Study to Evaluate the Safety and Efficacy of ATYR1923 In Patients With Severe Pneumonia Related to COVID-19
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ClinicalTrials.gov Identifier: NCT04412668 |
Recruitment Status :
Completed
First Posted : June 2, 2020
Last Update Posted : January 29, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
SARS-CoV-2 (COVID-19) Severe Pneumonia | Drug: ATYR1923 1 mg/kg Drug: ATYR1923 3 mg/kg Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Patients will be randomized 1:1:1 to a single IV dose of ATYR1923 1 mg/kg, ATYR1923 3 mg/kg, or placebo. |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | The Investigator, Sponsor, and patient will be blinded to treatment assignment; study center pharmacy personnel will be unblinded. |
Primary Purpose: | Treatment |
Official Title: | A Randomized Double-blind Placebo-controlled Study to Evaluate the Safety and Efficacy of ATYR1923 In Adult Patients With Severe Pneumonia Related to SARS-CoV-2 Infection (COVID-19) |
Actual Study Start Date : | June 12, 2020 |
Actual Primary Completion Date : | December 21, 2020 |
Actual Study Completion Date : | December 21, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: ATYR1923 1 mg/kg
Single dose of ATYR1923 1 mg/kg
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Drug: ATYR1923 1 mg/kg
1 mg/kg of ATYR1923 administered intravenously |
Experimental: ATYR1923 3 mg/kg
Single dose of ATYR1923 3 mg/kg
|
Drug: ATYR1923 3 mg/kg
3 mg/kg of ATYR1923 administered intravenously |
Placebo Comparator: Placebo
Single dose of Placebo
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Drug: Placebo
Placebo administered intravenously |
- Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Baseline through Day 60 ]
- Time to hospital discharge [ Time Frame: Baseline through Day 60 ]
- Time to recovery (World Health Organization [WHO] Ordinal Scale score ≤3) [ Time Frame: Baseline through Day 60 ]
- Proportion of patients achieving recovery by Day 14 and Day 28 [ Time Frame: Baseline through Day 14 and Day 28 ]
- Duration of supplemental oxygen (O2) requirement [ Time Frame: Baseline through Day 60 ]
- Number of days with fever (temperature >100.4ºF [38.0ºC]) [ Time Frame: Baseline through Day 14 or discharge ]
- Change from baseline in World Health Organization (WHO) Ordinal Scale score on Days 5, 7, 14, 28, and 60 [ Time Frame: Baseline through Day 60 ]
- Time to improvement from inpatient hospital admission based on at least a 1 point reduction in WHO Ordinal Scale score [ Time Frame: Baseline through Day 60 ]
- All-cause mortality at Days 14, 28, and 60 [ Time Frame: Baseline through Day 60 ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Confirmation of SARS-CoV2 infection by PCR.
-
Severe pneumonia related to SARS-CoV2 infection, defined as fever or suspected respiratory infection with radiographic abnormalities suggestive of viral pneumonia, plus at least one of the following:
- Respiratory rate >30 breaths/min; or
- Severe respiratory distress, as determined by the Investigator; or;
- Oxygen saturation (SpO2) ≤93% on room air.
Exclusion Criteria:
- Patient is intubated/mechanically ventilated.
- In the opinion of the Investigator, patient's progression to death is imminent.
- Treatment with immunosuppressant/immunotherapy drugs, including but not limited to IL-6 inhibitors, TNF-α inhibitors, anti-IL-1 agents and janus kinase inhibitors within 5 half-lives or 30 days prior to Day 1.
- Use of chronic (>30 days) oral corticosteroids for a non COVID 19-related condition in a dose higher than prednisone 10 mg or equivalent per day.
- Weight >165 kg or <40 kg.

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): NCT04412668
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, District of Columbia | |
aTyr Investigative Site | |
Washington, District of Columbia, United States, 20010 | |
United States, Florida | |
University of Miami | |
Miami, Florida, United States, 33125 | |
United States, Iowa | |
University of Iowa | |
Iowa City, Iowa, United States, 52242 | |
United States, Maryland | |
Anne Arundel Medical Center | |
Annapolis, Maryland, United States, 21401 | |
United States, New Jersey | |
aTyr Investigative Site | |
Vineland, New Jersey, United States, 08360 | |
United States, Ohio | |
aTyr Investigative Site | |
Toledo, Ohio, United States, 43614 | |
United States, Virginia | |
Inova Fairfax Medical Campus | |
Falls Church, Virginia, United States, 22042 | |
Puerto Rico | |
Alliance Medical Service, Cardio Pulmonary Research | |
Guaynabo, Puerto Rico, 00968 | |
Manati Medical Center | |
Manatí, Puerto Rico, 00674 |
Study Director: | Gennyne Walker | aTyr Pharma, Inc. |
Responsible Party: | aTyr Pharma, Inc. |
ClinicalTrials.gov Identifier: | NCT04412668 |
Other Study ID Numbers: |
ATYR1923-C-003 |
First Posted: | June 2, 2020 Key Record Dates |
Last Update Posted: | January 29, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
SARS-CoV-2 CoV-2 ATYR1923 acute respiratory distress syndrome |
ARDS SARS-CoV-2 Infection COVID-19 Severe Pneumonia |
COVID-19 Pneumonia Respiratory Tract Infections Infections Pneumonia, Viral Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |