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.

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2 Infection
• Intervention / Treatment: Drug: RP7214 + Standard of care (SOC); Drug: Placebo + Standard of care (SOC)

• Study Type: Interventional
• Enrollment (Actual): 163
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Bangalore, India
    • Citizen Hospital
  • Bangalore, India
    • Madhu Superspeciality Hospital & Research Center
  • Bangalore, India
    • Rajalakshmi Hospital & Research Center
  • Chennai, India
    • Panimalar medical college hospital and research institute
  • Jaipur, India
    • Maharaja Agrasen Superspeciality Hospital
  • Kolkata, India
    • Nil Ratan Sircar Medical College and Hospital
  • Kozhikode, India
    • Malabar Medical College
  • Mumbai, India
    • BAJ RR Hospital & Research center
  • Nellore, India
    • DEC Healthcare Hospital
  • Nellore, India
    • Vijaya Super specialty Hospital
  • Pune, India
    • Jivanrekha Multispeciality Hospital
  • Pune, India
    • PCMC'S PGI Yashwantrao Chavan Memorial Hospital
  • Pune, India
    • Sant Dnyaneshwar Hospital (Accord Multispeciality Hospital)
  • Srikakulam, India
    • Govt General Hospital
  • Srikakulam, India
    • Great Eastern medical school and hospital
  • Visakhapatnam, India
    • King George Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Willing and able to provide informed consent.
2. Males and females of ≥ 18 years of age
3. Patient with mild COVID-19 infection having ≥ 1 symptoms.
4. Laboratory confirmed Covid-19 infection by Reverse Transcription Polymerase Chain Reaction (RT-PCR) in nasopharyngeal sample (within 72 hours prior to randomization).
5. Patient should have at least one pre-existing high-risk feature for developing severe Covid-19 illness.
6. Ability to swallow and retain oral medication.
7. Male patient who is surgically sterile, or who is willing to agree to use a contraceptive measure.
8. Women of childbearing potential should be willing to use a medically acceptable method of contraception.
9. Willing to receive telephone calls or have videoconferences with study team personnel.
10. 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:

1. Patient with asymptomatic Covid-19 infection.
2. Patient who has experienced the onset of any of Covid-19 symptoms > 5 days at the time of randomization.
3. Moderate to Severe COVID-19 infection
4. Patient with Covid-19 re-infection
5. Subjects who are severely immunocompromised
6. Subjects with autoimmune diseases
7. Patients with any bleeding disorder e.g., hemophilia and von Willebrand disease.
8. Current use of other DHODH inhibitors including teriflunomide or leflunomide.
9. 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.
10. Patients who have had received one or two doses of vaccine for Covid-19.
11. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RP7214 + Standard of care (SOC)	Drug: RP7214 + Standard of care (SOC); RP7214 tablets will be administered orally twice a day for 14 days
Placebo Comparator: Placebo + Standard of care (SOC)	Drug: Placebo + Standard of care (SOC); Placebo will be administered orally twice a for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients requiring Covid-19 related hospitalization by Day 15.	15 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Adverse Events (AEs) as assessed by laboratory tests, vital signs and physical examination.	15 days
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.	15 days

Collaborators and Investigators

• Sponsor: Rhizen Pharmaceuticals SA
• Collaborators: Incozen Therapeutics Pvt Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2021
• Primary Completion (Actual): March 25, 2022
• Study Completion (Actual): March 25, 2022

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: August 9, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Infections; Communicable Diseases
• Other Study ID Numbers: RP7214-2101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No