COVID-19Phase 1/2NCT04334044
Treatment of SARS Caused by COVID-19 With Ruxolitinib
A Phase 1/2 study testing Ruxolitinib Oral Tablet in people with COVID-19 and Severe Acute Respiratory Syndrome Coronavirus 2, run by Grupo Cooperativo de Hemopatías Malignas at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Severe Acute Respiratory Syndrome Coronavirus 2
- What is being tested?
- Ruxolitinib Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteMexico
- Study dates
- 1 Sep 2020to 30 Apr 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Mexico1 site
Grupo Cooperativo de Hemopatías Malignas
Huixquilucan, State of Mexico, 52763
About this study
Official title: Treatment of Severe Acute Respiratory Syndrome Caused by COVID-19 With Ruxolitinib
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.
- Being tested
- Ruxolitinib Oral Tablet
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruxolitinib Oral TabletDrug
Ruxolitinib 5 mg twice a day
| Study group | Role | What they receive |
|---|---|---|
| Ruxolitinib | Experimental | Ruxolitinib 5 mg BID since the beginning of dyspnea or increment of work of breathing with pneumonia changes in chest CT-scan Receives: Drug: Ruxolitinib Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of Pneumonia
Presence of recovery of pneumonia characterized by cease of respiratory symptoms
Measured: 14 days
Secondary outcomes (7)
Response of C-reactive protein
Increment or decrease in mg/ml of C-reactive protein
Measured: 14 days
Response of Ferritin
Increment or decrease in ng/ml of ferritin
Measured: 14 days
Response of D-dimer
Increment or decrease in mg/ml of D-dimer
Measured: 14 days
Rate of ICU admission
Requirement of Intensive Care Unit on the patients under treatment
Measured: 14 days
Rate of mechanical ventilation
Requirement of mechanical ventilation on the patients under treatment
Measured: 14 days
Overall Survival
Time since the diagnosis to the last follow up (recovery or death)
Measured: 1 month
Toxicity Rate
Rate of adverse events associated with ruxolitinib
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start1 Sep 2020
- Primary completion12 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Use of ruxolitinib on patients with respiratory distress and pneumonia changes on chest computed tomography
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Cooperativo de Hemopatías Malignas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334044
- Sponsor's protocol ID
- HAL 345/2020
- Status last verified
- Jul 2021
- First submitted
- 1 Apr 2020
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Severe Acute Respiratory Syndrome Caused by COVID-19 With Ruxolitinib
- ClinicalTrials.gov ID
- NCT04334044
- Acronym / sponsor ID
- HAL 345/2020
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Grupo Cooperativo de Hemopatías MalignasUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 3 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Use of ruxolitinib on patients with respiratory distress and pneumonia changes on chest computed tomography
| Arm | Type | Receives |
|---|---|---|
| Ruxolitinib | Experimental | Drug: Ruxolitinib Oral TabletRuxolitinib 5 mg BID since the beginning of dyspnea or increment of work of breathing with pneumonia changes in chest CT-scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ruxolitinib Oral TabletRuxolitinib 5 mg twice a day | Drug | Ruxolitinib |
Primary outcome
Recovery of Pneumonia
Time frame: 14 days
Presence of recovery of pneumonia characterized by cease of respiratory symptoms
7 secondary outcomes
Response of C-reactive protein
Time frame: 14 days
Response of Ferritin
Time frame: 14 days
Response of D-dimer
Time frame: 14 days
Rate of ICU admission
Time frame: 14 days
Rate of mechanical ventilation
Time frame: 14 days
Overall Survival
Time frame: 1 month
Toxicity Rate
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ruxolitinib Oral Tablet in people with COVID-19 and Severe Acute Respiratory Syndrome Coronavirus 2, run by Grupo Cooperativo de Hemopatías Malignas at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery of Pneumonia (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.