TD-0903 for ALI Associated With COVID-19
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04402866 |
Recruitment Status :
Completed
First Posted : May 27, 2020
Results First Posted : March 17, 2022
Last Update Posted : March 17, 2022
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Condition or disease | Intervention/treatment | Phase |
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Acute Lung Injury (ALI) Associated With COVID-19 Lung Inflammation Associated With COVID-19 | Drug: TD-0903 Drug: Placebo | Phase 2 |
Part 1 of the study includes up to 3 ascending dose cohorts, each comprised of 8 subjects (6 receiving TD-0903 and 2 receiving placebo).
Part 2 of the study will evaluate one dose of TD-0903 (selected based on the data from Part 1) as compared with placebo. Part 2 is targeting 198 subjects total.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 235 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Parallel group, randomized, double-blind, placebo-controlled |
Masking: | Triple (Participant, Care Provider, Investigator) |
Masking Description: | Pharmacist & Sponsor are not blinded for Part 1. Sponsor is blinded for Part 2. Pharmacist is not blinded for Part 2. |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, Multi-center Study of an Inhaled Pan-Janus Kinase Inhibitor, TD-0903, to Treat Symptomatic Acute Lung Injury Associated With COVID-19 |
Actual Study Start Date : | June 24, 2020 |
Actual Primary Completion Date : | April 21, 2021 |
Actual Study Completion Date : | April 21, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Part 1: TD-0903 - MAD Dose A
6 out of 8 subjects per cohort will be randomized to receive TD-0903 MAD Dose A
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Drug: TD-0903
Study Drug to be administered by inhalation |
Experimental: Part 1: TD-0903 - MAD Dose B
6 out of 8 subjects per cohort will be randomized to receive TD-0903 MAD Dose B
|
Drug: TD-0903
Study Drug to be administered by inhalation |
Experimental: Part 1: TD-0903 - MAD Dose C
6 out of 8 subjects per cohort will be randomized to receive TD-0903 MAD Dose C
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Drug: TD-0903
Study Drug to be administered by inhalation |
Experimental: Part 1: Placebo for MAD
2 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo
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Drug: Placebo
Placebo to be administered by inhalation |
Experimental: Part 2: TD-0903
99 subjects will be randomized to receive TD-0903
|
Drug: TD-0903
Study Drug to be administered by inhalation |
Experimental: Part 2: Placebo
99 subjects will be randomized to receive Placebo
|
Drug: Placebo
Placebo to be administered by inhalation |
- Part 2: Number of Respiratory Failure-free Days (RFDs) From Randomization to Day 28 [ Time Frame: Randomization to Day 28 ]
An RFD was defined as a day that a participant was alive and did not require the use of any respiratory support (invasive mechanical ventilation, non-invasive positive pressure ventilation, high-flow oxygen devices, or oxygen supplementation) from randomization through Day 28. The number of RFDs was 0 for participants who used respiratory support for 28 days or longer or for participants who died on or before Day 28.
A clinical status score of ≤ 4 on a given day was equivalent to an RFD. The clinical status categories and associated scores ranged from 1-8 where a higher score represented a worse outcome. A clinical status score of 4 was defined as a participant who was hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (whether or not related to COVID-19).
- Part 2: Change From Baseline in SaO2/FiO2 Ratio on Day 7 [ Time Frame: Baseline and Day 7 ]SaO2/FiO2 ratio was calculated as SaO2 divided by FiO2.
- Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28 [ Time Frame: Days 7, 14, 21 and 28 ]
The clinical status categories and associated scores ranged from 1-8 where a higher score represented a worse outcome. The scale was as follows:
- Score 1: Not hospitalized, no limitations on activities
- Score 2: Not hospitalized, but with limitations on activities and/or requiring home oxygen
- Score 3: Hospitalized, not requiring supplemental oxygen, and no longer requiring ongoing medical care
- Score 4: Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (whether or not related to COVID-19)
- Score 5: Hospitalized, requiring supplemental oxygen
- Score 6: Hospitalized, on non-invasive ventilation or high-flow oxygen devices
- Score 7: Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation
- Score 8: Death
- Part 2: Number of Participants Alive and Respiratory Failure-free on Day 28 [ Time Frame: Day 28 ]Defined as participants who were alive and did not require the use of any respiratory support (invasive mechanical ventilation, non-invasive positive pressure ventilation, high-flow oxygen devices, or oxygen supplementation) on Day 28.

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Willing and able to provide written informed consent on their own prior to performing study procedures. In the U.K., subject assent or proxy consent as per local site procedures, may also be acceptable if both a clinician and second health professional attest that the subject understands the risks and potential benefits of the study and elects to proceed. Outside the U.K., written informed consent may only be obtained from the subject or legally authorized representative. In the event the subject loses capacity during the study, the subject consents to continued participation, except where this is not clinically indicated.
- Willing and able to comply with study-related procedures/assessments
- Age 18 to 80 years old
- Hospitalized (or documentation of a plan to admit to the hospital if the subject is in an emergency department) and requiring supplemental oxygen to maintain saturation > 90%
- A diagnosis of symptomatic COVID-19 defined as a positive test for SARS-CoV-2 RNA detected by RT-PCR on a sample from the upper respiratory tract (e.g., nasopharyngeal, nasal, or oropharyngeal swab) collected < 72 hours prior to randomization
- Onset of COVID-19 -related symptoms > 2 days and </= 10 days prior to hospital admission
Exclusion Criteria:
- Subjects currently receiving invasive mechanical ventilation
- Presence or suspicion of active malignancy with the exception of cancer in situ (e.g., skin cancer)
- Evidence of serious active infection other than COVID-19
- Current diagnosis of human immunodeficiency virus, hepatitis B or C
- In the opinion of the investigator, unlikely to survive for > 24 hours from enrollment
- Women who are pregnant or might be pregnant, or who are currently breast-feeding. Subjects must agree to not donate ova or sperm through 30 days after the last dose of study medication
- Presence of significant comorbidity that, in the opinion of the investigator, predisposes the subject to mortality. Such conditions might include: a. New York Heart Association class IV Heart Failure b. Hepatic dysfunction (i.e., AST or ALT >3x upper limit of normal) c. Renal dysfunction (i.e., estimated glomerular filtration rate (eGFR) < 50mL/min) or receiving renal replacement therapy
- Presence of septic shock at time of enrollment
- Hemoglobin < 80 g/L
- Evidence of neutropenia (i.e., absolute neutrophil count < 1000 cells/uL), lymphopenia (i.e., absolute lymphocyte count < 200 cells/uL) or thrombocytopenia (i.e.Platelets < 50×10^9/L)
- Hypersensitivity to TD-0903 or its components, or to other JAK inhibitors
- Treatment with anti-IL 6 (e.g., tocilizumab, sarilumab), anti-IL-6R antagonists (e.g., abatacept), JAK inhibitors (e.g., baricitinib, tofacitinib) supplemental interferon therapy, or tyrosine kinase inhibitors (e.g., erlotinib, gefinitib) in the past 30 days, or plans to receive a JAK inhibitor during the study period
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Current treatment with conventional synthetic disease-modifying anti-rheumatic drugs (DMARDs)/immunosuppressive agents including:
- Methotrexate, cyclosporine, mycophenolate, tacrolimus, penicillamine, or sulfasalazine within 2 weeks prior to enrollment
- Azathioprine or cyclophosphamide within 12 weeks prior to enrollment
- Monoclonal antibodies targeting B cells (e.g., rituximab) within 12 weeks prior to enrollment
- Tumor necrosis factor-alpha (TNFα)) inhibitors within 4 weeks prior to enrollment
- Participating in other clinical trials involving any other experimental treatment for COVID-19, except in the context of a single-arm antiviral or convalescent plasma compassionate-use protocol
- Subjects with active or incompletely treated pulmonary tuberculosis, or known history of non-tuberculosis mycobacterium over past 12 months
- Subject requires continuous oxygen supplementation for underlying cardio-respiratory history in the past 90 days
- Body Mass Index ≥40 kg/m2
- Receipt of live vaccine (i.e., live attenuated) in the 4 weeks prior to visit 1 or plans to receive a live vaccine (or live attenuated) during the study period. Note: Use of non-live (inactivated) vaccinations is allowed for all subjects
- History of venous thromboembolism (VTE), deep venous thrombosis (DVT), Pulmonary Embolism (PE) or known hypercoagulable disorder (e.g., factor V Leiden, antiphospholipid antibody syndrome, protein C or S deficiency)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04402866
United States, California | |
Theravance Biopharma Investigational Site | |
Duarte, California, United States, 91010 | |
United States, Colorado | |
Theravance Biopharma Investigational Site | |
Denver, Colorado, United States, 80220 | |
United States, Florida | |
Theravance Biopharma Investigational Site | |
Sebring, Florida, United States, 33870 | |
United States, Massachusetts | |
Theravance Biopharma Investigational Site | |
Boston, Massachusetts, United States, 02135 | |
Theravance Biopharma Investigational Site | |
Fall River, Massachusetts, United States, 02720 | |
United States, Montana | |
Theravance Biopharma Investigational Site | |
Kalispell, Montana, United States, 59901 | |
United States, New York | |
Theravance Biopharma Investigational Site | |
Glens Falls, New York, United States, 12801 | |
Theravance Biopharma | |
Hyde Park, New York, United States, 11040 | |
United States, Ohio | |
Theravance Biopharma Investigational Site | |
Columbus, Ohio, United States, 43214 | |
United States, Pennsylvania | |
Theravance Biopharma Investigational Site | |
Allentown, Pennsylvania, United States, 18103 | |
Theravance Biopharma Investigational Site | |
Bethlehem, Pennsylvania, United States, 18015 | |
United States, Washington | |
Theravance Biopharma Investigational Site | |
Wenatchee, Washington, United States, 98801 | |
Brazil | |
Theravance Biopharma Investigational Site | |
Bela Vista, Brazil, 01323-001 | |
Theravance Biopharma Investigational Site | |
Botucatu, Brazil, 18618-686 | |
Theravance Biopharma Investigational Site | |
Caxias Do Sul, Brazil, 95070-560 | |
Theravance Biopharma Investigational Site | |
São José Do Rio Preto, Brazil, 15090-000 | |
Finland | |
Theravance Biopharma Investigational Site | |
Helsinki, Finland, 00290 | |
Theravance Biopharma Investigational Site | |
Turku, Finland, 20520 | |
Moldova, Republic of | |
Theravance Biopharma Investigational Site | |
Chisinau, Moldova, Republic of, MD-2025 | |
Romania | |
Theravance Biopharma Investigational Site | |
Bucharest, Romania, 21105 | |
Ukraine | |
Theravance Biopharma Investigational Site | |
Brovary, Ukraine, 07 400 | |
Theravance Biopharma Investigational Site | |
Kyiv, Ukraine, 01 103 | |
Theravance Biopharma Investigational Site | |
Kyiv, Ukraine, 01 601 | |
United Kingdom | |
Theravance Biopharma Investigational Site | |
Manchester, United Kingdom, M23 9QZ |
Study Director: | Medical Monitor | Theravance Biopharma |
Documents provided by Theravance Biopharma:
Responsible Party: | Theravance Biopharma |
ClinicalTrials.gov Identifier: | NCT04402866 |
Other Study ID Numbers: |
0188 2020-001807-18 ( EudraCT Number ) |
First Posted: | May 27, 2020 Key Record Dates |
Results First Posted: | March 17, 2022 |
Last Update Posted: | March 17, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Acute lung injury ALI COVID-19 Coronavirus Disease 2019 inflammatory lung conditions |
Inflammatory lung disease ARDS SARS-CoV-2 Pneumonia |
COVID-19 Pneumonia Lung Injury Acute Lung Injury Inflammation Respiratory Tract Infections Infections Pneumonia, Viral Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Wounds and Injuries Pathologic Processes Thoracic Injuries |