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

SARS-CoV-2 Infection Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05007236
• Other study ID #: RP7214-2101
• Status: Completed
• Phase: Phase 2
• Start date: September 20, 2021
• Est. completion date: March 25, 2022

Study information

• Verified date: April 2022
• Source: Rhizen Pharmaceuticals SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: March 25, 2022
• Est. primary completion date: March 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• SARS-CoV-2 Infection

Intervention

Drug:
• RP7214 + Standard of care (SOC)
RP7214 tablets will be administered orally twice a day for 14 days
• Placebo + Standard of care (SOC)
Placebo will be administered orally twice a for 14 days

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
Rhizen Pharmaceuticals SA	Incozen Therapeutics Pvt Ltd

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients requiring Covid-19 related hospitalization by Day 15.		15 days
Secondary	Change from baseline in SARS-CoV-2 viral load at Days 3, 7 and 15 by quantitative RT-PCR test		15 days
Secondary	Time to symptom resolution in patients receiving RP7214 as compared to placebo		15 days
Secondary	Proportion of patients demonstrating symptom resolution		15 days
Secondary	Time to symptom improvement in patients receiving RP7214 as compared to placebo		15 days
Secondary	Proportion of patients demonstrating symptom improvement		15 days
Secondary	Adverse Events (AEs) as assessed by laboratory tests, vital signs and physical examination.		15 days
Secondary	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