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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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SARS-CoV-2 Infection

Intervention / Treatment
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* Drug: RP7214 + Standard of care (SOC)
* Drug: Placebo + Standard of care (SOC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |