101-PGC-005 for the Treatment of COVID-19

NCT05656521 | Unknown Phase 2

• 1 other identifier: PGC-005-IN-101-2
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 5

Brief Summary

This is a prospective, randomized, comparative, multi-centric, adaptive design clinical study to evaluate efficacy, safety, and tolerability of 101-PGC-005 ('005) when used alongside standard of care (SOC) for the treatment of hospitalized patients with coronavirus disease (COVID-19).

Conditions

COVID-19

Keywords

COVID-19; Infectious Disease; Dexamethasone; Inflammation; Cytokine Storm

Outcome Measures

Primary Outcomes (1)

• Clinical Improvement

  Clinical improvement or shift in WHO 11-point ordinal scale rating

  Baseline through Days 10, 14, 28

Secondary Outcomes (8)

• Reduction in Symptoms

  Baseline through Days 10, 14, 28

• Reduction in Inflammatory Markers

  Baseline and Days 14, 28

• Reduction in Oxygen Supplementation

  28 days

• Discharge Rate from hospital

  28 days

• Reduction in ICU Admission/Mechanical Ventilation

  28 days

Study Arms (2)

'005 Treatment Arm

EXPERIMENTAL

'005 IV 20 mg + Standard of care

Drug: 101-PGC-005

Dexamethasone Treatment Arm

ACTIVE COMPARATOR

Dexamethasone 6 mg + Standard of care

Drug: Dexamethasone

Interventions

101-PGC-005 DRUG

'005 is a targeted prodrug of dexamethasone that binds to activated macrophages.

'005 Treatment Arm

Dexamethasone DRUG

Dexamethasone is a glucocorticoid commonly prescribed to treat inflammation.

Dexamethasone Treatment Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients of age 18 to 65 years (both inclusive) who have been hospitalized for treatment of moderate COVID-19 disease.
• Patients with 'moderate' COVID-19 disease severity, as defined by Comprehensive Guidelines for Management of COVID-19 patients, Directorate General of Health Services, MoHFW, GOI; AND having any of the following symptoms and signs prior to randomization:
• Fever, cough, with or without sore throat/throat irritation, body ache/headache, malaise/weakness, diarrhoea or gastrointestinal upset, with or without anorexia/nausea/vomiting, with or without loss of smell and/or taste, shortness of breath/breathlessness and difficulty in breathing
• Respiratory rate of \>24 to \<30 breaths/min,
• SpO2: 90 - 93% on room air
• Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs (sample collected within 7 days prior to randomization)
• Elevated CRP, ESR or Ferritin levels
• In case of female patients of child-bearing potential, a negative urine pregnancy test prior to beginning the therapy.
• Willing to sign voluntary informed consent for participation in the study and willing to adhere to all protocol procedures. In case the subject is unable to provide informed consent than the same should be obtained from legally acceptable representative (LAR).

You may not qualify if:

• Patients with 'mild' or 'severe' COVID-19 disease severity, as defined by latest Comprehensive Guidelines for Management of COVID-19 patients, Directorate General of Health Services, MoHFW, GOI at the time of randomization. This includes any one or more of the following
• Peripheral Blood oxygen saturation ≥94% or \<90%
• Respiratory Rate or \<24 or ≥30 breaths per minute
• First positive RT-PCR more than 7 days prior to treatment administration
• Patients with evidence of other serious infectious, malignant, autoimmune, kidney, hepatic, cardiovascular or other systemic disease and/or laboratory abnormality, which, in the opinion of the investigator, prevent the patient from participating in the study
• Subjects with Chronic liver disease (Child Pugh class B or C) and chronic renal disease (GFR\<30ml/min).
• Renal dysfunction \[Serum Creatinine \> 2.5 times of ULN or calculated creatinine clearance \< 30ml/min\], Liver Dysfunction \[Total Bilirubin \> 3times ULN \& AST/ALT \> 5times ULN\].
• Chronic systemic glucocorticoid treatment or any immunosuppressive treatment
• History of human immunodeficiency virus (HIV) or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
• Pregnant and Lactating patients.
• Patients who require IL-6 inhibitors for management of inflammation at the time of study entry.
• Subject has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year.
• Hospital discharge is anticipated in ≤ 24 hours or anticipated transfer to another hospital which is not a study site within 72 hours.
• Patients that are currently or have participated in such studies participating in other clinical studies with investigational drug, biological agent or device within 1 month or within 5 half-lives (of the drug/biologic) prior to randomization (whichever is longer).

Sponsors & Collaborators

• 101 Therapeutics: lead

Study Sites (5)

Government Medical College & General Hospital

Srikakulam, Andhra Pradesh, India

Location

Victoria Hospital Bangalore

Bangalore, Karnataka, India

Location

Sangvi Multispeciality Hospital

Pune, Maharashtra, India

Location

SMS Medical College and Attached Hospitals

Jaipur, Rajasthan, India

Location

Santosh Medical College and Hospital

Ghaziabad, Uttar Pradesh, India

Location

MeSH Terms

Conditions

COVID-19; Communicable Diseases; Inflammation; Cytokine Release Syndrome

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Systemic Inflammatory Response Syndrome; Shock

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 19, 2022
• Study Start: January 31, 2023
• Primary Completion: April 21, 2023
• Study Completion: June 1, 2023
• Last Updated: May 30, 2023

Record last verified: 2023-05

Locations

IN (5)