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

Sponsor
Rhizen Pharmaceuticals SA (Industry)
Overall Status
Completed
CT.gov ID
NCT05007236
Collaborator
Incozen Therapeutics Pvt Ltd (Other)
163
Enrollment
16
Locations
2
Arms
6.1
Actual Duration (Months)
10.2
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: RP7214 + Standard of care (SOC)
  • Drug: Placebo + Standard of care (SOC)
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
163 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Sep 20, 2021
Actual Primary Completion Date :
Mar 25, 2022
Actual Study Completion Date :
Mar 25, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: RP7214 + Standard of care (SOC)

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

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

Outcome Measures

Primary Outcome Measures

  1. Proportion of patients requiring Covid-19 related hospitalization by Day 15. [15 days]

Secondary Outcome Measures

  1. Change from baseline in SARS-CoV-2 viral load at Days 3, 7 and 15 by quantitative RT-PCR test [15 days]

  2. Time to symptom resolution in patients receiving RP7214 as compared to placebo [15 days]

  3. Proportion of patients demonstrating symptom resolution [15 days]

  4. Time to symptom improvement in patients receiving RP7214 as compared to placebo [15 days]

  5. Proportion of patients demonstrating symptom improvement [15 days]

  6. Adverse Events (AEs) as assessed by laboratory tests, vital signs and physical examination. [15 days]

  7. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Citizen Hospital Bangalore India
2 Madhu Superspeciality Hospital & Research Center Bangalore India
3 Rajalakshmi Hospital & Research Center Bangalore India
4 Panimalar medical college hospital and research institute Chennai India
5 Maharaja Agrasen Superspeciality Hospital Jaipur India
6 Nil Ratan Sircar Medical College and Hospital Kolkata India
7 Malabar Medical College Kozhikode India
8 BAJ RR Hospital & Research center Mumbai India
9 DEC Healthcare Hospital Nellore India
10 Vijaya Super specialty Hospital Nellore India
11 Jivanrekha Multispeciality Hospital Pune India
12 PCMC'S PGI Yashwantrao Chavan Memorial Hospital Pune India
13 Sant Dnyaneshwar Hospital (Accord Multispeciality Hospital) Pune India
14 Govt General Hospital Srikakulam India
15 Great Eastern medical school and hospital Srikakulam India
16 King George Hospital Visakhapatnam India

Sponsors and Collaborators

  • Rhizen Pharmaceuticals SA
  • Incozen Therapeutics Pvt Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rhizen Pharmaceuticals SA
ClinicalTrials.gov Identifier:
NCT05007236
Other Study ID Numbers:
  • RP7214-2101
First Posted:
Aug 16, 2021
Last Update Posted:
Apr 21, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infections
Communicable Diseases
COVID-19

Study Results

No Results Posted as of Apr 21, 2022