Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Participants With Acute COVID-19 Disease

Phase 2TerminatedNCT04432298

Kyntra Bio22 enrolled

Overview

This study evaluates the efficacy and safety of intravenous (IV) infusions of pamrevlumab when compared with placebo in participants who are hospitalized with acute COVID-19 disease.

This is a randomized, double-blind, placebo-controlled, phase 2, proof-of-concept study to evaluate the efficacy and safety of IV pamrevlumab, a monoclonal antibody, against connective-tissue growth factor (CTGF), in participants hospitalized with acute COVID-19 disease. All concomitant medications, including approved and non-approved treatments for COVID-19 (such as, hydroxychloroquine or interleukin 6 \[IL-6\] inhibitors), as well as supplemental oxygenation needs, will be collected and recorded. In addition, the following will be collected and recorded: documentation of Severe Acute Respiratory Syndrome coronavirus (SARS-Cov-2) infection, documentation of any other infection(s) prior to or during hospitalization, and whether or not aggressive care is withheld or withdrawn, including the reason for withholding or withdrawal of care (such as a Do Not Resuscitate/Do Not Intubate \[DNR/DNI\] order or a resource limitation).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

COVID-19

Interventions

PamrevlumabDRUG

Sterile liquid for injection

PlaceboDRUG

Sterile liquid for injection

Eligibility

Sex: ALLMin age: 40 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Confirmed SARS-CoV-2 infection 2. Respiratory compromise requiring hospitalization for COVID-19 disease as evidenced by at least one (or more) of the following criteria: * Interstitial pneumonia on chest x-ray or high-resolution computed tomography (findings of consolidation or ground glass opacities), OR * Peripheral capillary oxygen saturation \< 94% on room air, OR * Requiring non-invasive supplemental oxygen (such as, nasal cannula, face mask) to maintain SpO2 3. Not requiring mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) use at time of randomization 4. Not participating in another clinical trial for the treatment of COVID-19 disease through Day 28 Exclusion Criteria: 1. Female participants who are pregnant or nursing 2. Participation in a clinical trial with another investigational drug for COVID-19 disease 3. Anticipated discharge from the hospital or transfer to another hospital or long-term care facility which is not a study site within 72 hours of randomization 4. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies

Locations (4)

Research Center

Detroit, Michigan, United States

Research Center

Greensboro, North Carolina, United States

Research Center

Philadelphia, Pennsylvania, United States

Research Center

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Number of Participants Alive Who Never Received Mechanical Ventilation and/or Extracorporeal Membrane Oxygenation (ECMO) at Day 28

Time frame: Day 28

Secondary Outcomes

Number of Participants Alive, Discharged Home, and Not on Supplemental Oxygen at Day 28

Time frame: Day 28

Number of Participants Alive Who Never Received Mechanical Ventilation and/or ECMO at Day 14

Time frame: Day 14

Time to Recovery as Based on a Modified 8-Point Ordinal Scale

Recovery was defined as the first day on which the participant satisfied 1 of the following 3 categories from the 8-point ordinal scale: (1) hospitalized, not requiring supplemental oxygen; (2) Not hospitalized (discharged), but with limitation on activities and/or requiring home supplemental oxygen; (3) Not hospitalized (discharged), with no limitations on activities and not requiring supplemental oxygen).

Time frame: Day 28

Days in Intensive Care Unit/Critical Care Unit (ICU/CCU) (Either on or Off Mechanical Ventilation and/or ECMO)

Days in ICU/CCU was calculated as Event end date/time - Event start data/time + 1. Participants who died in ICU/CCU before Day 28, days in ICU/CCU is calculated up to the death date. Days in ICU/CCU were censored after Day 28.

Time frame: up to Day 28

Days on Mechanical Ventilation and/or ECMO

Days on Mechanical Ventilation and/or ECMO was calculated as Event end date/time - Event start data/time. Participants who died on MV/ECMO before Day 28, days on MV/ECMO is calculated up to the death date. Days on MV/ECMO are censored after Day 28.

Time frame: up to Day 28

Time to Mechanical Ventilation/ECMO or All-cause Mortality

Data from ClinicalTrials.gov

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