Inc.
COVID-19
A COVID-19 Study to Evaluate Safety and Pharmacokinetics of COVID-HIGIV Administered in Healthy Adults
This study is designed to evaluate three dose levels of Anti-SARS-CoV-2 Immunoglobulin Intravenous (Human) (COVID-HIGIV) for safety and pharmacokinetics (PK) in healthy adults.
- Trial name
- NCT04661839
- Testing
- COVID-HIGIV
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
SARS-CoV-2 Infection, COVID-19
Safety and Immunogenicity of RNA-based Vaccines Against SARS-CoV-2 Variants in Healthy Participants
This trial consisted of three parts, Part A, Part B, and Part C, and evaluated the safety and immunogenicity of a third (booster) injection of the multivalent vaccine BNT162b2 (B.1.1.7 + B.1.617.2), and the safety and…
- Conditions
- SARS-CoV-2 Infection, COVID-19, SARS-CoV-2 Acute Respiratory Disease, SARS (Disease)
- Trial name
- NCT05004181
- Testing
- BNT162b2, Multivalent BNT162b2 (B.1.1.7 + B.1.617.2), Monovalent BNT162b2 (B.1.1.7)
- Where
- 35 sites in United States, Germany and 2 more
- Volunteers
- 1,380 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Bipolar Depression, Suicidal Ideas
Sequential Therapy for the Treatment of Severe Bipolar Depression.
NeuroRx is developing NRX-101, a fixed-dose combination oral capsule composed of d-cycloserine (DCS) and lurasidone for the maintenance of remission from Severe Bipolar Depression with Acute Suicidal Ideation (C-SSRS level 4 or…
- Conditions
- Bipolar Depression, Suicidal Ideas, Suicidal Ideation, Suicide, Attempted
- Trial name
- STABIL-B (NCT02974010)
- Testing
- NRX-101 Oral Capsule, Lurasidone Oral Capsule, Ketamine Intravenous Infusion
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- NeuroRx, Inc.
Acute Ischaemic Stroke, Transient Ischaemic Attack
[SOCRATES -Acute Stroke Or Transient IsChaemic Attack TReated With Aspirin or Ticagrelor and Patient OutcomES]
The primary objective of the study is to compare the effect of 90-day treatment with ticagrelor (180 mg [two 90 mg tablets] loading dose on Day 1 followed by 90 mg twice daily maintenance dose for the remainder of the study) vs…
- Trial name
- SOCRATES (NCT01994720)
- Testing
- ticagrelor, Acetylsalicylic acid (ASA)
- Where
- 521 sites in United States, Argentina and 31 more
- Volunteers
- 13,307 people
- Sponsor
- AstraZeneca
Coronavirus Disease 2019 (COVID-19)
A Study of Rivaroxaban to Reduce the Risk of Major Venous and Arterial Thrombotic Events, Hospitalization and Death in Medically Ill Outpatients With Acute, Symptomatic Coronavirus Disease 2019 (COVID-19) Infection
The purpose of this study is to evaluate whether rivaroxaban reduces the risk of a composite endpoint of major venous and arterial thrombotic events, all-cause hospitalization, and all-cause mortality compared with placebo in…
- Trial name
- PREVENT-HD (NCT04508023)
- Testing
- Rivaroxaban, Standard of Care (SOC)
- Where
- 17 sites in United States
- Volunteers
- 1,284 people
- Sponsor
- Janssen Research & Development, LLC
Blood Coagulation Disorders, Acute Major Bleeding
Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy
The purpose of this study is to evaluate efficacy, safety and tolerance of BERIPLEX® P/N (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by coumarin derivatives in subjects who require immediate…
- Trial name
- NCT00708435
- Testing
- Beriplex® P/N (Kcentra), Fresh frozen plasma
- Where
- 69 sites in United States, Belarus and 4 more
- Volunteers
- 216 people
- Sponsor
- CSL Behring
COVID-19
Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) in Hospitalized Participants With Coronavirus Disease (COVID-19)
The purpose of the study is to determine if Liquid Alpha1-Proteinase Inhibitor (Human) (Liquid Alpha1-PI) plus SMT can reduce the proportion of participants dying or requiring intensive care unit (ICU) admission on or before Day…
- Trial name
- NCT04547140
- Testing
- Liquid Alpha1-Proteinase Inhibitor (Human), Standard Medical Treatment
- Where
- 20 sites in United States, Brazil and 3 more
- Volunteers
- 57 people
- Sponsor
- Grifols Therapeutics LLC
COVID, Covid-19
A Study of APL-9 in Adults With Mild to Moderate ARDS Due to COVID-19
The purpose of this study is to evaluate the safety and effectiveness of APL-9 in adults with mild to moderate ARDS (acute respiratory distress syndrome) caused by COVID-19 who are hospitalized and require supplemental oxygen…
- Conditions
- COVID, Covid-19, Coronavirus, Coronavirus Infection
- Trial name
- NCT04402060
- Testing
- APL-9, Vehicle Control
- Where
- 24 sites in United States, Brazil
- Volunteers
- 72 people
- Sponsor
- Apellis Pharmaceuticals, Inc.
COVID-19, Coronavirus
A Study to Assess Pulsed Inhaled Nitric Oxide vs Placebo in Subjects With Mild or Moderate COVID-19
A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pulsed inhaled iNO compared to placebo in subjects with COVID-19.
- Conditions
- COVID-19, Coronavirus, Coronavirus Infection
- Trial name
- COViNOX (NCT04421508)
- Testing
- INOpulse
- Where
- 17 sites in United States
- Volunteers
- 191 people
- Sponsor
- Bellerophon Pulse Technologies
Pneumonitis, SARS-CoV Infection
GLS-1027 for the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection (COVID-19)
This clinical trial will evaluate the safety, tolerability and efficacy of GLS-1027 in the prevention of severe pneumonitis caused by SARS-CoV-2 infection
- Trial name
- NCT04590547
- Testing
- GLS-1027
- Where
- 17 sites in United States, Bulgaria and 3 more
- Volunteers
- 132 people
- Sponsor
- GeneOne Life Science, Inc.
Biological Availability, Healthy Participants
Relative Bioavailability Study of Nirmatrelvir/Ritonavir 4 Different Fixed Dose Combination Tablets Relative to the Commercial Tablets in Healthy Participants
The purpose of this study is to estimate the relative bioavailability of nirmatrelvir/ritonavir of 4 different FDC tablet formulations relative to the commercial tablet formulation under fasted conditions in healthy adult…
- Trial name
- NCT05525910
- Testing
- Nirmatrelvir/ ritonavir, Nirmatrelvir/ritonavir
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Pfizer
COVID-19
Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Participants in Intensive Care Unit (ICU) With Coronavirus Disease (COVID-19)
The purpose of the study is to determine if a high dose of Intravenous Immune Globulin (IVIG) plus Standard Medical Treatment (SMT) can reduce all-cause mortality versus SMT alone in hospitalized participants with COVID-19…
- Trial name
- NCT04480424
- Testing
- GAMUNEX-C, Standard Medical Treatment
- Where
- 18 sites in United States
- Volunteers
- 100 people
- Sponsor
- Grifols Therapeutics LLC
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
A Study of Pevonedistat in People With Blood Cancers or Solid Tumors With Kidney or Liver Problems
Pevonedistat is a medicine to treat people with blood cancers or solid tumors. The main aim of the study is to learn about the levels of pevonedistat in the blood of participants with blood cancers or solid tumors, who also have…
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute, Renal Insufficiency
- Trial name
- NCT03814005
- Testing
- Azacitidine, Pevonedistat
- Where
- 8 sites in United States, Spain
- Volunteers
- 17 people
- Sponsor
- Takeda
CoronaVirus Induced Disease-2019 (COVID-19)
Study of Oral Ibrutinib Capsules to Assess Respiratory Failure in Adult Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) and Pulmonary Injury
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection.
- Trial name
- iNSPIRE (NCT04375397)
- Testing
- Ibrutinib
- Where
- 9 sites in United States
- Volunteers
- 46 people
- Sponsor
- AbbVie
Pulmonary Disease, Chronic Obstructive
Dose Finding Study of Nemiralisib (GSK2269557) in Subjects With an Acute Moderate or Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Nemiralisib is being developed as an anti-inflammatory drug for the treatment of inflammatory airways disease. This study is designed to assess the dose response, efficacy, safety, and pharmacokinetics of nemiralisib across a…
- Trial name
- NCT03345407
- Testing
- Nemiralisib ELLIPTA 50 µg, Nemiralisib ELLIPTA 100 µg, Nemiralisib ELLIPTA 250 µg
- Where
- 161 sites in United States, Argentina and 14 more
- Volunteers
- 943 people
- Sponsor
- GlaxoSmithKline
Peripheral Artery Disease
Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities
The purpose of study was to test whether rivaroxaban added to standard of care treatment, when compared to placebo, had the potential to reduce the incidence of the clinical events related to the clots and complications of the…
- Trial name
- VOYAGER PAD (NCT02504216)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- 532 sites in United States, Argentina and 32 more
- Volunteers
- 6,564 people
- Sponsor
- Bayer
COVID-19
AZD7442 - a Potential Combination Therapy for the Prevention and Treatment of COVID-19
In this first-in-humans dose escalation study, AZD7442 (AZD8895 + AZD1061) will be evaluated for safety, tolerability, pharmacokinetics, and generation of anti-drug antibodies (ADAs).
- Trial name
- NCT04507256
- Testing
- AZD7442
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
COVID-19
Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult and Pediatric Patients With COVID-19
Phase 1 To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2 Phase 2 To evaluate the…
- Trial name
- NCT04425629
- Testing
- casirivimab+imdevimab combination therapy
- Where
- 114 sites in United States, Mexico and 1 more
- Volunteers
- 10,078 people
- Sponsor
- Regeneron Pharmaceuticals
Respiratory Distress Syndrome, Adult
Efficacy and Safety of FP-1201-lyo (Interferon Beta-1a) in Patients Having Acute Respiratory Distress Syndrome (ARDS)
In this study effectiveness and safety of a new drug FP-1201-lyo (recombinant human interferon beta-1a) is compared to placebo. Investigation is conducted with patients who have acute respiratory distress syndrome (ARDS).
- Trial name
- INTEREST (NCT02622724)
- Testing
- Interferon beta-1a
- Where
- 71 sites in Belgium, Czechia and 6 more
- Volunteers
- 301 people
- Sponsor
- Faron Pharmaceuticals Ltd