COVID-19 PneumoniaPhase 2/3NCT05706454
Phase 2/Phase 3 Study To Evaluate The Efficacy And Safety Of Ramatroban Along With The Standard Of Care In Subjects Hospitalized For COVID Pneumonia
A Phase 2/3 study testing Ramatroban in people with COVID-19 Pneumonia and COVID-19 Respiratory Infection, run by KARE Biosciences at 7 sites in India.
Trial summary
Phase II/Phase III study to evaluate the safety and efficacy of Ramatroban 75 mg tablet against Placebo in subjects hospitalized for pneumonia due to SARS-CoV-2 infection. Approximately 324 eligible subjects will be randomized in a 1:1 ratio to one of the two treatment groups. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- COVID-19 Pneumonia, COVID-19 Respiratory Infection
- What is being tested?
- Ramatroban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 324 participants
- Where
- 7 sitesIndia
- Study dates
- 10 Nov 2022to 31 May 2026
- Phase
- Phase 2/3
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects of age 18 years and above.
- Subject (or legally authorized representative) willing to provide informed consent and agrees to comply with planned study procedures.
- Subjects hospitalized for SARS-COV-2 infection, having hypoxemia (SpO2: ≤ 93% on room air) and radiological evidence supporting COVID-19 pneumonia.
- Subjects meeting 8-point WHO Ordinal Scale 5 or 6
- Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay in any specimen, as documented by either of the following:
- PCR positive in a sample collected < 72 hours prior to randomization; OR
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- PCR positive in sample collected ≥ 72 hours but < 10 days prior to randomization AND non-improving or progressive disease suggestive of ongoing SARS-CoV-2 infection.
- Note: In case if the subject is not having previous reports, a quantitative analysis will be performed
- Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 36.
- Agrees to not participate in another clinical trial (both pharmacologic and other types of interventions) for the treatment of COVID-19 through-out the study period
Who cannot join
- Subject with immediately life-threatening SARS-CoV-2 infection.
- -Life-threatening disease is defined as respiratory failure, septic shock, and/or multiple organ dysfunction or failure
- Subjects on invasive mechanical ventilation at screening or randomization.
- Female subject who is pregnant, breastfeeding, or planning to become pregnant.
- Subject having other clinically significant gastrointestinal (GI) disease/ GI surgery that in the opinion of the investigator would interfere with the absorption of Ramatroban or subject is unable to swallow oral medications.
- Subject with pre-existing clinically significant spontaneous bleeding abnormality, or any other condition as per investigator's judgment.
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- Known HIV/Hepatitis B or Hepatitis C infection.
- Severe liver disease (ALT, AST >5 times the upper limit of normal, total bilirubin > 2 times the upper limit of normal).
- Subject with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis.
- Subject participated in any other clinical study using any investigational drug in the past 30 days before the screening visit.
- Subject with a history of life-threatening neoplasms within 5 years prior to the screening visit, other than carcinoma in situ of the cervix or basal cell carcinoma of the skin.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
India7 sites, 7 recruiting
- Recruiting
Shakti Superspecialty Hospital
Ahmedabad, Gujarat, 382405
Devendra D Gadhadra, 9374643422, gadhadradevendra@gmail.com
- Recruiting
Lifecare Hospital
Mumbai, Maharashtra, 400028,
Sandeep Gaidhani, 7588606598, drsandeepgaidhani@gmail.com
- Recruiting
DEC Health Care
Nellore, Andhra Pradesh, 524001
Manoj Kumar, 9700487720, manojkumarmddec@gmail.com
- Recruiting
Sangvi Multispecialty Hospital Pvt Ltd
Pune, Maharashtra, 411027
Ketan Kshirsagar, 9049002749, drketan.sangavihospital@gmail.com
- Recruiting
Saikrupa Hospital
Pune, Maharashtra, 411033
Rahul Sonwane, 9420705185, dr.rahulsonawane7@gmail.com
- Recruiting
Spandan Hospital
Pune, Maharashtra, 411033
Prakash Shende, 9822246881, deprakashshende1979@gmil.com
- Recruiting
PDEA'S Ayurved Rugnalaya & Sterling Multispeciality Hospital
Pune, Maharashtra, 411044
Shailesh R Adwani, 7776027744, shaileshadwanis@gmail.com
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multi- Centre, Adaptive Phase 2/Phase 3 Study To Evaluate The Efficacy And Safety Of Ramatroban Along With The Standard Of Care In Subjects Hospitalized For SARS-CoV-2 Infection
Phase II/Phase III study to evaluate the safety and efficacy of Ramatroban 75 mg tablet against Placebo in subjects hospitalized for pneumonia due to SARS-CoV-2 infection.
Approximately 324 eligible subjects will be randomized in a 1:1 ratio to one of the two treatment groups.
Read more
Group I: Ramatroban 75 mg tablet + Standard of care; Group II: Placebo + Standard of care.
Phase 2
Primary Objective:
To evaluate the safety of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.
Secondary Objective:
To assess the efficacy of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.
Phase 3
Primary Objective:
To evaluate the efficacy of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.
Secondary Objective:
To evaluate the safety of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.
Long COVID [Follow-up Phase- Objectives- (Phase 2 \& 3)]
- To examine lipid mediators, specifically thromboxane A2, prostaglandin D2, F2-isoprostane and/or their metabolites in convalescent subjects after treatment.
- To assess the efficacy of Ramatroban administered during the acute illness in preventing/mitigating subsequent development of long COVID / PASC
- Conditions
- COVID-19 Pneumonia, COVID-19 Respiratory Infection
- Being tested
- Ramatroban, Placebo
- Keywords
- COVID-19, Ramatroban, Post-Acute Sequelae SARS-CoV-2 infection (PASC), Thromboxane, Prostaglandin D2, F2-Isoprostane
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamatrobanDrug
Also called BAYu3405, IUPAC Name: 3-[(3R)-3-[(4-fluorophenyl)sulfonylamino]-1,2,3,4-tetrahydrocarbazol-9-yl]propanoic acid
Route of Administration: Oral Dose: 75 mg; Frequency: Twice daily; Total duration of intervention: 28 days.
Subjects will be evaluated over a study period of approximately 365 days.
PlaceboDrug
Matching placebo will be administered orally twice a day
| Study group | Role | What they receive |
|---|---|---|
| Ramatroban 75 mg tablet | Experimental | Not described Receives: Drug: Ramatroban |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Serious Adverse Events (SAE)
Measured: Baseline - Day 29
Time to Clinical recovery (TTCR)
Measured: Baseline - Day 15
Secondary outcomes (12)
Composite endpoint of death or need for mechanical ventilation or ECMO
Measured: Baseline - Day 29
Rate of mechanical ventilation or vasopressor therapy, or ECMO
Measured: Day 29
Ventilator free days
Measured: Baseline-Day 29
Duration of hospitalization
Measured: Baseline-Day 29
Duration of ICU stay
Measured: Baseline-Day 29
Number of subjects who had thrombotic events
Measured: Within Day 29
Mortality rate
Measured: Till Day 29
Change in hemoglobin, platelets, WBC, creatinine, need for renal replacement.
Measured: Baseline- Day 29
Occurrence of serious ventricular arrhythmia
Measured: censored at hospital discharge
Total red blood cell units transfused
Measured: Baseline -Day 29
Major or Clinically Significant Non-Major Bleeding
Measured: Baseline -Day 29
Change from baseline of inflammation and coagulation markers
Measured: Baseline- Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start10 Nov 2022
- Primary completion1 Jul 2024 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Parallel Group, Placebo Controlled Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KARE Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- JSS Medical Research Inc., Biomedical Advanced Research and Development Authority, Coefficient Giving, Charak Laboratories India Pvt. Ltd, Charak Foundation, BioLink Life Sciences, Inc.
- Responsible party
- Sponsor
- Investigators
- Ajay Gupta, MD, Principal investigator, KARE BiosciencesMartin Ogletree, PhD, Study director, Points & Assists, LLC.Deanna J Nelson, PhD, Study director, BioLink Life Sciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706454
- Sponsor's protocol ID
- RAMBAN-1
- Status last verified
- Jan 2023
- First submitted
- 23 Jan 2023
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multi- Centre, Adaptive Phase 2/Phase 3 Study To Evaluate The Efficacy And Safety Of Ramatroban Along With The Standard Of Care In Subjects Hospitalized For SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT05706454
- Acronym / sponsor ID
- RAMBAN-1
- Conditions
- COVID-19 Pneumonia, COVID-19 Respiratory Infection
- Keywords
- COVID-19, Ramatroban, Post-Acute Sequelae SARS-CoV-2 infection (PASC), Thromboxane, Prostaglandin D2, F2-Isoprostane
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- KARE BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- JSS Medical Research Inc., Biomedical Advanced Research and Development Authority, Coefficient Giving, Charak Laboratories India Pvt. Ltd, Charak Foundation, BioLink Life Sciences, Inc.
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 31 Jan 2023 (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.
Phase II/Phase III study to evaluate the safety and efficacy of Ramatroban 75 mg tablet against Placebo in subjects hospitalized for pneumonia due to SARS-CoV-2 infection.
Approximately 324 eligible subjects will be randomized in a 1:1 ratio to one of the two treatment groups.
Group I: Ramatroban 75 mg tablet + Standard of care; Group II: Placebo + Standard of care.
Phase 2
Primary Objective:
To evaluate the safety of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.
Secondary Objective:
To assess the efficacy of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.
Phase 3
Primary Objective:
To evaluate the efficacy of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.
Secondary Objective:
To evaluate the safety of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.
Long COVID [Follow-up Phase- Objectives- (Phase 2 \& 3)]
- To examine lipid mediators, specifically thromboxane A2, prostaglandin D2, F2-isoprostane and/or their metabolites in convalescent subjects after treatment.
- To assess the efficacy of Ramatroban administered during the acute illness in preventing/mitigating subsequent development of long COVID / PASC
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Parallel Group, Placebo Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Ramatroban 75 mg tablet | Experimental | Drug: Ramatroban |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female subjects of age 18 years and above.
- Subject (or legally authorized representative) willing to provide informed consent and agrees to comply with planned study procedures.
- Subjects hospitalized for SARS-COV-2 infection, having hypoxemia (SpO2: ≤ 93% on room air) and radiological evidence supporting COVID-19 pneumonia.
- Subjects meeting 8-point WHO Ordinal Scale 5 or 6
- Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay in any specimen, as documented by either of the following:
Key exclusion criteria (11 listed)
- Subject with immediately life-threatening SARS-CoV-2 infection.
- -Life-threatening disease is defined as respiratory failure, septic shock, and/or multiple organ dysfunction or failure
- Subjects on invasive mechanical ventilation at screening or randomization.
- Female subject who is pregnant, breastfeeding, or planning to become pregnant.
- Subject having other clinically significant gastrointestinal (GI) disease/ GI surgery that in the opinion of the investigator would interfere with the absorption of Ramatroban or subject is unable to swallow oral medications.
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 |
|---|---|---|
| RamatrobanAlso: BAYu3405, IUPAC Name: 3-[(3R)-3-[(4-fluorophenyl)sulfonylamino]-1,2,3,4-tetrahydrocarbazol-9-yl]propanoic acidRoute of Administration: Oral Dose: 75 mg; Frequency: Twice daily; Total duration of intervention: 28 days. Subjects will be evaluated over a study period of approximately 365 days. | Drug | Ramatroban 75 mg tablet |
| PlaceboMatching placebo will be administered orally twice a day | Drug | Placebo |
Primary outcome
Rate of Serious Adverse Events (SAE)
Time frame: Baseline - Day 29
Time to Clinical recovery (TTCR)
Time frame: Baseline - Day 15
12 secondary outcomes
Composite endpoint of death or need for mechanical ventilation or ECMO
Time frame: Baseline - Day 29
Rate of mechanical ventilation or vasopressor therapy, or ECMO
Time frame: Day 29
Ventilator free days
Time frame: Baseline-Day 29
Duration of hospitalization
Time frame: Baseline-Day 29
Duration of ICU stay
Time frame: Baseline-Day 29
Number of subjects who had thrombotic events
Time frame: Within Day 29
Mortality rate
Time frame: Till Day 29
Change in hemoglobin, platelets, WBC, creatinine, need for renal replacement.
Time frame: Baseline- Day 29
Occurrence of serious ventricular arrhythmia
Time frame: censored at hospital discharge
Total red blood cell units transfused
Time frame: Baseline -Day 29
Major or Clinically Significant Non-Major Bleeding
Time frame: Baseline -Day 29
Change from baseline of inflammation and coagulation markers
Time frame: Baseline- Day 29
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
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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.
Ajay Gupta, MD principal investigator
KARE Biosciences
Martin Ogletree, PhD study director
Points & Assists, LLC.
Deanna J Nelson, PhD study director
BioLink Life Sciences, Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ramatroban in people with COVID-19 Pneumonia and COVID-19 Respiratory Infection, run by KARE Biosciences at 7 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: status not confirmed, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jayashri Krishnan, PhD (9771407484, Jayashri.krishnan@jssresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Serious Adverse Events (SAE) (time frame: Baseline - Day 29). The study lists 2 primary outcomes in all. 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 31 Jan 2023.