Clinical trials: Cytokine Storm
COVID-19
101-PGC-005 for the Treatment of COVID-19
This is a prospective, randomized, comparative, multi-centric, adaptive design clinical study to evaluate efficacy, safety, and tolerability of 101-PGC-005 ('005) when used alongside standard of care (SOC) for the treatment of…
- Trial name
- NCT05656521
- Testing
- 101-PGC-005, Dexamethasone
- Where
- 5 sites in India
- Volunteers
- 62 people
- Sponsor
- 101 Therapeutics
Severe COVID-19 Disease
RAPA-501-Allo Therapy of COVID-19-ARDS
The first-in-human Phase 1 study component will evaluate two dose levels of RAPA-501-ALLO off the shelf cells in patients with COVID-19-related ARDS, with key endpoints of safety, biologic and potential disease-modifying effects.
- Trial name
- NCT04482699
- Testing
- RAPA-501-Allo off-the-shelf Therapy of COVID-19
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Rapa Therapeutics LLC
Sars-CoV2
Rhu-pGSN for Severe Covid-19 Pneumonia
Study Objectives: Primary To assess the efficacy (survival without organ failure on Day 14) of three doses of rhu-pGSN administered intravenously (IV) plus standard of care (SOC) to hospitalized subjects with a primary diagnosis…
- Trial name
- NCT04358406
- Testing
- Recombinant human plasma gelsolin (Rhu-pGSN)
- Where
- 3 sites in Romania, Spain
- Volunteers
- 64 people
- Sponsor
- BioAegis Therapeutics Inc.
Cytokine Release Syndrome
Study of CTO1681 for the Prevention and Treatment of CRS in Patients Receiving CAR T-Cell Therapy
This is an interventional study to evaluate the use of CTO1681 in preventing or reducing CAR T-cell-induced toxicities like cytokine release syndrome (CRS).
- Trial name
- NCT05905328
- Testing
- CTO1681 10 µg, CTO1681 20 μg, CTO1681 30 μg
- Where
- 6 sites in United States
- Volunteers
- 54 people
- Sponsor
- CytoAgents, Inc.
Acute Respiratory Distress Syndrome, Respiratory Failure
MRG-001 as an Immunoregulatory and Regenerative Therapy for ARDS Patients
This is a phase IIa, dose-ranging, proof-of-concept study of MRG-001 in patients with ARDS. The aim is to determine the safety and preliminary efficacy of MRG-001 across two dose ranges.
- Conditions
- Acute Respiratory Distress Syndrome, Respiratory Failure, Respiratory Distress Syndrome, Respiratory Tract Diseases
- Trial name
- SUMMIT (NCT06308926)
- Testing
- MRG-001 (Low-dose), MRG-001 (High-dose)
- Volunteers
- 60 people
- Sponsor
- MedRegen LLC
COVID-19
A Prospective, Phase II Study to Evaluate Safety of 101-PGC-005 ('005) for Moderate to Severe COVID-19 Disease Along With Standard of Care
In December 2019, a novel pneumonia caused by a previously unknown pathogen emerged in Wuhan, China. The pathogen was soon identified as a novel coronavirus (SARS-CoV-2), which is closely related to severe acute respiratory…
- Trial name
- NCT05195749
- Testing
- 101-PGC-005 ('005) + SOC
- Where
- Israel
- Volunteers
- 3 people
- Sponsor
- 101 Therapeutics
COVID-19
A Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE)
Study KIN-1901-2001 is a multi-center, adaptive, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of gimsilumab in subjects with lung injury or acute respiratory distress syndrome (ARDS)…
- Trial name
- NCT04351243
- Testing
- Gimsilumab
- Where
- 33 sites in United States
- Volunteers
- 227 people
- Sponsor
- Kinevant Sciences GmbH
Coronavirus, COVID
A Phase 2 Study to Evaluate Axatilimab for Hospitalized Participants With Respiratory Involvement Secondary to COVID-19
This was a randomized, double-blind, placebo-controlled, 29-day study to assess the efficacy and safety of axatilimab plus standard of care (SOC), compared with placebo plus SOC, in participants with respiratory signs and…
- Conditions
- Coronavirus, COVID, ARDS, Cytokine Storm
- Trial name
- NCT04415073
- Testing
- SNDX-6352
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- Syndax Pharmaceuticals
COVID-19
A Study to Evaluate OP-101 (Dendrimer N-acetyl-cysteine) in Severe Coronavirus Disease 2019 (COVID-19) Patients
The primary purpose of Stage-I of this study is to evaluate the safety and tolerability of OP-101 in patients with severe COVID-19 and of Stage 2 of this study is to evaluate the efficacy of OP-101 in patients with severe…
- Trial name
- PRANA (NCT04458298)
- Testing
- OP-101
- Where
- 8 sites in United States
- Volunteers
- 28 people
- Sponsor
- Ashvattha Therapeutics, Inc.
Coronavirus Infection, Cytokine Storm
Yoga Pranayama Adjuvant to Treat Burden COVID-19
COronaVIrus Disease or Severe Acute Respiratory Syndrome -CoV-2 or COVID-19, mortality occurs mainly from immunological behavior or by suicide after healing .
- Conditions
- Coronavirus Infection, Cytokine Storm, Mental Disorder
- Trial name
- YOCO (NCT04413747)
- Testing
- morning Yoga-based breathing support, pre_lunch Yoga-based breathing support, pre_dinner Yoga-based breathing support
- Where
- Italy
- Volunteers
- 1,000 people
- Sponsor
- Health Ricerca e Sviluppo S.R.L.
Coronavirus Disease 2019 (COVID-19) Pneumonia
Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Patients With COVID-19
The primary objective of this study is to assess whether the use of lenzilumab in addition to current standard of care can alleviate the immune-mediated cytokine release syndrome (CRS) and improve ventilator-free survival in…
- Trial name
- NCT04351152
- Testing
- Lenzilumab, Standard of Care
- Where
- 29 sites in United States, Brazil
- Volunteers
- 520 people
- Sponsor
- Humanigen, Inc.
COVID-19
INB03 for the Treatment of Pulmonary Complications From COVID-19
The purpose of this study is to determine whether XPro1595 can prevent the progression of respiratory complications in COVID19 patients.
- Trial name
- NCT04370236
- Testing
- INB03
- Where
- 9 sites in United States
- Volunteers
- 79 people
- Sponsor
- Inmune Bio, Inc.
COVID-19
Expanded Access Program of Ruxolitinib for the Emergency Treatment of Cytokine Storm From COVID-19 Infection
To provide ruxolitinib through an expanded access program for the treatment of cytokine storm due to COVID-19 in the United States to patients who are eligible but not able to be hospitalized or who are hospitalized with a…
- Trial name
- NCT04355793
- Testing
- Ruxolitinib
- Sponsor
- Incyte Corporation
Covid19, ARDS
Expanded Access for Use of bmMSC-Derived Extracellular Vesicles in Patients With COVID-19 Associated ARDS
ExoFlo, Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Allograft Product, Infusion Treatment is currently being studied in Protocol DB-EF-PhaseIII-0001 in patients COVID-19 associated moderate to severe acute…
- Conditions
- Covid19, ARDS, Hypoxia, Cytokine Storm
- Trial name
- NCT04657458
- Testing
- ExoFlo
- Sponsor
- Direct Biologics, LLC
Cytokine Storm (Covid-19)
Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm
This was a randomized, double-blind, placebo-controlled, 29-day, multicenter study to assess the efficacy and safety of ruxolitinib + standard-of-care (SoC) therapy, compared with placebo + SoC therapy, in patients aged ≥12 years…
- Trial name
- RUXCOVID (NCT04362137)
- Testing
- Ruxolitinib
- Where
- 61 sites in United States, Argentina and 10 more
- Volunteers
- 432 people
- Sponsor
- Novartis Pharmaceuticals
SARS-CoV2 Infection
Efficacy and Safety of EXOSOME-MSC Therapy to Reduce Hyper-inflammation In Moderate COVID-19 Patients
In COVID-19 infection caused by the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), there is a dysregulation of the immune system response that causes cytokine storm syndrome.
- Trial name
- EXOMSC-COV19 (NCT05216562)
- Testing
- Exosome-MSC Intravenous injection, COVID-19 Standard Treatment
- Where
- 3 sites in Indonesia
- Volunteers
- 60 people
- Sponsor
- Dermama Bioteknologi Laboratorium
COVID-19
Cytokine and Eicosanoid Mediators in Coronavirus Disease 2019 (COVID-19)
This study is a prospective, single center, observational, cohort study of patients to (1) describe the kinetics and temporal relationship of changes in eicosanoid and cytokine mediators in patients with severe COVID-19 admitted…
- Trial name
- NCT04452942
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- EicOsis Human Health Inc.
Acute Respiratory Distress Syndrome, Coronavirus
Pemziviptadil (PB1046), a Long-acting, Sustained Release Human VIP Analogue, Intended to Provide Clinical Improvement to Hospitalized COVID-19 Patients at High Risk for Rapid Clinical Deterioration and Acute Respiratory Distress Syndrome (ARDS).
This is a multicenter, randomized, double-blind, parallel group study to investigate the efficacy of pemziviptadil (PB1046) by improving the clinical outcomes in hospitalized COVID-19 patients at high risk for rapid clinical…
- Conditions
- Acute Respiratory Distress Syndrome, Coronavirus, Hypoxic Respiratory Failure, Hypoxemic Respiratory Failure
- Trial name
- VANGARD (NCT04433546)
- Testing
- Pemziviptadil (PB1046), Low Dose (10 mg) Control
- Where
- 4 sites in United States
- Volunteers
- 54 people
- Sponsor
- PhaseBio Pharmaceuticals Inc.
Immunity, Vaccine Reaction
Efficacy and Tolerability of ABBC1 in Volunteers Receiving the Influenza or Covid-19 Vaccine
The immune system response needs to be forceful but also balanced for a rapid recovery from infection which avoids harmful overreactions.
- Conditions
- Immunity, Vaccine Reaction, Influenza, Covid19
- Trial name
- NCT04798677
- Testing
- ABBC1 Immunoessential
- Where
- Spain
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- AB Biotek
COVID-19
Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the treatment of participants with COVID-19-associated Acute Respiratory Distress Syndrome (ARDS) who require mechanical ventilation.
- Trial name
- NCT04377620
- Testing
- Ruxolitinib
- Where
- 36 sites in United States, Russia
- Volunteers
- 211 people
- Sponsor
- Incyte Corporation