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
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| ClinicalTrials.gov Identifier: NCT05706454 |
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Recruitment Status :
Recruiting
First Posted : January 31, 2023
Last Update Posted : January 31, 2023
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COVID-19 Pneumonia COVID-19 Respiratory Infection | Drug: Ramatroban Drug: Placebo | Phase 2 Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 324 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Randomized, Parallel Group, Placebo Controlled Trial |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | Participant, Investigator and Outcome Assessor Blinded Method of concealment: Pharmacy-controlled Randomization |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | November 10, 2022 |
| Estimated Primary Completion Date : | July 1, 2024 |
| Estimated Study Completion Date : | May 31, 2026 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Ramatroban 75 mg tablet |
Drug: Ramatroban
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. Other Names:
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| Placebo Comparator: Placebo |
Drug: Placebo
Matching placebo will be administered orally twice a day |
- Rate of Serious Adverse Events (SAE) [ Time Frame: Baseline - Day 29 ]
- Time to Clinical recovery (TTCR) [ Time Frame: Baseline - Day 15 ]
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
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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
- 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.
i. 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
Exclusion Criteria:
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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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05706454
| Contact: Jayashri Krishnan, PhD | 9771407484 | Jayashri.krishnan@jssresearch.com | |
| Contact: Sonika Newar, PhD | 8800799887 | Sonika.newar@jssresearch.com |
| India | |
| DEC Health Care | Recruiting |
| Nellore, Andhra Pradesh, India, 524001 | |
| Contact: Manoj Kumar 9700487720 manojkumarmddec@gmail.com | |
| Shakti Superspecialty Hospital | Recruiting |
| Ahmedabad, Gujarat, India, 382405 | |
| Contact: Devendra D Gadhadra 9374643422 gadhadradevendra@gmail.com | |
| Lifecare Hospital | Recruiting |
| Mumbai, Maharashtra, India, 400028, | |
| Contact: Sandeep Gaidhani 7588606598 drsandeepgaidhani@gmail.com | |
| Sangvi Multispecialty Hospital Pvt Ltd | Recruiting |
| Pune, Maharashtra, India, 411027 | |
| Contact: Ketan Kshirsagar 9049002749 drketan.sangavihospital@gmail.com | |
| Saikrupa Hospital | Recruiting |
| Pune, Maharashtra, India, 411033 | |
| Contact: Rahul Sonwane 9420705185 dr.rahulsonawane7@gmail.com | |
| Spandan Hospital | Recruiting |
| Pune, Maharashtra, India, 411033 | |
| Contact: Prakash Shende 9822246881 deprakashshende1979@gmil.com | |
| PDEA'S Ayurved Rugnalaya & Sterling Multispeciality Hospital | Recruiting |
| Pune, Maharashtra, India, 411044 | |
| Contact: Shailesh R Adwani 7776027744 shaileshadwanis@gmail.com | |
| Principal Investigator: | Ajay Gupta, MD | KARE Biosciences | |
| Study Director: | Martin Ogletree, PhD | Points & Assists, LLC. | |
| Study Director: | Deanna J Nelson, PhD | BioLink Life Sciences, Inc. |
| Responsible Party: | KARE Biosciences |
| ClinicalTrials.gov Identifier: | NCT05706454 |
| Other Study ID Numbers: |
RAMBAN-1 |
| First Posted: | January 31, 2023 Key Record Dates |
| Last Update Posted: | January 31, 2023 |
| Last Verified: | January 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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COVID-19 Ramatroban Post-Acute Sequelae SARS-CoV-2 infection (PASC) |
Thromboxane Prostaglandin D2 F2-Isoprostane |
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Infections COVID-19 Pneumonia Respiratory Tract Infections Pneumonia, Viral Virus Diseases Coronavirus Infections |
Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Ramatroban Platelet Aggregation Inhibitors |