COVID-19, Severe Acute Respiratory Syndrome Coronavirus 2
Conditions
Brief summary
In December 2019, a new virus emerged in Wuhan, China rapidly becoming a pandemic with registered cases above 800,000 around the world. The virus is now known as SARS-CoV2 calling its disease coronavirus-19 or COVID-19. The mortality of the virus has been reported around 2-10% and its causes because of the proinflammatory immune response generated on the host. The cytokines involved in the immune response to COVID-19 are IL-1, IL-2, IL4, IL-6, IL-10, IL-12, IL-13, IL-17, GCSF, MCSF, IP-10, MCP-1, MIP-1α, HGF, IFN-γ y TNF-α. Ruxolitinib is an inhibitor of JAK 1/2 which is responsable for multiple cellular signals including the proinflammatory IL-6. Ruxolitinib works as and immunomodulator decreasing the cytotoxic T lymphocytes and increasing the Treg cells. This study is intended to stop the disregulated immune response caused by COVID-19 that generates the pneumonia and subsequent severe acute respiratory syndrome.
Interventions
Ruxolitinib 5 mg twice a day
Sponsors
Grupo Cooperativo de Hemopatías Malignas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Use of ruxolitinib on patients with respiratory distress and pneumonia changes on chest computed tomography
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with diagnosed COVID-19 with confirmatory test * Increase in work of breathing or presence of dyspnea * Presence of lung changes associated with COVID pneumonia by chest imaging * Informed consent
Exclusion criteria
* Pregnancy or breastfeeding * Thrombocytopenia below 20,000 cells/mm3 * Neutropenia below 500 cels/mm3 * Known and active infection of HIV, Hepatitis C, Hepatitis B, Herpes Zoster or Mycobacterium Tuberculosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery of Pneumonia | 14 days | Presence of recovery of pneumonia characterized by cease of respiratory symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response of Ferritin | 14 days | Increment or decrease in ng/ml of ferritin |
| Response of D-dimer | 14 days | Increment or decrease in mg/ml of D-dimer |
| Rate of ICU admission | 14 days | Requirement of Intensive Care Unit on the patients under treatment |
| Response of C-reactive protein | 14 days | Increment or decrease in mg/ml of C-reactive protein |
| Overall Survival | 1 month | Time since the diagnosis to the last follow up (recovery or death) |
| Toxicity Rate | 1 month | Rate of adverse events associated with ruxolitinib |
| Rate of mechanical ventilation | 14 days | Requirement of mechanical ventilation on the patients under treatment |
Countries
Mexico
Outcome results
None listed