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Rhu-pGSN for Severe Covid-19 Pneumonia

NCT04358406 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-11-28

Study results available
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Summary

Study Objectives:

Primary

* To assess the efficacy (survival without organ failure on Day 14) of three doses of rhu-pGSN administered intravenously (IV) plus standard of care (SOC) to hospitalized subjects with a primary diagnosis of COVID-19 pneumonia and a severity score of 4, 5 or 6 on the World Health Organization (WHO) 9-point severity scale
* To evaluate the safety and tolerability of three IV doses of rhu-pGSN administered to hospitalized subjects with a primary diagnosis of COVID-19 pneumonia and a severity score of 4, 5, or 6 on the WHO 9-point severity scale

Secondary

* To further assess the efficacy of IV administered rhu-pGSN
* To assess changes in WHO 9-point severity score for SOC with or without rhu-pGSN
* To evaluate the effect of administered rhu-pGSN on survival rates
* To assess the relationship of pGSN levels (and other biomarkers) at baseline with clinical outcomes
* \[OPTIONAL\] To follow the pharmacokinetics (PK) of administered rhu-pGSN

Immunogenicity

• To investigate the development of antibodies against rhu-pGSN post-treatment

Conditions

  • Sars-CoV2

Interventions

DRUG

Recombinant human plasma gelsolin (Rhu-pGSN)

Intravenous administration of rhu-pGSN at 12 mg/kg, 3 doses

OTHER

Placebo

Normal saline in matched volume to treatment arm. Undistinguishable in syringe.

Sponsors & Collaborators

  • BioAegis Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Mark J DiNubile, MD · BioAegis Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-30
Primary Completion
2021-05-25
Completion
2022-01-28
FDA Drug
Yes

Countries

  • Romania
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04358406 on ClinicalTrials.gov