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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05822583




Registration number
NCT05822583
Ethics application status
Date submitted
4/02/2023
Date registered
21/04/2023
Date last updated
19/09/2024

Titles & IDs
Public title
Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Immune Modulation Strategy Trial
Scientific title
Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Immune Modulation Strategy Trial
Secondary ID [1] 0 0
STRIVE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - abatacept infusion
Treatment: Drugs - Placebo group

Experimental: active treatment group - Active treatment group (IV abatacept infusion, 10 mg/kg up to 1750 mg) + baseline IM

Placebo comparator: Control group - Placebo group (IV infusion of normal saline) + baseline IM


Treatment: Drugs: abatacept infusion
The dose of abatacept will be 10 mg/kg given as a single infusion on Day 0, with a maximum dose of 1,750 mg, so any participant with weight of \>175 kg will receive a dose of 1750 mg. + baseline IM (immune modulator)

Treatment: Drugs: Placebo group
Placebo group (IV infusion of normal saline) + baseline IM
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Days to Recovery Scale
Timepoint [1] 0 0
60 days post-intervention
Secondary outcome [1] 0 0
time to sustained recovery though Day 60
Timepoint [1] 0 0
baseline to day 60
Secondary outcome [2] 0 0
all-cause mortality though Day 60
Timepoint [2] 0 0
baseline to day 60
Secondary outcome [3] 0 0
time to progression
Timepoint [3] 0 0
baseline to day 60
Secondary outcome [4] 0 0
Three-category ordinal outcome
Timepoint [4] 0 0
Day 60
Secondary outcome [5] 0 0
the pulmonary ordinal outcome
Timepoint [5] 0 0
Day 5, 14, and 28

Eligibility
Key inclusion criteria
* Confirmation of SARS-CoV2 infection by nucleic acid test (NAT) or equivalent non-NAT test [list of approved tests in the PIM] within 14 days of randomization.
* Requiring hospitalization for the management of COVID-19
* Has evidence of COVID-19 pneumonia (PNA) defined as either receiving supplementary oxygen =2L of low flow oxygen with evidence of airspace disease on chest imaging (X ray, computer tomography or ultrasound) OR receiving supplementary oxygen >2L and <10 L of low flow oxygen.
* Currently receiving or planned to receive (ordered) one IM drug (for example, a corticosteroid or baricitinib) as part of treatment of COVID-19 prior to randomization.
* Has started supplemental oxygen for the treatment of COVID-19 within the past 5 calendar days. Patients on home oxygen are eligible if current oxygen flow rate is increased from baseline and other above criteria are met.
* Investigator agrees that the pneumonia is due to COVID-19.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Oxygen requirement of =10L or more of low flow oxygen (or equivalent if using Venturi mask, etc), or requiring either HFNO, NIV, IMV, or ECMO.
* Participant has received more than one baseline IM for treatment of the current COVID-19 infection at time of trial enrollment. (Examples: corticosteroid, baricitinib, tocilizumab, anakinra, abatacept, or infliximab.)
* Participant anticipated to not meet all inclusion criteria within 24 hours of randomization in the opinion of the investigator.
* Allergy to investigational agent.
* Neutropenia (absolute neutrophil count <1000 cells/µL) (<1.0 x 10 3 /µL or <1.0 G/L) on most recent lab within 2 calendar days of randomization.
* Lymphopenia (absolute lymphocyte count <200 cells/µL) (<0.20 x 10 3 /µL or <0.20 G/L) on most recent lab within 2 calendar days of randomization.
* Known or suspected active or recent serious infection (bacterial, fungal, viral, or parasitic infection, excepting SARS-CoV-2) that in the opinion of the investigator could constitute a risk when taking investigational agent. Note: Broad spectrum empiric antibiotic usage does not exclude participation.
* Known or suspected history of untreated tuberculosis (TB). TB diagnosis may be suspected based on medical history and concomitant therapies that would suggest TB infection. Participants are also excluded if they have known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening required).
* Have received any live vaccine (or live attenuated) within 3 months before screening or intend to receive a live vaccine (or live attenuated) during the trial. Use of prior non-live (inactivated) vaccinations is allowed for all participants, including any vaccine for COVID-19.
* Pre-existing immunomodulation or immunosuppression that meets any of the following: Participant has received abatacept for an indication other than COVID- 19 within 5 half-lives (65 days) of enrollment (Abatacept elimination half-life is 13.1 days.) Participant is receiving immune modulatory therapy for autoimmune, transplant management or another indication AND has one or more of the following: evidence of active infection (other than COVID-19) or has required reduction in their immune modulatory therapy in the preceding 6 months due to infectious complication (routine reduction as SOC is not an exclusion) or has required intensification in immunotherapy within the preceding 6 months due to organ rejection/worsening underlying disease status (e.g., intensification with an additional agent on top of usual immunosuppressive regimen)
* Participant has recently received or is anticipated to require immune modulatory agents for their underlying disease including chemotherapeutic treatments likely to induce neutropenia (&lt;1.0 x 10 9 cells/µL) or lymphopenia (&lt;1.0 x 10 9 cells/µL)
* Participant has untreated advanced HIV (known CD4 &lt;200 in the past 6 months) AND is not established on antiretroviral therapy
* Pregnancy
* Breastfeeding
* Co-enrollment in other trials not predetermined to be compatible with this trial.
* In the investigator's judgment, the patient has any advanced organ dysfunction that would not make participation appropriate.
* The treating clinician expects inability to participate in trial procedures or participation would not be in the best interests of the patient.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Westmead Hospital (Site 612-058) - Westmead
Recruitment hospital [2] 0 0
Monash Health (612-009) - Clayton
Recruitment hospital [3] 0 0
Austin Health (612-020) - Heidelberg
Recruitment hospital [4] 0 0
The Alfred Hospital (612-017) - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
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United States of America
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Colorado
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kansas
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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Mississippi
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United States of America
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Missouri
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United States of America
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Nebraska
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United States of America
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New Hampshire
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United States of America
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New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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Tennessee
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Texas
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United States of America
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Utah
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United States of America
State/province [30] 0 0
Virginia
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United States of America
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Washington
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United States of America
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West Virginia
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United States of America
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Wisconsin
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Denmark
State/province [34] 0 0
C
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Denmark
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Aalborg
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Denmark
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Aarhus
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Denmark
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Copenhagen
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Denmark
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Hellerup
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Denmark
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Hillerød
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Denmark
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Hvidovre
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Georgia
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Tbilisi
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Germany
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Cologne
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Greece
State/province [43] 0 0
Attica
Country [44] 0 0
Greece
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Evros
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India
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Tamil Nadu
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Korea, Republic of
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Seongnam
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Korea, Republic of
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Seoul
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Poland
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Warsaw
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Spain
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Barcelona
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Thailand
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Bangkok
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Thailand
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Khon Kaen
Country [52] 0 0
Ukraine
State/province [52] 0 0
Ivano-Frankivs'k
Country [53] 0 0
Ukraine
State/province [53] 0 0
Kyiv
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Ukraine
State/province [54] 0 0
Zhytomyr

Funding & Sponsors
Primary sponsor type
Other
Name
University of Minnesota
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
COVID-19 can trigger a dysregulated immune response, and previous studies have shown that immune modulation can improve outcomes in hospitalized patients. This trial is designed to determine whether intensification of immune modulation early in the course of the disease (while patients are on low flow oxygen) with abatacept (active arm) combined with standard of care (SOC) improves recovery as compared with placebo + SOC (placebo arm). For both groups, intensification of immunomodulation will be provided as part of SOC in case of signs of disease progression (patient requires high flow nasal oxygen (HFNO) or more support) and/or if the patient has rapidly increasing oxygen requirement.
Trial website
https://clinicaltrials.gov/study/NCT05822583
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jens Lundgren, PhD
Address 0 0
University of Copenhagen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Cavan Reilly, PhD
Address 0 0
Country 0 0
Phone 0 0
612-624-9644
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05822583