Efficacy and Safety of Tofacitinib in Patients With COVID-19 Pneumonia

NCT04750317 | Completed Phase 2 DMC

• 1 other identifier: 107892
• Study Type: interventional
• Target: 414
• Locations: 1 country
• Sites: 1

Brief Summary

TOFA-COV-2 is a cohort study of the efficacy of tofacitinib in reducing the risk of mechanical ventilation and/or death in patients with moderately severe COVID-19 pneumonia who received standard of care treatment (SoC). The study population consists of adults (≥18 years) with COVID-19, who are admitted to the university hospitals and don't require invasive or noninvasive ventilation on admission. All patients are divided into four groups depending on nadir levels of oxygen saturation and therapy: (1) patients with oxygen saturation ≤93% who received tofacitinib and SoC, (2) patients with oxygen saturation ≤93% who received only SoC, (3) patients with oxygen saturation \>93% who received tofacitinib and SoC, (4) patients with oxygen saturation \>93% who received only SoC. The aim of the study is to test the hypothesis that addition of tofacitinib to SoC could reduce the risk of mechanical ventilation and/or death.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Death

  Death registered by medical personnel during in-hospital stay

  Within 28 days from admission

• Mechanical ventilation

  Initiation of mechanical ventilation during in-hospital stay in patients who did not require ventilation on admission

  Within 28 days from admission

Study Arms (4)

Patients with reduced oxygen saturation ≤93% treated with tofacitinib

EXPERIMENTAL

Patients with oxygen saturation ≤93% on admission treated with tofacitinib and standard of care treatment

Drug: Tofacitinib

Patients with reduced oxygen saturation treated with SoC

NO INTERVENTION

Patients with oxygen saturation ≤93% on admission treated with standard of care only

Patients with preserved oxygen saturation >93% on admission treated with tofacitinib

EXPERIMENTAL

Patients with oxygen saturation \>93% on admission treated with tofacitinib and standard of care

Drug: Tofacitinib

Patients with preserved oxygen saturation >93% on admission treated with SoC

NO INTERVENTION

Patients with oxygen saturation \>93% on admission treated with standard of care only

Interventions

Tofacitinib DRUG

Tofacitinib was administered at a dose 10 mg twice daily on day 1, followed by 5 mg twice daily on day 2-5. The dosage was reduced up to 5 mg once daily in patients with moderate renal impairment or moderate hepatic impairment.

Patients with preserved oxygen saturation >93% on admission treated with tofacitinib; Patients with reduced oxygen saturation ≤93% treated with tofacitinib

Eligibility Criteria

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

You may qualify if:

• SARS-CoV2 Infection diagnosed by PCR and/or typical lesions on CT-scan (4 or 5 on CO-RADS scale) in combination with at least one of the following:
• oxygen saturation at rest ≤93% on ambient air,
• AND/OR C-reactive protein ≥50 mg/L,
• AND/OR fever (≥38.0°C) that persisted for at least two days despite treatment with nonsteroidal antiinflammatory drugs or paracetamol
• Written Informed Consent

You may not qualify if:

• Age \<18 years
• Coexistent infection other than COVID-19
• Requirement for invasive mechanical ventilation
• Estimated glomerular filtration rate calculated using CKD-EPI formula ≤30 ml/min/1.73 m2;
• Elevated ALT and/or AST levels more than 3 times the upper limit of normal
• Chronic use of glucocorticoids or immunosuppressive agents
• Administration of interleukin-6 inhibitors and/or high-dose glucocorticoids (≥250 mg prednisone equivalent intravenously) for the treatment of COVID-19

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

Sechenov First Moscow State Medical University (Sechenov University) - University Clinical Hospital

Moscow, 119991, Russia

Location

MeSH Terms

Conditions

COVID-19

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sergey Moiseev, MD

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 11, 2021
• Study Start: May 11, 2020
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: February 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)