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Study on Abatacept for Improving Recovery in Hospitalized COVID-19 Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for patients who are hospitalized with COVID-19, a respiratory infection caused by the coronavirus. The trial will evaluate the effectiveness of a medication called ORENCIA, which contains the active substance abatacept. This medication is given as a solution for infusion, meaning it is administered directly into the bloodstream through a vein. The study will also use a placebo, which is a substance with no active medication, to compare the effects of the treatment.

The purpose of the study is to determine if early administration of ORENCIA can improve the clinical recovery of patients with COVID-19 over a period of 60 days. Participants in the study will receive either the medication or a placebo shortly after being hospitalized. The trial will monitor their recovery process, focusing on how quickly they recover and their overall health status during the study period.

The study will track several outcomes, including the time it takes for patients to recover, their survival rate, and any need for additional medical support like mechanical ventilation. Safety will also be closely monitored by observing any serious side effects or adverse events that may occur during the trial. The goal is to gather information that could help improve treatment strategies for patients with COVID-19 in the future.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomisation

    After you have consented to join the trial, you will be assigned by a computer system to receive either the study medication or a matching placebo. the assignment is random and you will not know which one you receive.

  2. Step 2

    Administration of study medication

    If you are assigned to the active group, you will receive oreNCIA 1750 mg (abatacept) prepared as a solution for infusion. the medication is given by intravenous infusion, which means it is delivered into a vein using a small pump over a period of time. the dose is a single infusion administered early after randomisation.

    If you are assigned to the control group, you will receive normal saline in a volume that matches the active infusion. this is also given by intravenous infusion in the same manner.

  3. Step 3

    Monitoring during infusion

    While the infusion is being administered, clinical staff will observe you for any immediate reactions. vital signs such as heart rate, blood pressure, and breathing will be checked regularly.

  4. Step 4

    Post‑infusion observation

    After the infusion is completed, you will remain under observation for a short period. staff will continue to monitor for any delayed reactions or side effects.

  5. Step 5

    Daily clinical assessments

    Starting the day after infusion, you will be evaluated each day for up to 60 days. the assessment uses the days to recovery scale (drs‑60), which records whether you have recovered, remain unwell, or have experienced serious outcomes such as death.

    The daily assessment includes checks of your breathing, need for additional oxygen, and overall health status.

  6. Step 6

    Scheduled follow‑up visits

    In addition to daily assessments, you will have specific follow‑up visits (for example on day 7, day 14, day 30, and day 60). during these visits, staff will record any adverse events, review your recovery progress, and collect safety data.

  7. Step 7

    Final study completion

    On day 60, the trial period ends for you. a final evaluation will be performed to determine your recovery status and to document any outcomes that occurred during the study.

Who can join the trial?

10 criteria

  • Must be at least 18 years old.
  • Must provide informed consent, which means agreeing to participate in the study after understanding what it involves.
  • Must be admitted to the hospital or waiting for hospital admission with signs or symptoms of a respiratory infection, which affects breathing.
  • Must have a confirmed SARS-CoV2 infection (the virus that causes COVID-19) through a specific test done within the last 14 days.
  • Must need to be in the hospital for the treatment of COVID-19.
  • Must show signs of COVID-19 pneumonia, which is a lung infection, and meet one of the following conditions:
    • Receiving low flow oxygen (more than 0 liters per minute and up to 2 liters per minute) with evidence of lung disease on a chest image like an X-ray, CT scan, or ultrasound.
    • Receiving low flow oxygen (more than 2 liters per minute and less than 10 liters per minute).
    • Must be currently receiving or planning to receive one IM drug (a type of medication given by injection, like a corticosteroid or baricitinib, but not abatacept) as part of COVID-19 treatment before being randomly assigned to a group in the study.
    • Must have started using supplemental oxygen for COVID-19 treatment within the last 5 days. If already using oxygen at home, the oxygen flow rate must have increased from the level before COVID-19, and all other study criteria must be met.
    • The study investigator must agree that the pneumonia is caused by COVID-19.

Who cannot join the trial?

8 criteria

  • Patients who are not hospitalized cannot participate in the study.
  • Patients who do not have COVID-19 are excluded from the study.
  • Patients who are not adults are excluded from the study. This means the study is only for people who are 18 years or older.
  • Patients who are unable to give their consent to participate in the study are excluded. Consent means agreeing to take part in the study after understanding what it involves.
  • Patients who are pregnant or breastfeeding are excluded from the study.
  • Patients who have a known allergy or severe reaction to any of the study medications are excluded.
  • Patients who are participating in another clinical trial at the same time are excluded.
  • Patients who have a medical condition that the study doctors believe would make it unsafe for them to participate are excluded.
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Investigated drugs

Immune Modulation Strategy is being tested to see if it can help improve recovery in patients with respiratory infections, like COVID-19. This strategy involves using medications that can help regulate the immune system, potentially reducing the severity of the infection and aiding in faster recovery. The trial aims to determine if adding a second immune-modulating treatment early in the hospital stay can lead to better outcomes for patients.

What is already known about the treatment

Remdesivir – Remdesivir is administered intravenously, typically in a hospital setting, for the treatment of COVID-19. It is currently approved for use in many countries and is widely discussed in medical literature as a treatment option for COVID-19. The main therapeutic indication for Remdesivir is the treatment of COVID-19 in hospitalized patients. At the molecular level, Remdesivir works by inhibiting the replication of the virus that causes COVID-19, thereby reducing the viral load in the body. It is classified as an antiviral medication.

Investigated diseases

COVID-19 – COVID-19 is a contagious disease caused by the SARS-CoV-2 virus. It primarily affects the respiratory system, leading to symptoms such as fever, cough, and difficulty breathing. The disease can progress to severe respiratory distress, especially in older adults and those with underlying health conditions. In some cases, it may cause complications like pneumonia, acute respiratory distress syndrome, and multi-organ failure. The virus spreads mainly through respiratory droplets from coughs, sneezes, or talking. The progression and severity of symptoms can vary widely among individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504487-41-00Protocol codeINSIGHT 018BEstimated enrolment1 545 patientsSponsorUniversity Of Minnesota

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