A Multicenter study to assess whether early administration of Immune Modulators in hospitalized patients with COVID-19 improves clinical recovery compared with early administration of placebo.

INSIGHT Protocol Number 018 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 and Viral Emergencies STRIVE. - STRIVE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/076792

Enrollment

1500

Registered

2024-11-14

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J989- Respiratory disorder, unspecified

Interventions

Intervention1: Abatacept: 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 Control Intervention1: Normal Saline: IV infusion of normal saline

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age =18 years. 2. Informed consent for trial participation. 3. Hospital admission (or boarding in an emergency department or other area awaiting hospital admission) with signs and/or symptoms of a respiratory infection. 4. Confirmation of SARS-CoV2 infection by nucleic acid test (NAT) or equivalent non-NAT test [list of approved tests in the PIM] collected within 14 days of randomization. 5. Requiring hospitalization for the management of COVID-19.

Exclusion criteria

Exclusion criteria: 1. The patient is expected to be discharged from the hospital within the next 24 hours. 2. Medical condition other than the acute respiratory infection (and its manifestations) that is likely to result in death within 7 days of randomization. 3. Moribund condition, defined as prior cardiac arrest during this hospitalization and life expectancy less than 48 hours of randomization. 4. Patient undergoing comfort care measures only such that treatment focuses on end-of-life symptom management over prolongation of life. 5. Expected inability or unwillingness to participate in study procedures. 6. In the opinion of the investigator, participation in a trial is not in the best interest of the patient.

Design outcomes

Primary

Measure	Time frame
1) All-cause mortality 2) Time to sustained recovery 3) Clinical Recovery Scale (CRS)Timepoint: 60 days after randomization	—

Secondary

Measure	Time frame
1.Time to discharge from the initial hospitalization 2. Days alive and at home through the end of follow-upTimepoint: Day 14, 28 and 60	—

Countries

India, South Africa, Spain, Thailand, Uganda, Ukraine

Contacts

Public ContactNagalingeswaran Kumarasamy

Voluntary Health Services Infectious Diseases Medical Centre

kumarasamy@cartcrs.org9176912007

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026