COVIDPhase 2/3NCT04447469

Study of Mavrilimumab (KPL-301) in Participants Hospitalized With Severe Corona Virus Disease 2019 (COVID-19) Pneumonia and Hyper-inflammation

A Phase 2/3 study testing mavrilimumab in people with COVID, run by Kiniksa Pharmaceuticals International, plc at 32 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Interventional, randomized, double-blind, placebo-controlled study encompassing 2 development phases (Phase 2 and Phase 3). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID
What is being tested?: mavrilimumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 814 participants
Where: 32 sitesin 5 countries
Study dates: 28 Jul 2020to 14 Jan 2022
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject (or legally authorized representative) is able and willing to provide informed consent, which includes compliance with study requirements and restrictions listed in the consent form. Consent must be performed per institutional regulations.
Age of ≥ 18 years
Positive SARS-CoV-2 (2019-nCoV) test within 14 days prior to randomization
Hospitalized for SARS-CoV-2 (2019-nCoV)
Bilateral pneumonia on chest x-ray or computed tomography
Clinical laboratory results indicative of hyper-inflammation within 7 days prior to randomization
Cohort 1: Receiving any form of non-invasive ventilation OR oxygenation to maintain SpO2 ≥ 92% and non-mechanically ventilated (examples include nasal cannula, face mask, venturi mask, high-flow nasal cannula, or non-invasive positive pressure ventilation)
Cohort 2: Recently ventilated with mechanical ventilation beginning within 48 hours prior to randomization

Who cannot join

Onset of COVID-19 symptoms > 14 days prior to randomization
Hospitalized > 7 days prior to randomization
Need for invasive mechanical ventilation (Only for Cohort 1)
Need for ECMO
Serious prior or concomitant illness that in the opinion of the Investigator precludes the subject from enrolling in the trial
Recent treatment with cell-depleting biological therapies (eg, anti-CD20) within 12 months, non-cell-depleting biological therapies (such as anti-tumor necrosis factor [TNF], anakinra, anti-IL-6 receptor [eg, tocilizumab], or abatacept) within 8 weeks (or 5 half-lives, whichever is longer), treatment with alkylating agents within 12 weeks, treatment with cyclosporine A, azathioprine, cyclophosphamide, mycophenolate mofetil (MMF), or other immunosuppressant (except for corticosteroids) within 4 weeks prior to randomization. Medications that become standard of care for COVID-19 and/or receive emergency use authorization may be allowed after discussion with the medical monitor.

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If subject is receiving or has received hydroxychloroquine within 3 months prior to screening visit, a corrected QT interval by Federicia method (QTcF) on Screening electrocardiogram (ECG) ≥500ms is exclusionary. If subject has a pacemaker, this criterion does not apply.
Enrolled in another investigational study of a medical intervention within 30 days prior to randomization. Participation in open label trials involving investigational treatments for COVID-19 may be allowed upon approval by the Sponsor.
Life expectancy less than 48 hours, in the opinion of the Investigator
Known human immunodeficiency virus infection (regardless of immunological status), known hepatitis B virus surface antigen positivity and/or anti-hepatitis C virus positivity

Trial locations and contacts

32 sites in 5 countries.

Country

City, postcode or hospital

32 sites in 5 countries

Brazil11 sites

Hospital Adventista de Belem
Belém, 66093-904
Hospital Luxemburgo - Associação Mário Penna
Belo Horizonte, Minas Gerais, 30380-472
UPECLIN - Unidade de Pesquisa Clínica
Botucatu, São Paulo, 18618-686
IPECC - Instituto de Pesquisa Clínica de Campinas
Campinas, São Paulo, 13060-080
IEP HGF - Instituto de Estudos e Pesquisas Clinicas do Ceará
Fortaleza, 60192-340
Hospital Bruno Born
Lajeado, Rio Grande do Sul, 95900-000
CPCLIN - Centro de Pesquisas Clínicas
Natal, Rio Grande do Norte, 59025-050
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, 65470-000
Hospital Cardio Pulmonar
Salvador, Estado de Bahia, 40170-130
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José, 15090-000
Hospital Alemão Oswaldo Cruz
São Paulo, 01323-020

Other trials in Brazil

United States9 sites

Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Affinity Health
Chicago, Illinois, 60644
University of Cincinnati
Cincinnati, Ohio, 45229
University of Texas Health Sciences
Houston, Texas, 77030
UCLA Medical Center
Los Angeles, California, 90095
Allina Health System
Minneapolis, Minnesota, 55407
Tulane University School of Medicine
New Orleans, Louisiana, 70112
SHARP Health Care
San Diego, California, 92110
Mercy Clinic Hospitalists
Springfield, Missouri, 65804

Other trials in United States

South Africa6 sites

IATROS International
Bloemfontein, 9301
University of Cape Town - Lung Institute
Cape Town, Western Cape, 7700
Tiervlei Trial Center
Cape Town, 7530
TASK Eden
George, 6529
Into Research - Little Company of Mary Medical Center
Pretoria, 0181
Limpopo Clinical Research Initiative
Rustenburg, 0299

Other trials in South Africa

Peru4 sites

Hospital Nacional Alberto Sabogal Sologuren
Bellavista, 07011
Essalud - Hospital de Emergencias Grau
Lima Cercado, 15082
Hospital Nacional Cayetano Heredia
San Martín de Porres, 15102
Clinica Providencia
San Miguel, 15088

Other trials in Peru

Chile2 sites

Clinica Las Condes
Santiago, 7550000
Hospital Clinico Universidad de Chile
Santiago, 8380456

Other trials in Chile

About this study

Official title: A Phase 2/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Mavrilimumab (KPL-301) Treatment in Adult Subjects Hospitalized With Severe COVID-19 Pneumonia and Hyper-inflammation

Interventional, randomized, double-blind, placebo-controlled study encompassing 2 development phases (Phase 2 and Phase 3).

Read the detailed description

The Phase 2 portion of the study will evaluate the efficacy and safety of 2 dose levels of mavrilimumab relative to placebo (standard of care) in participants who have tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with x-ray/computed tomography (CT) evidence of bilateral pneumonia and active or recent signs of hyperinflammation (fever or clinical laboratory results indicative of hyper-inflammation). The Phase 3 portion is intended to confirm Phase 2 efficacy and safety findings. In both Phase 2 and Phase 3, participants will be enrolled into 2 cohorts: Cohort 1 will include non-mechanically ventilated, hospitalized participants who require supplemental oxygen to maintain oxygen saturation (SpO2) ≥ 92% (ie, "non-mechanically ventilated" participants); Cohort 2 will include hospitalized participants for whom mechanical ventilation was recently initiated (ie, "mechanically ventilated" participants). Following Screening, enrolled participants in each cohort will be randomized 1:1:1 to receive one of 2 mavrilimumab dose levels, or placebo as a single intravenous (IV) infusion (Day 1). Participants will undergo primary study assessments through Day 29 and will be followed for safety through Day 90.

Conditions: COVID
Being tested: mavrilimumab, Placebo
Keywords: COVID-19, pneumonia, hyper-inflammation
Medical subject headings: COVID-19, Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

mavrilimumabDrug
Also called KPL-301, CAM3001
anti-granulocyte-macrophage colony-stimulating factor receptor alpha (GM-CSF-Rα) monoclonal antibody (human isoform immunoglobulin G [IgG4])
PlaceboOther
matching placebo

Study groups in NCT04447469
Study group	Role	What they receive
10 mg/kg (Cohort 1)	Active comparator	Non-mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion Receives: Drug: mavrilimumab
6 mg/kg (Cohort 1)	Active comparator	Non-mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion Receives: Drug: mavrilimumab
Placebo (Cohort 1)	Placebo comparator	Non-mechanically ventilated participants administered placebo as a single IV infusion Receives: Other: Placebo
10 mg/kg (Cohort 2)	Active comparator	Mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion Receives: Drug: mavrilimumab
6 mg/kg (Cohort 2)	Active comparator	Mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion Receives: Drug: mavrilimumab
Placebo (Cohort 2)	Placebo comparator	Mechanically ventilated participants administered placebo as a single IV infusion Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Cohort 1, Phase 2: Percentage of Participants Alive and Free of Mechanical Ventilation at Day 29
Mechanical ventilation is defined as invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Mechanical ventilation status was evaluated based on the National Institute of Allergy and Infectious Diseases (NIAID) clinical outcome 8-point ordinal scale. Participants whose clinical outcome met a NIAID score of 2 were considered as using mechanical ventilation.
The NIAID score is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.
Measured: Day 29
Cohort 1, Phase 3: Percentage of Participants Alive and Free of Mechanical Ventilation at Day 29
Mechanical ventilation is defined as invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Mechanical ventilation status was evaluated based on the National Institute of Allergy and Infectious Diseases (NIAID) clinical outcome 8-point ordinal scale. Participants whose clinical outcome met a NIAID score of 2 were considered as using mechanical ventilation.
The NIAID score is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.
Measured: Day 29
Cohort 2, Phase 2: Percentage of Participants Who Died by Day 29
Defined as the proportion of subjects with mechanical ventilation who have died by Day 29.
Measured: Day 29
Cohort 2, Phase 3: Percentage of Participants Who Died by Day 29
Defined as the proportion of subjects with mechanical ventilation who have died by Day 29.
Measured: Day 29

Secondary outcomes (8)

Cohort 1, Phase 2: Time to 2-point Clinical Improvement by Day 29
Defined as time from randomization to a 2-point improvement on the NIAID 8-point ordinal scale, or discharge from the hospital, whichever came first. Participants who died before Day 29 were censored at Day 30. Kaplan-Meier method used to estimate the survival functions for each treatment arm.
The NIAID score is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.
Measured: Day 29
Phase 2, Cohort 1: Time to Return to Room Air or Discharge by Day 29
Defined as time from randomization to breathing room air (NIAID score ≥ 5), or discharge from the hospital, whichever came first. Participants who died before Day 29 were censored at Day 30.
Measured: Day 29
Phase 2, Cohort 1: Percentage of Participants Who Die by Day 29
95% CI were calculated using Clopper-Pearson exact method based on the beta distribution.
Measured: Day 29
Phase 2, Cohort 2: Time to 1-Point Clinical Improvement by Day 29
Defined as time from randomization to the date of a 1-point improvement on the NIAID score 8-point ordinal scale or discharge from the hospital, whichever occurred first, by Day 29. Participants who did not have 1-point improvement on the NIAID nor discharge from the hospital were censored at the date of the last NIAID 8-point ordinal scale assessment on/before Day 29. Participants who died were censored at Day 32.
Measured: Day 29
Phase 3, Cohort 1: Percentage of Participants Who Died at Day 29
Mortality rate at day 29 is the proportion of subjects who die by day 29. 95% CI were calculated using Clopper-Pearson exact method based on the beta distribution.
Measured: Day 29
Phase 3, Cohort 1: Ventilation-Free Survival (Time to Ventilation or Death) by Day 29
Time to ventilation or death by Day 29 was defined as time (in days) from randomization to the date of death or start date of using mechanical ventilation (NIAID score ≤ 2) by Day 29. Participants who never had NIAID score ≤ 2 by Day 29 were censored at last assessment date of NIAID 8-point ordinal scale.
Measured: Day 29
Phase 3, Cohort 1: Overall Survival by Day 29
Overall survival was defined as time from randomization to the date of death on/before Day 29. Participants who did not have a death record by Day 29 were censored at last date known alive on/before Day 29.
Measured: Day 29
Phase 3, Cohort 2: Time to 1-point Clinical Improvement by Day 29
Defined as time from randomization to the date of a 1-point improvement on the NIAID 8-point ordinal scale or discharge from the hospital, whichever occurred first, by Day 29. Participants who did not have 1-point improvement on the NIAID nor discharge from the hospital were censored at the date of the last NIAID 8-point ordinal scale assessment on/before Day 29. Participants who died were censored at Day 35.
Measured: Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jul 202014 Jan 2022

First posted25 Jun 2020
Study start28 Jul 2020
Primary completion12 Nov 2021
Study completion14 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COVIDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 814 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04447469
Sponsor's protocol ID: KPL-301-C203
Status last verified: Dec 2024
First submitted: 23 Jun 2020
Last updated: 22 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: The Sponsor will review IPD requests proposals from qualified researchers

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Mavrilimumab (KPL-301) Treatment in Adult Subjects Hospitalized With Severe COVID-19 Pneumonia and Hyper-inflammation
ClinicalTrials.gov ID: NCT04447469
Acronym / sponsor ID: KPL-301-C203
Conditions: COVID
Keywords: COVID-19, pneumonia, hyper-inflammation
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 814 participants (actual)
Lead sponsor: Kiniksa Pharmaceuticals International, plcIndustry (pharma, biotech, devices)
Collaborators: Kiniksa Pharmaceuticals, Ltd.
Study start: 28 Jul 2020 (actual)
Primary completion: 12 Nov 2021 (actual)
Study completion: 14 Jan 2022 (actual)
First posted: 25 Jun 2020 (actual)
Results: Posted 22 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Interventional, randomized, double-blind, placebo-controlled study encompassing 2 development phases (Phase 2 and Phase 3).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
10 mg/kg (Cohort 1)	Active comparator	Drug: mavrilimumabNon-mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion
6 mg/kg (Cohort 1)	Active comparator	Drug: mavrilimumabNon-mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion
Placebo (Cohort 1)	Placebo comparator	Other: PlaceboNon-mechanically ventilated participants administered placebo as a single IV infusion
10 mg/kg (Cohort 2)	Active comparator	Drug: mavrilimumabMechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion
6 mg/kg (Cohort 2)	Active comparator	Drug: mavrilimumabMechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion
Placebo (Cohort 2)	Placebo comparator	Other: PlaceboMechanically ventilated participants administered placebo as a single IV infusion

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Subject (or legally authorized representative) is able and willing to provide informed consent, which includes compliance with study requirements and restrictions listed in the consent form. Consent must be performed per institutional regulations.
Age of ≥ 18 years
Positive SARS-CoV-2 (2019-nCoV) test within 14 days prior to randomization
Hospitalized for SARS-CoV-2 (2019-nCoV)
Bilateral pneumonia on chest x-ray or computed tomography

Key exclusion criteria (10 listed)

Onset of COVID-19 symptoms > 14 days prior to randomization
Hospitalized > 7 days prior to randomization
Need for invasive mechanical ventilation (Only for Cohort 1)
Need for ECMO
Serious prior or concomitant illness that in the opinion of the Investigator precludes the subject from enrolling in the trial

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
mavrilimumabAlso: KPL-301, CAM3001anti-granulocyte-macrophage colony-stimulating factor receptor alpha (GM-CSF-Rα) monoclonal antibody (human isoform immunoglobulin G [IgG4])	Drug	10 mg/kg (Cohort 1), 10 mg/kg (Cohort 2), 6 mg/kg (Cohort 1), 6 mg/kg (Cohort 2)
Placebomatching placebo	Other	Placebo (Cohort 1), Placebo (Cohort 2)

Primary outcome

Cohort 1, Phase 2: Percentage of Participants Alive and Free of Mechanical Ventilation at Day 29
Time frame: Day 29
Mechanical ventilation is defined as invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Mechanical ventilation status was evaluated based on the National Institute of Allergy and Infectious Diseases (NIAID) clinical outcome 8-point ordinal scale. Participants whose clinical outcome met a NIAID score of 2 were considered as using mechanical ventilation. The NIAID score is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.
Cohort 1, Phase 3: Percentage of Participants Alive and Free of Mechanical Ventilation at Day 29
Time frame: Day 29
Mechanical ventilation is defined as invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Mechanical ventilation status was evaluated based on the National Institute of Allergy and Infectious Diseases (NIAID) clinical outcome 8-point ordinal scale. Participants whose clinical outcome met a NIAID score of 2 were considered as using mechanical ventilation. The NIAID score is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.
Cohort 2, Phase 2: Percentage of Participants Who Died by Day 29
Time frame: Day 29
Defined as the proportion of subjects with mechanical ventilation who have died by Day 29.
Cohort 2, Phase 3: Percentage of Participants Who Died by Day 29
Time frame: Day 29
Defined as the proportion of subjects with mechanical ventilation who have died by Day 29.

8 secondary outcomes

Cohort 1, Phase 2: Time to 2-point Clinical Improvement by Day 29
Time frame: Day 29
Phase 2, Cohort 1: Time to Return to Room Air or Discharge by Day 29
Time frame: Day 29
Phase 2, Cohort 1: Percentage of Participants Who Die by Day 29
Time frame: Day 29
Phase 2, Cohort 2: Time to 1-Point Clinical Improvement by Day 29
Time frame: Day 29
Phase 3, Cohort 1: Percentage of Participants Who Died at Day 29
Time frame: Day 29
Phase 3, Cohort 1: Ventilation-Free Survival (Time to Ventilation or Death) by Day 29
Time frame: Day 29
Phase 3, Cohort 1: Overall Survival by Day 29
Time frame: Day 29
Phase 3, Cohort 2: Time to 1-point Clinical Improvement by Day 29
Time frame: Day 29

Results and safety

Results posted to the registry on 22 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 2: 10 mg/kg (Cohort 1)	37	29
Phase 2: 6 mg/kg (Cohort 1)	42	32
Phase 2: Placebo (Cohort 1)	41	28
Phase 2: 10 mg/kg (Cohort 2)	18	7
Phase 2: 6 mg/kg (Cohort 2)	15	6
Phase 2: Placebo (Cohort 2)	17	7
Phase 3: 10 mg/kg (Cohort 1)	198	162
Phase 3: 6 mg/kg (Cohort 1)	192	154
Phase 3: Placebo (Cohort 1)	192	150
Phase 3: 10 mg/kg (Cohort 2)	20	9
Phase 3: 6 mg/kg (Cohort 2)	22	12
Phase 3: Placebo (Cohort 2)	20	7

Primary outcome: Cohort 1, Phase 2: Percentage of Participants Alive and Free of Mechanical Ventilation at Day 29

Time frame: Day 29. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Phase 2: 10 mg/kg (Cohort 1) n = 35	Phase 2: 6 mg/kg (Cohort 1) n = 40	Phase 2: Placebo (Cohort 1) n = 39
Value	85.7 (69.7 to 95.2)	87.5 (73.2 to 95.8)	74.4 (57.9 to 87.0)

Phase 2: 10 mg/kg (Cohort 1) vs Phase 2: Placebo (Cohort 1): Odds Ratio (OR): 2.069 (95% CI 0.555 to 8.615), p = 0.2598, Fisher Exact
Phase 2: 6 mg/kg (Cohort 1) vs Phase 2: Placebo (Cohort 1): Odds Ratio (OR): 2.414 (95% CI 0.653 to 9.957), p = 0.1610, Fisher Exact
Phase 2: 10 mg/kg (Cohort 1) vs Phase 2: Placebo (Cohort 1): Stratified Odds Ratio: 2.091 (95% CI 0.612 to 7.144), p = 0.2448, Cochran-Mantel-Haenszel

Population analysed: Phase 2: Modified Intent-to-Treat (mITT) Analysis Set: All randomized participants who passed screening and received study drug (two enrolled and treated participants \[1 each in the 6 mg/kg and placebo groups\] were randomized and dosed in violation of inclusion/exclusion criteria and were thus excluded from this Set).

Primary outcome: Cohort 1, Phase 3: Percentage of Participants Alive and Free of Mechanical Ventilation at Day 29

Time frame: Day 29. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Phase 3: 10 mg/kg (Cohort 1) n = 198	Phase 3: 6 mg/kg (Cohort 1) n = 192	Phase 3: Placebo (Cohort 1) n = 192
Value	84.3 (78.5 to 89.1)	82.8 (76.7 to 87.9)	81.3 (75.0 to 86.5)

Phase 3: 10 mg/kg (Cohort 1) vs Phase 3: Placebo (Cohort 1): Stratified Odds Ratio: 1.231 (95% CI 0.715 to 2.120), p = 0.4534, Cochran-Mantel-Haenszel
Phase 3: 6 mg/kg (Cohort 1) vs Phase 3: Placebo (Cohort 1): Stratified Odds Ratio: 1.097 (95% CI 0.636 to 1.891), p = 0.7414, Cochran-Mantel-Haenszel

Population analysed: Phase 3: Intent-to-Treat (ITT) Analysis Set: All randomized participants.

Primary outcome: Cohort 2, Phase 2: Percentage of Participants Who Died by Day 29

Time frame: Day 29. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Phase 2: 10 mg/kg (Cohort 2) n = 15	Phase 2: 6 mg/kg (Cohort 2) n = 15	Phase 2: Placebo (Cohort 2) n = 17
Value	46.7 (21.3 to 73.4)	53.3 (26.6 to 78.7)	47.1 (23.0 to 72.2)

Phase 2: 10 mg/kg (Cohort 2) vs Phase 2: Placebo (Cohort 2): Odds Ratio (OR): 0.984 (95% CI 0.198 to 4.884), p = 1.0000, Fisher Exact
Phase 2: 6 mg/kg (Cohort 2) vs Phase 2: Placebo (Cohort 2): Odds Ratio (OR): 1.286 (95% CI 0.260 to 6.417), p = 1.0000, Fisher Exact

Primary outcome: Cohort 2, Phase 3: Percentage of Participants Who Died by Day 29

Time frame: Day 29. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Phase 3: 10 mg/kg (Cohort 2) n = 20	Phase 3: 6 mg/kg (Cohort 2) n = 22	Phase 3: Placebo (Cohort 2) n = 20
Value	40.0 (19.1 to 63.9)	27.3 (10.7 to 50.2)	55.0 (31.5 to 76.9)

Phase 3: 10 mg/kg (Cohort 2) vs Phase 3: Placebo (Cohort 2): Difference in Proportion: -15.0 (95% CI -45.6 to 15.6)
Phase 3: 6 mg/kg (Cohort 2) vs Phase 3: Placebo (Cohort 2): Difference in Proportions: -27.7 (95% CI -56.4 to 0.9)

Population analysed: Phase 3: Intent-to-Treat (ITT) Analysis Set: All randomized participants.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment (all-cause mortality) or first dose of study drug (adverse events) to the end of study; the maximum study duration was 44 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 2: 10 mg/kg (Cohort 1)	5 of 35 (14.3%)	19 of 35 (54.3%)	4 of 35
Phase 2: 6 mg/kg (Cohort 1)	7 of 41 (17.1%)	18 of 41 (43.9%)	5 of 41
Phase 2: Placebo (Cohort 1)	13 of 40 (32.5%)	23 of 40 (57.5%)	9 of 40
Phase 2: 10 mg/kg (Cohort 2)	10 of 15 (66.7%)	11 of 15 (73.3%)	7 of 15
Phase 2: 6 mg/kg (Cohort 2)	12 of 15 (80%)	12 of 15 (80%)	9 of 15
Phase 2: Placebo (Cohort 2)	10 of 17 (58.8%)	14 of 17 (82.4%)	9 of 17
Phase 3: 10 mg/kg (Cohort 1)	48 of 195 (24.6%)	90 of 195 (46.2%)	20 of 195
Phase 3: 6 mg/kg (Cohort 1)	49 of 188 (26.1%)	86 of 188 (45.7%)	30 of 188
Phase 3: Placebo (Cohort 1)	43 of 191 (22.5%)	83 of 191 (43.5%)	30 of 191
Phase 3: 10 mg/kg (Cohort 2)	13 of 20 (65%)	12 of 20 (60%)	7 of 20
Phase 3: 6 mg/kg (Cohort 2)	14 of 21 (66.7%)	13 of 21 (61.9%)	8 of 21
Phase 3: Placebo (Cohort 2)	15 of 20 (75%)	17 of 20 (85%)	12 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. The Sponsor will review IPD requests proposals from qualified researchers

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

32 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing mavrilimumab in people with COVID, run by Kiniksa Pharmaceuticals International, plc at 32 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Brazil, United States, South Africa, Peru, Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort 1, Phase 2: Percentage of Participants Alive and Free of Mechanical Ventilation at Day 29 (time frame: Day 29). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04447469.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.