Treatment of SARS Caused by COVID-19 With Ruxolitinib
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ClinicalTrials.gov Identifier: NCT04334044 |
Recruitment Status :
Completed
First Posted : April 3, 2020
Last Update Posted : July 7, 2021
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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 |
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COVID-19 Severe Acute Respiratory Syndrome Coronavirus 2 | Drug: Ruxolitinib Oral Tablet | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
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 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 : | September 1, 2020 |
Actual Primary Completion Date : | April 12, 2021 |
Actual Study Completion Date : | April 30, 2021 |

Arm | Intervention/treatment |
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Experimental: Ruxolitinib
Ruxolitinib 5 mg BID since the beginning of dyspnea or increment of work of breathing with pneumonia changes in chest CT-scan
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Drug: Ruxolitinib Oral Tablet
Ruxolitinib 5 mg twice a day |
- Recovery of Pneumonia [ Time Frame: 14 days ]Presence of recovery of pneumonia characterized by cease of respiratory symptoms
- Response of C-reactive protein [ Time Frame: 14 days ]Increment or decrease in mg/ml of C-reactive protein
- Response of Ferritin [ Time Frame: 14 days ]Increment or decrease in ng/ml of ferritin
- Response of D-dimer [ Time Frame: 14 days ]Increment or decrease in mg/ml of D-dimer
- Rate of ICU admission [ Time Frame: 14 days ]Requirement of Intensive Care Unit on the patients under treatment
- Rate of mechanical ventilation [ Time Frame: 14 days ]Requirement of mechanical ventilation on the patients under treatment
- Overall Survival [ Time Frame: 1 month ]Time since the diagnosis to the last follow up (recovery or death)
- Toxicity Rate [ Time Frame: 1 month ]Rate of adverse events associated with ruxolitinib

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04334044
Mexico | |
Grupo Cooperativo de Hemopatías Malignas | |
Huixquilucan, Estado De México, Mexico, 52763 |
Responsible Party: | Grupo Cooperativo de Hemopatías Malignas |
ClinicalTrials.gov Identifier: | NCT04334044 |
Other Study ID Numbers: |
HAL 345/2020 |
First Posted: | April 3, 2020 Key Record Dates |
Last Update Posted: | July 7, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Severe Acute Respiratory Syndrome Syndrome Disease Pathologic Processes Respiratory Tract Infections Infections Pneumonia, Viral |
Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |