Corona Virus Infection Clinical Trial
Official title:
A proof-of Concept Study of the Use of Janus Kinase 1 and 2 Inhibitor, Baricitinib, in the Treatment of COVID-19-related Pneumonia
The objective of the study is to assess the efficacy and safety of Baricitinib in the
treatment of patients with COVID-19 pneumonia.
This will be a proof-of-concept trial with an exploratory single-arm proof of concept Phase
IIa study to assess the efficacy and safety profile of Baricitinib in a limited number of
patients with severe acute respiratory syndrome (SARS)-CoV-2 pneumonia. If the initial proof
of concept phase will lead to favourable results, an open-label, Phase II, randomized
controlled trial will be then designed and performed to confirm the results obtained in the
proof of concept phase. The proof-of-concept phase guarantees that no safety issues arise on
a limited number of patients in the use of a drug new to the current condition being treated.
Baricitinib 4 mg/daily will be prescribed for 7 days to eligible patients showing signs of acute inflammatory response activation. The primary outcome of the study will be the response to treatment. A patient is considered responder in the absence of either moderate to severe oxygenation impairment or death, whichever occurs first, within 8 days from enrolment. The main secondary outcomes will include the responder rate and mortality at 15 days, the quantification of patients experiencing moderate to severe oxygenation impairment, rate of patients admitted to the intensive care unit, length of hospitalization, mortality at 28 days, rate of re-admission, and adverse events. The duration of the study will be 28 days. In the proof of concept phase, 13 patients will be enrolled; if the responders will be at least 4 patients without safety issues, Baricitinib will be considered for further studies. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
| Completed |
NCT04578210 -
Safety Infusion of NatuRal KillEr celLs or MEmory T Cells as Adoptive Therapy in COVID-19 pnEumonia or Lymphopenia
|
Phase 1/Phase 2 | |
| Completed |
NCT05065827 -
Lung Ultrasound Findings in Patients With COVID-19 in a UK ED
|
||
| Completed |
NCT04720794 -
A Study To Evaluate The Performance of the Lucira Health All-In-One COVID-19 Test Kit vs Hologic Panther Fusion
|
N/A | |
| Enrolling by invitation |
NCT04659486 -
Adolescents With COVID-19/MIS-C at HCFMUSP
|
N/A | |
| Completed |
NCT04598620 -
Non-invasive Prognostication of COVID-19 Patients by Use of Biomarkers in Exhaled Breath Condensate
|
||
| Completed |
NCT05517941 -
Effect of Active Cycle Breathing Technique Along With Incentive Spirometer on COVID19 Patient
|
N/A | |
| Recruiting |
NCT04480333 -
Safety, Tolerability and Pharmacokinetics of Inhaled Nanoparticle Formulation of Remdesivir (GS-5734) and NA-831
|
Phase 1 | |
| Recruiting |
NCT04565782 -
Corona Virus Infection Among Liver Transplant Recipients
|
||
| Active, not recruiting |
NCT04558476 -
Efficacy of CONvalescent Plasma in Patients With COVID-19 Treated With Mechanical Ventilation
|
Phase 2 | |
| Completed |
NCT05639998 -
BBV152/BBV154 Heterologus Prime-Boost Study
|
Phase 2 | |
| Completed |
NCT04526769 -
Detecting SARS-CoV-2 in Tears
|
||
| Withdrawn |
NCT04386447 -
Phase II RCT to Assess Efficacy of Intravenous Administration of Oxytocin in Patients Affected by COVID-19
|
Phase 2 | |
| Completed |
NCT04523246 -
Training the Innate Immune System Against SARS-CoV-2 (COVID-19) Using the Shingrix Vaccine in Nursing Home Residents
|
Early Phase 1 | |
| Completed |
NCT05736926 -
Anal Fissure Among Survivors of COVID-19 Virus Infection.
|
||
| Recruiting |
NCT04583566 -
Differential Expression of Cytokines, Transcriptome and miRNA in Coronavirus Disease 2019 (COVID-19) Egyptian's Patients
|
||
| Completed |
NCT04643678 -
Anakinra in the Management of COVID-19 Infection
|
Phase 2/Phase 3 | |
| Recruiting |
NCT04579588 -
Understanding Immunity to the Flu Vaccine in COVID-19 Patients
|
||
| Terminated |
NCT03331445 -
Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections
|
Phase 2 | |
| Recruiting |
NCT04573348 -
T Cells Response to SARS COV 2 Peptides
|