COVID-19 Clinical Trial
Official title:
Mavrilimumab to Reduce Progression of Acute Respiratory Failure in Patients With Severe COVID-19 Pneumonia and Systemic Hyper-inflammation
Verified date | August 2021 |
Source | Virginia Commonwealth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this prospective, Phase 2, multicenter, blinded, randomized placebo controlled study is to demonstrate that early treatment with mavrilimumab prevents progression of respiratory failure in patients with severe COVID-19 pneumonia and clinical and biological features of hyper-inflammation.
Status | Completed |
Enrollment | 2 |
Est. completion date | November 30, 2020 |
Est. primary completion date | November 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Written informed consent must be obtained before any assessment is performed 2. Documented COVID19 pneumonia defined as positive SARS-CoV2 test AND abnormalities/ infiltrates on chest x-ray or computed tomography AND active fever or documented fever within 24-48 hours or ongoing anti-pyretic use to suppress fever 3. Hypoxia (Room air SpO2 <92% or requirement for supplemental oxygen) 4. Increased serum inflammatory marker (CRP > 5 mg/dL) 5. Severity of disease warrants inpatient hospitalization Exclusion Criteria: 1. Onset of COVID-19 symptoms >14 days 2. Age < 18 years-old 3. Hospitalized >7 days 4. Mechanically ventilated 5. Serious concomitant illness which in the opinion of the investigator precludes the patient from enrolling in the trial, including (but not limited to): - History of immunodeficiency (congenital or acquired) - Neutropenia (absolute neutrophil count <1,500/mm3) - History of solid-organ or bone marrow transplant - History of current systemic autoimmune or autoinflammatory disease(s) requiring systemic immune-modulating drugs - History of myeloproliferative disorder or active malignancy receiving cytotoxic chemotherapy - Pre-existing severe pulmonary disease (i.e. steroid dependent asthma, COPD on home oxygen, or other restrictive/obstructive lung disease requiring home oxygen) - Pre-existing severe left ventricular systolic dysfunction (i.e. LVEF <35%) - Known or suspected active tuberculosis (TB), latent TB, or history of incompletely treated TB or at high risk for latent TB (from exposure or prior incarceration) - History of active or latent viral hepatitis (i.e. Hepatitis B or C) - Concomitant uncontrolled systemic bacterial or fungal infection - Concomitant viral infection other than COVID-19 (e.g. Influenza, other respiratory viruses) - History of chronic liver disease with portal hypertension - History of end-stage renal disease on chronic renal replacement therapy 6. Recent treatment with cell-depleting biological therapies (e.g., anti-CD20) within 12 months, cell-depleting biological therapies (such as anti-tumor necrosis factor [TNF], anakinra, anti-Interleukin [IL]-6 receptor [e.g. tocilizumab], or abatacept) within 8 weeks (or 5 half-lives, whichever is longer), treatment with alkylating agents within 12 weeks, treatment with cyclosporine A, azathioprine, cyclophosphamide, or mycophenolate mofetil (MMF) within 4 weeks 7. Recent treatment with intramuscular live (attenuated) vaccine within 4 weeks 8. Chronic or recent corticosteroid use > 10 mg/day 9. Pregnant. Breast-feeding women are eligible with the decision to continue or discontinue breast-feeding during therapy taking into account the risk of infant exposure, the benefits of breast-feeding to the infant, and benefits of treatment to the mother 10. Enrolled in another investigational study using immunosuppressive therapy 11. Known hypersensitivity to mavrilimumab or any of its excipients 12. In the opinion of the investigator, unable to comply with the requirements to participate in the study 13. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of investigational drug. Such methods include: - Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception - Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment - Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject - Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University | Kiniksa Pharmaceuticals, Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Subjects Alive and Off of Oxygen at Day 14 | Number of subjects alive and off of oxygen | 14 days | |
Secondary | Number of Subjects Alive and Without Respiratory Failure at 28 Days | Number of subjects alive and without respiratory failure | 28 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT06065033 -
Exercise Interventions in Post-acute Sequelae of Covid-19
|
N/A | |
Completed |
NCT06267534 -
Mindfulness-based Mobile Applications Program
|
N/A | |
Completed |
NCT05047601 -
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
|
Phase 2/Phase 3 | |
Recruiting |
NCT05323760 -
Functional Capacity in Patients Post Mild COVID-19
|
N/A | |
Recruiting |
NCT04481633 -
Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
|
N/A | |
Completed |
NCT04612972 -
Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru
|
Phase 3 | |
Completed |
NCT04537949 -
A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
|
Phase 1/Phase 2 | |
Recruiting |
NCT05494424 -
Cognitive Rehabilitation in Post-COVID-19 Condition
|
N/A | |
Active, not recruiting |
NCT06039449 -
A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2
|
Phase 3 | |
Enrolling by invitation |
NCT05589376 -
You and Me Healthy
|
||
Completed |
NCT05158816 -
Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
|
||
Recruiting |
NCT04341506 -
Non-contact ECG Sensor System for COVID19
|
||
Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
Completed |
NCT04512079 -
FREEDOM COVID-19 Anticoagulation Strategy
|
Phase 4 | |
Completed |
NCT05975060 -
A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT05542862 -
Booster Study of SpikoGen COVID-19 Vaccine
|
Phase 3 | |
Terminated |
NCT05487040 -
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
|
Phase 1 | |
Withdrawn |
NCT05621967 -
Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
|
N/A | |
Terminated |
NCT04498273 -
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
|
Phase 3 | |
Active, not recruiting |
NCT06033560 -
The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure
|