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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Bispebjerg Hospital Copenhagen Denmark
Hospital Clinico San Carlos Madrid Spain
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Evangelismos S.A. Athens Greece
Centre Hospitalier De Tourcoing Tourcoing France
Karolinska University Hospital Solna Sweden
University Hospital Galway Galway Ireland
Lillebaelt Hospital Kolding Denmark
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Assistance Publique Hopitaux De Paris Paris France
Centre Hospitalier Universitaire De Toulouse Toulouse France
Hospital Clinic De Barcelona Barcelona Spain
Aalborg University Hospital Aalborg Denmark
University General Hospital Of Alexandroupoli Alexandroupoli Greece
Rigshospitalet Copenhagen Denmark
Gentofte Hospital Hellerup Denmark
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Del Mar Barcelona Spain
Samodzielny Publiczny Wojewodzki Szpital Zespolony W Szczecinie Szczecin Poland
Wojewodzki Szpital Zakazny W Warszawie SPZOZ Warsaw Poland
Odense University Hospital Odense Denmark
Thoracic General Hospital Of Athens I Sotiria Athens Greece
Zealand University Hospital Koege Denmark
Nordsjaellands Hospital Hillerød Denmark
Cqex Utaxqvfnrq Hoficmzp Cork Ireland
Sudhf Hkwdwx Ssxtkvvf Onvwzsttqtci Nicosia Cyprus
Lordt Gwxgvfa Hybihpwg Oe Aqgszh Athens Greece
Ukhytnymfw Hwqzoyqw Clbbobr Cologne Germany
Almmjqkrpf Pwpnauly Hapzyvzy Dw Pxzby Paris France
Aixehw Uemfvwxyep Hwbdjpbr Aarhus Denmark
Gkziac Uakrngqzgo Fcxfrehhr Frankfurt Germany
Sp Vxpiulcamqocbhm Uuqrbipwux Hhevemah Dublin Ireland
Hbrrpcjn Hyrisgic Hvidovre Denmark
Ukxmzlvdlm Hoddyljfk Phflx Skmqscevxch Cgbodkw Fhzi Paris France
Fehsskzfw Pvwe Li Icpfjlytxohjc Bselcmovp Dak Hexcwjfq Ulajafykqtzuc Lb Peu Madrid Spain
Hscyhwbk Uupviyvaouhko Hlxjujru Tofqm y Peeykx Ixtvapjo Cgldrs douemrwrsjfvmholg (nfoy Badalona Spain
Hzyhsyjh Vqib dhavszps Barcelona Spain
Ulshbxnqkw Gcelapm Htcnqtjh Aoqgdzg Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Cyprus Cyprus
Not recruiting
15.08.2023
Denmark Denmark
Not recruiting
15.08.2023
France France
Not recruiting
15.08.2023
Germany Germany
Not recruiting
15.08.2023
Greece Greece
Not recruiting
15.08.2023
Ireland Ireland
Not recruiting
15.08.2023
Poland Poland
Not recruiting
15.08.2023
Spain Spain
Not recruiting
15.08.2023
Sweden Sweden
Not recruiting
15.08.2023

Trial locations

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.

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 ID:
2023-504487-41-00
Protocol code:
INSIGHT 018B
NCT ID:
NCT05822583
Trial Phase:
Therapeutic confirmatory (Phase III)

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