Treatment of SARS Caused by COVID-19 With Ruxolitinib

• Sponsor: Grupo Cooperativo de Hemopatías Malignas (Other)
• Overall Status: Completed
• CT.gov ID: NCT04334044
• Collaborator: (none)
• Enrollment: 77
• Location: 1
• Arm: 1
• Actual Duration (Months): 7.9
• Patients Per Site Per Month: 9.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19; Severe Acute Respiratory Syndrome Coronavirus 2	Drug: Ruxolitinib Oral Tablet	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 77 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Use of ruxolitinib on patients with respiratory distress and pneumonia changes on chest computed tomographyUse of ruxolitinib on patients with respiratory distress and pneumonia changes on chest computed tomography
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment of Severe Acute Respiratory Syndrome Caused by COVID-19 With Ruxolitinib
• Actual Study Start Date: Sep 1, 2020
• Actual Primary Completion Date: Apr 12, 2021
• Actual Study Completion Date: Apr 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ruxolitinib Ruxolitinib 5 mg BID since the beginning of dyspnea or increment of work of breathing with pneumonia changes in chest CT-scan	Drug: Ruxolitinib Oral Tablet; Ruxolitinib 5 mg twice a day

Outcome Measures

Primary Outcome Measures

1. Recovery of Pneumonia [14 days]

   Presence of recovery of pneumonia characterized by cease of respiratory symptoms

Secondary Outcome Measures

1. Response of C-reactive protein [14 days]

   Increment or decrease in mg/ml of C-reactive protein

2. Response of Ferritin [14 days]

   Increment or decrease in ng/ml of ferritin

3. Response of D-dimer [14 days]

   Increment or decrease in mg/ml of D-dimer

4. Rate of ICU admission [14 days]

   Requirement of Intensive Care Unit on the patients under treatment

5. Rate of mechanical ventilation [14 days]

   Requirement of mechanical ventilation on the patients under treatment

6. Overall Survival [1 month]

   Time since the diagnosis to the last follow up (recovery or death)

7. Toxicity Rate [1 month]

   Rate of adverse events associated with ruxolitinib

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grupo Cooperativo de Hemopatías Malignas	Huixquilucan	Estado De México	Mexico	52763

Sponsors and Collaborators

• Grupo Cooperativo de Hemopatías Malignas

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Grupo Cooperativo de Hemopatías Malignas
• ClinicalTrials.gov Identifier: NCT04334044
• Other Study ID Numbers: HAL 345/2020
• First Posted: Apr 3, 2020
• Last Update Posted: Jul 7, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Severe Acute Respiratory Syndrome; Syndrome

Study Results

No Results Posted as of Jul 7, 2021