Treatment of Severe Acute Respiratory Syndrome Caused by COVID-19 With Ruxolitinib
Latest Information Update: 04 Nov 2021
At a glance
- Drugs Ruxolitinib (Primary)
- Indications COVID 2019 infections; Severe acute respiratory syndrome
- Focus Therapeutic Use
- 05 Jul 2021 Status changed from recruiting to completed.
- 01 Feb 2021 Planned End Date changed from 1 Jun 2020 to 1 May 2021.
- 01 Feb 2021 Planned primary completion date changed from 1 Jun 2020 to 1 Mar 2021.
Most Recent Events
Trial Overview
Purpose
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.
Primary Endpoints
Recovery of Pneumonia
description: Presence of recovery of pneumonia characterized by cease of respiratory symptoms
time_frame: 14 days
Other Endpoints
Response of C-reactive protein
description: Increment or decrease in mg/ml of C-reactive protein
time_frame: 14 days
Response of Ferritin
description: Increment or decrease in ng/ml of ferritin
time_frame: 14 days
Response of D-dimer
description: Increment or decrease in mg/ml of D-dimer
time_frame: 14 days
Rate of ICU admission
description: Requirement of Intensive Care Unit on the patients under treatment
time_frame: 14 days
Rate of mechanical ventilation
description: Requirement of mechanical ventilation on the patients under treatment
time_frame: 14 days
Overall Survival
description: Time since the diagnosis to the last follow up (recovery or death)
time_frame: 1 month
Toxicity Rate
description: Rate of adverse events associated with ruxolitinib
time_frame: 1 month [1]
Diseases Treated
Indication | Qualifiers | Patient Segments |
---|---|---|
COVID 2019 infections | treatment | - |
Severe acute respiratory syndrome | treatment | - |
Biomarker
NCT Number | Biomarker Name | Biomarker Function |
---|---|---|
NCT04334044 | C-reactive protein (CRP) | Outcome Measure |
D-dimer | Outcome Measure | |
Ferritin | Outcome Measure | |
seryl-tRNA synthetase | Brief Title |
Subjects
- Subject Type patients
-
Number
Planned: 20
Actual: 77
- Sex male & female
- Age Group ≥ 18 years; adult
Patient 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
Patient 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
Trial Details
Identifiers
Identifier | Owner |
---|---|
NCT04334044 | ClinicalTrials.gov: US National Institutes of Health |
HAL345-2020 | - |
Trial Dates
-
Initiation Dates
Planned : 01 Apr 2020
Actual : 01 Sep 2020
-
Primary Completion Dates
Planned : 01 Mar 2021
Actual : 12 Apr 2021
-
End Dates
Planned : 01 May 2021
Actual : 30 Apr 2021
Other Details
- Design open; prospective
- Phase of Trial Phase I/II
- Location Mexico
- Focus Therapeutic Use
Interventions
Drugs | Route | Formulation |
---|---|---|
RuxolitinibPrimary Drug | Oral | Tablet |
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)
Trial Centres
Centres
Centre Name | Location | Trial Centre Country |
---|---|---|
Grupo Cooperativo de Hemopatías Malignas |
-
|
-
|
Grupo Cooperativo de Hemopatías Malignas | Huixquilucan, Estado De México | Mexico |
Trial History
Event Date | Event Type | Comment |
---|---|---|
08 Jul 2021 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 08 Jul 2021 |
07 Jul 2021 | Biomarker Update | Biomarkers information updated Updated 04 Nov 2021 |
05 Jul 2021 | Status change - completed | Status changed from recruiting to completed. Updated 08 Jul 2021 |
01 Feb 2021 | Completion date | Planned End Date changed from 1 Jun 2020 to 1 May 2021. Updated 05 Feb 2021 |
01 Feb 2021 | Other trial event | Planned primary completion date changed from 1 Jun 2020 to 1 Mar 2021. Updated 05 Feb 2021 |
16 Apr 2020 | Status change - recruiting | Status changed from not yet recruiting to recruiting. Updated 20 Apr 2020 |
07 Apr 2020 | New trial record | New trial record Updated 07 Apr 2020 |
References
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov
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