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CompletedNCT05007236Updated Apr 21, 2022

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

A Phase 2 interventional study of RP7214 + Standard of care (SOC) and Placebo + Standard of care (SOC) in SARS-CoV-2 Infection, sponsored by Rhizen Pharmaceuticals SA. Completed at 16 sites in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-21.

Sponsored by Rhizen Pharmaceuticals SA · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
163
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 163 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Rhizen Pharmaceuticals SA is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
163 participants (actual)

Study arms

  • Experimental
    RP7214 + Standard of care (SOC)

    Drug: RP7214 + Standard of care (SOC)

  • Placebo comparator
    Placebo + Standard of care (SOC)

    Drug: Placebo + Standard of care (SOC)

Interventions

  • DrugRP7214 + Standard of care (SOC)

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

  • DrugPlacebo + Standard of care (SOC)

    Placebo will be administered orally twice a for 14 days

06

What researchers measure

Primary outcomes

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

    Time frame: 15 days

Secondary outcomes

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

    Time frame: 15 days

  2. Time to symptom resolution in patients receiving RP7214 as compared to placebo

    Time frame: 15 days

  3. Proportion of patients demonstrating symptom resolution

    Time frame: 15 days

  4. Time to symptom improvement in patients receiving RP7214 as compared to placebo

    Time frame: 15 days

  5. Proportion of patients demonstrating symptom improvement

    Time frame: 15 days

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

    Time frame: 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.

    Time frame: 15 days

07

Study locations

16 sites
  • 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05007236
Lead sponsor
Rhizen Pharmaceuticals SA
Collaborators
Incozen Therapeutics Pvt Ltd
Responsible party
Sponsor
First posted
Aug 16, 2021
Start date
Sep 20, 2021
Primary completion
Mar 25, 2022
Completion
Mar 25, 2022
Last update
Apr 21, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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