Clinical trial NCT05007236: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: SARS-CoV-2 Infection
Lead sponsor: Rhizen Pharmaceuticals SA
Sponsor class: INDUSTRY
Collaborators: name: Incozen Therapeutics Pvt Ltd
First posted: 2021-08-16
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Proportion of patients requiring Covid-19 related hospitalization by Day 15.
timeFrame: 15 days
Secondary outcomes:
measure: Change from baseline in SARS-CoV-2 viral load at Days 3, 7 and 15 by quantitative RT-PCR test
timeFrame: 15 days
measure: Time to symptom resolution in patients receiving RP7214 as compared to placebo
timeFrame: 15 days
measure: Proportion of patients demonstrating symptom resolution
timeFrame: 15 days
measure: Time to symptom improvement in patients receiving RP7214 as compared to placebo
timeFrame: 15 days
measure: Proportion of patients demonstrating symptom improvement
timeFrame: 15 days
measure: Adverse Events (AEs) as assessed by laboratory tests, vital signs and physical examination.
timeFrame: 15 days
measure: 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.
timeFrame: 15 days
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Citizen Hospital
city: Bangalore
country: India
facility: Madhu Superspeciality Hospital & Research Center
city: Bangalore
country: India
facility: Rajalakshmi Hospital & Research Center
city: Chennai
country: India
facility: Panimalar medical college hospital and research institute
city: Jaipur
country: India
facility: Maharaja Agrasen Superspeciality Hospital
city: Kolkata
country: India
facility: Nil Ratan Sircar Medical College and Hospital
city: Kozhikode
country: India
facility: Malabar Medical College
city: Mumbai
country: India
facility: BAJ RR Hospital & Research center
city: Nellore
country: India
facility: DEC Healthcare Hospital
city: Nellore
country: India
facility: Vijaya Super specialty Hospital
city: Pune
country: India
facility: Jivanrekha Multispeciality Hospital
city: Pune
country: India
facility: PCMC'S PGI Yashwantrao Chavan Memorial Hospital
city: Pune
country: India
facility: Sant Dnyaneshwar Hospital (Accord Multispeciality Hospital)
city: Srikakulam
country: India
facility: Govt General Hospital
city: Srikakulam
country: India
facility: Great Eastern medical school and hospital
city: Visakhapatnam
country: India
facility: King George Hospital
Study officials:
References: