COVID-19Phase 2NCT05656521
101-PGC-005 for the Treatment of COVID-19
A Phase 2 study testing 101-PGC-005 and Dexamethasone in people with COVID-19, run by 101 Therapeutics at 5 sites in India.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19
- What is being tested?
- 101-PGC-005 and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 5 sitesIndia
- Study dates
- 31 Jan 2023to Jun 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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).
Who cannot join
- 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).
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- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
India5 sites
Victoria Hospital Bangalore
Bangalore, Karnataka
Santosh Medical College and Hospital
Ghaziabad, Uttar Pradesh
SMS Medical College and Attached Hospitals
Jaipur, Rajasthan
Sangvi Multispeciality Hospital
Pune, Maharashtra
Government Medical College & General Hospital
Srikakulam, Andhra Pradesh
About this study
Official title: A Prospective, Randomized, Comparative, Multi-centric, Adaptive Design Clinical Study to Evaluate Efficacy, Safety, and Tolerability of 101-PGC-005 ('005) for the Treatment of Moderate Corona Virus Disease (COVID-19) Patients
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).
Read the detailed description
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.
- Conditions
- COVID-19
- Being tested
- 101-PGC-005, Dexamethasone
- Keywords
- COVID-19, Infectious Disease, Dexamethasone, Inflammation, Cytokine Storm
- Medical subject headings
- COVID-19, Communicable Diseases, Inflammation, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
101-PGC-005Drug
'005 is a targeted prodrug of dexamethasone that binds to activated macrophages.
DexamethasoneDrug
Dexamethasone is a glucocorticoid commonly prescribed to treat inflammation.
| Study group | Role | What they receive |
|---|---|---|
| '005 Treatment Arm | Experimental | '005 IV 20 mg + Standard of care Receives: Drug: 101-PGC-005 |
| Dexamethasone Treatment Arm | Active comparator | Dexamethasone 6 mg + Standard of care Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Improvement
Clinical improvement or shift in WHO 11-point ordinal scale rating
Measured: Baseline through Days 10, 14, 28
Secondary outcomes (8)
Reduction in Symptoms
Improvement in COVID-19 Symptoms such as fever, heart rate, and oxygen saturation
Measured: Baseline through Days 10, 14, 28
Reduction in Inflammatory Markers
Improvement in biochemical inflammatory markers such as CRP, Neutrophil-Lymphocyte (N/L) ratio, D-Dimer, Sr. Ferritin, IL-6, and TNF-α
Measured: Baseline and Days 14, 28
Reduction in Oxygen Supplementation
Measured: 28 days
Discharge Rate from hospital
Measured: 28 days
Reduction in ICU Admission/Mechanical Ventilation
Measured: 28 days
Reduction in time to Respiratory Viral Clearance
Measured: Days 3, 7, 10, 14
Reduction in Lung Injury on Chest HRCT
Measured: Baseline and 14, 28 Days
Reduction in All-cause Mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start31 Jan 2023
- Primary completion21 Apr 2023
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- 101 Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656521
- Sponsor's protocol ID
- PGC-005-IN-101-2
- Status last verified
- May 2023
- First submitted
- 13 Dec 2022
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Comparative, Multi-centric, Adaptive Design Clinical Study to Evaluate Efficacy, Safety, and Tolerability of 101-PGC-005 ('005) for the Treatment of Moderate Corona Virus Disease (COVID-19) Patients
- ClinicalTrials.gov ID
- NCT05656521
- Acronym / sponsor ID
- PGC-005-IN-101-2
- Conditions
- COVID-19
- Keywords
- COVID-19, Infectious Disease, Dexamethasone, Inflammation, Cytokine Storm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (actual)
- Lead sponsor
- 101 TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 21 Apr 2023 (actual)
- Study completion
- Jun 2023 (estimated)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| '005 Treatment Arm | Experimental | Drug: 101-PGC-005'005 IV 20 mg + Standard of care |
| Dexamethasone Treatment Arm | Active comparator | Drug: DexamethasoneDexamethasone 6 mg + Standard of care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (14 listed)
- 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
- 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].
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 101-PGC-005'005 is a targeted prodrug of dexamethasone that binds to activated macrophages. | Drug | '005 Treatment Arm |
| DexamethasoneDexamethasone is a glucocorticoid commonly prescribed to treat inflammation. | Drug | Dexamethasone Treatment Arm |
Primary outcome
Clinical Improvement
Time frame: Baseline through Days 10, 14, 28
Clinical improvement or shift in WHO 11-point ordinal scale rating
8 secondary outcomes
Reduction in Symptoms
Time frame: Baseline through Days 10, 14, 28
Reduction in Inflammatory Markers
Time frame: Baseline and Days 14, 28
Reduction in Oxygen Supplementation
Time frame: 28 days
Discharge Rate from hospital
Time frame: 28 days
Reduction in ICU Admission/Mechanical Ventilation
Time frame: 28 days
Reduction in time to Respiratory Viral Clearance
Time frame: Days 3, 7, 10, 14
Reduction in Lung Injury on Chest HRCT
Time frame: Baseline and 14, 28 Days
Reduction in All-cause Mortality
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 101-PGC-005 and Dexamethasone in people with COVID-19, run by 101 Therapeutics at 5 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Improvement (time frame: Baseline through Days 10, 14, 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.