Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Immune Modulation Strategy Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 29 April 2024
• Main ID: NCT05822583
• Date of registration: 04/02/2023
• Prospective Registration: Yes
• Primary sponsor: University of Minnesota
• 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
• Date of first enrolment: July 6, 2023
• Target sample size: 1500
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT05822583
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 4

Countries of recruitment

Australia, Denmark, Georgia, Germany, Korea, Republic of, Spain, Ukraine, United States

Contacts

• Name: Cavan Reilly, PhD
• Affiliation: University of Minnesota

• Name: Jens Lundgren, PhD
• Affiliation: University of Copenhagen

• Name: Cavan Reilly, PhD

Key inclusion & exclusion criteria

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.

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 (<1.0 x 10 9 cells/µL) or lymphopenia (<1.0 x 10 9 cells/µL)

- Participant has untreated advanced HIV (known CD4 <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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

COVID-19

Intervention(s)

Drug: Placebo group

Drug: abatacept infusion

Primary Outcome(s)

Days to Recovery Scale [Time Frame: 60 days post-intervention]

Secondary Outcome(s)

time to sustained recovery though Day 60 [Time Frame: baseline to day 60]

the pulmonary ordinal outcome [Time Frame: Day 5, 14, and 28]

time to progression [Time Frame: baseline to day 60]

all-cause mortality though Day 60 [Time Frame: baseline to day 60]

Three-category ordinal outcome [Time Frame: Day 60]

Secondary ID(s)

STRIVE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors