COVID-19 Infection Clinical Trial
Official title:
A Phase 2 Trial to Evaluate the Safety and Tolerability of Clazakizumab® [Anti-Interleukin (IL)-6 Monoclonal] Compared to Placebo for the Treatment of COVID-19 Infection
The purpose of this study is to investigate the effectiveness and safety of treatment with clazakizumab compared to a placebo (inactive substance). We are proposing to try this drug to treat coronavirus disease 2019 (COVID-19) infection. Patients with COVID-19 infection have been shown to have increases in certain inflammatory processes. Clazakizumab is an antibody (immune system protein) that blocks certain inflammatory processes. The treatment plan is to attempt to inhibit or block these inflammatory processes in order to try to limit the damage COVID-19 causes to the lungs.
The purpose of this randomized, double-blind, placebo-controlled trial is to evaluate the
safety and efficacy of clazakizumab vs placebo for the prevention of acute respiratory
distress syndrome (ARDS) in patients with COVID-19 and pulmonary manifestations. The study
will compare clazakizumab to placebo in a randomized, double-blind fashion followed by an
open-label dose of clazakizumab if there is no improvement or a worsening of condition occurs
after 24-hours or anytime during the first 14 days after the first dose of clazakizumab or
placebo. We hypothesize that clazakizumab will be safely tolerated and will reduce the risk
of progression of COVID-19 to acute respiratory distress syndrome.
Primary Objective:
• To evaluate the safety and tolerability of clazakizumab vs placebo for the treatment of
patients with COVID-19 disease and signs of pulmonary involvement
Sixty adult patients with COVID-19 and signs of pulmonary involvement at Houston Methodist
who are not in need of ventilator support at the time of enrollment.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04997551 -
Double Blind Randomized Clinical Trial of Use of Colchicine Added to Standard Treatment in Hospitalized With Covid-19
|
Phase 3 | |
| Recruiting |
NCT04977024 -
SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer
|
Phase 2 | |
| Completed |
NCT05049226 -
Third Dose Vaccination With AstraZeneca or Pfizer COVID-19 Vaccine Among Adults Received Sinovac COVID-19 Vaccine
|
Phase 2 | |
| Completed |
NCT04666025 -
SARS-CoV-2 Donor-Recipient Immunity Transfer
|
||
| Terminated |
NCT04455815 -
A Trial Looking at the Use of Camostat in People Who Have Tested Positive for Coronavirus (COVID-19) (SPIKE-1)
|
Phase 2 | |
| Completed |
NCT04662437 -
The Status of Parathyroid Hormone Secretion in Covid-19 Patients
|
||
| Recruiting |
NCT05792878 -
Study of COVID-19 Infection and Its Clinical Prognosis in Chronic Hepatitis B Patients With Antiviral Therapy
|
||
| Completed |
NCT04659200 -
Thyroid Function Tests and Status of Thyroid Autoantibodies in Covid-19 Patients
|
||
| Recruiting |
NCT04470583 -
Evaluating Clinical Parameters of COVID-19 in Pregnancy
|
||
| Withdrawn |
NCT04377568 -
Efficacy of Human Coronavirus-immune Convalescent Plasma for the Treatment of COVID-19 Disease in Hospitalized Children
|
Phase 2 | |
| Completed |
NCT04848610 -
The Factors That Affect the Infection of COVID-19
|
||
| Recruiting |
NCT04582903 -
Send-In Sample Collection for Comprehensive Analyses of Innate and Adaptive Immune Responses During Acute COVID-19 and Convalescence
|
||
| Recruiting |
NCT06032000 -
Evaluation of Safety and Immunogenicity of a SARS-CoV-2(Severe Acute Respiratory Syndrome Coronavirus 2) Booster Vaccine (LEM-mR203)
|
Phase 1 | |
| Terminated |
NCT04941703 -
"CHANGE COVID-19 Severity"
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04639466 -
A Synthetic MVA-based SARS-CoV-2 Vaccine, GEO-CM04S1, for the Prevention of COVID-19 Infection
|
Phase 1/Phase 2 | |
| Completed |
NCT04575038 -
CRISIS2: A Phase 2 Study of the Safety and Antiviral Activity of Brequinar in Non-hospitalized Pts With COVID-19
|
Phase 2 | |
| Recruiting |
NCT05022446 -
The Impact of COVID-19 on Pulmonary Procedures
|
||
| Completed |
NCT04347798 -
IMPACT: IMPact of Antimalarials on Covid-19 Infections in RAPPORT
|
||
| Active, not recruiting |
NCT04650178 -
Well-being in Cancer Patients With Neuropathy During COVID-19 Who Participated in Prior Clinical Trials
|
||
| Recruiting |
NCT04169542 -
Impact of COVID-19 Pandemic on Out-of-Pocket Costs, Lost Wages, and Unemployment in Patients With Breast Cancer Undergoing Breast Surgery
|