Study to Evaluate the Efficacy and Safety of Oral RP7214, a DHODH Inhibitor, in Patients With Symptomatic Mild COVID-19 Infection.
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.
1 other identifier
interventional
163
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2021
Shorter than P25 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2021
CompletedFirst Posted
Study publicly available on registry
August 16, 2021
CompletedStudy Start
First participant enrolled
September 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2022
CompletedApril 21, 2022
April 1, 2022
6 months
August 9, 2021
April 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients requiring Covid-19 related hospitalization by Day 15.
15 days
Secondary Outcomes (7)
Change from baseline in SARS-CoV-2 viral load at Days 3, 7 and 15 by quantitative RT-PCR test
15 days
Time to symptom resolution in patients receiving RP7214 as compared to placebo
15 days
Proportion of patients demonstrating symptom resolution
15 days
Time to symptom improvement in patients receiving RP7214 as compared to placebo
15 days
Proportion of patients demonstrating symptom improvement
15 days
- +2 more secondary outcomes
Study Arms (2)
RP7214 + Standard of care (SOC)
EXPERIMENTALPlacebo + Standard of care (SOC)
PLACEBO COMPARATORInterventions
RP7214 tablets will be administered orally twice a day for 14 days
Placebo will be administered orally twice a for 14 days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rhizen Pharmaceuticals SAlead
- Incozen Therapeutics Pvt Ltdcollaborator
Study Sites (16)
Citizen Hospital
Bangalore, India
Madhu Superspeciality Hospital & Research Center
Bangalore, India
Rajalakshmi Hospital & Research Center
Bangalore, India
Panimalar medical college hospital and research institute
Chennai, India
Maharaja Agrasen Superspeciality Hospital
Jaipur, India
Nil Ratan Sircar Medical College and Hospital
Kolkata, India
Malabar Medical College
Kozhikode, India
BAJ RR Hospital & Research center
Mumbai, India
DEC Healthcare Hospital
Nellore, India
Vijaya Super specialty Hospital
Nellore, India
Jivanrekha Multispeciality Hospital
Pune, India
PCMC'S PGI Yashwantrao Chavan Memorial Hospital
Pune, India
Sant Dnyaneshwar Hospital (Accord Multispeciality Hospital)
Pune, India
Govt General Hospital
Srikakulam, India
Great Eastern medical school and hospital
Srikakulam, India
King George Hospital
Visakhapatnam, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2021
First Posted
August 16, 2021
Study Start
September 20, 2021
Primary Completion
March 25, 2022
Study Completion
March 25, 2022
Last Updated
April 21, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share