CTRI/2021/12/038848招募中2 期
A Phase 2, Randomized, Double blind, Placebo-controlled, Two-arm Study to Evaluate the Efficacy and Safety of Hydroxyprogesterone Caproate Intramuscular Injection Plus Dexamethasone Compared to Dexamethasone Alone in Patients with Moderate COVID-19 disease (Non-intubated, Nonmechanical Ventilation). - NA
试验速览
- 阶段
- 2 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients must meet all inclusion criteria to be eligible for study Participation.
- •1. Willing and able to provide written informed consent, or with alegal representative who can provide informed consent, or
- •enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator prior to performing study procedures
- •2. Male or female patients aged between 45 to 60 years, both
- •inclusive, with gender balance ensured through stratification upon randomization.
- •3. Patient has COVID-19 symptoms less than or equal to 10 days with moderate
- •severity including any of the following consistent with classification of moderate disease severity:
- •O2 saturation (SpO2) 90 percent to less than or equal to93 percent on room air or
- •Respiratory rate greater than or equal to 24 per min, breathlessness
- •4. Patients with score of 5 on WHO ordinal scale for clinical
- •improvement [non-invasive ventilation or high-flow oxygen]
- •Note: Patients admitted with immediate need for mechanical
- •ventilation are of a severity too critical for inclusion into this
- •protocol. Patients who are already in the hospital and have been removed from mechanical ventilation are not eligible.
- •5. Vaccination status for COVID-19 will not influence eligibility for the study.
- •6. Patient laboratory-confirmed COVID-19 infection as determined by PCR or other commercial or public health assay in any specimen, as documented by either of the following:
- •Patient has a SARS-CoV-2 PCR positive sample collected less than 72 hours prior to randomization
- •Patient has a SARS-CoV-2 PCR positive sample collected greater than or equal to72 hours prior to randomization, with a documented inability to obtain a repeat sample (e.g., due to lack of testing supplies, limited testing capacity, results taking greater than24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 pneumonia.
- •7. Patient understands and agrees to comply with planned study procedures.
- •8. Patient agrees to be placed on a prophylactic dose of
- •anticoagulation medication for prevention of deep venous
- •thrombosis (DVT) while hospitalized
- •9. Patients who are women of childbearing potential must have a negative pregnancy test
排除标准
- •Patients will not be eligible for study participation if they meet any of the exclusion criteria.
- •1. Patient has severe COVID-19 infection as per ICMR guideline
- •(Respiratory rate >30/min, breathlessness or SpO2 < 90% on
- •room air). Patients with WHO ordinal scale for clinical
- •improvement severity scores 6 or 7 at baseline will be excluded.
- •2. Patient is currently receiving extracorporeal membrane
- •oxygenation (ECMO), nitric oxide therapy, or high-frequency
- •oscillatory ventilation
- •3. Patient is unlikely to survive for > 24 hours from randomization, in the opinion of the investigator
- •4. Patient has a history of chronic oxygen use or any pre-existing respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization
- •5. Patient has a history of venous thromboembolism (VTE), DVT, or pulmonary embolus
- •6. Patient has a malignancy of any type
- •7. Patient has breast cancer or a history of breast cancer and now cancer free for < 5 years
- •8. Patient has suspected active uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19)
- •9. Patients with any of following laboratory results out of the ranges detailed below at screening should be discussed depending on their medication:
- •Absolute neutrophil count less than or equal to 1.0 Ã?â?? 109/L
- •Platelets < 50 Ã?â?? 109/L
- •Alanine aminotransferase or aspartate aminotransferase > 5 Ã?â?? upper limit of normal
- •10. Patient is sharing a ventilator, or co-ventilating, with any other patient.
- •11. Patient has had treatment with immunomodulators or
- •immunosuppressant drugs, including but not limited to antiinterleukin (IL)-6, IL-6R, IL-1RA, IL-1 Beta within 7 days prior to randomization
- •12. Patient has history of long-term use of antirejection or
- •immunomodulatory drugs
- •13. Patient is pregnant or lactating
- •14. Patient has severe chronic kidney disease greater than or equal to Stage 4 or requiring dialysis
- •15. Patient has a known hypersensitivity to progesterone or DEX
- •16. Patient is taking systemic corticosteroids for an indication other than COVID-19
- •17. Patient has known or active human immunodeficiency virus
- •(HIV)/ acquired immune deficiency syndrome (AIDS) infection
- •18. Patient has known or active tuberculosis (TB) infection or evidence of latent TB
- •19. Patient has known or active hepatitis B or hepatitis C
- •20. History or presence of conditions that may place the patient at increased risk as determined by the investigator.
- •21. Has taken other investigational drugs or participated in any
- •clinical study within 30 days or 5 half-lives (if known) of the
- •investigational drugââ?¬•s PK, PD, or biological activity (if known),
- •whichever is longer, prior to first dose of study drug in this study or is currently participating in another clinical study.
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