COVID-19Phase 2SafeDropNCT04920916
Safety and Efficacy of Dupilumab for Treatment of Hospitalized COVID-19 Patients
A Phase 2 study testing Dupilumab in people with COVID-19, run by University of Virginia at 1 site in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled, superiority phase IIa trial to assess the safety and efficacy of dupilumab use in hospitalized patients with moderate to severe COVID-19 infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2021to 18 Apr 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18 years of age or older at the time of enrollment.
- Patients hospitalized with a positive RT-PCR for SARS-CoV-2 within the last 14 days, with illness duration within the last 14 days, and evidence of moderate to severe COVID-19 infection as defined by NIH COVID-19 Severity Categorization (8):
- Moderate illness: Individuals who show evidence of lower respiratory disease during clinical assessment or imaging and who have saturation of oxygen SpO2≥ 94% on room air at sea level.
- Severe illness: Individuals who have SpO2 <94% on room air at sea level, a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <300 mm Hg, respiratory frequency >30 breaths/min, or lung infiltrates >50%.
- Patient and/or legally authorized representative is willing and able to provide written informed consent and comply with all protocol requirements.
- Patients with hematologic malignancies or solid tumors are eligible.
Show all 14Show fewer
- Patients with autoimmune disorders are eligible.
- Patients with immunodeficiency and organ or stem cell transplant recipients are eligible.
- Patients with acute or chronic renal injury/failure are eligible.
- Patients with neutropenia/lymphopenia are eligible.
- Patients with elevated liver function tests are eligible.
- Women who are not taking contraception are eligible.
- Patients who are currently or have recently received steroids and/or remdesivir are eligible.
- Patient agrees to not participate in another clinical trial for the treatment of COVID-19 through end of study period.
Who cannot join
- Patients who do not require inpatient admission for COVID-19 infection.
- Patients who require invasive mechanical ventilation at time of enrollment.
- A pre-existing condition or use of a medication that, in the opinion of the site investigator, may place the individual at a substantially increased risk due to study participation.
- Pregnancy or breast feeding (lactating women who agree to discard breast milk from day 1 until two weeks after the last study product is given are not excluded).
- Allergy to Dupilumab or its excipients.
- Received any of the following in the two weeks prior to screening as treatment of COVID-19:
Show all 13Show fewer
- small molecule tyrosine kinase inhibitors (e.g. imatinib, gefitinib, acalabrutinib, etc.);
- monoclonal antibodies targeting cytokines (e.g., TNF inhibitors, anti-interleukin-1 [IL-1], anti-IL-6 [or sarilumab], etc.);
- monoclonal antibodies targeting T-cells or B-cells as treatment for COVID-19;
- Any other immunomodulatory (other than steroids) medications within 5 half-lives or 30 days prior to randomization.
- Current acute parasitic helminth infection or history of chronic parasitic infection.
- History of ocular scleritis, uveitis, keratitis or recent (<6 months) eye injury (chemical or traumatic), infection or vascular occlusion.
- Have received any live vaccine (that is, live attenuated) within 4 weeks before screening, or intend to receive a live vaccine (or live attenuated) during the study. Note: Use of non-live (inactivated) vaccinations is allowed for all subjects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of the Treatment of Hospitalized Patients With COVID 19 Infection With an Inhibitor of IL-4 and IL-13 Signaling: A Phase IIa Trial
This is a randomized, double-blind, placebo-controlled, superiority phase IIa trial to assess the safety and efficacy of dupilumab use in hospitalized patients with moderate to severe COVID-19 infection. Subsequently, we conducted a 1 year follow up study to investigate the occurrence of Post COVID conditions (PCC) in our study population through assessment of pulmonary function, symptoms, neurocognition and immune biomarkers to observe for any treatment group differences.
Read the detailed description
A total of 40 eligible subject were enrolled and randomized in a 1:1 ratio to receive either dupilumab or placebo, stratifying on the disease severity measured by the required oxygen ≤ 15L or > 15L by nasal cannula. Both arms received standard of care management per current National Institutes of Health (NIH) COVID-19 treatment guideline in addition to their randomized treatments. Patients were then followed prospectively for up to 360 days after enrollment.
As an extension to the randomized double-blind placebo-controlled trial assessing dupilumab for treatment of those hospitalized with acute moderate to severe COVID-19, subjects were followed up at 1 year for evaluation of pulmonary function testing (PFT), pulmonary imaging, immune biomarkers, neurocognition and symptoms.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabBiological
Also called Dupixent
Participants will receive a loading dose of dupilumab (600 mg, given as two 300 mg subcutaneous injections) on day 0/1. If participants are still hospitalized a second and third dose (300 mg) will be given on days 14 and 28.
PlaceboDrug
Normal Saline.
| Study group | Role | What they receive |
|---|---|---|
| Dupilimab | Experimental | Dupilimab: 600 mg, given as two 300 mg subcutaneous injections on day 0/1. If participants are still hospitalized a second and third dose (300 mg) will be given on days 14 and 28. Receives: Biological: Dupilumab |
| Placebo | Placebo comparator | Normal saline will be given as two one mL subcutaneous injections on day 0/1. If participants are still hospitalized a second and third dose (1 mL) will be given on days 14 and 28. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day 28 Ventilator Free Survival
Proportion of patients alive and free of invasive mechanical ventilation
Measured: at 28 Days ± 2d
Follow up Study 1 Year Outcome: Pulmonary Function Testing- Oxygen Diffusion and 6 Minute Walk Testing
Proportion of patients with abnormal diffusing capacity for carbon monoxide (DLCO) and/or 6 minute walk testing 1 year after acute COVID-19 infection.
Measured: 365 ± 90 days
Secondary outcomes (18)
Proportion of Patients With Eosinophilia
defined as an absolute eosinophil count > 0.6 k/µl at ≥ 1 measurement throughout the study period
Measured: Day 0 through Day 60
Cumulative Incidence of Grade 3 and 4 Clinical Adverse Events, Serious Adverse Events (SAEs) or Death
defined as number of new events divided by the total number of individuals in the population at risk for the time interval
Measured: Day 0 through Day 60
SARS-CoV-2 Variants
Prevalence of delta variant in study population.
Measured: Day 0
Change in Plasma Total Immunoglobulin E (IgE) Levels
Change in levels (difference between day 14- day 0 levels).
Measured: Day 0 and Day 14
Change in C-reactive Protein (CRP)
Change in levels (difference between day 14- day 0 levels)
Measured: Day 0 through Day 14
Change in Ferritin
Change in levels (difference between day 14- day 0 levels).
Measured: Day 0 through Day 14
Duration of Hospitalization
Measured in days
Measured: Day 0 through Day 30
Day 60 All Cause Mortality
All cause mortality by day 60
Measured: Day 60
Day 28 All-cause Mortality Rate
Mortality rate
Measured: at Day 28
Day 60 Ventilator Free Survival
Proportion of patients alive and free of invasive mechanical ventilation
Measured: Day 60
Percentage of Patients Needing Extracorporeal Membrane Oxygenation (ECMO)
Percentage
Measured: Day 0 through Day 60
Percentage of Patients Needing Renal Replacement Therapy
Percentage
Measured: Day 0 through Day 60
Percentage of Patients Needing Vasopressors
Percentage
Measured: Day 0 through Day 60
Follow Up Study 1 Year Outcome: All-cause Mortality at 1 Year
Percent of subjects who died by 1 year.
Measured: 365 days
Follow-up Study 1 Year Outcome: Differences in High Resolution Computed Tomography (HRCT) Chest Scan Appearance Post Recovery
Compare Enrollment HRCT to 1 year HRCT. Percent of abnormal on CT. Reported as percent of subjects with any abnormality on CT.
Measured: 365 ± 90 days
Follow-up Study 1 Year Outcome: Conduct a 6 Minute Walk Testing
Proportion of patients with greater than 3% oxygen desaturation during 6 minute walk testing
Measured: 365 ± 90 days
Follow up Study 1 Year Outcome: Pulmonary Function Testing- Abnormal Spirometry
Percentage of subjects with a percent of predicted (compared to Global Lung Function Initiative (GLI) predicted values based on age, sex, height and ethnicity) below normal for forced expiratory volume (FEV1) or forced vital capacity (FVC), which are measures used to determine the volume of air that can be exhaled in one breath.
Measured: 365 ± 90 days
Follow-up Study 1 Year Outcome: Assess Neurocognitive Function Using the MOCA
Determine the proportion of patients with reduce neurocognitive function. Neurocognitive testing included completion of Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety, PROMIS Depression, the Montreal Cognitive Assessment (MOCA), the Insomnia Severity Index (ISI), the Katz Index of Independence In Activities of Daily Living (Katz-ADL), EuroQOL (EQ)-5D-5L and Neuro- Quality of Life (QoL) questionnaires. Reduced neurocognitive function was determined if scoring from at least one of these tests was deemed a variation from population norm per scoring instructions.
Measured: 365 ± 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start25 May 2021
- Primary completion18 Apr 2023
- Study completion18 Apr 2023
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- The Paul Manning Foundation, Virginia Catalyst
- Responsible party
- Principal investigator, William Petri, MD, PhD, University of Virginia
- Investigators
- William A Petri Jr., MD, PhD, Principal investigator, University of Virginia Division of Infectious Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920916
- Sponsor's protocol ID
- HSR210184
- Other IDs
- HSR220171
- Acronym
- SafeDrop
- Status last verified
- Oct 2023
- First submitted
- 8 Jun 2021
- Last updated
- 3 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Sasson J, Donlan AN, Ma JZ, Haughey HM, Coleman R, Nayak U, Mathers AJ, Laverdure S, Dewar R, Jackson PEH, Heysell SK, Sturek JM, Petri WA Jr. Safety and Efficacy of Dupilumab for the Treatment of Hospitalized Patients With Moderate to Severe Coronavirus Disease 2019: A Phase 2a Trial. Open Forum Infect Dis. 2022 Jul 27;9(8):ofac343. doi: 10.1093/ofid/ofac343. eCollection 2022 Aug.
PubMed 35959207Hendrick J, Ma JZ, Haughey HM, Coleman R, Nayak U, Kadl A, Sturek JM, Jackson P, Young MK, Allen JE, Petri WA Jr. Pulmonary function and survival one year after dupilumab treatment of acute moderate to severe COVID-19: A follow up study from a Phase IIa trial. medRxiv [Preprint]. 2023 Sep 2:2023.09.01.23293947. doi: 10.1101/2023.09.01.23293947.
PubMed 37693596Sasson J, Donlan AN, Ma JZ, Haughey HM, Coleman R, Nayak U, Mathers AJ, Laverdure S, Dewar R, Jackson PEH, Heysell SK, Sturek JM, Petri WA Jr. Safety and Efficacy of Dupilumab for the Treatment of Hospitalized Patients with Moderate to Severe COVID 19: A Phase IIa Trial. medRxiv [Preprint]. 2022 May 19:2022.03.30.22273194. doi: 10.1101/2022.03.30.22273194.
PubMed 35411349
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Treatment of Hospitalized Patients With COVID 19 Infection With an Inhibitor of IL-4 and IL-13 Signaling: A Phase IIa Trial
- ClinicalTrials.gov ID
- NCT04920916
- Acronym / sponsor ID
- SafeDrop / HSR210184
- Conditions
- COVID-19
- Keywords
- Anti-Inflammatory Agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- The Paul Manning Foundation, Virginia Catalyst
- Study start
- 25 May 2021 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 18 Apr 2023 (actual)
- First posted
- 10 Jun 2021 (actual)
- Results
- Posted 3 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled, superiority phase IIa trial to assess the safety and efficacy of dupilumab use in hospitalized patients with moderate to severe COVID-19 infection. Subsequently, we conducted a 1 year follow up study to investigate the occurrence of Post COVID conditions (PCC) in our study population through assessment of pulmonary function, symptoms, neurocognition and immune biomarkers to observe for any treatment group differences.
Detailed description
A total of 40 eligible subject were enrolled and randomized in a 1:1 ratio to receive either dupilumab or placebo, stratifying on the disease severity measured by the required oxygen ≤ 15L or > 15L by nasal cannula. Both arms received standard of care management per current National Institutes of Health (NIH) COVID-19 treatment guideline in addition to their randomized treatments. Patients were then followed prospectively for up to 360 days after enrollment.
As an extension to the randomized double-blind placebo-controlled trial assessing dupilumab for treatment of those hospitalized with acute moderate to severe COVID-19, subjects were followed up at 1 year for evaluation of pulmonary function testing (PFT), pulmonary imaging, immune biomarkers, neurocognition and symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dupilimab | Experimental | Biological: DupilumabDupilimab: 600 mg, given as two 300 mg subcutaneous injections on day 0/1. If participants are still hospitalized a second and third dose (300 mg) will be given on days 14 and 28. |
| Placebo | Placebo comparator | Drug: PlaceboNormal saline will be given as two one mL subcutaneous injections on day 0/1. If participants are still hospitalized a second and third dose (1 mL) will be given on days 14 and 28. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female 18 years of age or older at the time of enrollment.
- Patients hospitalized with a positive RT-PCR for SARS-CoV-2 within the last 14 days, with illness duration within the last 14 days, and evidence of moderate to severe COVID-19 infection as defined by NIH COVID-19 Severity Categorization (8):
- Patient and/or legally authorized representative is willing and able to provide written informed consent and comply with all protocol requirements.
- Patients with hematologic malignancies or solid tumors are eligible.
- Patients with autoimmune disorders are eligible.
Key exclusion criteria (13 listed)
- Patients who do not require inpatient admission for COVID-19 infection.
- Patients who require invasive mechanical ventilation at time of enrollment.
- A pre-existing condition or use of a medication that, in the opinion of the site investigator, may place the individual at a substantially increased risk due to study participation.
- Pregnancy or breast feeding (lactating women who agree to discard breast milk from day 1 until two weeks after the last study product is given are not excluded).
- Allergy to Dupilumab or its excipients.
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 |
|---|---|---|
| DupilumabAlso: DupixentParticipants will receive a loading dose of dupilumab (600 mg, given as two 300 mg subcutaneous injections) on day 0/1. If participants are still hospitalized a second and third dose (300 mg) will be given on days 14 and 28. | Biological | Dupilimab |
| PlaceboNormal Saline. | Drug | Placebo |
Primary outcome
Day 28 Ventilator Free Survival
Time frame: at 28 Days ± 2d
Proportion of patients alive and free of invasive mechanical ventilation
Follow up Study 1 Year Outcome: Pulmonary Function Testing- Oxygen Diffusion and 6 Minute Walk Testing
Time frame: 365 ± 90 days
Proportion of patients with abnormal diffusing capacity for carbon monoxide (DLCO) and/or 6 minute walk testing 1 year after acute COVID-19 infection.
18 secondary outcomes
Proportion of Patients With Eosinophilia
Time frame: Day 0 through Day 60
Cumulative Incidence of Grade 3 and 4 Clinical Adverse Events, Serious Adverse Events (SAEs) or Death
Time frame: Day 0 through Day 60
SARS-CoV-2 Variants
Time frame: Day 0
Change in Plasma Total Immunoglobulin E (IgE) Levels
Time frame: Day 0 and Day 14
Change in C-reactive Protein (CRP)
Time frame: Day 0 through Day 14
Change in Ferritin
Time frame: Day 0 through Day 14
Duration of Hospitalization
Time frame: Day 0 through Day 30
Day 60 All Cause Mortality
Time frame: Day 60
Day 28 All-cause Mortality Rate
Time frame: at Day 28
Day 60 Ventilator Free Survival
Time frame: Day 60
Percentage of Patients Needing Extracorporeal Membrane Oxygenation (ECMO)
Time frame: Day 0 through Day 60
Percentage of Patients Needing Renal Replacement Therapy
Time frame: Day 0 through Day 60
Percentage of Patients Needing Vasopressors
Time frame: Day 0 through Day 60
Follow Up Study 1 Year Outcome: All-cause Mortality at 1 Year
Time frame: 365 days
Follow-up Study 1 Year Outcome: Differences in High Resolution Computed Tomography (HRCT) Chest Scan Appearance Post Recovery
Time frame: 365 ± 90 days
Follow-up Study 1 Year Outcome: Conduct a 6 Minute Walk Testing
Time frame: 365 ± 90 days
Follow up Study 1 Year Outcome: Pulmonary Function Testing- Abnormal Spirometry
Time frame: 365 ± 90 days
Follow-up Study 1 Year Outcome: Assess Neurocognitive Function Using the MOCA
Time frame: 365 ± 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35959207Sasson J, Donlan AN, Ma JZ, Haughey HM, Coleman R, Nayak U, Mathers AJ, Laverdure S, Dewar R, Jackson PEH, Heysell SK, Sturek JM, Petri WA Jr. Safety and Efficacy of Dupilumab for the Treatment of Hospitalized Patients With Moderate to Severe Coronavirus Disease 2019: A Phase 2a Trial. Open Forum Infect Dis. 2022 Jul 27;9(8):ofac343. doi: 10.1093/ofid/ofac343. eCollection 2022 Aug.
- Results publication: PubMed 37693596Hendrick J, Ma JZ, Haughey HM, Coleman R, Nayak U, Kadl A, Sturek JM, Jackson P, Young MK, Allen JE, Petri WA Jr. Pulmonary function and survival one year after dupilumab treatment of acute moderate to severe COVID-19: A follow up study from a Phase IIa trial. medRxiv [Preprint]. 2023 Sep 2:2023.09.01.23293947. doi: 10.1101/2023.09.01.23293947.
- Derived from this study: PubMed 35411349Sasson J, Donlan AN, Ma JZ, Haughey HM, Coleman R, Nayak U, Mathers AJ, Laverdure S, Dewar R, Jackson PEH, Heysell SK, Sturek JM, Petri WA Jr. Safety and Efficacy of Dupilumab for the Treatment of Hospitalized Patients with Moderate to Severe COVID 19: A Phase IIa Trial. medRxiv [Preprint]. 2022 May 19:2022.03.30.22273194. doi: 10.1101/2022.03.30.22273194.
- Individual participant dataSharing planned: Yes
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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.
William A Petri Jr., MD, PhD principal investigator
University of Virginia Division of Infectious Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dupilumab in people with COVID-19, run by University of Virginia at 1 site in United States.
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 14 inclusion and 13 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 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 3 Nov 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?
Day 28 Ventilator Free Survival (time frame: at 28 Days ± 2d). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04920916, which also lists 3 linked publications.
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 3 Nov 2023.