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

NCT ID: NCT05007236

Last Updated: 2022-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-20
• Study Completion Date: 2022-03-25

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.

Conditions

SARS-CoV-2 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

RP7214 + Standard of care (SOC)

Group Type: EXPERIMENTAL

RP7214 + Standard of care (SOC)

Intervention Type: DRUG

RP7214 tablets will be administered orally twice a day for 14 days

Placebo + Standard of care (SOC)

Group Type: PLACEBO_COMPARATOR

Placebo + Standard of care (SOC)

Intervention Type: DRUG

Placebo will be administered orally twice a for 14 days

Interventions

RP7214 + Standard of care (SOC)

RP7214 tablets will be administered orally twice a day for 14 days

Intervention Type: DRUG

Placebo + Standard of care (SOC)

Placebo will be administered orally twice a for 14 days

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incozen Therapeutics Pvt Ltd

UNKNOWN

Sponsor Role: collaborator

Rhizen Pharmaceuticals SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

India

Other Identifiers

RP7214-2101

Identifier Type: -

Identifier Source: org_study_id