This is a prospective, randomized, comparative, multi-centric, adaptive design clinicalstudy to evaluate efficacy, safety, and tolerability of 101-PGC-005 ('005) when usedalongside standard of care (SOC) for the treatment of hospitalized patients withcoronavirus disease (COVID-19).
The study is planned as an adaptive Phase II/III clinical study to allow for seamless
transition to Phase III after completion of Phase II. The study will begin as initially
only a Phase II to evaluate and compare the efficacy, safety, and tolerability of bolus
injection of 20 mg '005 vs dexamethasone 6 mg injection for the treatment of COVID-19.
The treatment period with the investigational product in the test group will be 3
consecutive days. However, in the comparator group, the patient will be allowed to take 6
mg dexamethasone daily for the duration of their treatment, based on the investigator's
clinical judgement for a total of not more than 10 days or until the time of discharge,
whichever is earlier. All patients in either test or control groups will be allowed to
take other concomitant SOC as per the prescribed schedule for entire duration of the
study, as applicable.
Drug: 101-PGC-005
'005 is a targeted prodrug of dexamethasone that binds to activated macrophages.
Drug: Dexamethasone
Dexamethasone is a glucocorticoid commonly prescribed to treat inflammation.
Inclusion Criteria:
1. Male or female patients of age 18 to 65 years (both inclusive) who have been
hospitalized for treatment of moderate COVID-19 disease.
2. 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:
1. 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
2. Respiratory rate of >24 to <30 breaths/min,
3. SpO2: 90 - 93% on room air
3. Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or oropharyngeal
swabs (sample collected within 7 days prior to randomization)
4. Elevated CRP, ESR or Ferritin levels
5. In case of female patients of child-bearing potential, a negative urine pregnancy
test prior to beginning the therapy.
6. 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).
Exclusion Criteria:
1. 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
1. Peripheral Blood oxygen saturation ≥94% or <90%
2. Respiratory Rate or <24 or ≥30 breaths per minute
2. First positive RT-PCR more than 7 days prior to treatment administration
3. 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
4. Subjects with Chronic liver disease (Child Pugh class B or C) and chronic renal
disease (GFR<30ml/min).
5. 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].
6. Chronic systemic glucocorticoid treatment or any immunosuppressive treatment
7. History of human immunodeficiency virus (HIV) or active infection with hepatitis B
virus (HBV) or hepatitis C virus (HCV)
8. Pregnant and Lactating patients.
9. Patients who require IL-6 inhibitors for management of inflammation at the time of
study entry.
10. Subject has a psychiatric disease that is not well controlled where controlled is
defined as: stable on a regimen for more than one year.
11. Hospital discharge is anticipated in ≤ 24 hours or anticipated transfer to another
hospital which is not a study site within 72 hours.
12. 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).
Government Medical College & General Hospital
Srikakulam, Andhra Pradesh, India
Victoria Hospital Bangalore
Bangalore, Karnataka, India
Sangvi Multispeciality Hospital
Pune, Maharashtra, India
SMS Medical College and Attached Hospitals
Jaipur, Rajastan, India
Santosh Medical College and Hospital
Ghāziābād, Uttar Pradesh, India
Not Provided