COVIDPhase 2FORCENCT04371367
Avdoralimab an Anti-C5aR Antibody, in Patients With COVID-19 Severe Pneumonia ( FORCE )
A Phase 2 study testing avdoralimab in people with COVID, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The primary objective of this trial is to improve the proportion of COVID-19 patients with severe pneumonia who no longer need to be hospitalized, and to reduce the need for and duration of mechanical ventilation in patients with COVID-19 pneumonia complicated by acute respiratory distress syndrome (ARDS). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID
- What is being tested?
- avdoralimab
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2020to 30 Mar 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COVID-19 severe pneumonia patients need for oxygen therapy ≥ 5 l/min or high-flow oxygen therapy
- COVID-19 related Acute Respiratory Distress Syndrome (ARDS) requiring mechanical ventilation
Who cannot join
- Pregnant woman
- Uncontrolled sepsis of bacterial or fungal origin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized Study Versus Placebo of Avdoralimab (IPH5401), an Anti-C5aR Antibody, in Patients With COVID-19 Severe Pneumonia
The primary objective of this trial is to improve the proportion of COVID-19 patients with severe pneumonia who no longer need to be hospitalized, and to reduce the need for and duration of mechanical ventilation in patients with COVID-19 pneumonia complicated by acute respiratory distress syndrome (ARDS).
- Conditions
- COVID
- Being tested
- avdoralimab, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
avdoralimabBiological
Also called IPH5401
intravenous administration of avdoralimab
PlaceboOther
intravenous administration of placebo
| Study group | Role | What they receive |
|---|---|---|
| avdoralimab | Experimental | Biological/Vaccine: avdoralimab intravenous administration of avdoralimab
Other Names:
• IPH5401 Receives: Biological: avdoralimab |
| Placebo | Placebo comparator | intravenous administration of Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement using WHO ordinal scale
improvement of WHO ordinal scale
Measured: day 28
Number of ventilator-free days at Day 28 (VFD28)
Number of days without mechanical ventilation at Day 28 for COVID-19 related Acute Respiratory Distress Syndrome (ARDS) Patients hospitalized in ICU
Measured: day 28
Secondary outcomes (1)
Number of participants with treatment-related adverse events
Measured: day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start27 Apr 2020
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Collaborators
- Innate Pharma
- Responsible party
- Sponsor
- Investigators
- Emilie Garrido-Pradalie, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371367
- Sponsor's protocol ID
- 2020-21
- Acronym
- FORCE
- Status last verified
- May 2021
- First submitted
- 29 Apr 2020
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carvelli J, Meziani F, Dellamonica J, Cordier PY, Allardet-Servent J, Fraisse M, Velly L, Barbar SD, Lehingue S, Guervilly C, Desgrouas M, Camou F, Piperoglou C, Vely F, Demaria O, Karakunnel J, Fares J, Batista L, Rotolo F, Viotti J, Boyer-Chammard A, Lacombe K, Le Dault E, Carles M, Schleinitz N, Vivier E; FOR COVID Elimination (FORCE) Study Group. Avdoralimab (Anti-C5aR1 mAb) Versus Placebo in Patients With Severe COVID-19: Results From a Randomized Controlled Trial (FOR COVID Elimination [FORCE]). Crit Care Med. 2022 Dec 1;50(12):1788-1798. doi: 10.1097/CCM.0000000000005683. Epub 2022 Oct 10.
PubMed 36218354Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized Study Versus Placebo of Avdoralimab (IPH5401), an Anti-C5aR Antibody, in Patients With COVID-19 Severe Pneumonia
- ClinicalTrials.gov ID
- NCT04371367
- Acronym / sponsor ID
- FORCE / 2020-21
- Conditions
- COVID
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Collaborators
- Innate Pharma
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this trial is to improve the proportion of COVID-19 patients with severe pneumonia who no longer need to be hospitalized, and to reduce the need for and duration of mechanical ventilation in patients with COVID-19 pneumonia complicated by acute respiratory distress syndrome (ARDS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| avdoralimab | Experimental | Biological: avdoralimabBiological/Vaccine: avdoralimab intravenous administration of avdoralimab Other Names: • IPH5401 |
| Placebo | Placebo comparator | Other: Placebointravenous administration of Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COVID-19 severe pneumonia patients need for oxygen therapy ≥ 5 l/min or high-flow oxygen therapy
- COVID-19 related Acute Respiratory Distress Syndrome (ARDS) requiring mechanical ventilation
Key exclusion criteria (2 listed)
- Pregnant woman
- Uncontrolled sepsis of bacterial or fungal origin
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 |
|---|---|---|
| avdoralimabAlso: IPH5401intravenous administration of avdoralimab | Biological | avdoralimab |
| Placebointravenous administration of placebo | Other | Placebo |
Primary outcome
Clinical improvement using WHO ordinal scale
Time frame: day 28
improvement of WHO ordinal scale
Number of ventilator-free days at Day 28 (VFD28)
Time frame: day 28
Number of days without mechanical ventilation at Day 28 for COVID-19 related Acute Respiratory Distress Syndrome (ARDS) Patients hospitalized in ICU
1 secondary outcome
Number of participants with treatment-related adverse events
Time frame: day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Derived from this study: PubMed 36218354Carvelli J, Meziani F, Dellamonica J, Cordier PY, Allardet-Servent J, Fraisse M, Velly L, Barbar SD, Lehingue S, Guervilly C, Desgrouas M, Camou F, Piperoglou C, Vely F, Demaria O, Karakunnel J, Fares J, Batista L, Rotolo F, Viotti J, Boyer-Chammard A, Lacombe K, Le Dault E, Carles M, Schleinitz N, Vivier E; FOR COVID Elimination (FORCE) Study Group. Avdoralimab (Anti-C5aR1 mAb) Versus Placebo in Patients With Severe COVID-19: Results From a Randomized Controlled Trial (FOR COVID Elimination [FORCE]). Crit Care Med. 2022 Dec 1;50(12):1788-1798. doi: 10.1097/CCM.0000000000005683. Epub 2022 Oct 10.
- Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
- Individual participant dataSharing planned: No
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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.
Emilie Garrido-Pradalie study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing avdoralimab in people with COVID, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 2 inclusion and 2 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 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical improvement using WHO ordinal scale (time frame: day 28). The study lists 2 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 NCT04371367, which also lists 2 linked publications.
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 27 May 2021.