TOFAcitinib Plus Hydroxycloroquine vs Hydroxycloroquine in Patients With COVID-19 Interstitial Pneumonia

Study Purpose

Multifocal interstitial pneumonia represents the most common cause of admission in intensive care units and death in SARS-CoV2 infections. In our Hospital, similarly to what reported in literature, up to 25% of admitted patients with pneumonitis requires mechanical ventilation or oro-tracheal intubation within 5-10 days. No established treatment is available for this condition. Preliminary evidence is accumulating about the efficacy of an aggressive treatment of the corona virus-induced inflammation and, in particular, investigators believe that blocking JAK1 is clinically rewarding in down-regulating IL-6 driven inflammation in patients with corona-virus infection. Thus, investigators designed a randomized controlled trial to test the hypothesis that adding Tofacitinib to the standard treatment in the early phase of COVID related pneumonitis could prevent the development of severe respiratory failure needing mechanical ventilation.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - SARS-CoV2 Infection diagnosed by rt-PCR - CT-scan confirmed interstitial pneumonia - Hospital admission from less than 24h - P/F ratio >150 mmHg - Written Informed Consent

    Exclusion Criteria:

    - Age <18 ys or >65 - Patients in mechanical ventilation at time of admission - Severe Hearth failure (NYHA 3 or 4) - QTc > 470 ms or >500 ms in wide QRS patients - Severe History of Chronic Ischemic Heart Disease, defined as history of Major Adverse Cardiovascular Event and/or recent (one year) revascularization.
- History of recurrent Deep Venous Thrombosis and Pulmonary Embolism or established thrombophilic conditions (e.g. history of anti-phospholipid antibodies, …) - Active Bacterial or Fungal Infection - Hematological cancer - Metastatic or intractable cancer - Pre-existent neurodegenerative disease - Severe Hepatic Impairment, - History of acute diverticular disease or intestinal perforation - HBsAg positive and/or HBV-DNA positive patients - Severe Renal Failure (Creatinine Clearance <30ml/h) - Active Herpes zoster infection - Patients with active or latent TB - Severe anemia (Hb<9g/dl) - Lymphocyte count below 750/mcl - Neutrophil count below 1000/mcl - Platelet count below 50000/mcl - Pregnancy or Lactation - History of intolerance to the experimental drugs or excipients - Degenerative maculopathy or other relevant retinal disease - Inability to give informed consent (severe transitory or permanent mental impairment, incapacitation)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04390061
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Università Politecnica delle Marche
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherOtherOtherOtherOtherOtherOtherOther
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pneumonitis, Interstitial, COVID-19
Arms & Interventions

Arms

Experimental: tofacitinib+HYQ

Tofacitinib 10mg cp twice a day + Hydroxychloroquine 200mg cp three times a day, both for 14 days

Active Comparator: Hydroxychloroquine

Hydroxychloroquine 200mg cp three times a day for 14 days

Interventions

Drug: - Tofacitinib

Jak-1/3 inhibitor

Drug: - Hydroxychloroquine

Standard Therapy

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Armando Gabrielli, MD

a.gabrielli@staff.univpm.it

0712206104

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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