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OpenTrials
Completed

NCT Number: NCT05007236

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Citizen Hospital, Bangalore, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing and able to provide informed consent.
  • Males and females of ≥ 18 years of age
  • Patient with mild COVID-19 infection having ≥ 1 symptoms.
  • Laboratory confirmed Covid-19 infection by Reverse Transcription Polymerase Chain Reaction (RT-PCR) in nasopharyngeal sample (within 72 hours prior to randomization).
  • Patient should have at least one pre-existing high-risk feature for developing severe Covid-19 illness.
  • Ability to swallow and retain oral medication.
  • Male patient who is surgically sterile, or who is willing to agree to use a contraceptive measure.
  • Women of childbearing potential should be willing to use a medically acceptable method of contraception.
  • Willing to receive telephone calls or have videoconferences with study team personnel.
  • 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

  • Patient with asymptomatic Covid-19 infection.
  • Patient who has experienced the onset of any of Covid-19 symptoms > 5 days at the time of randomization.
  • Moderate to Severe COVID-19 infection
  • Patient with Covid-19 re-infection
  • Subjects who are severely immunocompromised
  • Subjects with autoimmune diseases
  • Patients with any bleeding disorder e.g., hemophilia and von Willebrand disease.
  • Current use of other DHODH inhibitors including teriflunomide or leflunomide.
  • 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.
  • Patients who have had received one or two doses of vaccine for Covid-19.
  • 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

Treatment and study plan

RP7214 + Standard of care (SOC)

Drug

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

Placebo + Standard of care (SOC)

Drug

Placebo will be administered orally twice a for 14 days

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

Sponsors and collaborators

Lead sponsor

Rhizen Pharmaceuticals SA

Industry

Collaborators

  • Incozen Therapeutics Pvt Ltd

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 16, 2021
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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