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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05007236
Other study ID # RP7214-2101
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
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