Treatment of SARS Caused by COVID-19 With Ruxolitinib

Phase 1

Completed

• Conditions: COVID-19; Severe Acute Respiratory Syndrome Coronavirus 2
• Interventions: Drug: Ruxolitinib Oral Tablet

• Registration Number: NCT04334044
• Lead Sponsor: Grupo Cooperativo de Hemopatías Malignas

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-01
• Study First Submitted QC: 2020-04-02
• Study First Posted: 2020-04-03
• Study Start: 2020-09-01
• Primary Completion: 2021-04-12
• Study Completion: 2021-04-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-05
• Last Update Posted: 2021-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ruxolitinib	Ruxolitinib Oral Tablet	Ruxolitinib 5 mg BID since the beginning of dyspnea or increment of work of breathing with pneumonia changes in chest CT-scan

Primary Outcome Measures

Name	Time	Method
Recovery of Pneumonia	14 days	Presence of recovery of pneumonia characterized by cease of respiratory symptoms

Secondary Outcome Measures

Name	Time	Method
Response of C-reactive protein	14 days	Increment or decrease in mg/ml of C-reactive protein
Response of Ferritin	14 days	Increment or decrease in ng/ml of ferritin
Toxicity Rate	1 month	Rate of adverse events associated with ruxolitinib
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
Rate of mechanical ventilation	14 days	Requirement of mechanical ventilation on the patients under treatment
Overall Survival	1 month	Time since the diagnosis to the last follow up (recovery or death)

Trial Locations

Locations (1)

Grupo Cooperativo de Hemopatías Malignas; 🇲🇽 Huixquilucan, Estado De México, Mexico