Treatment of SARS Caused by COVID-19 With Ruxolitinib

COVID-19 Clinical Trial

Official title:

Treatment of Severe Acute Respiratory Syndrome Caused by COVID-19 With Ruxolitinib

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04334044
• Other study ID #: HAL 345/2020
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 1, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: July 2021
• Source: Grupo Cooperativo de Hemopatías Malignas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: April 30, 2021
• Est. primary completion date: April 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Severe Acute Respiratory Syndrome
• Severe Acute Respiratory Syndrome Coronavirus 2
• Syndrome

Intervention

Drug:
• Ruxolitinib Oral Tablet
Ruxolitinib 5 mg twice a day

Locations

Country	Name	City	State
Mexico	Grupo Cooperativo de Hemopatías Malignas	Huixquilucan	Estado De México

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Cooperativo de Hemopatías Malignas

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery of Pneumonia	Presence of recovery of pneumonia characterized by cease of respiratory symptoms	14 days
Secondary	Response of C-reactive protein	Increment or decrease in mg/ml of C-reactive protein	14 days
Secondary	Response of Ferritin	Increment or decrease in ng/ml of ferritin	14 days
Secondary	Response of D-dimer	Increment or decrease in mg/ml of D-dimer	14 days
Secondary	Rate of ICU admission	Requirement of Intensive Care Unit on the patients under treatment	14 days
Secondary	Rate of mechanical ventilation	Requirement of mechanical ventilation on the patients under treatment	14 days
Secondary	Overall Survival	Time since the diagnosis to the last follow up (recovery or death)	1 month
Secondary	Toxicity Rate	Rate of adverse events associated with ruxolitinib	1 month