Study to Evaluate the Efficacy and Safety of Oral RP7214, a DHODH Inhibitor, in Patients With Symptomatic Mild COVID-19 Infection.

• ClinicalTrials.gov Identifier: NCT05007236
• Recruitment Status: Completed
• First Posted: August 16, 2021
• Last Update Posted: April 21, 2022
• Sponsor: Rhizen Pharmaceuticals SA
• Collaborator: Incozen Therapeutics Pvt Ltd
• Information provided by (Responsible Party): Rhizen Pharmaceuticals SA

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.

Condition or disease	Intervention/treatment	Phase
SARS-CoV-2 Infection	Drug: RP7214 + Standard of care (SOC); Drug: Placebo + Standard of care (SOC)	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 163 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: September 20, 2021
• Actual Primary Completion Date: March 25, 2022
• Actual Study Completion Date: March 25, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Proportion of patients requiring Covid-19 related hospitalization by Day 15. [ Time Frame: 15 days ]

Secondary Outcome Measures :

1. Change from baseline in SARS-CoV-2 viral load at Days 3, 7 and 15 by quantitative RT-PCR test [ Time Frame: 15 days ]
2. Time to symptom resolution in patients receiving RP7214 as compared to placebo [ Time Frame: 15 days ]
3. Proportion of patients demonstrating symptom resolution [ Time Frame: 15 days ]
4. Time to symptom improvement in patients receiving RP7214 as compared to placebo [ Time Frame: 15 days ]
5. Proportion of patients demonstrating symptom improvement [ Time Frame: 15 days ]
6. Adverse Events (AEs) as assessed by laboratory tests, vital signs and physical examination. [ Time Frame: 15 days ]
7. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

India

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

Sponsors and Collaborators

Rhizen Pharmaceuticals SA

Incozen Therapeutics Pvt Ltd

More Information

• Responsible Party: Rhizen Pharmaceuticals SA
• ClinicalTrials.gov Identifier: NCT05007236
• Other Study ID Numbers: RP7214-2101
• First Posted: August 16, 2021
• Last Update Posted: April 21, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Infections; Communicable Diseases; COVID-19; Disease Attributes; Pathologic Processes; Respiratory Tract Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases