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CERC-002

Phase 2

COVID-19 Pneumonia | Small molecule | Infectious Disease |Avalo Therapeutics, Inc.|Last Updated: Mar 24, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment88

FDA Designations

No designations recorded

Clinical trial landscape

CERC-002 · 1 trial · 3 indications

Phase 2 1
NCT04412057Clinical Trial to Evaluate CERC-002 in Adults With COVID-19 Pneumonia and Acute Lung InjuryCOVID-19 Pneumonia
COMPLETED88 Analytics
PHASE2COMPLETED
Clinical Trial to Evaluate CERC-002 in Adults With COVID-19 Pneumonia and Acute Lung Injury
COVID-19 PneumoniaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Subjects Alive and Free of Respiratory Failure
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

Secondary Endpoints

Number of Subjects Who Are Alive at Day 28
Baseline to Day 28
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CERC-002EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
CERC-002DRUGAdministered once subcutaneously at 16 mg/kg dose up to a maximum dose of 1200 mg.
PlaceboDRUGAdministered once subcutaneously
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: 1. Subject/legally authorized representative (LAR) is able to understand and provide written informed consent, and assent (as applicable) to participate in this study. 2. Subject is ≥18 years of age at the time of informed consent and assent (as applicable). 3. Subject is male o...

Countries:United States
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Frequently asked questions about CERC-002

What is CERC-002 used for in COVID-19 Pneumonia?

CERC-002 is an investigational small molecule being studied for the treatment of COVID-19 pneumonia and acute lung injury. It was evaluated in a Phase 2 clinical trial in adults with these conditions. The drug is not approved and remains in clinical development.

Who makes CERC-002?

CERC-002 is being developed by Avalo Therapeutics, Inc., a biopharmaceutical company. The company's stock trades under the ticker symbol AVTX. Avalo Therapeutics is responsible for the clinical development of this investigational drug.

What phase is CERC-002 in?

CERC-002 is in Phase 2 clinical development. It has completed a Phase 2 trial for COVID-19 pneumonia and acute lung injury. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is CERC-002 in?

CERC-002 has been studied in one clinical trial, identified as NCT04412057. This was a Phase 2, randomized, double-blind, placebo-controlled trial in adults with COVID-19 pneumonia and acute lung injury. The trial enrolled 88 participants and has been completed.

Is CERC-002 the same as another drug?

CERC-002 is the sole name provided for this investigational drug. No alternative names have been mentioned in the available information. It is being developed by Avalo Therapeutics for COVID-19 pneumonia and acute lung injury.