SARS-CoV-2 InfectionPhase 2NCT05007236
Study to Evaluate the Efficacy and Safety of Oral RP7214, a DHODH Inhibitor, in Patients With Symptomatic Mild COVID-19 Infection.
A Phase 2 study of SARS-CoV-2 Infection, run by Rhizen Pharmaceuticals SA at 16 sites in India.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2 Infection
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 163 participants
- Where
- 16 sitesIndia
- Study dates
- 20 Sep 2021to 25 Mar 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
India16 sites
Citizen Hospital
Bangalore
Madhu Superspeciality Hospital & Research Center
Bangalore
Rajalakshmi Hospital & Research Center
Bangalore
Panimalar medical college hospital and research institute
Chennai
Maharaja Agrasen Superspeciality Hospital
Jaipur
Nil Ratan Sircar Medical College and Hospital
Kolkata
Malabar Medical College
Kozhikode
BAJ RR Hospital & Research center
Mumbai
DEC Healthcare Hospital
Nellore
Vijaya Super specialty Hospital
Nellore
Jivanrekha Multispeciality Hospital
Pune
PCMC'S PGI Yashwantrao Chavan Memorial Hospital
Pune
Sant Dnyaneshwar Hospital (Accord Multispeciality Hospital)
Pune
Govt General Hospital
Srikakulam
Great Eastern medical school and hospital
Srikakulam
King George Hospital
Visakhapatnam
About this study
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.
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.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- RP7214 + Standard of care (SOC), Placebo + Standard of care (SOC)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| RP7214 + Standard of care (SOC) | Experimental | Not described Receives: Drug: RP7214 + Standard of care (SOC) |
| Placebo + Standard of care (SOC) | Placebo comparator | Not described Receives: Drug: Placebo + Standard of care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients requiring Covid-19 related hospitalization by Day 15.
Measured: 15 days
Secondary outcomes (7)
Change from baseline in SARS-CoV-2 viral load at Days 3, 7 and 15 by quantitative RT-PCR test
Measured: 15 days
Time to symptom resolution in patients receiving RP7214 as compared to placebo
Measured: 15 days
Proportion of patients demonstrating symptom resolution
Measured: 15 days
Time to symptom improvement in patients receiving RP7214 as compared to placebo
Measured: 15 days
Proportion of patients demonstrating symptom improvement
Measured: 15 days
Adverse Events (AEs) as assessed by laboratory tests, vital signs and physical examination.
Measured: 15 days
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.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start20 Sep 2021
- Primary completion25 Mar 2022
- Study completion25 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhizen Pharmaceuticals SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Incozen Therapeutics Pvt Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007236
- Sponsor's protocol ID
- RP7214-2101
- Status last verified
- Apr 2022
- First submitted
- 9 Aug 2021
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05007236
- Acronym / sponsor ID
- RP7214-2101
- Conditions
- SARS-CoV-2 Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Rhizen Pharmaceuticals SAIndustry (pharma, biotech, devices)
- Collaborators
- Incozen Therapeutics Pvt Ltd
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RP7214 + Standard of care (SOC) | Experimental | Drug: RP7214 + Standard of care (SOC) |
| Placebo + Standard of care (SOC) | Placebo comparator | Drug: Placebo + Standard of care (SOC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RP7214 + Standard of care (SOC)RP7214 tablets will be administered orally twice a day for 14 days | Drug | RP7214 + Standard of care (SOC) |
| Placebo + Standard of care (SOC)Placebo will be administered orally twice a for 14 days | Drug | Placebo + Standard of care (SOC) |
Primary outcome
Proportion of patients requiring Covid-19 related hospitalization by Day 15.
Time frame: 15 days
7 secondary outcomes
Change from baseline in SARS-CoV-2 viral load at Days 3, 7 and 15 by quantitative RT-PCR test
Time frame: 15 days
Time to symptom resolution in patients receiving RP7214 as compared to placebo
Time frame: 15 days
Proportion of patients demonstrating symptom resolution
Time frame: 15 days
Time to symptom improvement in patients receiving RP7214 as compared to placebo
Time frame: 15 days
Proportion of patients demonstrating symptom improvement
Time frame: 15 days
Adverse Events (AEs) as assessed by laboratory tests, vital signs and physical examination.
Time frame: 15 days
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of SARS-CoV-2 Infection, run by Rhizen Pharmaceuticals SA at 16 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients requiring Covid-19 related hospitalization by Day 15. (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.