Tofacitinib for Treatment of Moderate COVID-19

NCT04415151 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 2000027848
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized, double blinded, placebo controlled study is to assess the efficacy and safety of tofacitinib in hospitalized adult (18-99 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.

Conditions

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (1)

• Disease Severity

  The primary objective of this study is to determine whether tofacitinib improves the clinical outcomes of patients with moderate SARS-CoV-2 infection as determined by the primary outcome measure: Proportion of subjects alive and not needing any form of mechanical ventilation, high flow oxygen, or ECMO by day 14.

  14 days

Secondary Outcomes (15)

• Clinical Improvement (Last Measure)

  Up to 14 days

• Clinical Improvement (Improved Score)

  Up to 14 days

• Time to Recovery

  Up to 14 days

• Time to Clinical Improvement

  Up to 14 days

• Clinical Status

  Up to 28 Days

Other Outcomes (1)

• Adverse Events

  Up to 14 days

Study Arms (2)

Tofacitinib

EXPERIMENTAL

Tofacitinib will be administered in a dose of 10 mg PO BID until return to their clinical baseline (as defined by supplementary oxygen requirement), and then will continue to be administered at 5 mg PO BID for a total treatment duration of 14 days.

Drug: Tofacitinib 10 mg

Placebo

PLACEBO COMPARATOR

Matching placebo will be administered.

Drug: Placebo

Interventions

Tofacitinib 10 mg DRUG

Tofacitinib will be administered in a dose of 10 mg twice daily by mouth (PO BID) until return to their clinical baseline (as defined by supplementary oxygen requirement), and then will continue to be administered at 5 mg PO BID for a total treatment duration of 14 days.

Tofacitinib

Placebo DRUG

Matching placebo tablets will be administered.

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Health System

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Interventions

tofacitinib

Results Point of Contact

• Title: Hyung Chun, MD, FAHA
• Organization: Yale School of Medicine

hyung.chun@yale.edu

(203) 785-6012

Study Officials

• Hyung Chun, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 4, 2020
• Study Start: October 14, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: March 28, 2025
• Results First Posted: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)