Tofacitinib for Treatment of Moderate COVID-19

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    Yale University
Send
Updated on 5 August 2020
See if I qualify
ct scan
mechanical ventilation
pneumonia
PCR test
covid-19
chest x-ray
SARS
chest ct
tofacitinib
coronavirus infection
hs-crp
acute respiratory syndrome (sars)

Summary

The purpose of this randomized, double blinded, placebo controlled study is to assess the efficacy and safety of tofacitinib in hospitalized adult (18-65 years old) patients with SARS-CoV-2 and pneumonia who require supplemental oxygen and have serologic markers of inflammation but do not need mechanical ventilation.

Description

The purpose of this randomized, double blinded, placebo controlled Phase 2b study is to assess the efficacy and safety of tofacitinib in hospitalized adult (18-65 years old) male and female patients with SARS-CoV-2 and pneumonia who require supplemental oxygen and have serologic markers of inflammation but do not need mechanical ventilation (see Inclusion criteria). Sixty patients will be recruited to receive tofacitinib or placebo in addition to standard of care (SOC) in a 2:1 ratio.

Subjects will be screened during hospitalization. Patients with confirmed SARS-CoV-2 infection, and meeting all other Inclusion and Exclusion criteria, will be randomized to either treatment with tofacitinib or placebo in addition to SOC during hospitalization (dose adjusted, if required), with the exception of any immunomodulatory agents (as documented in the inclusion/exclusion criteria). Tofacitinib will be administered in a dose of 10 mg PO BID until return to their clinical baseline (as defined by need for supplementary oxygen), and will continue to be administered at 5 mg PO BID for a total duration of therapy of 14 days; follow-up off tofacitinib will continue up to Day 90. We anticipate completion of subject recruitment in 6 months.

Details
Condition Covid 19
Age 18years - 65years
Treatment Placebo, Tofacitinib 10 mg
Clinical Study IdentifierNCT04415151
SponsorYale University
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
Participants with laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) or other commercially available or public health assay prior to Day 1
Participants with evidence of pneumonia assessed by radiographic imaging (chest x ray or chest CT scan) AND Requiring 3L O2 OR 2L O2 and hsCRP > 70 mg/L
Participants who are hospitalized and receiving supportive care for COVID-19
Participant (or legally authorized representative/surrogate) capable of giving signed informed consent

Exclusion Criteria

Medical Conditions
Require mechanical ventilation or ECMO on Day 1 at the time of randomization
Have current, or history of, venous thromboembolism (deep vein thrombosis or pulmonary embolism)
Have a personal or first-degree family history of blood clotting disorders
Participants who are immunocompromised, with known immunodeficiencies, or taking potent immunosuppressive agents (eg, azathioprine, cyclosporine)
Participants with any current malignancy or lymphoproliferative disorders that requires active treatment
Females of child bearing potential who are pregnant or breastfeeding
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk associated with study participation or, in the investigator's judgment, make the participant inappropriate for the study
Anticipated survival < 72 hours as assessed by the Investigator
Infection History
Suspected or known active systemic bacterial, fungal, or viral infections
(with the exception of COVID-19) including but not limited to
Secondary bacterial pneumonia
Active herpes zoster infection
Known active tuberculosis or history of inadequately treated tuberculosis
Known HBV, HCV, or HIV
Prior/Concomitant Therapy
Have received any of the following treatment regimens specified in the
timeframes outlined
below
Within 4 weeks prior to the first dose of study intervention
Prior treatment with any JAK inhibitors, potent immunosuppressants, or any biologic agents including IL-6 inhibitors (eg, tocilizumab) or IL-1 inhibitors (eg, anakinra)
Prior treatment with any potent cytochrome P450 inducer, such as rifampin, within the past 28 days or 5 half-lives, whichever is longer
Within 48 hours prior to the first dose of study intervention
Treatment with corticosteroids equivalent to prednisone or methylprednisolone >20 mg/day
Treatment with herbal supplements
Diagnostic Assessments
Severe hepatic impairment, defined as Child-Pugh class C
Severe anemia (hemoglobin <8 g/dL)
ANY of the following abnormalities in clinical laboratory tests at screening, confirmed by a single repeat, if deemed necessary
WBC <1000/mm3
Absolute lymphocyte count <500 cells/mm3
Absolute neutrophil count <1000 cells/mm3
Alanine transaminase/aspartate transaminase (ALT/AST) > 5 times the upper limit of normal
Estimated glomerular filtration rate (eGFR) < 40 mL/min/1.73 m2)
Other Exclusions
Known allergy to tofacitinib
Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

ct scan
mechanical ventilation
pneumonia
PCR test
covid-19
chest x-ray
SARS
chest ct
tofacitinib
coronavirus infection
hs-crp
acute respiratory syndrome (sars)

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.