SARS-CoV-2 (COVID-19) Severe PneumoniaPhase 2NCT04412668
Study to Evaluate the Safety and Efficacy of ATYR1923 (Efzofitimod) In Participants With Severe Pneumonia Related to COVID-19
A Phase 2 study testing Efzofitimod 1 mg/kg and Efzofitimod 3 mg/kg in people with SARS-CoV-2 (COVID-19) Severe Pneumonia, run by aTyr Pharma, Inc. at 10 sites in 2 countries.
Trial summary
To evaluate the safety and preliminary efficacy of efzofitimod, compared to placebo matched to efzofitimod, in hospitalized participants with SARS-CoV-2 (COVID-19) severe pneumonia not requiring mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SARS-CoV-2 (COVID-19) Severe Pneumonia
- What is being tested?
- Efzofitimod 1 mg/kg and Efzofitimod 3 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 4 Jun 2020to 23 Oct 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmation of SARS-CoV-2 infection by polymerase chain reaction (PCR).
- Severe pneumonia related to SARS-CoV-2 infection, defined as fever or suspected respiratory infection with radiographic abnormalities suggestive of viral pneumonia, plus at least 1 of the following:
- Respiratory rate >30 breaths/minute;
- Severe respiratory distress, as determined by the Investigator;
- Oxygen saturation (SpO2) ≤93% on room air.
Who cannot join
- Participant is intubated/mechanically ventilated.
- In the opinion of the Investigator, participant's progression to death is imminent.
- Treatment with immunosuppressant/immunotherapy drugs, including but not limited to interleukin (IL)-6 inhibitors, tumor necrosis factor-alpha (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.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States8 sites
Anne Arundel Medical Center
Annapolis, Maryland, 21401
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
University of Iowa
Iowa City, Iowa, 52242
University of Miami
Miami, Florida, 33125
aTyr Investigative Site
Toledo, Ohio, 43614
aTyr Investigative Site
Vineland, New Jersey, 08360
aTyr Investigative Site
Washington D.C., District of Columbia, 20010
Puerto Rico2 sites
Alliance Medical Service, Cardio Pulmonary Research
Guaynabo, 00968
Manati Medical Center
Manati, 00674
About this study
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)
To evaluate the safety and preliminary efficacy of efzofitimod, compared to placebo matched to efzofitimod, in hospitalized participants with SARS-CoV-2 (COVID-19) severe pneumonia not requiring mechanical ventilation.
- Conditions
- SARS-CoV-2 (COVID-19) Severe Pneumonia
- Being tested
- Efzofitimod 1 mg/kg, Efzofitimod 3 mg/kg, Placebo
- Keywords
- SARS-CoV-2, CoV-2, ATYR1923 (efzofitimod), acute respiratory distress syndrome, ARDS, SARS-CoV-2 Infection, COVID-19, Severe Pneumonia
- Medical subject headings
- COVID-19, Pneumonia, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efzofitimod 1 mg/kgDrug
Concentrate for solution for infusion
Efzofitimod 3 mg/kgDrug
Concentrate for solution for infusion
PlaceboDrug
Concentrate for solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| Efzofitimod 1 mg/kg | Experimental | Participants will receive single dose of efzofitimod 1 milligrams/kilograms (mg/kg) IV infusion on Day 1. Receives: Drug: Efzofitimod 1 mg/kg |
| Efzofitimod 3 mg/kg | Experimental | Participants will receive single dose of efzofitimod 3 mg/kg IV infusion on Day 1. Receives: Drug: Efzofitimod 3 mg/kg |
| Placebo | Placebo comparator | Participants will receive placebo matched to efzofitimod IV infusion on Day 1. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs were defined as adverse events (AEs) with an onset following administration of the first dose of study drug. AEs were defined as any untoward medical occurrence in a participant administered study drug and that does not necessarily have a causal relationship with the study drug. Worsening of a pre-existing medical condition should have been considered an AE if there was either an increase in severity, frequency, or duration of the condition or an association with significantly worse outcomes. SAEs were defined as any AE that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes as fatal, life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, an important medical event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in 'Reported Adverse Events' Section.
Measured: Baseline up to Day 60
Secondary outcomes (7)
Time to Hospital Discharge
Time to hospital discharge was based on Kaplan-Meier estimate and was calculated as: discharge date - study drug administration date. Participants who died during hospitalization were censored at death date. Participants who remained hospitalized at end of study (EOS) were censored at EOS visit.
Measured: Baseline up to Day 60
Time to Recovery (World Health Organization [WHO] Ordinal Scale Score ≤3)
Time to recovery was based on Kaplan-Meier estimate and was calculated as: date of first time with a WHO scale score ≤3 - study drug administration date or date of discharge from hospital - study drug administration date, whichever occurred first. In the case that a participant did not reach WHO scale score ≤3 criteria, the participant was censored at EOS visit.
Measured: Baseline up to Day 60
Number of Participants Who Achieved Recovery (WHO Ordinal Scale Score ≤3) by Day 14 and Day 28
The number of participants was the non-missing value at the visit, which was used as the denominator for percentage calculation.
Measured: Baseline through Day 14 and Day 28
Number of Days With Supplemental Oxygen (O2)
Number of days with supplemental O2 was calculated as stop date of supplemental O2 - start date of supplemental oxygen +1, if supplemental O2 started after study drug administration; otherwise, number of days with supplemental O2 was calculated as stop date of supplemental O2 - date of study drug administration +1. If there were multiple periods of supplemental O2, total days were the sum of each period.
Measured: Baseline up to Day 60
Number of Days With Fever (Temperature >100.4ºF [38.0ºC])
Number of days with fever was calculated as stop date of fever - start date of fever +1, if fever started after study drug administration; otherwise, number of days with fever was calculated as stop date of fever - date of study drug administration +1. If there were multiple periods of fever, total days was the sum of each period.
Measured: Baseline up to Day 14
Number of Participants With a Change From Baseline in World Health Organization (WHO) Ordinal Scale Score on Day 60
WHO ordinal scale rated the clinical improvement of the participants on a scale of 0-8, where 0=No clinical or virological evidence of infection, 1=No limitation of activities, 2=limitation of activities, 3=Hospitalized, no oxygen therapy, 4=Oxygen by mask or nasal prongs, 5=Non-invasive ventilation or high flow oxygen, 6=Intubation and mechanical ventilation, 7=Ventilation + additional organ support, 8=Death. Change from Baseline data were represented on a scale of -7 to 4, where -7=a better change from Baseline score and 4=a worse change from Baseline score. Change from Baseline was derived as: visit value - Baseline value.
Measured: Baseline, Day 60
Time to Improvement From Inpatient Hospital Admission Based on at Least a 1-Point Reduction in WHO Ordinal Scale Score
Time to improvement was based on Kaplan-Meier estimate and was defined as the date of decrease in WHO scale compared to Baseline by at least 1 point - study drug administration date or date of discharge from hospital - study drug administration date, whichever occurred first. In the case that a participant did not reach an improvement, the participant was censored at end of study date.
Measured: Baseline up to Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start4 Jun 2020
- Primary completion23 Oct 2020
- Study completion23 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SARS-CoV-2 (COVID-19) Severe PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1:1 to a single intravenous (IV) dose of efzofitimod 1 mg/kg, efzofitimod 3 mg/kg, or placebo matched to efzofitimod.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- aTyr Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412668
- Sponsor's protocol ID
- ATYR1923-C-003
- Status last verified
- Jul 2023
- First submitted
- 1 Jun 2020
- Last updated
- 18 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04412668
- Acronym / sponsor ID
- ATYR1923-C-003
- Conditions
- SARS-CoV-2 (COVID-19) Severe Pneumonia
- Keywords
- SARS-CoV-2, CoV-2, ATYR1923 (efzofitimod), acute respiratory distress syndrome, ARDS, SARS-CoV-2 Infection, COVID-19, Severe Pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- aTyr Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 23 Oct 2020 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 2 Jun 2020 (actual)
- Results
- Posted 18 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and preliminary efficacy of efzofitimod, compared to placebo matched to efzofitimod, in hospitalized participants with SARS-CoV-2 (COVID-19) severe pneumonia not requiring mechanical ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomized 1:1:1 to a single intravenous (IV) dose of efzofitimod 1 mg/kg, efzofitimod 3 mg/kg, or placebo matched to efzofitimod.
| Arm | Type | Receives |
|---|---|---|
| Efzofitimod 1 mg/kg | Experimental | Drug: Efzofitimod 1 mg/kgParticipants will receive single dose of efzofitimod 1 milligrams/kilograms (mg/kg) IV infusion on Day 1. |
| Efzofitimod 3 mg/kg | Experimental | Drug: Efzofitimod 3 mg/kgParticipants will receive single dose of efzofitimod 3 mg/kg IV infusion on Day 1. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo matched to efzofitimod IV infusion on Day 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmation of SARS-CoV-2 infection by polymerase chain reaction (PCR).
- Severe pneumonia related to SARS-CoV-2 infection, defined as fever or suspected respiratory infection with radiographic abnormalities suggestive of viral pneumonia, plus at least 1 of the following:
Key exclusion criteria (5 listed)
- Participant is intubated/mechanically ventilated.
- In the opinion of the Investigator, participant's progression to death is imminent.
- Treatment with immunosuppressant/immunotherapy drugs, including but not limited to interleukin (IL)-6 inhibitors, tumor necrosis factor-alpha (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efzofitimod 1 mg/kgConcentrate for solution for infusion | Drug | Efzofitimod 1 mg/kg |
| Efzofitimod 3 mg/kgConcentrate for solution for infusion | Drug | Efzofitimod 3 mg/kg |
| PlaceboConcentrate for solution for infusion | Drug | Placebo |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to Day 60
TEAEs were defined as adverse events (AEs) with an onset following administration of the first dose of study drug. AEs were defined as any untoward medical occurrence in a participant administered study drug and that does not necessarily have a causal relationship with the study drug. Worsening of a pre-existing medical condition should have been considered an AE if there was either an increase in severity, frequency, or duration of the condition or an association with significantly worse outcomes. SAEs were defined as any AE that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes as fatal, life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, an important medical event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in 'Reported Adverse Events' Section.
7 secondary outcomes
Time to Hospital Discharge
Time frame: Baseline up to Day 60
Time to Recovery (World Health Organization [WHO] Ordinal Scale Score ≤3)
Time frame: Baseline up to Day 60
Number of Participants Who Achieved Recovery (WHO Ordinal Scale Score ≤3) by Day 14 and Day 28
Time frame: Baseline through Day 14 and Day 28
Number of Days With Supplemental Oxygen (O2)
Time frame: Baseline up to Day 60
Number of Days With Fever (Temperature >100.4ºF [38.0ºC])
Time frame: Baseline up to Day 14
Number of Participants With a Change From Baseline in World Health Organization (WHO) Ordinal Scale Score on Day 60
Time frame: Baseline, 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 up to Day 60
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Efzofitimod 1 mg/kg and Efzofitimod 3 mg/kg in people with SARS-CoV-2 (COVID-19) Severe Pneumonia, run by aTyr Pharma, Inc. at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to Day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.