Phase 3
Completed N=342
Treatment of COVID-19 Patients With Anti-interleukin Drugs
Source: ClinicalTrials.gov NCT04330638 ↗Enrolled (actual)
342
Serious AEs
23.1%
Results posted
Mar 2023
Primary outcomePrimary: Time to Clinical Improvement — 12; 12; 11; 12 days
◆ Published Evidence
Highly cited
163citations · ~33 / year
Effect of anti-interleukin drugs in patients with COVID-19 and signs of cytokine release syndrome (COV-AID): a factorial, randomised, controlled trial.
Summary
The purpose of this study is to test the safety and effectiveness of individually or simultaneously blocking IL-6 and IL-1 versus standard of care on blood oxygenation and systemic cytokine release syndrome in patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure and systemic cytokine release syndrome
Linked Publications (4)
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Effect of anti-interleukin drugs in patients with COVID-19 and signs of cytokine release syndrome (COV-AID): a factorial, randomised, controlled trial.
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Treatment of severely ill COVID-19 patients with anti-interleukin drugs (COV-AID): A structured summary of a study protocol for a randomised controlled trial.
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Interleukin-1 blocking agents for treating COVID-19.
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Plasma Ferritin as Marker of Macrophage Activation-Like Syndrome in Critically Ill Patients With Community-Acquired Pneumonia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Clinical Improvement |
12; 12; 11; 12 | — |
| SECONDARY Time Untill Discharge |
14; 12; 12; 13 | — |
| SECONDARY Time Until Independence From Supplemental Oxygen or Discharge |
12; 12; 11; 12 | — |
| SECONDARY Time Until Independence From Invasive Ventilation |
21; 27; 23; 54 | — |
| SECONDARY Number of Days in ICU |
11; 10; 11; 10 | — |
| SECONDARY Number of Days in ICU in Patients Ventilated at Day of Randomization |
20; 22; 20; 22 | — |
| SECONDARY Number of Days Without Supplemental Oxygen Use |
9; 9; 10; 8 | — |
| SECONDARY Number of Invasive Ventilator Days |
5; 5; 5; 5 | — |
| SECONDARY Number of Invasive Ventilator Days in Patients Ventilated at Day of Randomization |
15; 16; 15; 16 | — |
| SECONDARY Number of Invasive Ventilator-free Days |
18; 18; 18; 17 | — |
| SECONDARY Number of Invasive Ventilator-free Days in Patients Ventilated at Day of Randomization |
6; 6; 7; 5 | — |
| SECONDARY Percentage of Days in ICU |
42; 36; 38; 40 | — |
| SECONDARY Percentage of Invasive Ventilator Days |
23; 21; 21; 23 | — |
| SECONDARY Time Until First Use of High-flow Oxygen Device, Ventilation, or Death |
NA; NA; NA; NA | — |
Eligibility Criteria
Inclusion Criteria
- Recent ( ≥ 6 days of flu-like symptoms or malaise yet ≤16 days of flu-like symptoms or malaise prior to randomization) infection with COVID-19.
- Confident COVID-19 diagnosis confirmed by antigen detection test and/or PCR and/or positive serology, or any emerging and validated diagnostic laboratory test for COVID-19 within this period.
- In some patients, it may be impossible to get a confident laboratory confirmation of COVID-19 diagnosis after 24h of hospital admission because viral load is low and/or problems with diagnostic sensitivity. In those cases, in absence of an alternative diagnosis, and with highly suspect bilateral ground glass opacities on recent ( 1000 mcg/L and rising since last 24h
- single ferritin above 2000 mcg/L in patients requiring immediate high flow oxygen device or mechanical ventilation
- lymphopenia defined as 700 mcg/L and rising since last 24h
- increased LDH (above 300 IU/L) and rising last 24h
- D-Dimers > 1000 ng/mL and rising since last 24h
- CRP above 70mg/L and rising since last 24h and absence of bacterial infection
- if three of the above are present at admission, no need to document 24h rise
- Chest X-ray or CT scan showing bilateral infiltrates within last 2 days
- Admitted to specialized COVID-19 ward or an ICU ward taking care of COVID-19 patients
- Age ≥ 18yrs
- Male or Female
- Willing and able to provide informed consent or legal representative willing to provide informed consent
Exclusion Criteria
- Patients with known history of serious allergic reactions, including anaphylaxis, to any of the study medications, or any component of the product.
- mechanical ventilation > 24 h at Randomization
- Patient on ECMO at time of screening
- clinical frailty scale above 3 (This frailty score is the patient status before first symptoms of COVID-19 episode.)
- active bacterial or fungal infection
- unlikely to survive beyond 48h
- neutrophil count below 1500 cells/microliter
- platelets below 50.000/microliter
- Patients enrolled in another investigational drug study
- patients on high dose systemic steroids (> 20 mg methylprednisolone or equivalent) for COVID-19 unrelated disorder
- patients on immunosuppressant or immunomodulatory drugs
- patients on current anti-IL1 or anti-IL6 treatment
- signs of active tuberculosis
- serum transaminase levels >5 times upper limit of normal
- bowel perforation or diverticulitis
- pregnant or breastfeeding females (all female subjects deemed of childbearing potential by the investigator must have negative pregnancy test at screening)
- Women of childbearing potential must have a negative serum pregnancy test pre-dose on day 1. Woùmen of childbearing potential must consistently and correctly use (during the entire treatment period and 3 months after last reatment) 1 highly effective method for contraception.
Data sourced from ClinicalTrials.gov (NCT04330638) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.