COVID-19 PneumoniaPhase 2NCT04412057

Clinical Trial to Evaluate CERC-002 in Adults With COVID-19 Pneumonia and Acute Lung Injury

A Phase 2 study testing CERC-002 in people with COVID-19 Pneumonia and Acute Lung Injury, run by Aevi Genomic Medicine, LLC, a Cerecor company at 11 sites in United States.

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

The study is a prospective, randomized, placebo-controlled, double-blind phase 2 clinical study of the efficacy and safety of CERC-002, a potent inhibitor of LIGHT (Lymphotoxin-like, exhibits Inducible expression, and competes with Herpes Virus Glycoprotein D for Herpesvirus Entry Mediator, a receptor expressed by T… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19 Pneumonia, Acute Lung Injury, ARDS
What is being tested?: CERC-002
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 88 participants
Where: 11 sitesUnited States
Study dates: 17 Jul 2020to 19 Jan 2021
Phase: Phase 2
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/legally authorized representative (LAR) is able to understand and provide written informed consent, and assent (as applicable) to participate in this study.
Subject is ≥18 years of age at the time of informed consent and assent (as applicable).
Subject is male or non-pregnant, non-lactating female, who if of childbearing potential agrees to comply with any applicable contraceptive requirements if. discharged from the hospital prior to completing the study.
Subject has a diagnosis of COVID-19 infection through an approved testing method.
Subject has been hospitalized due to clinical diagnosis of pneumonia with acute lung injury defined as diffuse bilateral radiographic infiltrates with partial pressure of arterial oxygen/percentage of inspired oxygen (PaO2/FiO2) >100 and <300.
Subject's oxygen saturation at rest in ambient air <93%

Who cannot join

Subject is intubated.
Subject is currently taking immunomodulators or anti-rejection drugs.
Subject has been administered an immunomodulating biologic drug within 60 days of baseline.
Subject is in septic shock defined as persistent hypotension requiring vasopressors to maintain mean arterial pressure (MAP) of 65 mm Hg or higher and a serum lactate level greater than 2 mmol/L (18 mg/dL) despite adequate volume resuscitation.
Subject has received any live attenuated vaccine, such as varicella-zoster, oral polio, or rubella, within 3 months prior to the baseline visit.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

AnMed Health Medical Center
Anderson, South Carolina, 29621
Lowcountry Infectious Diseases, P.A.
Charleston, South Carolina, 29414
Carolina Institute for Clinical Research, LLC
Fayetteville, North Carolina, 28304
Parkview Research Center
Fort Wayne, Indiana, 46845
Midway Immunology and Research Center
Ft. Pierce, Florida, 34982
BRCR Global Texas
McAllen, Texas, 78503
MedPharmics, LLC
Metairie, Louisiana, 70006
Hoag Memorial Hospital
Newport Beach, California, 92663
Temple University Hospital
Philadelphia, Pennsylvania, 19140
LSUHSC - Shreveport
Shreveport, Louisiana, 71103
Triple O Research Institute, P.A.
West Palm Beach, Florida, 33407

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of CERC-002 in Adults With COVID-19 Pneumonia and Acute Lung Injury

LIGHT is a cytokine in the tumor necrosis factor super family (TNFSF14) which drives inflammation and induces many other cytokines including IL-1, IL-6 and GM-CSF. LIGHT levels have been shown to be elevated in COVID-19 infected patients and inhibiting LIGHT is hypothesized to ameliorate the cytokine storm which has shown to be a major factor in progression of ARDS.

The study will assess the efficacy and safety of CERC-002 in patients with severe COVID-19 over a 28 day period as single dose on top of standard of care.

Conditions: COVID-19 Pneumonia, Acute Lung Injury, ARDS
Being tested: CERC-002, Placebo
Medical subject headings: Acute Lung Injury

What participants receive

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

CERC-002Drug
Also called AEVI-002 and MDGN-002
Administered once subcutaneously at 16 mg/kg dose up to a maximum dose of 1200 mg.
PlaceboDrug
Administered once subcutaneously

Study groups in NCT04412057
Study group	Role	What they receive
CERC-002	Experimental	Not described Receives: Drug: CERC-002
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Number of Subjects Alive and Free of Respiratory Failure
Respiratory failure defined based on resource utilization requiring at least one of the following:
- Endotracheal intubation and mechanical ventilation
- Oxygen delivered by high-flow nasal cannula (heated, humidified oxygen delivered via reinforced nasal cannula at flow rates >20L/min with fraction of delivered oxygen ≥0.5)
- Noninvasive positive pressure ventilation,
- Extracorporeal membrane oxygenation
Measured: Baseline to Day 28

Secondary outcomes (1)

Number of Subjects Who Are Alive at Day 28
1-month mortality defined as the number of subjects who are alive at the Day 28/ET visit
Measured: Baseline to Day 28

Timeline

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

17 Jul 202019 Jan 2021

First posted2 Jun 2020
Study start17 Jul 2020
Primary completion14 Dec 2020
Study completion19 Jan 2021

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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for COVID-19 PneumoniaStudies 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04412057
Sponsor's protocol ID: CERC-002-CVID-201
Status last verified: Mar 2022
First submitted: 29 May 2020
Last updated: 24 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Perlin DS, Neil GA, Anderson C, Zafir-Lavie I, Raines S, Ware CF, Wilkins HJ. Randomized, double-blind, controlled trial of human anti-LIGHT monoclonal antibody in COVID-19 acute respiratory distress syndrome. J Clin Invest. 2022 Feb 1;132(3):e153173. doi: 10.1172/JCI153173.
PubMed 34871182
Perlin DS, Zafir-Lavie I, Roadcap L, Raines S, Ware CF, Neil GA. Levels of the TNF-Related Cytokine LIGHT Increase in Hospitalized COVID-19 Patients with Cytokine Release Syndrome and ARDS. mSphere. 2020 Aug 12;5(4):e00699-20. doi: 10.1128/mSphere.00699-20.
PubMed 32817460

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of CERC-002 in Adults With COVID-19 Pneumonia and Acute Lung Injury
ClinicalTrials.gov ID: NCT04412057
Acronym / sponsor ID: CERC-002-CVID-201
Conditions: COVID-19 Pneumonia, Acute Lung Injury, ARDS
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: Aevi Genomic Medicine, LLC, a Cerecor companyIndustry (pharma, biotech, devices)
Study start: 17 Jul 2020 (actual)
Primary completion: 14 Dec 2020 (actual)
Study completion: 19 Jan 2021 (actual)
First posted: 2 Jun 2020 (actual)
Results: Posted 4 Mar 2022

Clinical summary

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

The study will assess the efficacy and safety of CERC-002 in patients with severe COVID-19 over a 28 day period as single dose on top of standard of care.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
CERC-002	Experimental	Drug: CERC-002
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

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

Key inclusion criteria (6 listed)

Subject/legally authorized representative (LAR) is able to understand and provide written informed consent, and assent (as applicable) to participate in this study.
Subject is ≥18 years of age at the time of informed consent and assent (as applicable).
Subject is male or non-pregnant, non-lactating female, who if of childbearing potential agrees to comply with any applicable contraceptive requirements if. discharged from the hospital prior to completing the study.
Subject has a diagnosis of COVID-19 infection through an approved testing method.
Subject has been hospitalized due to clinical diagnosis of pneumonia with acute lung injury defined as diffuse bilateral radiographic infiltrates with partial pressure of arterial oxygen/percentage of inspired oxygen (PaO2/FiO2) >100 and <300.

Key exclusion criteria (5 listed)

Subject is intubated.
Subject is currently taking immunomodulators or anti-rejection drugs.
Subject has been administered an immunomodulating biologic drug within 60 days of baseline.
Subject is in septic shock defined as persistent hypotension requiring vasopressors to maintain mean arterial pressure (MAP) of 65 mm Hg or higher and a serum lactate level greater than 2 mmol/L (18 mg/dL) despite adequate volume resuscitation.
Subject has received any live attenuated vaccine, such as varicella-zoster, oral polio, or rubella, within 3 months prior to the baseline visit.

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
CERC-002Also: AEVI-002 and MDGN-002Administered once subcutaneously at 16 mg/kg dose up to a maximum dose of 1200 mg.	Drug	CERC-002
PlaceboAdministered once subcutaneously	Drug	Placebo

Primary outcome

Number of Subjects Alive and Free of Respiratory Failure
Time frame: Baseline to Day 28
Respiratory failure defined based on resource utilization requiring at least one of the following: * Endotracheal intubation and mechanical ventilation * Oxygen delivered by high-flow nasal cannula (heated, humidified oxygen delivered via reinforced nasal cannula at flow rates >20L/min with fraction of delivered oxygen ≥0.5) * Noninvasive positive pressure ventilation, * Extracorporeal membrane oxygenation

1 secondary outcome

Number of Subjects Who Are Alive at Day 28
Time frame: Baseline to Day 28

Results and safety

Results posted to the registry on 4 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CERC-002	41	37
Placebo	42	35

Primary outcome: Number of Subjects Alive and Free of Respiratory Failure

Time frame: Baseline to Day 28. Count of participants. Unit: Participants

Measure	CERC-002 n = 31	Placebo n = 31
Value	26	20

CERC-002 vs Placebo: Odds Ratio (OR): 2.86 (90% CI 1.04 to 7.88), p = 0.0440, Regression, Logistic

Population analysed: The number of subjects alive and free of respiratory failure up to Day 28/Early Termination (ET). The study was designed with broad eligibility criteria allowing patients who received high-flow oxygen or positive-pressure oxygen prior to dosing to be enrolled. As overlap was expected patients who were in respiratory failure before dosing or who required elevation in their ventilation support were excluded from the primary analysis (N=20, 9 CERC-002 patients and 11 placebo patients).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CERC-002	8 of 40 (20%)	10 of 40 (25%)	4 of 40
Placebo	12 of 42 (28.6%)	6 of 42 (14.3%)	9 of 42

Limitations and caveats (from the sponsor): The study was designed to use broad eligibility criteria including patients who received high-flow oxygen or positive-pressure oxygen prior to randomization. Some overlap was expected between the entry criteria and the primary endpoint. Therefore patients who were in respiratory failure before dosing or who required an elevation in their ventilation support were excluded (N=20). In addition, to increase statistical power, a 1-sided χ2 test was used.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 34871182Perlin DS, Neil GA, Anderson C, Zafir-Lavie I, Raines S, Ware CF, Wilkins HJ. Randomized, double-blind, controlled trial of human anti-LIGHT monoclonal antibody in COVID-19 acute respiratory distress syndrome. J Clin Invest. 2022 Feb 1;132(3):e153173. doi: 10.1172/JCI153173.
Derived from this study: PubMed 32817460Perlin DS, Zafir-Lavie I, Roadcap L, Raines S, Ware CF, Neil GA. Levels of the TNF-Related Cytokine LIGHT Increase in Hospitalized COVID-19 Patients with Cytokine Release Syndrome and ARDS. mSphere. 2020 Aug 12;5(4):e00699-20. doi: 10.1128/mSphere.00699-20.
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.

Scott White, MD study director

Aevi Genomic Medicine, LLC, a Cerecor company

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CERC-002 in people with COVID-19 Pneumonia and Acute Lung Injury, run by Aevi Genomic Medicine, LLC, a Cerecor company at 11 sites in United States.

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 6 inclusion and 5 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 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. 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?

Yes. Results are posted in the registry (first posted 4 Mar 2022). 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?

Number of Subjects Alive and Free of Respiratory Failure (time frame: Baseline to Day 28). 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 NCT04412057, 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 24 Mar 2022.