A Multicenter, Adaptive, Randomized, Controlled Trial Platform to Evaluate Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory Infections: Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE) - Immune Modulation Strategy Trial

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 1520

Inclusion Criteria

Age =18 years, Informed consent for trial participation, Hospital admission (or boarding in an emergency department or other area awaiting hospital admission) with signs and/or symptoms of a respiratory infection, Confirmation of SARS-CoV2 infection by nucleic acid test (NAT) or equivalent non-NAT test collected within the prior 14 days, Requiring hospitalisantion for the management of COVID-19, Has evidence of COVID-19 pneumonia (PNA) defined as either: a.Receiving supplemental low flow oxygen, >0 L/min and =2 L/min, with evidence of airspace disease on chest imaging (X-ray, computer tomography or ultrasound). OR b.Receiving supplemental low flow oxygen, >2 L/min and <10 L/min, Currently receiving or planned to receive (ordered) one IM drug (for example, a corticosteroid or baricitinib, but NOT abatacept) 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 pre-COVID-19 level and all other study criteria are met., Investigator agrees that the pneumonia is due to COVID-19.

Exclusion Criteria

The patient is expected to be discharged from the hospital within the next 24 hours., Allergy to investigational agent., Neutropenia: absolute neutrophil count <1000 cells/µL (<1.0 x 103/µL or <1.0 x 109/L) on most recent lab within 2 calendar days of randomization, Lymphopenia: absolute lymphocyte count <200 cells/µL (<0.20 x 103/µL or <0.20 x 109/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)., 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: a.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.) b.Participant is receiving immune modulatory therapy for autoimmune, transplant management or another indication AND has one or more of the following: i.evidence of active infection (other than COVID-19) or ii.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 iii.has required intensification in immune modulatory therapy 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). c.Participant has recently received or is anticipated to require immune modulatory agents for their underlying disease including chemotherapeutic treatments likely to induce neutropenia or lymphopenia. d.Participant has untreated advanced HIV (known CD4 <200 cells/mm3 in the past 6 months) AND is not established on antiretroviral therapy., Pregnancy or intention to become pregnant within 60 days of randomization., Currently breastfeeding, Co-enrollment in other trials not predetermined to be compatible with this trial., Known estimated glomerular filtration rate (eGRF) <30 mL/min/1.73m**2, In the investigator’s judgment, the participant 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., Continuous renal replacement therapy or chronic dialysis, Current pregnancy, Current breastfeeding and unwillingness to defer breastfeeding for 30 days after the last dose of investigational agent., Women of child-bearing potential who are unwilling to abstain from sexual intercourse with men or practice appropriate contraception through 30 days from the last dose of the investiga

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

STRIVE Appendix E1: S-217622 (Ensitrelvir)

RecruitingPhase 3

Ohmagari Norio

Updated 4/1/2024