Study to Evaluate the Efficacy and Safety of Oral RP7214, a DHODH Inhibitor, in Patients With Symptomatic Mild COVID-19 Infection.
Primary Purpose
SARS-CoV-2 Infection
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
RP7214 + Standard of care (SOC)
Placebo + Standard of care (SOC)
Sponsored by
About this trial
This is an interventional treatment trial for SARS-CoV-2 Infection
Eligibility Criteria
Inclusion Criteria:
- Willing and able to provide informed consent.
- Males and females of ≥ 18 years of age
- Patient with mild COVID-19 infection having ≥ 1 symptoms.
- Laboratory confirmed Covid-19 infection by Reverse Transcription Polymerase Chain Reaction (RT-PCR) in nasopharyngeal sample (within 72 hours prior to randomization).
- Patient should have at least one pre-existing high-risk feature for developing severe Covid-19 illness.
- Ability to swallow and retain oral medication.
- Male patient who is surgically sterile, or who is willing to agree to use a contraceptive measure.
- Women of childbearing potential should be willing to use a medically acceptable method of contraception.
- Willing to receive telephone calls or have videoconferences with study team personnel.
- Willing and able to understand the nature of this study, comply with the study procedures and follow-up procedures as per the study protocol.
Exclusion Criteria:
- Patient with asymptomatic Covid-19 infection.
- Patient who has experienced the onset of any of Covid-19 symptoms > 5 days at the time of randomization.
- Moderate to Severe COVID-19 infection
- Patient with Covid-19 re-infection
- Subjects who are severely immunocompromised
- Subjects with autoimmune diseases
- Patients with any bleeding disorder e.g., hemophilia and von Willebrand disease.
- Current use of other DHODH inhibitors including teriflunomide or leflunomide.
- Patients who are on or immediately require Covid-19 directed treatment such as antivirals, immunomodulatory treatment, convalescent plasma, oral/ intravenous steroids, or monoclonal antibodies at the time of screening.
- Patients who have had received one or two doses of vaccine for Covid-19.
- Patients participating in another clinical study or use of any investigational product within 4 weeks or 5 half-lives of the drug, whichever is longer, before the date of dosing
Sites / Locations
- Citizen Hospital
- Madhu Superspeciality Hospital & Research Center
- Rajalakshmi Hospital & Research Center
- Panimalar medical college hospital and research institute
- Maharaja Agrasen Superspeciality Hospital
- Nil Ratan Sircar Medical College and Hospital
- Malabar Medical College
- BAJ RR Hospital & Research center
- DEC Healthcare Hospital
- Vijaya Super specialty Hospital
- Jivanrekha Multispeciality Hospital
- PCMC'S PGI Yashwantrao Chavan Memorial Hospital
- Sant Dnyaneshwar Hospital (Accord Multispeciality Hospital)
- Govt General Hospital
- Great Eastern medical school and hospital
- King George Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
RP7214 + Standard of care (SOC)
Placebo + Standard of care (SOC)
Arm Description
Outcomes
Primary Outcome Measures
Proportion of patients requiring Covid-19 related hospitalization by Day 15.
Secondary Outcome Measures
Change from baseline in SARS-CoV-2 viral load at Days 3, 7 and 15 by quantitative RT-PCR test
Time to symptom resolution in patients receiving RP7214 as compared to placebo
Proportion of patients demonstrating symptom resolution
Time to symptom improvement in patients receiving RP7214 as compared to placebo
Proportion of patients demonstrating symptom improvement
Adverse Events (AEs) as assessed by laboratory tests, vital signs and physical examination.
Change in the disease-specific inflammatory markers (Ferritin, C-reactive protein (CRP), D-dimer, neutrophil to lymphocyte/CD8+ ratio, LDH, IL-6) as compared to baseline.
Full Information
NCT ID
NCT05007236
First Posted
August 9, 2021
Last Updated
April 20, 2022
Sponsor
Rhizen Pharmaceuticals SA
Collaborators
Incozen Therapeutics Pvt Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05007236
Brief Title
Study to Evaluate the Efficacy and Safety of Oral RP7214, a DHODH Inhibitor, in Patients With Symptomatic Mild COVID-19 Infection.
Official Title
A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Oral RP7214, a DHODH Inhibitor, in Patients With Symptomatic Mild SARS-CoV-2 Infection.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
March 25, 2022 (Actual)
Study Completion Date
March 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rhizen Pharmaceuticals SA
Collaborators
Incozen Therapeutics Pvt Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomized, double-blind, placebo-controlled study of RP7214 in patients with symptomatic mild SARS-CoV-2 infection, having at least one high-risk feature (e.g., age > 60 years, hypertension, diabetes mellitus, chronic lung disease, chronic kidney disease, liver disease, cerebrovascular disease, obesity, cancer) for developing severe Covid-19 illness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
163 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RP7214 + Standard of care (SOC)
Arm Type
Experimental
Arm Title
Placebo + Standard of care (SOC)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
RP7214 + Standard of care (SOC)
Intervention Description
RP7214 tablets will be administered orally twice a day for 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo + Standard of care (SOC)
Intervention Description
Placebo will be administered orally twice a for 14 days
Primary Outcome Measure Information:
Title
Proportion of patients requiring Covid-19 related hospitalization by Day 15.
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Change from baseline in SARS-CoV-2 viral load at Days 3, 7 and 15 by quantitative RT-PCR test
Time Frame
15 days
Title
Time to symptom resolution in patients receiving RP7214 as compared to placebo
Time Frame
15 days
Title
Proportion of patients demonstrating symptom resolution
Time Frame
15 days
Title
Time to symptom improvement in patients receiving RP7214 as compared to placebo
Time Frame
15 days
Title
Proportion of patients demonstrating symptom improvement
Time Frame
15 days
Title
Adverse Events (AEs) as assessed by laboratory tests, vital signs and physical examination.
Time Frame
15 days
Title
Change in the disease-specific inflammatory markers (Ferritin, C-reactive protein (CRP), D-dimer, neutrophil to lymphocyte/CD8+ ratio, LDH, IL-6) as compared to baseline.
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Willing and able to provide informed consent.
Males and females of ≥ 18 years of age
Patient with mild COVID-19 infection having ≥ 1 symptoms.
Laboratory confirmed Covid-19 infection by Reverse Transcription Polymerase Chain Reaction (RT-PCR) in nasopharyngeal sample (within 72 hours prior to randomization).
Patient should have at least one pre-existing high-risk feature for developing severe Covid-19 illness.
Ability to swallow and retain oral medication.
Male patient who is surgically sterile, or who is willing to agree to use a contraceptive measure.
Women of childbearing potential should be willing to use a medically acceptable method of contraception.
Willing to receive telephone calls or have videoconferences with study team personnel.
Willing and able to understand the nature of this study, comply with the study procedures and follow-up procedures as per the study protocol.
Exclusion Criteria:
Patient with asymptomatic Covid-19 infection.
Patient who has experienced the onset of any of Covid-19 symptoms > 5 days at the time of randomization.
Moderate to Severe COVID-19 infection
Patient with Covid-19 re-infection
Subjects who are severely immunocompromised
Subjects with autoimmune diseases
Patients with any bleeding disorder e.g., hemophilia and von Willebrand disease.
Current use of other DHODH inhibitors including teriflunomide or leflunomide.
Patients who are on or immediately require Covid-19 directed treatment such as antivirals, immunomodulatory treatment, convalescent plasma, oral/ intravenous steroids, or monoclonal antibodies at the time of screening.
Patients who have had received one or two doses of vaccine for Covid-19.
Patients participating in another clinical study or use of any investigational product within 4 weeks or 5 half-lives of the drug, whichever is longer, before the date of dosing
Facility Information:
Facility Name
Citizen Hospital
City
Bangalore
Country
India
Facility Name
Madhu Superspeciality Hospital & Research Center
City
Bangalore
Country
India
Facility Name
Rajalakshmi Hospital & Research Center
City
Bangalore
Country
India
Facility Name
Panimalar medical college hospital and research institute
City
Chennai
Country
India
Facility Name
Maharaja Agrasen Superspeciality Hospital
City
Jaipur
Country
India
Facility Name
Nil Ratan Sircar Medical College and Hospital
City
Kolkata
Country
India
Facility Name
Malabar Medical College
City
Kozhikode
Country
India
Facility Name
BAJ RR Hospital & Research center
City
Mumbai
Country
India
Facility Name
DEC Healthcare Hospital
City
Nellore
Country
India
Facility Name
Vijaya Super specialty Hospital
City
Nellore
Country
India
Facility Name
Jivanrekha Multispeciality Hospital
City
Pune
Country
India
Facility Name
PCMC'S PGI Yashwantrao Chavan Memorial Hospital
City
Pune
Country
India
Facility Name
Sant Dnyaneshwar Hospital (Accord Multispeciality Hospital)
City
Pune
Country
India
Facility Name
Govt General Hospital
City
Srikakulam
Country
India
Facility Name
Great Eastern medical school and hospital
City
Srikakulam
Country
India
Facility Name
King George Hospital
City
Visakhapatnam
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
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Study to Evaluate the Efficacy and Safety of Oral RP7214, a DHODH Inhibitor, in Patients With Symptomatic Mild COVID-19 Infection.
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