Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04334044
Other study ID # HAL 345/2020
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date September 1, 2020
Est. completion date April 30, 2021

Study information

Verified date July 2021
Source Grupo Cooperativo de Hemopatías Malignas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date April 30, 2021
Est. primary completion date April 12, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms

  • COVID-19
  • Severe Acute Respiratory Syndrome
  • Severe Acute Respiratory Syndrome Coronavirus 2
  • Syndrome

Intervention

Drug:
Ruxolitinib Oral Tablet
Ruxolitinib 5 mg twice a day

Locations

Country Name City State
Mexico Grupo Cooperativo de Hemopatías Malignas Huixquilucan Estado De México

Sponsors (1)

Lead Sponsor Collaborator
Grupo Cooperativo de Hemopatías Malignas

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recovery of Pneumonia Presence of recovery of pneumonia characterized by cease of respiratory symptoms 14 days
Secondary Response of C-reactive protein Increment or decrease in mg/ml of C-reactive protein 14 days
Secondary Response of Ferritin Increment or decrease in ng/ml of ferritin 14 days
Secondary Response of D-dimer Increment or decrease in mg/ml of D-dimer 14 days
Secondary Rate of ICU admission Requirement of Intensive Care Unit on the patients under treatment 14 days
Secondary Rate of mechanical ventilation Requirement of mechanical ventilation on the patients under treatment 14 days
Secondary Overall Survival Time since the diagnosis to the last follow up (recovery or death) 1 month
Secondary Toxicity Rate Rate of adverse events associated with ruxolitinib 1 month
See also
  Status Clinical Trial Phase
Withdrawn NCT06065033 - Exercise Interventions in Post-acute Sequelae of Covid-19 N/A
Completed NCT06267534 - Mindfulness-based Mobile Applications Program N/A
Completed NCT05047601 - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection Phase 2/Phase 3
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Recruiting NCT05323760 - Functional Capacity in Patients Post Mild COVID-19 N/A
Completed NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Completed NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Recruiting NCT05494424 - Cognitive Rehabilitation in Post-COVID-19 Condition N/A
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Enrolling by invitation NCT05589376 - You and Me Healthy
Completed NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Completed NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Completed NCT05975060 - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants. Phase 2/Phase 3
Active, not recruiting NCT05542862 - Booster Study of SpikoGen COVID-19 Vaccine Phase 3
Terminated NCT05487040 - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease Phase 1
Withdrawn NCT05621967 - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation N/A
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Active, not recruiting NCT06033560 - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure